Guru Focus: Idenix Pharmaceuticals Lagging Behind In Breakthrough Hepatitis C Drug Development

Posted on 7/13/12 on www.gurufocus.com. The author is worried about Idenix's pan-genotype nuc, IDX184. I'm not as worried, but Idenix definitely needs other drugs beside it's own to pair IDX184 with - preferably those well into Phase IIb or Phase III studies.  Those are drugs that are most likely to make it to market first, barring any errant new safety signals that would gum up the works and put pinholes in the dreams of investors everywhere. A good example to follow is Medivr/Janssen's protease inhibitor TMC435. That partnership has done an outstanding job of partnering with every company with a drug that looks hopeful, expanding their status as the 'preferred partner' drug in every combination that looks effective and safe.  On the other hand, we've learned in HIV that a good, potent, well-tolerated nuc (preferably ones with a unique resistance profile) will always come in handy. A good drug never has to worry. Only the company developing it does. 

Idenix Pharmaceuticals Lagging Behind In Breakthrough Hepatitis C Drug Development
July 13, 2012

Idenix Pharmaceuticals (IDIX) is one of the biopharmaceutical companies focused on discovering, developing and commercializing drugs for the treatment of life-threatening human viral diseases such as Hepatitis C. Hepatitis C is a form of liver disease that is passed on from one person to another through contact of bodily fluids. The Hepatitis C virus can severely damage the liver as it is asymptomatic and therefore, the effects are slowly felt over a long period of time. Hepatitis C has the potential to kill if not detected early enough.

It is estimated that 75% to 85% of Hepatitis C infections become chronic, leading to serious liver disease such as cirrhosis and may even causing liver cancer. Researchers at the Centers for Disease Control and Prevention estimate that about 50% of the 3.2 million Americans who have chronic Hepatitis C do not know about it. This is frightening to say the least, given that Hepatitis C is now estimated to be killing more Americans than HIV, the virus that causes AIDS. The Hepatitis C virus has also been found to be more prevalent in the "baby boomer" generation born between 1945 and 1964. This was a time when casual sharing of needles and drug use was the norm. I was floored to discover that the current worldwide figure of persons considered to be living with chronic viral hepatitis stands at between 480 million and 540 million, with approximately 130 million to 170 million of them infected with the Hepatitis C virus.

IDX184 is a pan-genotypic oral nucleotide polymerase inhibitor and Idenix Pharmaceutical’s lead product for the treatment of Hepatitis C. It is Idenix’s belief that the Hepatitis C treatment paradigm will evolve rapidly within the next three to five years as various companies continue to develop direct-acting antivirals (DAAs) from different drug classes. The treatments would potentially reduce the duration of treatment from one year to six months or less, increase the sustained virologic response rates and improve drug tolerability. It would also be extremely convenient as patients would be able to take all the drugs orally. I believe this is significant as the side effects associated with the combination of Interferon and Ribaravin during treatment disqualify many Hepatitis C-infected candidates from undergoing the treatment. Therefore, a breakthrough in this area would be a huge stride for Idenix and has the potential to affect its share price positively. Idenix Pharmaceuticals has also co-developed a Hepatitis B drug candidate, telbivudine, with Norvatis Pharma AG (NVS). The product is commercially sold as Tyzeka®, and Idenix Pharmaceuticals earns royalties from the product sales.

Idenix Pharmaceuticals stock began trading on July 2004 with an initial public offering of 5.8 million shares at $14 per share. On 23 April, 2012 Idenix Pharmaceuticals gained 6.5% to even out at slightly below $9. Earlier in March 2012 the share price had traded at an average of $12. Idenix Pharmaceuticals released its fourth quarter and financial results for the year ending Dec. 31, 2011 in February. Its total revenue was $7 million compared to 10.2 million in the year ending Dec. 31, 2010. The company recorded a net loss of $52 million on Dec. 31, 2011 as compared to $61.6 million on Dec. 31, 2010. The share price seems to fluctuate a lot so if you’re looking to trade in stock it is probably advisable to consider day-trading or swing-trading as compared to making a long-term investment.

Another competitor, Gilead Sciences (GILD) made astronomical progress in April 2012, when a mid-stage clinical trial revealed that a combination of the GS-7977 drug and the antiviral Ribaravin cleared the virus in approximately 88% of the patients. The GS-7977 drug was administered together with Ribaravin, completely eliminating the need for the injectable interferon. Gilead Sciences is the world’s largest HIV drug maker, so this news comes as no surprise.

Gilead’s shares have evened out at an average of $51 after they jumped from about $47 to an average of $53. These developments have clearly placed Gilead Sciences ahead of the pack, and I would not hesitate to recommend trading its shares.

Vertex Pharmaceuticals (VRTX) is also in the process of carrying out a study to evaluate the effectiveness of a Hepatitis C treatment on patients who are not on antiretroviral therapy for HIV versus those who are on a Atripla- or Reyataz-based treatment for HIV. Vertex Pharmaceuticals is carrying out the study in collaboration with Janssen, one of Johnson & Johnson (JNJ)'s pharmaceutical companies. The study is intended to evaluate the safety and tolerability of the Incivek drug combination therapy in patients infected with both the Hepatitis C virus and HIV. The drug is marketed in the U.S. and Canada and is also available in the Far East and Japan.

Vertex Pharmaceuticals stock is trading at an average of $37. January 2012 was a terrible month for Vertex with their share price dipping to $34 after an analyst at Leerink Swann reduced the sales forecast for Incivek from $2.3 billion to $1.5 billion this year, citing recent developments of interferon-free regimens and the possibility of more aggressive developments. There is a great need for Hepatitis C treatment and more so amongst those infected with HIV. If Vertex Pharmaceuticals manages to develop a drug that can be safely used to treat those co-infected with Hepatitis C and HIV then it is safe to say that it will be worth your while to invest in Vertex Pharmaceuticals.

Victrelis, a product of Merck & Co. (MRK), was approved for the U.S. market by the Food and Drug Administration just last year for the treatment of Hepatitis C. It is surprising therefore when I learned from my research that the drug’s effectiveness is lowered when used in combination with some antiretroviral therapy drugs. It’s not all bad news though. Merck recently agreed to pay Endocyte (ECYT) up to $1 billion to develop and commercially market Vintafolide, an experimental cancer drug. Merck will own all the global rights meaning that a surge in sales will push its share price upwards. Merck is currently trading at an average of $28 and its future outlook does not look very promising at the moment.

Abbot Laboratories (ABT)'s main line of business is in the discovery, development, manufacture and sale of a wide range of health care products. Abbot Laboratories released data earlier in April 2012 from a mid-stage clinical trial that indicated combining ABT-450 boosted by an antiviral, Ritonavir, along with Ribaravin and a polymerase inhibitor achieved a 95% cure rate. Deutsche Bank consequently boosted Abbot Laboratories rating to “Buy” in March 2012 with a price target of $70. The share price is currently trading at slightly under $60. I’d say this is pretty close to what analysts at Deutsche Bank projected. Abbot Laboratories is in the process of separating into two healthcare companies by the end of the year, so it is advisable to carry out day trading and keep a close eye on the share price.

FDA advisory panel gives Truvada HIV prophylaxis a thumbs up...

Posted on 5/8 on Bloomberg.com . Yeah, I know it's not HCV-related, but Truvada is such a triumph of antiviral drug marketing that anything related to it draws me in like a moth to a flame. Gilead's launch and subsequent marketing and promotion of Truvada should be a mandatory case study in any business school worth it's salt. That it got before an FDA advisory panel on a possible indication for HIV prophylaxis is stunning. The fact that the panel gave it a thumbs up knocked me off my chair, over my desk and into the hallway.  Kudos to Gilead. I'll set aside my own reservations on Truvada prophylaxis - misuse leading to possible resistance, kidney toxicity in those predisposed to such and/or a precipitous drop in condom use  - to slap the Gilead marketing machine on the back and buy them whatever's on tap. Truly amazing. Now we'll see if the FDA follows the panels recommendations and see if it actually gets approved and on the market. 

Gilead’s Truvada Pill Is Safe for HIV Prevention
By Ryan Flinn and Shannon Pettypiece - May 8, 2012 6:45 PM PT

Gilead Sciences Inc. (GILD)’s pill Truvada was safe and effective when used to protect uninfected people from getting HIV, U.S. regulators said in a report indicating the main concerns are when and how it should be used.

Truvada was “well tolerated” and its ability to reduce the risk of infection was backed by two studies, the Food and Drug Administration staff said in a report today. Gilead, based in Foster City, California, is seeking to sell the drug as the first pill to keep people from becoming infected.

