Sounds good on the surface, but I've heard mixed things about the IL28B genetic test... at least four providers I've talked to that have been using the IL28B test say that it really doesn't predict much at all and in fact, can create an environment of 'treatment nihilism' if the patient turns out to have the T/T allele. According to anecdotal evidence, these providers have had subjects with the T/T allele respond just as favorably as those with the C/C allele and had cases where the patient with the C/C allele haven't responded at all. The bottom line - a genetic test should act only as one predictor of outcomes along with many others, such as age, fibrosis status, kidney function, adherence and social support, etc. No one should be denied therapy as a result of the IL28B test.
Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C Patients
Date: 25 February 2011
Source: Scripps Health Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C PatientsIndividualized Therapies Now Available for Drug Treatment of Hepatitis C
SAN DIEGO, Feb. 25, 2011 (GLOBE NEWSWIRE) -- Scripps Health is one of the first health systems in the United States to offer genetic testing as part of its care for hepatitis C patients planning to undergo drug treatment.
The tests offer hope to the more than 4 million patients diagnosed annually in the U.S. with hepatitis C and could spare them from taking interferon, which is commonly prescribed. Interferon causes flu-like symptoms as a side effect and costs more than $50,000 annually. Instead, the genetic test determines whether patients have a common gene variant that predicts a favorable cure rate if they are treated with the drug combination therapy of pegylated interferon and ribavirin.
A manuscript describing this approach to treatment, authored by Paul J. Pockros, MD, clinical director of research at the Scripps Translational Science Institute, head of the Division of Gastroenterology and Hepatology and director of the Liver Disease Center at Scripps Clinic, will be published in the journal Drugs in March.
"This is a huge step forward in the movement toward individualized medicine," said Dr. Pockros, "As a physician, knowing what drug therapies will have benefit and which ones won't based on a patient's IL28B genotype is significant because we are able to be more targeted in our approach to treatment."
This is the first of numerous genetic tests that will accurately give doctors vastly improved data, leading to better prescription of drug treatments. Later this year, a second test will be available that will accurately predict anemia in hepatitis C patients taking the pegylated interferon and ribavirin drug combination. Anemia is one of the most common side effects of the regimen. This will allow doctors to modify the therapy before starting the regimen to prevent patients from developing this problematic side effect.
Genetic testing for hepatitis C patients carries significant implications for patient care, as there are more than 4 million infected people in the United States, most of them undiagnosed and untreated.
Scripps Clinic now routinely orders IL28B genotyping on all patients with Hepatitis C who are potential candidates for anti-viral therapy. If the patients have a favorable IL28B genotype and advanced fibrosis on liver biopsy, doctors can initiate therapy with the current standard of care. If patients have a less favorable genotype or they have mild fibrosis, doctors can recommend waiting for FDA approval of direct acting antiviral drugs to improve their chances of response.
Currently, LabCorps Diagnostics is performing the IL28B testing for Scripps patients, a procedure covered by most insurance plans. The results are transmitted to the treating physician in about one week and the treatment choice is tailored based on the patient's likelihood to have a favorable response.
The hepatitis C genetic testing is the latest example of Scripps' leadership in individualized medicine. Scripps doctors were the first to use genetic testing for cardiovascular patients planning to undergo elective stent procedures to determine if they have one or more of the common gene variants linked to an inability to metabolize the anti-clotting drug Plavix (clopidrogel). Plavix is the second-most commonly prescribed drug in the United States and is given to most patients after they receive coronary stents.
ABOUT SCRIPPS HEALTH
Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a $2.3 billion nonprofit community health system based in San Diego, Calif. Scripps treats a half-million patients annually through the dedication of 2,500 affiliated physicians and 13,000 employees among its five acute-care hospital campuses, home health care services, and an ambulatory care network of physician offices and 22 outpatient centers and clinics. Scripps has been recognized by Thomson Reuters as one of the Top 10 health systems in the nation for quality care. Scripps is also at the forefront of clinical research, genomic medicine, wireless health and graduate medical education. With three highly respected graduate medical education programs, Scripps is a longstanding member of the Association of American Medical Colleges. More information can be found at www.scripps.org.
This information was brought to you by Cision http://www.cisionwire.com
CONTACT: Johnny Hagerman 858-361-8962 hagerman.johnny@scrippshealth.org
Friday, February 25, 2011
Wednesday, February 23, 2011
Medivir announces SVR24 in TMC435 in Phase 2b Treatment-naive patient population....
A might bit too early to fully put on my 'bullish' hat, still have to see what the final SVR will look like in all the arms (especially the placebo SOC arm), but TMC435 plus peg/riba looks awfully strong. Add in once daily dosing and equal DC's between placebo arm and TMC435 arms... the early data in this trial looks promising. We'll all be anxiously awaiting results for Medivir's ASPIRE trial in treatment-experienced patients coming in Q2 of this year.
HUDDINGE, Sweden, February 22, 2011 /PRNewswire-FirstCall/ -- Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces today further positive results from the phase 2b PILLAR (C205) study of TMC435 in treatment-naive patients with hepatitis C virus (HCV) genotype-1.
- TMC435 was safe and well tolerated with no clinically
relevant differences in adverse events between treatment groups and
standard of care (SoC).
- In the TMC435 treatment groups 83% of patients were able to stop
all therapy at week 24
- Potent and consistent antiviral efficacy was demonstrated with
SVR24 rates of up to 84%
"We are very pleased by both the efficacy and safety shown by TMC435 in this 48-Week interim analysis. With the additional features of once daily dosing, TMC435 also has a more convenient and competitive dosing regimen" stated Bertil Samuelsson, CSO of Medivir. "The recently published start of three global phase 3 clinical trials is an important milestone in the continued development of TMC435. We are now looking forward to the 48-week interim data from the phase 2b trial C206 (ASPIRE) in treatment-experienced patients during Q2 2011."
The 48-week interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naive patients showed further consistent high antiviral activity, and the good safety and tolerability previously demonstrated was confirmed. The 24-week (EOT) interim results were presented at the AASLD conference in Boston, MA, in November 2010.
Study design
In the PILLAR study, 75mg or 150mg TMC435 was given for either 12 or 24 weeks in combination with 24 weeks of ribavirin and pegIFNalpha-2A, the current standard of care (SoC). Patients in the TMC435 arms stopped all treatment at week 24 if certain predefined response-guided criteria were met. In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24. Patients who did not meet the above response-guided criteria continued with SoC until week 48 as did the placebo group.
Evaluation criteria
A protocol-defined interim analysis was performed when all patients completed their Week 48 visit or discontinued treatment earlier. Final SVR4 and SVR24 data were available for 98% (303/309; n/N) and 93% (288/309; n/N) of TMC435 treated patients, respectively. SVR24 is determined 24 weeks after the planned end of treatment (EoT) and was therefore not yet available for the patients in the placebo group and for some of those in the TMC435 group who received 48 weeks of treatment. SVR4, which is determined 4 weeks after the planned EoT, was available for 77% (59/77; n/M) of the patients in the placebo group.
