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.
Monday, November 22, 2010
Electronic patient diaries vs on-site side-effect reports: A case study featuring Locteron
Very nice article here on the power of ePRO (Electronic patient diaries) vs on-site patient reports to the physician on adverse events. It appears that evolving technology is helping to undermine the incidence of under-reporting of adverse events. This particular example adds credibility to Biolex's Locteron (Interferon Lambda) Phase IIb trial.
Biolex reveals ePRO surprise; selection process
By George Miller
Created Nov 22 2010 - 1:32am
Biolex CEO Jan Turek notes something unforeseen in the ePRO element of the company's recent trial of a hepatitis C treatment: The degree of difference in reports of side-effect severity in the weekly case report forms completed by clinicians versus the daily ePRO accounts of trial volunteers. Some 85 percent of reports by doctors describe mild side-effects, whereas the volunteers reporting electronically most often rated the severity as moderate or severe.
It was "a surprise to us and our key opinion leaders," Turek says in a phone interview. "It brought home the need for patient reports to be taken more seriously."
Findings from the trial do, however, reflect commonality between the reporting media types in the trial's side-effect result--a statistically significant 40 to 50 percent drop in the frequency and severity of flu-like symptoms for the 480-microgram dose of Biolex's Locteron compared with the PEG-Intron control.
Researchers were tracking the flu-like symptoms as a means of comparing the treatments in the Phase IIb trial. "What you measure drives how you gather data," explains Biolex CFO Dale Sander in the interview. Investigators as well as the key opinion leaders thought ePRO fit the bill. The side-effect data collected through the ePRO system are considered supplemental to the reports taken during weekly clinic visits.
Biolex used an ePRO system from Unithink [1] in the global trial. Among the key factors in its choice was the system's ability to instantaneously receive reports and capture them in the EDC system, rather than a set-up that involves reporting and later docking and uploading, says Amy Rigney, clinical ops director. "That was a differentiator."
Another was ease of patient use. "We wanted to be sure the ePRO system was programmed for several languages." Also, ePRO/EDC set-up allowed trial volunteers to report side effects via cellphone or laptop. "It didn't force the issue one way or the other," she says.
Biolex evaluated available ePRO systems in 2008 and had several months of discussions involving investigators, the data management group, and the clinical group. The company's IT team participated throughout the process to ensure overall systems compatibility, says Rigney, including the final selection of Unithink.
"Volunteers' recall and ability to assess a side effect is better when they are entering the data simultaneous with the event," she says. "You're getting it unfiltered."
Biolex reveals ePRO surprise; selection process
By George Miller
Created Nov 22 2010 - 1:32am
Biolex CEO Jan Turek notes something unforeseen in the ePRO element of the company's recent trial of a hepatitis C treatment: The degree of difference in reports of side-effect severity in the weekly case report forms completed by clinicians versus the daily ePRO accounts of trial volunteers. Some 85 percent of reports by doctors describe mild side-effects, whereas the volunteers reporting electronically most often rated the severity as moderate or severe.
It was "a surprise to us and our key opinion leaders," Turek says in a phone interview. "It brought home the need for patient reports to be taken more seriously."
Findings from the trial do, however, reflect commonality between the reporting media types in the trial's side-effect result--a statistically significant 40 to 50 percent drop in the frequency and severity of flu-like symptoms for the 480-microgram dose of Biolex's Locteron compared with the PEG-Intron control.
Researchers were tracking the flu-like symptoms as a means of comparing the treatments in the Phase IIb trial. "What you measure drives how you gather data," explains Biolex CFO Dale Sander in the interview. Investigators as well as the key opinion leaders thought ePRO fit the bill. The side-effect data collected through the ePRO system are considered supplemental to the reports taken during weekly clinic visits.
Biolex used an ePRO system from Unithink [1] in the global trial. Among the key factors in its choice was the system's ability to instantaneously receive reports and capture them in the EDC system, rather than a set-up that involves reporting and later docking and uploading, says Amy Rigney, clinical ops director. "That was a differentiator."
Another was ease of patient use. "We wanted to be sure the ePRO system was programmed for several languages." Also, ePRO/EDC set-up allowed trial volunteers to report side effects via cellphone or laptop. "It didn't force the issue one way or the other," she says.