The FDA asked its advisers to suggest who should get Truvada; what testing would be needed for administration; and what educational material should be used for patients and doctors. The advisers will meet May 10 to discuss the drug, the subject of debates over its appropriate use and cost.

Decisions to prescribe Truvada “should carefully weigh the individual risks for acquiring HIV, their understanding of the importance of adherence to medication, and their potential for development of renal toxicity,” the FDA staff said today in a report on the agency’s website. Education and counseling will be “critically important.”

Gilead fell less than 1 percent to $49.46 at the close of New York trading. The FDA isn’t required to follow what the advisory panel suggests.

Not Expected
Investors aren’t counting on expanded use of Truvada to boost sales much, said Robyn Karnauskas, an analyst with Deutsche Bank in New York. Instead, they are focused on Gilead getting new products to market before facing the loss of half of its revenue from patent expirations beginning in 2018.

“Right now, the company is in a position where they have flat sales and Truvada isn’t going to fix the patent cliff problem,” Karnauskas said.
Truvada sales for prevention are estimated to peak at about $150 million a year, said Tony Butler, an analyst with Barclays Capital in New York. Insurance reimbursement may be a challenge, he said.

Debate over the appropriate use of the drug has divided the AIDS community. Some AIDS advocacy groups say the drug will be a valuable tool for reducing new cases, particularly within stable partnerships where one person has AIDS and the other doesn’t. Others said it may lead to more infections, lower condom use and might build resistance to the medicine.

The population at high risk for contracting the disease includes at least 140,000 individuals whose spouses or partners have the disease, as well as 275,000 gay men who had more than two partners in the past year and didn’t wear condoms during sex, according to the U.S. Centers for Disease Control and Prevention, based in Atlanta.

Three Decades
“Thirty years into the epidemic we can’t dismiss any new options,” James Loduca, a spokesman for the San Francisco AIDS Foundation, said in an interview. “This won’t end AIDS by itself, but we can’t end it without this.”

Loduca said condoms aren’t enough to stem the tide of new infections, and using Truvada as a preventative measure would help if taken correctly.
While the number of people infected with HIV rose to 34 million worldwide in 2009, the virus that leads to AIDS, once a death sentence, can be reduced to low levels in the blood with use of combination antiviral medicines such as Truvada.

Michael Weinstein, president of the AIDS Healthcare Foundation, said approval and prescription of Truvada as a preventative may lead to less condom use and more infections, as well as increased resistance to the drug.

Really Paranoid
“Why would you take this medication if you intended to use condoms?” he said. “You’ve got to be really paranoid about your pants falling down to wear a belt and suspenders.”

His organization sued the FDA last year after the agency rejected its Freedom of Information act request for correspondence between regulators and Gilead. Weinstein said the studies don’t prove that the pill is effective enough to warrant approval. The AIDS Healthcare Foundation has lined up speakers for the public hearing later this week to oppose its preventative use, Weinstein said.

Barry Zingman, medical director at the AIDS Center at Montefiore hospital in the Bronx, one of the largest treatment centers in New York, said he hopes the drug is approved and plans to offer it to some patients.

$11,000 Cost
He said his big concern is the drug’s more than $11,000 a year price tag.

“People are really interested in the concept, but there have been issue related to insurance coverage,” Zingman said. “Approval would make a significant advance in insurance coverage.”

Aetna Inc. spokeswoman Tammy Arnold and WellPoint Inc. spokeswoman Lori McLaughlin said their companies would consider covering the treatment as a form of prophylaxis if approved by the FDA. UnitedHealth Group Inc. declined to comment.

Medicare, the federal program for the elderly and disabled, and Medicaid, the joint state-federal plan for the poor, typically reimburse for all FDA-approved indications.

If approved, the drug would mostly be given to people at high risk for infection, like men who have sex with men, intravenous drug users and sex workers, said Ken Mayer, medical research director at the Fenway Institute, the largest AIDS treatment center in New England. It would typically be given for a limited period of time, he said.

“I think it would be a mistake for the FDA not to approve this indication,” Mayer said. “If we can figure out how to use this most effectively we can really put a dent in the number of new infections.”

In a study of men who have sex with men, the drug reduced the risk of infection by 42 percent, though adherence in the trail was low, the agency said. In a study of heterosexual couples where one person was infected, the risk was reduced by 75 percent.

To contact the reporters on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net; Shannon Pettypiece in New York at spettypiece@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

NPR: The Race To Create The Best Antiviral Drugs

Radio interview and article with noted viral expert Carl Zimmer posted on NPR.org on 4/17/12.  Not specifically related to just HCV, it gives us a broad overview of some of the science behind creating new therapies to treat a variety of viral-related diseases. Very compelling, in my opinion. 

The Race To Create The Best Antiviral Drugs

If you've ever had a bacterial infection like staph or strep throat, your doctor may have prescribed penicillin. But if you've had the flu or a common cold virus, penicillin won't work. That's because antibacterials only kill bacteria, and both the flu and the common cold are viruses. So for illnesses like the flu, doctors prescribe antiviral drugs, which target the mechanisms that viruses use to reproduce.

"For example, there are antivirals for the flu that interfere with the virus as it tries to get out of its host cell," says science writer Carl Zimmer. "So this molecule latches on to that particular protein that the virus uses to escape, and interferes with it so that the virus is trapped inside."

Zimmer's latest piece for Wired magazine profiles the scientists who are developing antiviral medications, and examines the new ways medicine is working to attack viruses.

"There are some really amazing antivirals that have been invented over the last 40 years," he says. "There are antivirals for herpes. There are antivirals for HIV. ... Now, if you were to get Ebola and you tried to take HIV drugs, they'd do you no good at all because that HIV drug only works for HIV. It's a narrow-spectrum drug, and really, there are no broad-spectrum antivirals, at this point."

But scientists are now working to create a "penicillin-like" drug that will target viruses more broadly. In San Francisco, a company called Prosetta is working on a drug that doesn't affect a virus directly. Instead, it works by affecting the proteins that are naturally in cells that help viruses replicate.

"The basic idea behind it is that viruses need help to build themselves," says Zimmer. "What happens is quite amazing: [Viruses] get lots of different proteins in our cells and cooperate to push their own proteins into place. And so the viruses need these groups of host proteins to form."

Prosetta created a drug that prevents the host proteins from performing their cooperative jobs and helping the viruses out. Preliminary studies have shown that targeting these host proteins — and not the virus itself — can stop Ebola, influenza, rabies and other viruses.

Other researchers are working to replace or help interferons, our body's own natural virus-fighting system. Eleanor Fish, a researcher at the University of Toronto, is heading a project to create synthetic interferon, in order to accelerate the body's virus-fighting response.

"Today, people with Hepatitis C can get interferon treatment, but it doesn't work all that well. It has some benefit, but not as much as Eleanor Fish would like," says Zimmer. "So she has been essentially tweaking the interferon molecule to make it more effective, to make it last longer, to make it safe and to make it cheap. Because what she wants to do is deploy interferon all over the world where there isn't fancy refrigeration. She wants to help people who are dealing with viruses in very remote places."

A third approach, says Zimmer, involves creating an artificial protein that would latch onto viruses and then instruct them to literally self-destruct. Spearheaded by Todd Rider at MIT, the project has been tested in cells and in mice.

"Rider's basically hot-wiring your cells so that as soon as they get infected by a virus, that trips a switch," says Zimmer. "This doesn't exist naturally, but if you were to take a pill, the thinking is, then this molecule would go into your infected cells, and as soon as it detected the virus, it would kill the infected cell, and you would recover from your disease."

But successfully eradicating viruses may bring a host of other problems, says Zimmer. He points to broad-spectrum antibiotics, which wipe out good bacteria in addition to bad bacteria.

"Eventually your body may recover, and it can take awhile, and there may be some bad consequences of the antibiotics themselves," he says. "So it's going to be interesting to see what happens in the future if we are, in fact, knocking out lots of viruses. Because we don't understand the full ecology of the viruses that get into our bodies."

There are trillions of viruses that live in our bodies, even when we're not sick, says Zimmer.

"Some are harmful, some may not be harmful," he says. "Some may even help us defend against other viruses. It's very complicated in there, and we don't really understand it very well yet."

hysicians are now using bacteria to combat other diseases. Zimmer points to an example of a patient infected with the Clostridium difficile bacteria, which causes severe diarrhea and can frequently return, even when treated with antibiotics. The patient was treated with a transfusion of gut microbials from a healthy individual's fecal material to restore the bacterial flora in her intestinal tract.

"Literally two days later she started feeling better, and a couple weeks later, when they went to sample the bacteria that was there, they couldn't find the C. difficile anymore. It was just gone," he says. "The only thing they had done was essentially restore her ecology, essentially like restoring a wetland."