Results - Efficacy
Potent and sustained antiviral efficacy was demonstrated in the SVR4 and SVR24 rates with no major differences between TMC435 doses or length of triple therapy. At week 4 after cessation of treatment 87.2%, 86.5%, 84.9% and 88.5% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels. At week 24 after cessation of treatment 83.6%, 76.1%, 83.1% and 84.4% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels, i.e. SVR24. At week 4 after cessation of treatment 71.2% in the placebo SoC group had achieved undetectable HCV RNA levels.
The results are derived from an intent-to-treat (ITT) analysis of the patient population who took at least one dose of the study medication and who reached the criteria for stopping all treatment at 24 weeks (83%).
Sustained Virological Response 4 and 24 Weeks after Planned End of
Treatment (EoT);
TMC435 TMC435 TMC435 TMC435 Placebo
12PR24 24PR24 12PR24 24PR24
75mg q.d. 75mg q.d. 150mg q.d. 150mg q.d.
% (n/N) N=78 N=75 N=77 N=79 N=77
SVR4 87.2 (68/78) 86.5 (64/74) 84.9 (62/73) 88.5 (69/78) 71.2 (42/59)
SVR24 83.6 (61/73) 76.1 (51/67) 83.1 (59/71) 84.4 (65/77) N/A
* < 25 log10 IU/mL undetectable
q.d.: once daily, PR: pegIFNalpha-2A and ribavirin,
SVR4 and SVR24: patients with undetectable HCV RNA 4 and 24 weeks after planned EoT, respectively. N/A: Patients in the control arm continue SoC until Week 48 and SVR24 data was not available
Results - Safety and Tolerability
TMC435 was generally safe and well tolerated and overall incidence of adverse events (AEs) was similar across treatment groups. AEs leading to discontinuation of TMC435 or placebo treatment were reported in 7.8% of the placebo subjects and in 7.1% of the TMC435 treated subjects. In the safety analyses, special attention was given to the following AEs of interest: hepatobiliary AEs, pruritus, rash, anemia, and cardiac events. For each category of AEs of interest; the incidence was similar between TMC435 and placebo.
In laboratory parameters, there were no clinically relevant differences between any TMC435 groups and placebo except for mild on treatment reversible bilirubin elevations (total, direct and indirect) in the 150 mg TMC435 arm, which were normalized after TMC435 dosing was completed. There were no meaningful differences between treatment groups for any of the other laboratory parameters. Significant and rapid decreases in transaminases (ALT and AST) were observed in all TMC435 treatment groups.
HUDDINGE, Sweden, February 22, 2011 /PRNewswire-FirstCall/ -- Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces today further positive results from the phase 2b PILLAR (C205) study of TMC435 in treatment-naive patients with hepatitis C virus (HCV) genotype-1.
- TMC435 was safe and well tolerated with no clinically
relevant differences in adverse events between treatment groups and
standard of care (SoC).
- In the TMC435 treatment groups 83% of patients were able to stop
all therapy at week 24
- Potent and consistent antiviral efficacy was demonstrated with
SVR24 rates of up to 84%
"We are very pleased by both the efficacy and safety shown by TMC435 in this 48-Week interim analysis. With the additional features of once daily dosing, TMC435 also has a more convenient and competitive dosing regimen" stated Bertil Samuelsson, CSO of Medivir. "The recently published start of three global phase 3 clinical trials is an important milestone in the continued development of TMC435. We are now looking forward to the 48-week interim data from the phase 2b trial C206 (ASPIRE) in treatment-experienced patients during Q2 2011."
The 48-week interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naive patients showed further consistent high antiviral activity, and the good safety and tolerability previously demonstrated was confirmed. The 24-week (EOT) interim results were presented at the AASLD conference in Boston, MA, in November 2010.
Study design
In the PILLAR study, 75mg or 150mg TMC435 was given for either 12 or 24 weeks in combination with 24 weeks of ribavirin and pegIFNalpha-2A, the current standard of care (SoC). Patients in the TMC435 arms stopped all treatment at week 24 if certain predefined response-guided criteria were met. In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24. Patients who did not meet the above response-guided criteria continued with SoC until week 48 as did the placebo group.
Evaluation criteria
A protocol-defined interim analysis was performed when all patients completed their Week 48 visit or discontinued treatment earlier. Final SVR4 and SVR24 data were available for 98% (303/309; n/N) and 93% (288/309; n/N) of TMC435 treated patients, respectively. SVR24 is determined 24 weeks after the planned end of treatment (EoT) and was therefore not yet available for the patients in the placebo group and for some of those in the TMC435 group who received 48 weeks of treatment. SVR4, which is determined 4 weeks after the planned EoT, was available for 77% (59/77; n/M) of the patients in the placebo group.
Results - Efficacy
Potent and sustained antiviral efficacy was demonstrated in the SVR4 and SVR24 rates with no major differences between TMC435 doses or length of triple therapy. At week 4 after cessation of treatment 87.2%, 86.5%, 84.9% and 88.5% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels. At week 24 after cessation of treatment 83.6%, 76.1%, 83.1% and 84.4% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels, i.e. SVR24. At week 4 after cessation of treatment 71.2% in the placebo SoC group had achieved undetectable HCV RNA levels.
The results are derived from an intent-to-treat (ITT) analysis of the patient population who took at least one dose of the study medication and who reached the criteria for stopping all treatment at 24 weeks (83%).
Sustained Virological Response 4 and 24 Weeks after Planned End of
Treatment (EoT);
TMC435 TMC435 TMC435 TMC435 Placebo
12PR24 24PR24 12PR24 24PR24
75mg q.d. 75mg q.d. 150mg q.d. 150mg q.d.
% (n/N) N=78 N=75 N=77 N=79 N=77
SVR4 87.2 (68/78) 86.5 (64/74) 84.9 (62/73) 88.5 (69/78) 71.2 (42/59)
SVR24 83.6 (61/73) 76.1 (51/67) 83.1 (59/71) 84.4 (65/77) N/A
* < 25 log10 IU/mL undetectable
q.d.: once daily, PR: pegIFNalpha-2A and ribavirin,
SVR4 and SVR24: patients with undetectable HCV RNA 4 and 24 weeks after planned EoT, respectively. N/A: Patients in the control arm continue SoC until Week 48 and SVR24 data was not available
Results - Safety and Tolerability
TMC435 was generally safe and well tolerated and overall incidence of adverse events (AEs) was similar across treatment groups. AEs leading to discontinuation of TMC435 or placebo treatment were reported in 7.8% of the placebo subjects and in 7.1% of the TMC435 treated subjects. In the safety analyses, special attention was given to the following AEs of interest: hepatobiliary AEs, pruritus, rash, anemia, and cardiac events. For each category of AEs of interest; the incidence was similar between TMC435 and placebo.