Zimmer says fecal transplants have only been performed on patients when all other options fail — but they are seemingly quite effective.

"The problem is, as some other journalists have reported, is that the FDA has a very difficult time figuring out how to come up with regulations for this," he says. "Before it's going to become a widespread practice, the FDA is going to have to move beyond its old paradigm of giving people regular drugs to being able to give people tailored concoctions of living things — of bacteria, of maybe even viruses — as medical treatments."

These bacteria and viruses work in conjunction with other bacteria and viruses in the body, but scientists still know very little about their mechanisms, says Zimmer.

"There's this whole ecosystem of interactions going on inside our own bodies that we do not understand — barely at all," he says. "Scientists are just starting to figure it out with very big projects where they're sequencing all the genes these microbes have. But they're just at the beginning of understanding it."

The emerging role of the Infectious Disease physician in treating HCV...

An article published in POZ magazine on 4/13/12 on an opinion piece e-published ahead of print in   'Clinical Infectious Diseases' authored by Barbara McGovern, MD of Tufts University School of Medicine.  She makes a plea for Infectious Disease doctors to start treating Hepatitis C and relieve some of the burden on the thin and overworked ranks of Hepatologists.  She suggests 'establishing "centers of excellence" and instituting joint fellowships wherein HCV experts can pass their knowledge along to ID physicians; presenting conferences and workshops devoted to HCV evaluation and management; collecting data from the membership of the Infectious Diseases Society of America (IDSA) on obstacles to hepatitis C patient care; and offering real-time updates to HCV treatment guidelines.'  It's my opinion that IDs offer the perfect discipline for treating HCV and HCV/HIV co-infection as newer, all-oral, interferon-free regimens greatly expand the the pool of patients elgible (and willing) to be treated.  IDs have treated HIV for years - a disease state whose early treatment years display some uncanny parallels to the genesis of Direct Acting Antiviral therapy for Hepatitis C. The IDs know virology, they understand the implications for viral resistance, the concept of 'drug cocktails' which attack the virus at different points along it's life cycle, they know about side effect management, and most of all, their economic model is strikingly similar to that of the in-the-trenches Hepatologist.  It seems like a good fit from out here looking in. 

April 13, 2012

More Infectious Disease Docs Treat Hep C

We may soon see an end to obstacles in the care of people living with chronic hepatitis C virus (HCV)—but only if infectious disease (ID) doctors work with and learn from hepatologists, according to an opinion piece authored by Barbara McGovern, MD, of Tufts University School of Medicine and published online ahead of print by Clinical Infectious Diseases.

ID specialists have historically been reluctant to treat hepatitis C, even among their own patients living with HIV, because of the complexities of prognostic testing and combination treatment, low cure rates among people with genotype 1 HCV and the need for expert management of side effects.

HCV coinfection is more amenable to treatment now than in the past—including for those coinfected with both HIV and HCV—with the current generation of direct antiviral agents providing a 75 to 85 percent cure rate.

Further improvements—such as all-oral regimens that don't involve interferon—are expected within the next few years and will likely benefit both HCV-monoinfected and HIV/HCV-coinfected patients. This would be a great boon for all people living with HCV, for whom treatment can lead to remission of liver disease and reduced risk of liver cancer and cirrhosis.

With an estimated 170 million HCV cases worldwide—including 5 million in the United States, where hepatitis C death rates now exceed those from HIV—hepatologists, the usual go-to medical experts for hepatitis C care and management, are overwhelmed by the number of patients seeking their services. Their efforts will be stretched even thinner if the Centers for Disease Control and Prevention (CDC) implements planned screening guidelines that recommend testing everyone born between 1945 and 1965—an age range with an especially high HCV prevalence.

Bringing more people into care for hepatitis C, McGovern argues, will require expanding the ranks of ID specialists capable of dealing with the virus and its complications.

One reason HCV care has required highly specialized attention from hepatologists was the need for a liver biopsy to measure the progress of the disease. This may no longer be necessary, thanks to noninvasive testing via such methods as blood tests and elastography (measurement of tissue stiffness via ultrasound or magnetic resonance), which can be performed by ID specialists.

Another main reason why hepatologists have been needed for HCV therapy is the risk of decompensated cirrhosis—when a cirrhotic liver begins to lose its ability to function—for patients who don't receive antiviral therapy or whose therapy fails. Managing the complications of decompensated cirrhosis requires a hepatologist's specialized training. However, early HCV treatment greatly decreases the risks of cirrhosis.

Lastly, modern combo therapies for HCV require extensive knowledge of the relevant antiviral drugs and their interactions.

McGovern recommends sidestepping this dearth of hepatologists by cross-training ID specialists in the intricacies of HCV infection. Her recommendations include establishing "centers of excellence" and instituting joint fellowships wherein HCV experts can pass their knowledge along to ID physicians; presenting conferences and workshops devoted to HCV evaluation and management; collecting data from the membership of the Infectious Diseases Society of America (IDSA) on obstacles to hepatitis C patient care; and offering real-time updates to HCV treatment guidelines.

"Although HCV does not command the same media attention as for some emerging infectious diseases," McGovern wrote, "advancing liver disease will be exacting a tremendous toll in morbidity and mortality in the decades to come if wider access to treatment is not realized in the near future. In fact, in 2007, deaths from HCV infection exceeded deaths from HIV in the United States. Millions of HCV-infected patients will be depending on an expeditious response from the ID community, as we have done for many other infections in the past."

Open Invitation to the 2nd World Congress on Virology...

Click here for full information.


2nd World Congress on Virology is expected to bring the elite class of virologists and potential vaccine developers to share their eminent thoughts and experiences. Be there to witness some of the breakthroughs in field of virology.

At the successful meet of 1st International conference where researchers and developers converged to deliver their ideas and shared their experiences and breakthroughs. This event offered a platform to share technological advances and collaborations from different disciplines of virology, advances in public healthcare and for the socio economical development of society.

Virology-2012 highlights the following topics:

•  HIV Research • Agriculture Virology
•  Epidemic studies • Animal Virology
•  Influenza Viruses • Drug discovery program
•  Hepatitis Research • Anti Viral and Retro-viral drugs and therapy
•  Tumor Virology • Anti Viral Vaccine development

To Collaborate Scientific Professionals around the World

Dates of the Conference: 20-22 August 2012
Venue of the Conference: Renaissance Las Vegas Hotel, USA
Theme: Innovations and Therapeutic approaches in Virology

Merck posts 'Dear Doctor' letter regarding use of Victrelis with boosted HIV protease inhibitors...

Thank you NATAP.org. DHCP letter that came out today (Feb 6th, 2012) regarding drug-drug interactions with Boceprevir and ritonovir-boosted PIs. In short. "Merck does not recommend the coadministration of VICTRELIS and ritonavir-boosted HIV protease inhibitors." 



S. Sethu K. Reddy, MD Merck & Co., Inc.


Vice President PO Box 250

US Medical Affairs West Point, PA 19486-0250


February 6, 2012

IMPORTANT DRUG WARNING

SUBJECT: Results of Pharmacokinetic Study in Healthy Volunteers Given VICTRELIS™

(boceprevir) and Ritonavir-Boosted HIV Protease Inhibitors May Indicate Clinically Significant Drug

Interactions for Patients Coinfected with Chronic Hepatitis C and HIV


Dear Health Care Professional,

The purpose of this communication is to inform you of recent pharmacokinetic study results evaluating drug

interactions between VICTRELIS, an oral chronic hepatitis C virus (HCV) NS3/4A protease inhibitor, and

ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors in healthy volunteers (n=39).

VICTRELIS is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in

combination with peginterferon alfa and ribavirin (PR), in adult patients (18 years and older) with

compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous

interferon and ribavirin therapy. In the pharmacokinetic study, concomitant administration of VICTRELIS

with Norvir® (ritonavir) in combination with Reyataz® (atazanavir) or Prezista® (darunavir), or with Kaletra®

(lopinavir/ritonavir) resulted in reduced exposures of the HIV medicines and VICTRELIS. Specifically,

VICTRELIS reduced mean trough concentrations of ritonavir-boosted atazanavir, lopinavir, and darunavir

by 49%, 43%, and 59%, respectively. Mean reductions of 34% to 44% and 25% to 36% were observed in

AUC and Cmax of atazanavir, lopinavir, and darunavir. Coadministration of ritonavir-boosted atazanavir with

VICTRELIS did not alter the exposure of VICTRELIS, but coadministration of VICTRELIS with

lopinavir/ritonavir or ritonavir-boosted darunavir decreased the exposure of VICTRELIS by 45% and 32%,

respectively.

These drug interactions may be clinically significant for patients infected with both chronic HCV and HIV by

potentially reducing the effectiveness of these medicines when coadministered. VICTRELIS is not indicated

for use in patients who are infected with both HIV-1 and chronic HCV. The safety and efficacy of

VICTRELIS™ (boceprevir) has not been established in this coinfected population. Merck does not

recommend the coadministration of VICTRELIS and ritonavir-boosted HIV protease inhibitors.

Health care providers who might have initiated VICTRELIS in combination with PR in HIV-HCV coinfected

patients on fully suppressive antiretroviral therapy containing a ritonavir-boosted protease inhibitor should

discuss these findings with those patients, and closely monitor those patients for HCV treatment response

and for potential HCV and HIV virologic rebound.

Patients should be advised to contact their health care provider before stopping any of their

medications.

Merck is sharing these pharmacokinetic data with regulatory authorities in the countries where VICTRELIS

is approved. Merck will be submitting requests to regulators to update the product labeling with these data.

These data have been submitted for scientific presentation at an upcoming medical forum.

For more information, please consult the enclosed Prescribing Information for VICTRELIS. The Prescribing

Information can also be found at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf.

Should you have any questions, require further information on product safety, or wish to report an adverse

event with VICTRELIS, please contact Merck at 1-877-888-4231. Alternatively, an adverse event can be

reported directly to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Sincerely,

S. Sethu K. Reddy, MD

Enclosure: Prescribing Information for VICTRELIS

- 3 -

Indications and Usage for VICTRELISTM (boceprevir)

VICTRELIS was approved by the US Food and Drug Administration (FDA) on May 13, 2011 for the

treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon

alfa and ribavirin (PR), in adult patients (18 years and older) with compensated liver disease, including

cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

The following points should be considered when initiating VICTRELIS for treatment of chronic HCV

infection:

• VICTRELIS must not be used as monotherapy and should only be used in combination with PR.

• VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment

regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.

• VICTRELIS in combination with PR has not been studied in patients documented to be historical null

responders (<2-log10 HCV-RNA decline by Treatment Week 12) during prior therapy with PR. The clinical

studies included subjects who were poorly interferon responsive. Subjects with <0.5-log10 HCV-RNA

decline in viral load at Treatment Week 4 with PR alone are predicted to have a null response (<2-log10

viral load decline at Treatment Week 12) to PR therapy.

• Poorly interferon responsive patients who were treated with VICTRELIS in combination with PR have a

lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of

resistance-associated substitutions upon treatment failure, compared to patients with a greater response

to PR.

Selected Safety Information for VICTRELIS

All contraindications to PR also apply since VICTRELIS must be administered with PR.

Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with PR is

contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in

female patients and female partners of male patients. Patients must have a negative pregnancy test prior to

therapy; have monthly pregnancy tests; and use 2 or more forms of effective contraception, including

intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has

concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS

and concomitant ribavirin.

VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for

clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening

events. VICTRELIS is also contraindicated in coadministration with potent CYP3A4/5 inducers, where

significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy.

Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital,

phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John’s

Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca®

(tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally

administered midazolam.

- 4 -

Anemia and/or Neutropenia – The addition of VICTRELIS™ (boceprevir) to PR is associated with an

additional decrease in hemoglobin concentrations compared with PR alone and/or may result in worsening

of neutropenia associated with PR therapy alone. Dose reduction or discontinuation of peginterferon alfa

and/or ribavirin may be required. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not

be administered in the absence of PR.

Complete blood count (with white blood cell differential counts) must be conducted in all patients prior to

initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at Treatment

Weeks 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate.

The most commonly reported adverse reactions (>35%) in clinical trials in adult patients receiving the

combination of VICTRELIS with PR were: fatigue, anemia, nausea, headache, and dysgeusia. Of these

commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates ≥5%

above the rates for PR alone in either clinical study. The incidence of these adverse reactions in previously

untreated subjects that were treated with combination therapy with VICTRELIS compared with PR alone

were: fatigue (58% vs 59%), anemia (50% vs 30%), nausea (46% vs 42%), and dysgeusia (35% vs 16%),

respectively. The incidence of these adverse reactions in previous treatment failure patients that were

treated with combination therapy with VICTRELIS compared with PR alone were: fatigue (55% vs 50%),

anemia (45% vs 20%), nausea (43% vs 38%), and dysgeusia (44% vs 11%), respectively.

VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for

drug-drug interactions must be considered prior to and during therapy.

Celgene buys it's way into a feverish Hepatitis C market...

An article from Investor's Business Daily on recent biotech mergers, including Celgene's recent purchase of Avila Therapeutics, which may also put Celgene in the HCV DAA marketplace. I need a scorecard to keep up!

Gilead, Celgene Join Big Pharma On M&A Front
 By MARILYN ALVA, INVESTOR'S BUSINESS DAILY Posted 01/27/2012 02:19 PM ET

The biotech industry is gripped with acquisition fever.

Celgene (CELG) was the latest to catch the fever, announcing Thursday it would buy privately held Avila Therapeutics for $350 million.

The move expands Celgene's market-leading blood cancer arsenal, which includes top-gun Revlimid, by adding Avila's experimental drug therapy known as AVL-292, now in clinical development.

Gene mapping is making drug development more precise, targeting patients with certain genetic markers.
Avila also brings Celgene into the hot hepatitis C treatment arena with drugs called protease inhibitors now in preclinical development.

Biotech firms are racing to bring new hepatitis C drugs to market to replace the current regimen of virus-fighting cocktails, including injectable interferon, which often has crippling side effects.

The Celgene/Avila deal is small potatoes compared with HIV-focused Gilead Sciences' (GILD) recent acquisition of Pharmasset.

Gilead paid $11.2 billion, a huge premium, to get its hands on the company's hepatitis C drugs still in development.

The deal was unusual not only for its size, but also for the type of outfit doing the buying: another biotech firm.

Biotech mergers and acquisitions are not new. But biotech firms usually make smaller buys.

It's the large diversified drug firms that typically pay big money for biotech firms to offset blockbuster drugs losing patent protection and shrinking development pipelines.

Last year, France's Sanofi-Aventis (SNY) paid $20 billion for the remaining interest it had in Genzyme.

In 2009, Swiss drug giant Roche Holding (RHHBY) bought Genentech, the granddaddy of biotechs, for a cool $46.8 billion, giving it reason to declare itself the biggest biotech company in the world.

"Gilead's $11 billion acquisition really opened eyes for the potential of biotech companies to be big acquirers as well," said Steven Silver, biotech equity analyst with S&P Capital IQ.

Gilead, and now Celgene, are among a host of companies buying their way into new treatments for the hepatitis C virus, which affects liver function and afflicts some 170 million people worldwide.

Big Pharma is also on the hepatitis C warpath. In early January, Bristol-Myers Squibb (BMY) said it would pay $2.5 billion for biotech firm Inhibitex (INHX) to expand its war chest of hepatitis C drugs in development.

Its announcement came after Roche agreed to buy biotech outfit Anadys Pharmaceuticals (ANDS) for $250 million to bolster its hepatitis C pipeline.

"The hot theme for mergers and acquisitions right now is hepatitis C," said Silver.

2012 Annual CCO HIV and Hepatitis C Symposium: Implementing Best Practices in HIV, HCV, and Coinfection

Register today for this weekend-long annual symposium covering the year’s most important new advances in the treatment of HIV and hepatitis C. Designed for frontline clinicians treating HIV- or HCV-monoinfected and/or coinfected patients, the highly interactive program features plenary presentations, interactive case discussions, and roundtable sessions reviewing the most up-to-date clinical information. Please check the Web site for the latest information on the confirmed agenda and faculty.

The Westin Diplomat
3555 South Ocean Drive
Hollywood, Florida

HCV leaps ahead of HIV as leader of cause of death in the U.S.

From POZ.com. HCV surpasses HIV as a leading cause of death in the US, according to the CDC

November 10, 2011

Hepatitis C Surpasses HIV as Cause of Death in U.S.

It’s official. Chronic hepatitis C virus (HCV) infection is associated with more deaths than HIV infection, according to sobering new data presented by the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday, November 8, at the 62nd annual meeting of the American Association for the Studies of Liver Diseases (AASLD) in San Francisco.

The discouraging findings, presented by Scott Holmberg, MD, MPH, chief of the CDC’s Division of Viral Hepatitis Epidemiology and Surveillance Branch, come from data involving 21.8 million deaths reported to the National Center for Health Statistics between 1999 and 2007. The only cases included in the analysis involved reports that specified HIV, AIDS, HCV or hepatitis B virus (HBV) infection as possible contributors to the deaths.