In laboratory parameters, there were no clinically relevant differences between any TMC435 groups and placebo except for mild on treatment reversible bilirubin elevations (total, direct and indirect) in the 150 mg TMC435 arm, which were normalized after TMC435 dosing was completed. There were no meaningful differences between treatment groups for any of the other laboratory parameters. Significant and rapid decreases in transaminases (ALT and AST) were observed in all TMC435 treatment groups.
Tuesday, February 22, 2011
Antiviral Activity of Boceprevir Monotherapy inTreatment-Naive Subjects With Chronic Hepatitis C Genotype 2/3...
(From the APASL conference in Thailand. Thanks to Jules Levin and NATAP for the info. Looks like higher trough concentrations of BOC may result in better viral suppression of Genotype 2/3.)
"4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA"
Reported by Jules Levin
Presented at the 21st Conference of the Asian Pacific Association for the Study of the Liver; February 17-20, 2011; Bangkok, Thailand.
M. Silva,1 C. Kasserra,2 S. Gupta,2 M. Treitel,2 E. Hughes,3 E. O'Mara2 1Hospital Universitario Austral, Pilar, Argentina; 2Merck Research Laboratories, Kenilworth, NJ, USA;3Former employee of Merck Research Laboratories, Kenilworth, NJ, USA
AUTHOR CONCLUSIONS
· Boceprevir 400 mg TID is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection that is comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study
· Boceprevir trough concentrations in the 400 mg TID group were higher than the other BID groups and may be associated with the better viral responses that were observed
· Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects is of potential clinical interest
· Overall, boceprevir was well tolerated at doses of 200 mg BID, 400 mg BID, and 400 mg TID
ABSTRACT
Aim: To examine the effect of boceprevir, a novel hepatitis C virus (HCV) protease inhibitor, on HCV-RNA levels in subjects with HCV genotype (G) 2/3 infection.
Methods: This was a randomized, placebo-controlled study evaluating the antiviral activity of boceprevir monotherapy 200 mg BID (n = 11), 400 mg BID (n = 12), and 400 mg TID (n = 6) or placebo (n = 10) for 14 days in treatment-naive subjects.
Results: The maximum mean decrease in HCV-RNA was -0.37 log, -0.24 log, -1.60 log and 0.21 log in the 200 mg BID, 400 mg BID, 400 mg TID and placebo groups, respectively. Decreases in HCV-RNA in subjects receiving 200 mg BID and 400 mg BID were similar to placebo; however, the decrease in HCV-RNA in subjects receiving 400 mg TID was markedly different from placebo. At end of treatment, 4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA. Although the sample size was small, responses appeared similar in G2 (n = 9) and G3 (n = 30) subjects. Pharmacokinetic analysis revealed a less than dose proportional increase in bioavailability. Overall, boceprevir was well-tolerated.
Conclusion: Boceprevir (400 mg TID) is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection, comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study. Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects with detectable HCV RNA at week 4 is of potential clinical interest.
"4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA"
Reported by Jules Levin
Presented at the 21st Conference of the Asian Pacific Association for the Study of the Liver; February 17-20, 2011; Bangkok, Thailand.
M. Silva,1 C. Kasserra,2 S. Gupta,2 M. Treitel,2 E. Hughes,3 E. O'Mara2 1Hospital Universitario Austral, Pilar, Argentina; 2Merck Research Laboratories, Kenilworth, NJ, USA;3Former employee of Merck Research Laboratories, Kenilworth, NJ, USA
AUTHOR CONCLUSIONS
· Boceprevir 400 mg TID is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection that is comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study
· Boceprevir trough concentrations in the 400 mg TID group were higher than the other BID groups and may be associated with the better viral responses that were observed
· Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects is of potential clinical interest
· Overall, boceprevir was well tolerated at doses of 200 mg BID, 400 mg BID, and 400 mg TID
ABSTRACT
Aim: To examine the effect of boceprevir, a novel hepatitis C virus (HCV) protease inhibitor, on HCV-RNA levels in subjects with HCV genotype (G) 2/3 infection.
Methods: This was a randomized, placebo-controlled study evaluating the antiviral activity of boceprevir monotherapy 200 mg BID (n = 11), 400 mg BID (n = 12), and 400 mg TID (n = 6) or placebo (n = 10) for 14 days in treatment-naive subjects.
Results: The maximum mean decrease in HCV-RNA was -0.37 log, -0.24 log, -1.60 log and 0.21 log in the 200 mg BID, 400 mg BID, 400 mg TID and placebo groups, respectively. Decreases in HCV-RNA in subjects receiving 200 mg BID and 400 mg BID were similar to placebo; however, the decrease in HCV-RNA in subjects receiving 400 mg TID was markedly different from placebo. At end of treatment, 4 of 6 subjects receiving 400 mg TID had a >1 log drop in HCV-RNA. Although the sample size was small, responses appeared similar in G2 (n = 9) and G3 (n = 30) subjects. Pharmacokinetic analysis revealed a less than dose proportional increase in bioavailability. Overall, boceprevir was well-tolerated.
Conclusion: Boceprevir (400 mg TID) is associated with a decrease in HCV-RNA in subjects with HCV G2/3 infection, comparable to the viral load drop seen in G1 subjects receiving the same monotherapy dose in a previous study. Evaluation of the clinical dose of boceprevir (800 mg TID) as a component of triple therapy for G2/3-infected subjects with detectable HCV RNA at week 4 is of potential clinical interest.
FDA OKs OraSure's OraQuick HCV Rapid Test...
BETHLEHEM, Pa., Feb. 22, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick® HCV Rapid Antibody Test has now been approved by the U.S. Food and Drug Administration ("FDA") for use in detecting HCV antibodies with a fingerstick whole blood sample. The fingerstick whole blood claim is the second application to be approved by the FDA for the OraQuick® HCV test. The product received an initial approval for use in persons at risk for HCV infection with venous whole blood specimens in June 2010.
The OraQuick® HCV Rapid Antibody Test is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus that is approved by the FDA. The test, which utilizes the OraQuick® technology platform, provides results in 20 minutes.
"Receiving FDA approval to test individuals at risk using a fingerstick whole blood sample significantly expands the flexibility and versatility of our OraQuick® Rapid HCV Antibody Test," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "By eliminating the need for a blood draw, healthcare providers will be able to identify more individuals infected with hepatitis C and get them into care."
There are an estimated 4.1 million Americans, or 1.6 percent of the U.S. population, that are or have been infected with HCV. New infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.
The Company previously received approval to affix the CE mark to its OraQuick HCV test in December 2009 for use with oral fluid, fingerstick whole blood, venous whole blood, serum and plasma. The CE Mark was required in order to sell the product in the European Union.