Encouragingly, death rates associated with chronic HBV infection—a major cause of liver failure and liver cancer—remained relatively flat between 1999 and 2007. In 2007, for example, about 1,800 U.S. residents died of HBV-related complications, which translated into less than one chronic hepatitis B-attributable death per 100,000 people in this country.

Death rates related to HIV infection continue to fall. Whereas HIV contributed to 6 per 100,000 deaths in 1999, the rate dropped to less than four per 100,000 deaths in 2007.

Hepatitis C–related deaths have increased sharply, Holmberg’s team reported. Whereas HCV contributed to roughly 3 per 100,000 deaths in 1999, the HCV-related death rate exceeded 4 per 100,000 people in the United States by 2007.

With respect to crude numbers, roughly 12,700 HIV-related deaths were reported to the National Center for Health Statistics in 2007. More than 15,000 HCV-related deaths were reported to the center that year.

Most viral hepatitis deaths occurred in people in the prime of their lives. About 59 percent of people who died of complications related to hepatitis B were between the ages of 45 and 64. The impact of chronic hepatitis C was even more substantial—roughly 73 percent of the deaths related to HCV were in baby boomers.

Not surprisingly, death rates were highest among certain populations. For example, people coinfected with both HBV and HCV faced a 30-fold increase in the risk of death from liver disease or related complications. Alcohol abuse was associated with a four-fold increase in the risk of death. Coinfection with HIV nearly doubled the risk of death from HBV-related complications and quadrupled the risk of death from HCV-associated liver disease.

“[Achieving] declines in mortality similar to those seen with HIV,” Holmberg’s group concluded, “will require new policy directions and commitment to detect and link infectious persons to care and successful treatment.”

NanoViricides announces anti-HIV therapy could lead to functional cure...

NanoViricide press release on a successful HIV animal study comparing it's lead anti-HIV candidate that achieved efficacy similar to three-drug HAART therapy, apparently with less opportunity for drug toxicity. Nanoviricides utilizes new technology to 'mimic cellular structures to which the virus binds, specifically attacking and dismantling them'. The CEO claims that this could lead to a 'functional cure', which isn't complete eradication of the virus, but 'would allow an infected person to continue normal life even after discontinuation of therapy, maintaining undetectable viral load until a recurrence.'

NanoViricides announces anti-HIV therapy could lead to functional cure

Mon 10:53 am by Deborah Sterescu
NanoViricides announces anti-HIV therapy could lead to functional cure

NanoViricides (OTCBB:NNVC) reported Monday that its lead anti-HIV candidate achieved an efficacy level equivalent to a highly active anti-retroviral triple (HAART) drug cocktail in a recent animal study.

Treatment with the drug reduced HIV levels and protected human immune T-cells to the same extent as treatment with the cocktail did in a study of mice, said the company. The three drug-combination used for comparison is one of the current therapies recommended for patients with HIV.

NanoViricides, which uses special purpose nanomaterials to design viral therapies, also said that no evidence of drug toxicity was observed during the study, and that the investigational drug will now undergo further optimization.

The latest study verifies the company's previous results, which found that nanoviricides had a significant therapeutic effect, equal or superior to the same three-drug cocktail in a mouse study.

The company's nanoviricide therapy works to mimick cellular structures to which the virus binds, specifically attacking and dismantling them. By working differently than many combination therapies, the drug developer believes that the nanoviral treatment, or HIVCide, could compliment current standard-of-care, possibly achieving a "functional cure" of HIV/AIDS, NanoViricides said.

Although a functional cure is not a complete cure, it would allow an infected person to continue normal life even after discontinuation of therapy, maintaining undetectable viral load until a recurrence.

"Creating an adjunct drug that acts by a novel mechanism complementing the current HAART therapy is becoming extremely important," said CEO, Eugene Seymour.

"The HIV virus mutates constantly resulting in failure of HAART therapy regimens. In some countries, it has now mutated to such an extent that in up to 40% of patients the standard HAART therapy has become ineffective."

The company's nanoviricide class of drugs are being developed against a number of viral diseases, including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, oral and genital Herpes, viral Hepatitis C, and Ebola virus, among others.

A recent study of anti-flu treatment FluCide showed that the drug was better than oseltamivir, or Tamiflu, with a 1,000-fold greater viral load reduction than the standard flu therapy, after optimization.

"The results of the current study have provided important insight to guide the next cycle of chemical optimization. We clearly know now that we are on the right path," said president Anil R. Diwan

Gilead first company to share AIDS and HBV drugs with Medicines Patent Pool...

Gilead is the first to share it's HIV and HBV drugs with the international Medicines Patents Pool according to the NY Times on Monday July 12. The concept of the patent pool is to create an international independent agency that would hold patents on antiviral and antiretroviral drugs and sub-license them to low-cost manufacturers for little or no royalties as long as those manufacturers only supply the drugs to an agreed-upon list of poor countries. Great idea and hats off to Gilead!


Company Agrees to Share AIDS and Hepatitis Drugs With Patent Pool
By DONALD G. McNEIL Jr.

In the first agreement between a pharmaceutical company and the new international Medicines Patent Pool, Gilead Sciences announced Tuesday that it would license four of its AIDS and hepatitis B drugs to the pool.

The move is particularly important because it includes tenofovir and emtricitabine, which have emerged as important components of AIDS therapy and new prophylaxis regimens, like vaginal microbicides for women and once-a-day pills protecting gay men. Many poor countries now have only older drugs, some of which have harsh side effects.

Health advocates have long championed the idea of a pool: an independent agency that would hold patents on drugs and sub-license them to low-cost manufacturers for low or no royalties on the condition that they supply only poor countries. (In Uganda, above, cost cutting has set back anti-AIDS programs.)

The pool was created last year, but drugmakers resisted it, wanting to control quality and protect rights to future profits from middle-income countries. Until this week, the only participant was the National Institutes of Health, which turned over a partial patent on an obscure AIDS drug.

“This is a great achievement,” said James P. Love, a campaigner for lower drug prices who first proposed a pool in 2002. “The other drug companies didn’t want Gilead to sign anything, and this will put pressure on them.”

The pool must negotiate which countries can get which drugs, and Mr. Love said he will watch that carefully. Gilead may benefit, he noted, because it may now get modest royalties from sales in countries where it never bothered to take out patents.

FDA Approves Tibotec's New HIV Treatment, Edurant

FDA Approves Tibotec's New HIV Treatment, Edurant
5/20/2011

SILVER SPRING, Md., May 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).

Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor (NNRTI). The drug works by blocking HIV viral replication. Edurant is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood. Edurant is a pill taken once a day with food.

"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

The safety and effectiveness of Edurant is based on 48-week data from two Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week (with extension to 192 weeks) trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz (another FDA-approved NNRTI for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs.

Edurant was as effective as efavirenz in lowering viral load. In the Edurant and efavirenz groups, 83 percent and 80 percent of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.

The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping (insomnia), headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.

Edurant does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

Edurant is manufactured by Raritan, N.J.-based Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc.

For more information:

FDA: HIV and AIDS Activities

http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAIDSActivities/default.htm

FDA: Antiretroviral drugs used in the treatment of HIV infection

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm

CDC: HIV/AIDS

http://www.cdc.gov/hiv/default.htm

HHS: AIDS News and Resources

http://www.aids.gov/

AIDS Information

http://www.aidsinfo.nih.gov/

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries:Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Early H.I.V. Therapy Sharply Curbs Transmission....

I don't talk too much about HIV on Viral Matters, but the article originally appearing in the New York Times on May 12, happens to be a finding so incredibly important that NOT spreading the word would be a great disservice, even to the 3 people that read this blog ;). The data from this trial was so strong and deemed so important that the trial ended early, instead of it’s intended 2015 completion date. So what’s the big deal? Well, the authors have found that those who had HIV AND on antiretroviral therapy were 96% less likely to pass on the infection if they were taking antiretroviral drugs. That’s a big deal, so much so that it’s likely to change world policy on the treatment of HIV. The finding is bedeviled by the age-old problem we denizens of the globe have always faced since the dawn of antiretroviral therapy… it’s expensive and not everyone has access to the drugs they need in order to stop the spread, especially those in 3rd world countries. Hope springs eternal, however – great findings in medicine to advance ourselves against a global problem often find funding in the strangest places. Let’s hope the same is true for this.


Early H.I.V. Therapy Sharply Curbs Transmission
By DONALD G. McNEIL Jr.

People infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate, according to preliminary results from a large clinical trial released Thursday.

Patients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs — a finding that is so overwhelming that it is likely to change the way American AIDS doctors treat patients and what treatment policies are adopted by the World Health Organization and other countries, said Dr. Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases, which paid for the trial.

The data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early.

There have been previous studies, notably among drug abusers in San Francisco and Vancouver, British Columbia, that concluded that starting patients on drugs immediately would stop them from infecting others.

Those studies led Unaids, the United Nations AIDS-fighting agency, to adopt “test and treat” as its goal last year; the policy encourages doctors to start people on treatment as soon as they test positive for H.I.V. However, this is the first evidence from a randomized clinical trial, the gold standard in medical research.

AIDS prevention specialists not connected to the trial were enthusiastic.

“These results are phenomenal,” said Thomas J. Coates, director of the global health program at the University of California, Los Angeles, and the founder of the Center for AIDS Prevention Studies in San Francisco. “It was a tough study to do, and I’m thrilled it came out this way.”

Dr. Julio Montaner, an AIDS specialist at the University of British Columbia whose work among Vancouver heroin addicts helped lead to the Unaids policy, called the result of 96 percent protection “as good as it gets.”

“This is consistent with what we’ve been saying and doing in British Columbia for close to a decade,” he said. “How much more evidence do we need before we implement what we know works?”

The $73 million trial, known as HPTN 052, involved 1,763 couples in 13 cities on four continents. One member of each couple was infected with H.I.V.; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus.

In the other half, the infected person started treatment only when his or her CD4 count — a measure of the immune system’s strength — dropped below 250 per cubic millimeter.

In 28 of the couples, the uninfected person became infected with the partner’s strain of the virus. Twenty-seven of those 28 infections took place in couples in which the partner who was infected first was not yet getting treatment.

On Thursday, Dr. Fauci and Dr. Myron Cohen, an AIDS specialist from the University of North Carolina at Chapel Hill and the study’s director, announced that the data collected since the study began in 2005 had been “unblinded” to an independent safety review panel, which is standard procedure in clinical trials. When the panel realized how much protection early treatment afforded, it recommended that drug regimens be offered to all participants. Although participants will still be followed, the trial is effectively over because it will no longer be a comparison between two groups on different regimens.

The results carry moral implications for doctors in the United States. Although medical associations like the Infectious Diseases Society of America advocate starting patients on AIDS drugs early, the decision is made by the doctor and patient. Some patients fear the reported side effects of AIDS drugs and want to delay taking the drugs until they get obviously sick or until their CD4 counts fall, and some doctors go along with that, Dr. Fauci said, especially as long as their patients’ CD4 counts remain above 350.

But that means the patient may infect others during the delay. Of the 27 people in the study who became infected while their partners were not yet taking the drugs, 17 had partners whose CD4 counts were still above 350.

Asked if it could now be considered immoral for a doctor to accede to a patient’s request to delay starting drugs, Dr. Fauci said: “I’m not going to go there. I’m not going to say it’s immoral. But there is more and more data showing the advantages of starting as early as you can.”

Dr. Coates of U.C.L.A. said he hoped that treatment delays would fade away because the newest antiretroviral drugs had few side effects.

Although the evidence suggests that it would be good public health policy to lower infection rates by starting everyone on drugs as soon as they are infected, that is impossible in much of the world. For lack of money, clinics in Africa are turning away patients who are not just infected but close to death. And in some American states where money provided by the Ryan White Care Act has run out, poor uninsured people are on waiting lists.

Although the trial was relatively large, there are some limitations on interpreting the data.

More than 90 percent of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual.

“We would have liked to have a substantial number of men as potential study subjects, but they just weren’t interested,” Dr. Cohen said.

Although common sense suggests the results would be similar in the contexts of homosexual sex and sex between people who are not couples, strictly speaking, the results apply only to the type of people studied, Dr. Fauci said.

NATAP posts CROI coverage....

Always great coverage from the NATAP folks is just a click away... http://www.natap.org/2011/CROI/CROI.htm

Pharmacokinetic Interactions Between Antiretroviral Agents and the Investigational HCV Protease Inhibitor Telaprevir in Healthy Volunteers

Jules Levin reports on the DDIs between Telaprevir (TVR) and some of the current drugs to treat HIV. As you have probably read, the RVR rates for Telaprevir in co-infected patients ranged from 70 to 75% in a sample size of 60 randomized to patients not on treatment as well as patients currently on Viread or an Atazanavir regimen. No info was available on whether patients HIV was controlled during that four week period. Based on the data on DDIs between Telaprevir and ARTs presented by R van Heeswijk,et al, Telaprevir is both an inducer and inhibitor of CYP3A, which means it is likely to interact with most ARTs on the market. Indeed, they did see reduced exposure to Telaprevir and variable effects on HIV protease inhibitors and tenofovir.

Telaprevir AUC using the 750mg Q8h dose with Lopinavir, Durnavir, Atazanavir (ATV) and Fosamprenavir saw 54%, 20%, 35% and 32% reductions respectively. Looking at the HIV PI concentrations, Ritonavir boosted Lopinavir, Durnavir, Atazanavir and Fosamprenavir saw no change, 40% less, 17% increase and 47% decrease with Telaprevir 750mg q8h respectively.

These interactions prompted Vertex to choose regimens with the least effect on exposure for their co-infected trial. ATV/r 300/100mg qd + TVR 750mg q8h/P+r and Efavirenz 600mg qd + TVR 1125 q8h/P+r.

Despite the author conclusions below, there is cause for concern in regards to DDIs with common ARVs and TVR. The PK concentrations of drugs are highly variable in individuals due to a variety of reasons. Add DDIs to the mix and even the slightest change in drug concentrations can case a Cmin to dip below the IC50 of the virus, with potential to cause either HIV and/or HCVresistance. Because of this, we might see resurgence of Therapeutic Drug Monitoring (TDM)in an effort to prevent resistance - Chris

AUTHOR CONCLUSIONS

RTV-boosted HIV PIs + TVR 750 mg q8h
–(Mutual) drug interactions were observed
•Reduced exposure to TVR, variable effects on HIV PIs
–Protein displacement may play a role in reduction of total concentrations (in-vitro evaluation ongoing)
–Appropriate doses have not been established
–
EFV and Tenofovir + TVR 1125 mg q8h
–Small changes in TVR, EFV and tenofovir exposure
–Higher TVR dose (1125 mg q8h) partly offset interaction with EFV
–
Based on these results, a pilot study of TVR in HIV/HCV co-infection was initiated with ATV/r 300/100 mg qd + TVR 750 mg q8h or EFV 600 mg qd + TVR 1125 mg q8h (plus Peg-IFN and ribavirin)

Peregrine Completes Patient Enrollment in Phase Ib HCV/HIV Coinfection Trial

TUSTIN, CA -- (MARKET WIRE) -- 01/31/11 -- Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced the completion of enrollment in the company's Phase Ib dose escalation safety study of bavituximab in patients coinfected with chronic hepatitis C virus (HCV) and HIV. Previously this month, Peregrine initiated a randomized Phase II HCV trial to evaluate 12 weeks of therapy with bavituximab, a phosphatidylserine (PS)-targeting monoclonal antibody with immune-modulating potential, in combination with the antiviral drug ribavirin versus standard of care, pegylated interferon alpha 2a and ribavirin.

"Completion of enrollment in our third Phase I HCV trial is an important milestone for our bavituximab antiviral program, and sets the stage for reporting clinical data at a medical conference in the second quarter of this year while we begin to evaluate combination treatment with the antiviral agent ribavirin in a recently initiated study," said Steven W. King, president and chief executive officer of Peregrine. "Though standard treatment for chronic HCV may soon evolve with the introduction of new targeted antiviral drug candidates, immune stimulation with interferon remains a critical component of therapy. Preclinical data support the potential combination of bavituximab and ribavirin and we look forward to seeing how this combination initially compares to standard interferon and ribavirin treatment for 12 weeks in our Phase II study for patients infected with HCV."

In prior HCV clinical trials, bavituximab administered as monotherapy in single and multiple doses demonstrated a positive safety profile with no dose-limiting toxicities or serious adverse events. Bavituximab as a monotherapy also showed promising on therapy antiviral activity of up to 1.5 log viral load reduction.

Bavituximab may address a fundamental "immune evasion" mechanism exploited by many infectious pathogens. A growing body of published data from researchers worldwide shows that bavituximab's PS target, exposed on the surface of cells infected by viruses and protozoan parasites, suppresses the immune system's ability to fight disease. PS-targeting antibodies such as bavituximab bind to PS and block the immunosuppressive signals created by the target, thereby allowing the immune system to mount a robust immune response against the pathogen.