As previously announced, OraSure has entered into agreements with Merck & Co. (NYSE:MRK), through its predecessor Schering Plough Corp., to collaborate on the development and promotion of the OraQuick HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in the physicians' office markets in the United States and internationally.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of antibodies to HIV.
For more information on the Company, please go to www.orasure.com.
The OraQuick® HCV Rapid Antibody Test is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus that is approved by the FDA. The test, which utilizes the OraQuick® technology platform, provides results in 20 minutes.
"Receiving FDA approval to test individuals at risk using a fingerstick whole blood sample significantly expands the flexibility and versatility of our OraQuick® Rapid HCV Antibody Test," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "By eliminating the need for a blood draw, healthcare providers will be able to identify more individuals infected with hepatitis C and get them into care."
There are an estimated 4.1 million Americans, or 1.6 percent of the U.S. population, that are or have been infected with HCV. New infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.
The Company previously received approval to affix the CE mark to its OraQuick HCV test in December 2009 for use with oral fluid, fingerstick whole blood, venous whole blood, serum and plasma. The CE Mark was required in order to sell the product in the European Union.
As previously announced, OraSure has entered into agreements with Merck & Co. (NYSE:MRK), through its predecessor Schering Plough Corp., to collaborate on the development and promotion of the OraQuick HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in the physicians' office markets in the United States and internationally.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of antibodies to HIV.
For more information on the Company, please go to www.orasure.com.
Monday, February 21, 2011
Conatus Pharmaceuticals starts Phase 2b trial of MMP-Inhibitor CTS-1027 in Null Responders...
Great to see an early phase trial built around the null responder population. The company claims that CTS-1027 also has anti-inflammatory and anti-fibrotic effects which would also be of benefit.
Conatus Pharmaceuticals Inc. announced the treatment of the first patient in a multi-center Phase 2b clinical trial evaluating CTS-1027 in combination with Peginterferon Alfa-2a (Pegasys®) and ribavirin (Copegus®) in a treatment experienced, hepatitis C (HCV) null responder patient population. Safety, tolerability, and antiviral activity of the triple combination will be assessed after up to 48 weeks of therapy.
CTS-1027 is an oral, small molecule compound that inhibits the activity of key members of a class of protease enzymes, the matrix metalloproteinases or MMPs. CTS-1027 has been shown to reduce and/or block HCV infection in in vitro preclinical models and more recently, has displayed the potential to amplify the effectiveness of existing therapies in difficult to treat HCV-infected patients. This is in addition to CTS-1027′s anti-inflammatory and anti-fibrotic effects which have been well established in models of acute hepatitis and liver fibrosis.
“Our previous clinical trials indicate that CTS-1027 used in combination with existing standard-of-care HCV drugs has the potential to impact the second phase of HCV virus inhibitory kinetics in patients. This phase is associated with the gradual reduction and replacement of HCV infected cells by new uninfected liver cells. While reducing HCV virus production in infected cells is extremely important, eliminating HCV-infected cells is crucial to curing HCV,” said Dr. Steven J. Mento, President and CEO of Conatus. “We believe that CTS-1027 represents a novel approach to treating HCV disease and look forward to developing this drug candidate in combination with the existing standard-of-care drugs as well as the new antiviral drugs under development.”
“We have established a collaborative relationship with key opinion leaders and clinical investigators in the hepatitis community,” said Ms. MiRa Huyghe, Vice President of Clinical Development of Conatus. “We are encouraged by our investigators’ interest in CTS-1027 and together with our investigators look forward to offering a new treatment option for HCV null responders.”
“We are excited to participate in this Phase 2b trial of CTS-1027,” said Dr. Paul J. Pockros, Head, Division of Gastroenterology/Hepatology at The Scripps Clinic and Director of the SC Liver Research Consortium in La Jolla, CA. “Current treatment options for HCV null responders are very limited. We believe CTS-1027 may enhance the effectiveness of pegylated interferon and ribavirin in this difficult to treat patient population.”
This clinical trial is a placebo-controlled, multicenter, double-blind, randomized trial of Peginterferon Alfa-2a (Pegasys®) and ribavirin (Copegus®) with or without CTS-1027 in HCV null responders. Dosing will last for up to 48 weeks. The trial will also examine whether higher dose levels of CTS-1027 will improve on previously observed results. The Company expects approximately 260 patients to be enrolled. The clinical trial will be conducted at up to fifty medical centers in the U.S.
Pegasys® and Copegus® are registered trademarks of F. Hoffman-La Roche, Inc.
Source: Conatus Pharmaceuticals
Conatus Pharmaceuticals Inc. announced the treatment of the first patient in a multi-center Phase 2b clinical trial evaluating CTS-1027 in combination with Peginterferon Alfa-2a (Pegasys®) and ribavirin (Copegus®) in a treatment experienced, hepatitis C (HCV) null responder patient population. Safety, tolerability, and antiviral activity of the triple combination will be assessed after up to 48 weeks of therapy.
CTS-1027 is an oral, small molecule compound that inhibits the activity of key members of a class of protease enzymes, the matrix metalloproteinases or MMPs. CTS-1027 has been shown to reduce and/or block HCV infection in in vitro preclinical models and more recently, has displayed the potential to amplify the effectiveness of existing therapies in difficult to treat HCV-infected patients. This is in addition to CTS-1027′s anti-inflammatory and anti-fibrotic effects which have been well established in models of acute hepatitis and liver fibrosis.
“Our previous clinical trials indicate that CTS-1027 used in combination with existing standard-of-care HCV drugs has the potential to impact the second phase of HCV virus inhibitory kinetics in patients. This phase is associated with the gradual reduction and replacement of HCV infected cells by new uninfected liver cells. While reducing HCV virus production in infected cells is extremely important, eliminating HCV-infected cells is crucial to curing HCV,” said Dr. Steven J. Mento, President and CEO of Conatus. “We believe that CTS-1027 represents a novel approach to treating HCV disease and look forward to developing this drug candidate in combination with the existing standard-of-care drugs as well as the new antiviral drugs under development.”
“We have established a collaborative relationship with key opinion leaders and clinical investigators in the hepatitis community,” said Ms. MiRa Huyghe, Vice President of Clinical Development of Conatus. “We are encouraged by our investigators’ interest in CTS-1027 and together with our investigators look forward to offering a new treatment option for HCV null responders.”
“We are excited to participate in this Phase 2b trial of CTS-1027,” said Dr. Paul J. Pockros, Head, Division of Gastroenterology/Hepatology at The Scripps Clinic and Director of the SC Liver Research Consortium in La Jolla, CA. “Current treatment options for HCV null responders are very limited. We believe CTS-1027 may enhance the effectiveness of pegylated interferon and ribavirin in this difficult to treat patient population.”
This clinical trial is a placebo-controlled, multicenter, double-blind, randomized trial of Peginterferon Alfa-2a (Pegasys®) and ribavirin (Copegus®) with or without CTS-1027 in HCV null responders. Dosing will last for up to 48 weeks. The trial will also examine whether higher dose levels of CTS-1027 will improve on previously observed results. The Company expects approximately 260 patients to be enrolled. The clinical trial will be conducted at up to fifty medical centers in the U.S.
Pegasys® and Copegus® are registered trademarks of F. Hoffman-La Roche, Inc.
Source: Conatus Pharmaceuticals
Monday, February 14, 2011
Caring Ambassadors Program Launches Unique New DVD Series "Hepatitis C: Choices in Care"
Not necessarily in the realm of DAAs, but pretty cool and worth the space here on Viral Matters.
OREGON CITY, OR--(Marketwire - February 14, 2011) - The Caring Ambassadors Program (CAP) proudly announces the release of the new DVD series "Hepatitis C: Choices in Care -- Distinctive Viewpoints on Choices for Your Hepatitis C Journey." The 2-disc set offers over nine hours of leading expert physician interviews, patient consultations, panel discussions, Power Point presentations and 30 minutes of Qi Gong exercises specifically geared towards people living with hepatitis C.
About five million Americans are infected with HCV, making hepatitis C the most common chronic blood-borne viral illness in the U.S. HCV is the leading cause of chronic liver disease and liver cancer in the U.S. and the most common indication for liver transplantation. In January 2010, the Institute of Medicine (IOM) released its report, "Hepatitis and Liver Cancer, A National Strategy for the Prevention and Control of Viral Hepatitis." The committee found that many health care providers lack an adequate knowledge of HCV and that chronic hepatitis C patients are often confused about their treatment and disease management options.
The DVD series addresses these knowledge gaps by providing a shorter version of the book, Hepatitis C Choices, 4th Edition. The book presents evidence-based conventional and alternative treatment options and is the collective effort of leading medical experts and hepatitis C patient advocates. It is still the only book, and now DVD, of its kind.
"I was scared and did not know which way to turn when I was diagnosed with hepatitis C. I had a lot of unanswered questions," said Randy Dietrich, Board Chair of the Caring Ambassadors Program. "This information combined with the book was what I wanted to make an informed decision about my care."
The Caring Ambassadors Program produced "Hepatitis C: Choices in Care" to educate the public and health care community about hepatitis C. CAP believes it is vitally important that everyone with hepatitis C virus (HCV) know their disease status and have accurate and ample information to make the best health care decisions. Education is essential for making informed choices and taking charge of one's health.
"Hepatitis C: Choices in Care" is available for free viewing at the Caring Ambassadors Program Hepatitis C website at www.hepcchallenge.org. The entire DVD series "Hepatitis C: Choices in Care" can also be purchased for $10.00 plus shipping and handling.
Contact:
Lorren Sandt
503-632-9030
Lorren@HepCChallenge.org
OREGON CITY, OR--(Marketwire - February 14, 2011) - The Caring Ambassadors Program (CAP) proudly announces the release of the new DVD series "Hepatitis C: Choices in Care -- Distinctive Viewpoints on Choices for Your Hepatitis C Journey." The 2-disc set offers over nine hours of leading expert physician interviews, patient consultations, panel discussions, Power Point presentations and 30 minutes of Qi Gong exercises specifically geared towards people living with hepatitis C.
About five million Americans are infected with HCV, making hepatitis C the most common chronic blood-borne viral illness in the U.S. HCV is the leading cause of chronic liver disease and liver cancer in the U.S. and the most common indication for liver transplantation. In January 2010, the Institute of Medicine (IOM) released its report, "Hepatitis and Liver Cancer, A National Strategy for the Prevention and Control of Viral Hepatitis." The committee found that many health care providers lack an adequate knowledge of HCV and that chronic hepatitis C patients are often confused about their treatment and disease management options.
The DVD series addresses these knowledge gaps by providing a shorter version of the book, Hepatitis C Choices, 4th Edition. The book presents evidence-based conventional and alternative treatment options and is the collective effort of leading medical experts and hepatitis C patient advocates. It is still the only book, and now DVD, of its kind.
"I was scared and did not know which way to turn when I was diagnosed with hepatitis C. I had a lot of unanswered questions," said Randy Dietrich, Board Chair of the Caring Ambassadors Program. "This information combined with the book was what I wanted to make an informed decision about my care."
The Caring Ambassadors Program produced "Hepatitis C: Choices in Care" to educate the public and health care community about hepatitis C. CAP believes it is vitally important that everyone with hepatitis C virus (HCV) know their disease status and have accurate and ample information to make the best health care decisions. Education is essential for making informed choices and taking charge of one's health.
"Hepatitis C: Choices in Care" is available for free viewing at the Caring Ambassadors Program Hepatitis C website at www.hepcchallenge.org. The entire DVD series "Hepatitis C: Choices in Care" can also be purchased for $10.00 plus shipping and handling.
Contact:
Lorren Sandt
503-632-9030
Lorren@HepCChallenge.org
Friday, February 11, 2011
FDA gives Inhibitex treatment 'fast track' status
FDA gives Inhibitex treatment 'fast track' status
Feb 11, 2011
By The Associated Press
Biopharmaceutical company Inhibitex Inc. said Friday the Food and Drug Administration has designated its potential chronic hepatitis C treatment as a Fast Track development program.
The designation could help development and accelerate the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
The Alpharetta, Ga., company said the potential treatment, labeled INX-08189, is in an early-stage trial expected to be completed by the end of the first quarter. Inhibitex said characteristics of the drug that led to its Fast Track designation include a high genetic barrier to resistance and once-daily oral dosing.
Hepatitis C is a liver disease, and chronic cases of it are the leadng cause of liver transplants in the United States, according to Inhibitex.
Feb 11, 2011
By The Associated Press
Biopharmaceutical company Inhibitex Inc. said Friday the Food and Drug Administration has designated its potential chronic hepatitis C treatment as a Fast Track development program.
The designation could help development and accelerate the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
The Alpharetta, Ga., company said the potential treatment, labeled INX-08189, is in an early-stage trial expected to be completed by the end of the first quarter. Inhibitex said characteristics of the drug that led to its Fast Track designation include a high genetic barrier to resistance and once-daily oral dosing.
Hepatitis C is a liver disease, and chronic cases of it are the leadng cause of liver transplants in the United States, according to Inhibitex.
Medivir Announces Start of Phase 1a Trial of the Hepatitis C Polymerase Inhibitor TMC649128
Medivir Announces Start of Phase 1a Trial of the Hepatitis C Polymerase Inhibitor TMC649128
10-Feb-11 Huddinge, Sweden - Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases,today announces the start of a phase 1a clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus infection.
TMC649128 is a nucleoside NS5B polymerase inhibitor that has already demonstrated an attractive pre-clinical profile. It is anticipated that this profile would see TMC649128 be used in combination with HCV directly acting antiviral agents, given their high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.
In pre-clinical studies, TMC649128 displayed in vitro activity across multiple HCV genotypes and a high genetic barrier to resistance.