About the Phase Ib HCV Trial Peregrine's open-label, dose escalation safety study is designed to assess the safety and of bavituximab in up to 24 patients chronically infected with HCV and HIV. Patient cohorts received ascending dose levels of bavituximab weekly for up to 8 weeks. Primary endpoints include safety and pharmacokinetics, and secondary endpoints will measure HCV and HIV RNA by PCR. For further information about Peregrine's HCV trials, please visit www.peregrinetrials.com or http://www.clinicaltrials.gov/ct2/results?term=bavituximab.

About HCV According to the U.S. Centers for Disease Control and Prevention, an estimated 3.2 million individuals in the United States have chronic hepatitis C virus (HCV) infection. Chronic HCV infection is a serious disease that can result in long-term health problems, including liver damage, liver failure, liver cancer, or death. It is the leading cause of cirrhosis and liver cancer and the most common reason for liver transplant in the United States. Approximately 8,000 to 10,000 people die every year from HCV-related liver disease.

About Bavituximab's Antiviral Approach Bavituximab is the first in a new class of patented antibody therapeutics that target and bind to phosphatidylserine (PS), a specific phospholipid component of cell membranes. Bavituximab helps reactivate and direct the body's immune system to destroy infected cells and virus particles that exhibit this specific phospholipid on their surface. Since their target is host-derived rather than pathogen-derived, PS-targeting antibodies have the potential for broad-spectrum antiviral activity and are also expected to be much less susceptible to the viral mutations that often lead to drug resistance.

Researchers have found that PS is exposed on the outer membrane of cells infected with HCV, HIV, influenza, herpes viruses, hemorrhagic fever viruses, respiratory syncytial virus, measles as well as other viruses. A growing body of scientific publications, including Nature Medicine and The Journal of Experimental Medicine, has highlighted data on the role of PS and Peregrine's PS-targeting therapies in infectious diseases.

About Peregrine Pharmaceuticals Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.

Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that results from the Phase Ib or Phase II HCV trials will not be consistent with results experienced in earlier HCV clinical trials and preclinical studies, the risk that investigators may experience delays in patient enrollment, risk that results may not support registration filings with the U.S. Food and Drug Administration, and the risk that Peregrine may not have or raise adequate financial resources to complete the planned clinical programs. Factors that could cause actual results to differ materially or otherwise adversely impact the company's ability to obtain regulatory approval for its product candidates include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2010 and the quarterly report on Form 10-Q for the quarter ended October 31, 2010. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

Clinical Care Options 2011 HIV & Hepatitis C Symposium...

2011 Annual CCO
HIV and Hepatitis C Symposium:

A Unique Program Integrating New Advances and Treatment Strategies in HIV, HCV, and Coinfection

June 9-12, 2011: Washington, DC

Mark your calendar today!

CCO has combined our 2 outstanding annual update symposia to provide a unique new meeting that addresses both the separate concerns of HCV and HIV treaters, as well as the intersection between these fields.

The program has been carefully structured to make it easy for participants to choose to attend the entire meeting or just the HIV or HCV sessions. Whether you treat only HIV, only HCV, or both, the flexibility of the program allows you to attend the sessions that are right for you.

A full day will address the latest issues in HIV management, including antiretroviral strategies, the management of comorbidities, and the emerging clinical role of pre-exposure prophylaxis.

Another full day of state-of-the-art educational content will address the clinical role of the new HCV agents that are expected to enter the clinic in 2011, including plenary reviews, roundtable discussions, and case-based learning.

Finally, a unique half-day session will explore the intersection between the epidemics, including management of coinfection, using the new HCV drugs in patients receiving antiretroviral therapy, and lessons the 2 fields are learning from each other.

Full Agenda and Online Registration Coming Soon

If you have any advance questions, please reply to this message or send an email to memberservices@clinicaloptions.com.

HRSA Awards $1.6 Million to Improve Availability and Expansion of Hepatitis C (HCV) Treatment

A drop in the bucket, but some welcome funding (and increased exposure) for HCV and treatment of HCV in patients with HIV. I'd argue that similar attention and funding be targeted to mono-infection as well given the dire forecast on the financial and health consequences of not treating that population - Chris

ROCKVILLE, Md., Nov. 19, 2010 /PRNewswire via COMTEX/ -- The Health Resources and Services Administration (HRSA) has awarded $1.6 million in grants to support the Hepatitis C Treatment Expansion Initiative. The funds will aid organizations implementing effective, focused interventions designed to increase access to and completion of Hepatitis C (HCV) treatment for HIV-positive patients. Hepatitis C affects about 3.2 million people in the United States, and is responsible for approximately 17,000 deaths each year; about one quarter of HIV-infected persons in the U.S. are also infected with Hepatitis C.

The grants, funded under the Ryan White HIV/AIDS Program, Special Projects of National Significance, were awarded to 15 demonstration sites and one Evaluation and Technical Assistance Center (ETAC). This initiative will evaluate the effectiveness of the interventions to deliver HCV treatment among HIV-positive populations, and share best practice models with Ryan White grantees and other HIV medical providers to improve access and quality of Ryan White services for HIV patients.

"These funds are essential to expanding care and treatment to people living with HIV/AIDS and Hepatitis C" said HRSA Administrator Mary K. Wakefield, R.N., Ph.D. "This is an important opportunity to make measurable progress in treating coexisting conditions and creating a more knowledgeable care community to serve those most in need." The organizations receiving the awards comprise the first of two demonstration site cohorts, each with two-year project periods. In addition, HRSA awarded a separate four-year cooperative agreement to the University of South Florida to serve as the ETAC, which will evaluate and provide technical assistance to the demonstration sites.

Hepatitis C Treatment Expansion Initiative Awards Site City State Total St. Mary Medical Center Foundation Long Beach Calif. $78,954.00 East Bay AIDS Center (EBAC) Oakland Calif. $79,278.00 The Regents of the University of California, San Francisco San Francisco Calif. $80,000.00 Cambridge Health Alliance Cambridge Miss. $80,000.00 Kansas City Free Health Clinic Kansas City Mo. $80,000.00 Washington University St. Louis Mo. $79,935.00 Research Foundation of the State University of New York Albany N.Y.

$80,000.00 Bronx-Lebanon Hospital Center Bronx N.Y.

$80,000.00 Harlem United Community AIDS Center New York N.Y.

$79,860.00 William F. Ryan Community Health Center, Inc. New York N.Y.

$80,000.00 Clarion University of Pennsylvania Clarion Pa. $80,000.00 Bexar County Hospital District (dba University Health System) San Antonio Texas $80,000.00 Carilion Medical Center Roanoke Va. $79,390.00 Inova Health Care Services Springfield Va. $80,000.00 AIDS Resource Center of Wisconsin Milwaukee Wis.

$80,000.00 Total $1,197,417.00 Evaluation and Technical Assistant Center University of South Florida Tampa Fla.

$374,863.00 Grand Total $1,572,280.00 The Health Resources and Services Administration is part of the U.S. Department of Health and Human Services. HRSA is the primary Federal agency responsible for improving access to health care services for people who are uninsured, isolated, or medically vulnerable. For more information about HRSA and its programs, visit www.hrsa.gov.

SOURCE Health Resources and Services Administration (HRSA) www.prnewswire.com Copyright (C) 2010 PR Newswire. All rights reserved -0- KEYWORD: Maryland INDUSTRY KEYWORD: HEA

First micro-RNA-Targeted Drug to treat HCV enters Phase II Clinical Trials...

HOERSHOLM, Denmark and SAN DIEGO, September 22, 2010 /PRNewswire/ --

- Santaris Pharma A/S initiates Phase 2a clinical trial with miravirsen (SPC3649) to assess safety and tolerability in treatment-naive patients with chronic Hepatitis C

- miravirsen is the first microRNA-targeted drug to receive Investigational New Drug (IND) acceptance from FDA, paving the way to conduct Phase 2 trials for treatment of Hepatitis C in the United States

- Developed using Santaris Pharma A/S Locked Nucleic Acid (LNA) Drug Platform, miravirsen inhibits miR-122, a microRNA important for Hepatitis C viral replication, thereby significantly reducing the levels of Hepatitis C virus

- Due to unique mechanism-of-action, miravirsen holds promise as new treatment option for Hepatitis C patients, including the 50% of patients not responsive to current standard of care(1)

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced miravirsen (SPC3649), the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies to assess the safety and tolerability of the drug in treatment-naive patients infected with the Hepatitis C virus (HCV).

Paving the way to conduct the first clinical trials of a microRNA-targeted drug in the United States, Santaris Pharma A/S also received acceptance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA). In addition to the United States, the Phase 2a clinical trials will be conducted in the Netherlands, Germany, Poland, Romania, and Slovakia.