The phase 1a trial is a double-blind, randomized, placebo-controlled single-ascending dose trial to assess the safety, tolerability and pharmacokinetics in healthy volunteers and will be conducted in Belgium. TMC649128 is being developed in collaboration with Tibotec Pharmaceuticals.
Milestone payment
Medivir entered a Research and Development agreement in the field of hepatitis C virus polymerase with Ortho Biotech Products LP, an affiliate of Tibotec in May 2008. The development of TMC649128 falls under this agreement and by entering clinical development, a milestone payment of Euro 7 million has been triggered for payment to Medivir.
“We are extremely excited to see TMC649128, our first HCV nucleoside inhibitor, move into clinical development”, stated Bertil Samuelsson, CSO of Medivir. "The start of this phase 1a trial underlines Medivir’s commitment to the development of novel and innovative hepatitis C treatments. We view nucleoside inhibitors as cornerstone components of future HCV treatment paradigms in combination with directly acting antiviral agents and a TMC649128 component could set them apart from other HCV drug classes.”
For more information about Medivir, please contact;
Medivir (www.medivir.se) Rein Piir, CFO & VP Investor Relations Mobile: +46 708 537 292
M:Communications Europe: Mary-Jane Elliott / Amber Bielecka / Nick Francis Medivir@mcomgroup.com (Medivir@mcomgroup.com)
+44(0)20 7920 2330
USA: Jason Marshall +1 212 897 5497
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir’s Commitment of the HCV Area
Medivir and Tibotec are also jointly developing the once daily protease inhibitor TMC435 for treatment of hepatitis C virus infections (HCV).
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese™/Xerclear®. Medivir’s key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.
Xerese™/Xerclear® is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GlaxoSmithKline to be sold OTC in Europe and Russia and with Meda AB in North America. Medivir has retained the Rx rights for Xerclear® in Sweden and Finland.
For more information about Medivir, please visit the Company’s website: www.medivir.se.
10-Feb-11 Huddinge, Sweden - Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases,today announces the start of a phase 1a clinical trial with TMC649128 intended for the treatment of chronic hepatitis C virus infection.
TMC649128 is a nucleoside NS5B polymerase inhibitor that has already demonstrated an attractive pre-clinical profile. It is anticipated that this profile would see TMC649128 be used in combination with HCV directly acting antiviral agents, given their high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.
In pre-clinical studies, TMC649128 displayed in vitro activity across multiple HCV genotypes and a high genetic barrier to resistance.
The phase 1a trial is a double-blind, randomized, placebo-controlled single-ascending dose trial to assess the safety, tolerability and pharmacokinetics in healthy volunteers and will be conducted in Belgium. TMC649128 is being developed in collaboration with Tibotec Pharmaceuticals.
Milestone payment
Medivir entered a Research and Development agreement in the field of hepatitis C virus polymerase with Ortho Biotech Products LP, an affiliate of Tibotec in May 2008. The development of TMC649128 falls under this agreement and by entering clinical development, a milestone payment of Euro 7 million has been triggered for payment to Medivir.
“We are extremely excited to see TMC649128, our first HCV nucleoside inhibitor, move into clinical development”, stated Bertil Samuelsson, CSO of Medivir. "The start of this phase 1a trial underlines Medivir’s commitment to the development of novel and innovative hepatitis C treatments. We view nucleoside inhibitors as cornerstone components of future HCV treatment paradigms in combination with directly acting antiviral agents and a TMC649128 component could set them apart from other HCV drug classes.”
For more information about Medivir, please contact;
Medivir (www.medivir.se) Rein Piir, CFO & VP Investor Relations Mobile: +46 708 537 292
M:Communications Europe: Mary-Jane Elliott / Amber Bielecka / Nick Francis Medivir@mcomgroup.com (Medivir@mcomgroup.com)
+44(0)20 7920 2330
USA: Jason Marshall +1 212 897 5497
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
About Medivir’s Commitment of the HCV Area
Medivir and Tibotec are also jointly developing the once daily protease inhibitor TMC435 for treatment of hepatitis C virus infections (HCV).
About Medivir
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese™/Xerclear®. Medivir’s key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.
Xerese™/Xerclear® is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GlaxoSmithKline to be sold OTC in Europe and Russia and with Meda AB in North America. Medivir has retained the Rx rights for Xerclear® in Sweden and Finland.
For more information about Medivir, please visit the Company’s website: www.medivir.se.
Saturday, February 5, 2011
Cytokine Stimulation May Work as Hepatitis C or HIV Treatment, Clinical Research Shows...
According to a new study conducted by a team of Australian scientists, boosting the immune system in mice can clear them of HIV-like infection. Led by Dr. Marc Pellegrini from the Walter and Eliza Hall Institute, the research team showed that a cell signaling hormone called interleukin-7 (IL-7) reinvigorates the immune response to chronic viral infection, allowing the host to clear the virus completely.
Moreover, Pellegrini is confident the finding could lead to a cure for chronic viral infections such as HIV, hepatitis B, hepatitis C, and bacterial infections such as tuberculosis, which are great economic and global health issues.
For the new study, the team of researchers investigated the role of the cell signaling hormone IL-7, a naturally occurring immune hormone, in a mouse version of HIV infection. IL-7 is a cytokine (cell signaling hormone) with a key role in immune system development and maintenance. The research found that IL-7 boosted the immune response “in a pretty profound fashion”, said Pellegrini, noting that the animals were able to gradually clear the virus without much collateral tissue damage.
In addition, further investigations revealed that at the molecular level IL-7 switched off a gene called SOCS-3. According to Pellegrini, in an overwhelming infection the SOCS-3 gene become highly activated and suppresses the immune response, likely as a natural precaution in order to prevent “out-of-control” responses that would cause collateral damage to body issue.
The lead researcher noted that in the case of such overwhelming infections, the immune system effectively stops too early and the infection persists. Co-researcher on the SOCS-3 studies, Preston said switching off the SOCS-3 gene boosted the immune system and allowed the animals to completely eliminate the infection.
Original article: http://www.staho.com/immune-system-boosters-may-work-as-hepatitis-c-or-hiv-treatment-clinical-research-shows/2011327/
Moreover, Pellegrini is confident the finding could lead to a cure for chronic viral infections such as HIV, hepatitis B, hepatitis C, and bacterial infections such as tuberculosis, which are great economic and global health issues.
For the new study, the team of researchers investigated the role of the cell signaling hormone IL-7, a naturally occurring immune hormone, in a mouse version of HIV infection. IL-7 is a cytokine (cell signaling hormone) with a key role in immune system development and maintenance. The research found that IL-7 boosted the immune response “in a pretty profound fashion”, said Pellegrini, noting that the animals were able to gradually clear the virus without much collateral tissue damage.