The World Health Organization estimates about 3% of the world's population has been infected with HCV and that some 170 million are chronic carriers at risk of developing liver cirrhosis and/or liver cancer(2). Approximately 3-4 million Americans are chronically infected with an estimated 40,000 new infections per year(1). In Europe, there are about 4 million carriers(2). The current standard of care, pegylated interferon in combination with ribavirin, is effective in only about 50% of those treated(1).

Developed using Santaris Pharma A/S proprietary Locked Nucleic Acid (LNA) Drug Platform, miravirsen is a specific inhibitor of miR-122, a liver specific microRNA that the Hepatitis C virus requires for replication. Miravirsen is designed to recognize and sequester miR-122, making it unavailable to the Hepatitis C virus. As a result, the replication of the virus is effectively inhibited and the level of Hepatitis C virus is reduced.

"Advancing miravirsen, the first microRNA-targeted drug to enter clinical trials, into Phase 2 studies in patients with Hepatitis C demonstrates Santaris Pharma A/S leadership in developing RNA-targeted medicines," said Arthur A. Levin, Ph.D., Vice President, Chief Development Officer and President, US Operations. "Receiving IND acceptance from the FDA to conduct the first clinical trials with a microRNA-targeted drug in the United States brings Santaris Pharma A/S one step closer to potentially providing a growing number of patients chronically infected with HCV with a more effective and better tolerated treatment option."

The LNA Drug Platform is the only technology with both mRNA and microRNA targeted drugs in clinical trials, reinforcing the broad utility of the platform. The unique combination of small size and very high affinity, which is only achievable with LNA-based drugs, allows this new class of drugs to potently and specifically inhibit RNA targets in many different tissues without the need for complex delivery vehicles. LNA-based drugs are a promising new type of therapy that enables scientists to develop drugs to attack previously inaccessible pathways.

"Using our LNA Drug Platform to advance the first microRNA-targeted therapy into human clinical trials was certainly a scientific breakthrough," said Henrik Oerum, Ph.D., Vice President and Chief Scientific Officer of Santaris Pharma A/S. "We are extremely pleased with the results of the Phase I trials and excited to progress miravirsen into Phase 2 clinical trials. Because of its unique mechanism of action and tolerability profile, miravirsen has the potential to be an effective treatment option for patients with HCV."

The randomized, double-blind, placebo-controlled, ascending multiple-dose Phase 2a study will assess the safety and tolerability of miravirsen and is designed to enroll up to 55 treatment-naive patients with chronic Hepatitis C virus genotype 1 infection. Secondary endpoints include pharmacokinetics of miravirsen and its effect on viral load. Miravirsen will be given as subcutaneous injections weekly or every other week for four weeks.

Data from Phase 1 clinical studies with miravirsen in healthy volunteers show that the drug is well tolerated. A recent study published in Science demonstrated that miravirsen successfully inhibited miR-122 and dramatically reduced Hepatitis C virus in the liver and in the bloodstream in chimpanzees chronically infected with the Hepatitis C virus(3). Miravirsen provided continued efficacy in the animals up to several months after the treatment period with no adverse events and no evidence of viral rebound or resistance.

In addition to miravirsen, Santaris Pharma A/S has a robust product pipeline targeting mRNAs and microRNAs both internally as well as in partnerships and collaborations with miRagen Therapeutics (cardiovascular diseases), Shire plc (rare genetic disorders), Pfizer (undisclosed therapeutic areas), GlaxoSmithKline (viral disease) and Enzon Pharmaceuticals (oncology).

About microRNAs

MicroRNAs have emerged as an important class of small RNAs encoded in the genome. They act to control the expression of sets of genes and entire pathways and are thus thought of as master regulators of gene expression. Recent studies have demonstrated that microRNAs are associated with many disease processes. Because they are single molecular entities that dictate the expression of fundamental regulatory pathways, microRNAs represent potential drug targets for controlling many biologic and disease processes.

About Locked Nucleic Acid (LNA) Drug Platform

The LNA Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combines the Company's proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single-stranded LNA-based drug candidates against RNA targets, both mRNA and microRNA, for a range of diseases including metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders. The LNA Drug Platform overcomes the limitations of earlier antisense and siRNA technologies to deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The unique combination of small size and very high affinity, which is only achievable with LNA-based drugs, allows this new class of drugs to potently and specifically inhibit RNA targets in many different tissues without the need for complex delivery vehicles. LNA-based drugs are a promising new type of therapy that enables scientists to develop drugs to attack previously inaccessible clinical pathways. The most important features of LNA-based drugs include excellent specificity, providing optimal targeting; increased affinity to targets providing improved potency; and strong pharmacology upon systemic delivery without complicated delivery vehicles.

About Santaris Pharma A/S

Santaris Pharma A/S is a privately held clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies. The Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combine the Company's proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The Company's research and development activities focus on infectious diseases and metabolic disorders, while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, cardiovascular disease, infectious and inflammatory diseases, and rare genetic disorders. The Company has strategic partnerships with miRagen Therapeutics, Shire plc, Pfizer, GlaxoSmithKline, and Enzon Pharmaceuticals. As part of its broad patent estate, the Company holds exclusive worldwide rights to all therapeutic uses of LNA. Santaris Pharma A/S, founded in 2003, is headquartered in Denmark with operations in the United States. Please visit http://www.santaris.com for more information.

RetroVirox Inc seeking funding to advance it's HCV & HIV proprietary discovery programs...

RetroVirox Inc. is seeking to raise funds to support the company's hepatitis C virus (HCV) and other antiviral programs, including one aimed at Dengue virus. But the San Diego-based firm, which began operating in May 2009, wants to advance its antiviral programs only so far, through the investigational new drug (IND) application process or Phase I.

"We don't plan to be a clinical stage company," Juan Lama, president, CEO and director of RetroVirox, told BioWorld Today.

Instead, he said the company is focused on the early stages of discovery and preclinical development of lead compounds. RetroVirox could go in a few different directions based on that model.

It would work to identify new compounds that could lead to first-in-class antivirals and out-license those compounds, approach potential partners to continue clinical development, or possibly put all of its assets up for sale, Lama indicated.

The company is interested in partnerships, venture capital and also non-dilutive opportunities such as small business innovation research (SBIR) funding, he said.

Founded by a group of scientists and entrepreneurs in the fields of virology and drug discovery, the company's expertise is in utilizing cell-based assays to discover new small-molecule compounds with antiviral activity. To do this, RetroVirox has developed proprietary assays to identify compounds that block viral entry by targeting host factors rather than viral proteins.

RetroVirox employs four to six scientists with expertise in virology, assay development, high-throughout screening and medicinal chemistry.

The company offers its services to other biotech companies, providing antiviral assays and screening of libraries for antiviral compounds. In that regard, RetroVirox would work similar to a contract research organization, providing assays in the virology area and identifying potential new compounds to offset its research and development expenses.

Still, the company's major focus is on advancing its own discovery programs, explained Lama, who has governed the firm since its inception.

The company's platform technology has achieved proof-of-concept in the area of HIV, and based on that technology, RetroVirox is developing proprietary assays to create a platform to discover drugs against other major human viruses, including HCV. The technology potentially could be used to inhibit viral entry for almost any virus containing a lipid membrane, Lama said.

Ideally, RetroVirox would like to advance its HCV and HIV programs first, to an IND or Phase I. "We are actually working in both [programs] at the same time, although given the burden of HCV infection we intend to put more effort in the HCV program," Lama said.

In the U.S. alone, more than 3 million are infected with HCV.

So far, RetroVirox has received a little over $1.1 million in financing, with much of that coming from three National Institutes of Health Small Business Innovation Research (SBIR) awards, and the remaining from early stage investors.

The current SBIR Phase I funds would last for the next 18 months. A Phase II SBIR grant could cover another two to three-year period, Lama said.

Under the grants awarded in the last 12 months RetroVirox received $872,000 to fund development of novel HIV entry drugs that could potentially overcome limitations of current therapies. The company received its last award in May to finance the discovery of anti-HIV drugs that block removal of the virus receptor, the CD4 protein.

RetroVirox believes that the mode of action used in its antiviral programs has never been targeted before and holds some key advantages over other antivirals. The company takes aim at human proteins that are needed by the virus to become infectious and enter other cells.

While conventional viral entry inhibitors block binding between the viral envelope and receptor proteins, RetroVirox's approach targets intracellular intracellular proteins, which may not bind directly to viral factors. The company believes that those intracellular host factors could display higher barriers to the emergence of resistant virus, one of the major hurdles in antiviral therapy.

Unlike other entry inhibitors such as the FDA-approved CCR5 blocker maraviroc (Pfizer Inc.'s Selzentry), which act on one of the HIV receptors, RetroVirox's molecules are efficient at blocking entry of all HIV strains, regardless of the co-receptor used by the virus, Lama said.