In addition, further investigations revealed that at the molecular level IL-7 switched off a gene called SOCS-3. According to Pellegrini, in an overwhelming infection the SOCS-3 gene become highly activated and suppresses the immune response, likely as a natural precaution in order to prevent “out-of-control” responses that would cause collateral damage to body issue.
The lead researcher noted that in the case of such overwhelming infections, the immune system effectively stops too early and the infection persists. Co-researcher on the SOCS-3 studies, Preston said switching off the SOCS-3 gene boosted the immune system and allowed the animals to completely eliminate the infection.
Original article: http://www.staho.com/immune-system-boosters-may-work-as-hepatitis-c-or-hiv-treatment-clinical-research-shows/2011327/
Wednesday, February 2, 2011
Xconomy Biotech Editor Luke Timmerman on Vertex's push for CDC to increase HCV testing...
Seems like Luke gets the big picture and that's good. There is a ton of HCV out there, the current standard of care only works 40% of the time, and the costs associated with the burden of disease will be astronomical, with the majority of the cost falling on government payors. The details that need to be ironed out include questions such as what is to be done with patients who fail DAA therapy with the hopes of adequate sequential therapy still 2-3 years down the road? What does HCV resistance mean and is re-treatment a possibility? What are the implications of drug interactions? With the DAAs being such a 'high touch' drug, what are the economic incentives for a provider to treat given that current reimbursement rates are so low? What are the costs associated with patient non-adherence? What are the pros and cons for-profit corporations having a say in shaping public policy? No doubt the DAAs will represent a groundbreaking therapy for HCV, but with only 4-5 months before their potential launch, there are still many unanswered questions.
Vertex Urges CDC to Recommend Hep C Screening, To Nudge “Second Tsunami” of Patients
Luke Timmerman 2/2/11
If Vertex Pharmaceuticals gets its way in talks with U.S. public health officials, most people over 50 could soon get blood tests to screen for hepatitis C infections at the doctor’s office. If the U.S. Centers for Disease Control and Prevention (CDC) agrees this is a good idea, it could prompt another 1 million patients who don’t realize they are infected to come out of the woodwork and start clamoring for Vertex’s new hepatitis C drug over the next few years.
The Cambridge, MA-based biotech company (NASDAQ: VRTX), which has operations in San Diego, has joined other drugmakers in supporting studies they hope will persuade the CDC to recommend routine screening for hepatitis C, Vertex CEO Matt Emmens said in a recent interview. The company is one of the sponsors of what’s called the Viral Hepatitis Action Coalition, a public-private partnership with the CDC, which is conducting studies known as BEST-C. These studies could determine how effective it is to screen patients for hepatitis C infection more widely.
These studies, which are expected to cost a total of $3.6 million, could be worth billions to Vertex if they show that screening random Baby Boomers is worthwhile.
An estimated 600,000 patients in the U.S. are expected to seek treatment that could include Vertex’s drug, or a rival offering from Merck, if the FDA clears the new drugs for sale as analysts expect in the middle of this year. The two new protease inhibitors are being hailed as major steps forward, as they have been shown to roughly double cure rates of hepatitis C, a viral infection that damages the liver over many years. Vertex’s drug, telaprevir, has shown it can push the cure rate up as high as about 75 percent, while cutting the treatment time in half to about six months. That means patients don’t have to endure such a long period of flu-like symptoms, which has traditionally discouraged many patients from getting treatment.
The new advance from Vertex, demonstrated in a trio of pivotal clinical trials, has created this huge wave of pent-up demand from patients and doctors. Knowing this, many analysts have projected the product will be pretty much an instant hit, topping $2 billion in U.S. sales after just a couple years. But then, some expect sales to taper off, as many of the most motivated patients get cured, and don’t need the drug anymore. Essentially, they see Vertex possibly becoming a victim of its own success.
That’s not how it will play out, says Emmens, a marketing veteran who spent much of his career at Merck. An estimated 3.2 million to 3.9 million people in the U.S. have chronic hepatitis C infections. That’s a lot more than the initial wave of patients, which is mostly composed of people who sought treatment before but relapsed. Besides those patients, many more candidates are Baby Boomers who don’t know they contracted the hepatitis C infection decades ago through unprotected sex, IV drug use, or blood transfusions from contaminated supplies. Many of these infections lie dormant for about 20 years or more, but are just now starting to emerge over the decade to come, Emmens says. Some patients won’t see symptoms at all, and as the AP pointed out in this solid feature last month, it’s hard to tell which infected patients are likely to get the worst symptoms. The unluckiest ones will end up suffering severe liver scarring (cirrhosis), liver cancer, liver transplants, and ultimately, premature death.
Connecting with that massive crowd of patients, who aren’t motivated to seek treatment today because they don’t see any really bad symptoms yet, is one of the big marketing challenges Vertex faces. The company is planning to spend some of its $1.3 billion cash hoard on a public awareness campaign designed to urge people to get tested to see if they have the virus, Emmens says. But even more important than the ad campaign, Vertex is hoping the CDC will recommend routine hepatitis C screening, which would start turning up a lot more positive tests. If it does, Emmens he predicts it could prompt another 1 million patients to seek treat treatment around 2014 and later, right as the most people in the initial wave of highly motivated patients go home having been cured.
“You have an estimated 2 million people out there who are not aware they are infected,” Emmens says. “Some don’t know, or just don’t give a damn, or have other problems, and won’t seek treatment. But if you found 1 million new patients over a two or three-year period, there’s a second tsunami.”
As for analysts predicting telaprevir will rise and fall, Emmens shook his head. “That’s absurd. I understand they’ve got to do their job. But from a marketing guy’s perspective, that just doesn’t happen unless you lose your patent,” Emmens says. “Docs use what works. Patients will come in, and they will want the highest chance they can get of a cure. That’s what they really care about.” A shorter treatment period, and more convenient twice-daily dosing instead of thrice-daily are a couple of other features Vertex is hoping to incorporate into hepatitis C treatment, he adds.
Vertex has clearly been spending a lot of time lately thinking about making its case to insurers. The trick will be to persuade insurers that it’s worth spending quite a bit of money upfront on a potent new drug to attack a dormant infection, as opposed to waiting to see if patients get sick years later and rack up big hospital bills. Emmens notes that liver transplants cost around $300,000, and, obviously, not everyone who wants a new liver actually survives long enough to get to the top of the waiting list. Vertex, citing an actuarial study it sponsored to try to measure the cost of future treatment, says medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion—presumably when factoring in a lot of liver transplants.
I must say I’m personally wary of drugmakers who use their money and influence to rewrite health guidelines that end up favoring their bottom line. Companies that want to sell more drugs for high blood pressure, osteoporosis, and obesity have been known to push for new health guidelines that classify many more people as “Suddenly Sick” as a couple of my former Seattle Times colleagues wrote in a terrific investigative story in 2005. Whether this aggressive new treatment is really beneficial to people’s health over the long run is often unknown.
This case strikes me as somewhat different, though, because today’s available hepatitis C treatment is really so poor. Vertex and Merck are essentially coming along with drugs that represent a big leap ahead with potential to cure hundreds of thousands, maybe millions, of people. It will probably cost taxpayers a few billion dollars a year for many years to come, and it’s always hard to say for sure how many billions you might save down the road when people don’t end up in the hospital getting liver transplants. But you can be sure Vertex is working hard behind the scenes right now to convince officials that an ounce of prevention is worth a pound of cure.
Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. You can e-mail him at ltimmerman@xconomy.com, or follow him at twitter.com/ldtimmerman.
Original article: http://www.xconomy.com/boston/2011/02/02/vertex-urges-cdc-to-recommend-hep-c-screening-to-nudge-second-tsunami-of-patients/
Vertex Urges CDC to Recommend Hep C Screening, To Nudge “Second Tsunami” of Patients
Luke Timmerman 2/2/11
If Vertex Pharmaceuticals gets its way in talks with U.S. public health officials, most people over 50 could soon get blood tests to screen for hepatitis C infections at the doctor’s office. If the U.S. Centers for Disease Control and Prevention (CDC) agrees this is a good idea, it could prompt another 1 million patients who don’t realize they are infected to come out of the woodwork and start clamoring for Vertex’s new hepatitis C drug over the next few years.
The Cambridge, MA-based biotech company (NASDAQ: VRTX), which has operations in San Diego, has joined other drugmakers in supporting studies they hope will persuade the CDC to recommend routine screening for hepatitis C, Vertex CEO Matt Emmens said in a recent interview. The company is one of the sponsors of what’s called the Viral Hepatitis Action Coalition, a public-private partnership with the CDC, which is conducting studies known as BEST-C. These studies could determine how effective it is to screen patients for hepatitis C infection more widely.
These studies, which are expected to cost a total of $3.6 million, could be worth billions to Vertex if they show that screening random Baby Boomers is worthwhile.
An estimated 600,000 patients in the U.S. are expected to seek treatment that could include Vertex’s drug, or a rival offering from Merck, if the FDA clears the new drugs for sale as analysts expect in the middle of this year. The two new protease inhibitors are being hailed as major steps forward, as they have been shown to roughly double cure rates of hepatitis C, a viral infection that damages the liver over many years. Vertex’s drug, telaprevir, has shown it can push the cure rate up as high as about 75 percent, while cutting the treatment time in half to about six months. That means patients don’t have to endure such a long period of flu-like symptoms, which has traditionally discouraged many patients from getting treatment.
The new advance from Vertex, demonstrated in a trio of pivotal clinical trials, has created this huge wave of pent-up demand from patients and doctors. Knowing this, many analysts have projected the product will be pretty much an instant hit, topping $2 billion in U.S. sales after just a couple years. But then, some expect sales to taper off, as many of the most motivated patients get cured, and don’t need the drug anymore. Essentially, they see Vertex possibly becoming a victim of its own success.
That’s not how it will play out, says Emmens, a marketing veteran who spent much of his career at Merck. An estimated 3.2 million to 3.9 million people in the U.S. have chronic hepatitis C infections. That’s a lot more than the initial wave of patients, which is mostly composed of people who sought treatment before but relapsed. Besides those patients, many more candidates are Baby Boomers who don’t know they contracted the hepatitis C infection decades ago through unprotected sex, IV drug use, or blood transfusions from contaminated supplies. Many of these infections lie dormant for about 20 years or more, but are just now starting to emerge over the decade to come, Emmens says. Some patients won’t see symptoms at all, and as the AP pointed out in this solid feature last month, it’s hard to tell which infected patients are likely to get the worst symptoms. The unluckiest ones will end up suffering severe liver scarring (cirrhosis), liver cancer, liver transplants, and ultimately, premature death.
Connecting with that massive crowd of patients, who aren’t motivated to seek treatment today because they don’t see any really bad symptoms yet, is one of the big marketing challenges Vertex faces. The company is planning to spend some of its $1.3 billion cash hoard on a public awareness campaign designed to urge people to get tested to see if they have the virus, Emmens says. But even more important than the ad campaign, Vertex is hoping the CDC will recommend routine hepatitis C screening, which would start turning up a lot more positive tests. If it does, Emmens he predicts it could prompt another 1 million patients to seek treat treatment around 2014 and later, right as the most people in the initial wave of highly motivated patients go home having been cured.
“You have an estimated 2 million people out there who are not aware they are infected,” Emmens says. “Some don’t know, or just don’t give a damn, or have other problems, and won’t seek treatment. But if you found 1 million new patients over a two or three-year period, there’s a second tsunami.”
As for analysts predicting telaprevir will rise and fall, Emmens shook his head. “That’s absurd. I understand they’ve got to do their job. But from a marketing guy’s perspective, that just doesn’t happen unless you lose your patent,” Emmens says. “Docs use what works. Patients will come in, and they will want the highest chance they can get of a cure. That’s what they really care about.” A shorter treatment period, and more convenient twice-daily dosing instead of thrice-daily are a couple of other features Vertex is hoping to incorporate into hepatitis C treatment, he adds.
Vertex has clearly been spending a lot of time lately thinking about making its case to insurers. The trick will be to persuade insurers that it’s worth spending quite a bit of money upfront on a potent new drug to attack a dormant infection, as opposed to waiting to see if patients get sick years later and rack up big hospital bills. Emmens notes that liver transplants cost around $300,000, and, obviously, not everyone who wants a new liver actually survives long enough to get to the top of the waiting list. Vertex, citing an actuarial study it sponsored to try to measure the cost of future treatment, says medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion—presumably when factoring in a lot of liver transplants.
I must say I’m personally wary of drugmakers who use their money and influence to rewrite health guidelines that end up favoring their bottom line. Companies that want to sell more drugs for high blood pressure, osteoporosis, and obesity have been known to push for new health guidelines that classify many more people as “Suddenly Sick” as a couple of my former Seattle Times colleagues wrote in a terrific investigative story in 2005. Whether this aggressive new treatment is really beneficial to people’s health over the long run is often unknown.
This case strikes me as somewhat different, though, because today’s available hepatitis C treatment is really so poor. Vertex and Merck are essentially coming along with drugs that represent a big leap ahead with potential to cure hundreds of thousands, maybe millions, of people. It will probably cost taxpayers a few billion dollars a year for many years to come, and it’s always hard to say for sure how many billions you might save down the road when people don’t end up in the hospital getting liver transplants. But you can be sure Vertex is working hard behind the scenes right now to convince officials that an ounce of prevention is worth a pound of cure.
Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. You can e-mail him at ltimmerman@xconomy.com, or follow him at twitter.com/ldtimmerman.
Original article: http://www.xconomy.com/boston/2011/02/02/vertex-urges-cdc-to-recommend-hep-c-screening-to-nudge-second-tsunami-of-patients/
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