Biolex evaluated available ePRO systems in 2008 and had several months of discussions involving investigators, the data management group, and the clinical group. The company's IT team participated throughout the process to ensure overall systems compatibility, says Rigney, including the final selection of Unithink.
"Volunteers' recall and ability to assess a side effect is better when they are entering the data simultaneous with the event," she says. "You're getting it unfiltered."
Sunday, November 21, 2010
Phase II results of Gilead's GS 9190 & GS 9256 in combo with SOC....
Missed this during AASLD for some reason. Gilead has a big commitment to HCV, bringing in HCV thought leader heavy-weight/clinical research mogul John McHutchison, MD, from Duke as Senior Vice President, Liver Disease Therapeutics. They now boast seven unique molecules spanning six therapeutic classes with different mechanisms of action, five of which are in clinical trials and two going in to the clinic in '11. As for the Phase II trial presented as a late breaker oral session at AASLD, GS 9190 and GS 9256 look very good from an efficacy and tolerability standpoint. It's pretty clear that Peg-INF and especially Ribavirin aren't going anywhere. This should make the folks at Three Rivers/Kadmon pretty happy given that they've cornered the both the current and future branded Ribavirin market at a time when pill count and tolerability are going to be a huge factor for STAT-C therapy. Can't hurt the prospects for Locteron either. - Chris
Gilead's Investigational Hepatitis C Compounds GS 9190 and GS 9256 in Combination with Standard of Care Therapies Achieve Substantial Viral Suppression in Phase II Study
-- Compounds Among the Company's Seven HCV Pipeline Candidates Spanning Six Therapeutic Classes --
BOSTON, Oct 30, 2010 (BUSINESS WIRE) -- Gilead Sciences, Inc today announced data from a Phase IIa study showing that its investigational compounds GS 9190 and GS 9256, used in conjunction with current standard of care therapies, produced substantial suppression of the hepatitis C virus (HCV) within 28 days of treatment. The findings are being presented Monday, November 1, during a latebreaker oral session (#LB-1) at the 61st annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2010) in Boston.
"Patients with chronic hepatitis C urgently need new and better treatment options, particularly combination therapies involving antiviral drugs that employ multiple mechanisms of action to eradicate the virus," said the study's principal investigator, Stefan Zeuzem, MD, JW Goethe University Hospital, Frankfurt, Germany. "The data presented today support the continued clinical evaluation of GS 9190 and GS 9256 in combination with other hepatitis C therapies and provide additional clinical insight into the effect of ribavirin in the absence of interferon."
More than seven million people in industrialized countries are chronically infected with HCV, and as many as three million Americans have the disease. The current standard of care in HCV therapy is the oral antiviral ribavirin (RBV), administered in combination with peg-interferon (Peg-IFN), which is delivered via injection and achieves a sustained therapeutic response in only 40-55 percent of patients with HCV genotype 1, the most common form of HCV in the Americas and Europe.(1)
Gilead's three-arm Phase IIa trial (Study 196-0112) evaluated the safety and efficacy of GS 9190, an oral polymerase inhibitor, in combination with GS 9256, an oral protease inhibitor, when used as: 1) a dual antiviral therapy alone; 2) a three-drug regimen with RBV; or 3) a four-drug regimen with RBV and Peg-IFN. The study found that the all-oral regimen of GS 9190, GS 9256 and RBV produced substantial viral suppression, with a median maximal decline from baseline in HCV RNA of 5.1 log10 IU/mL during 28 days of treatment. Among patients given the four-drug regimen of GS 9190, GS 9256, RBV and Peg-IFN, 100 percent (14/14 patients) achieved Rapid Virologic Response (RVR) (HCV RNA < 25 IU/mL) at day 28, with 93 percent (13/14 patients) achieving undetectable viral levels (HCV RNA < 10 IU/mL). No virologic breakthroughs were observed in this arm.
"Oral combinations of multiple antiviral agents are expected to become the new standard of care for patients with hepatitis C, and our ultimate goal and vision is to develop a potent and well-tolerated fixed-dose combination product that will eliminate the need for peg-interferon," said John McHutchison, MD, Senior Vice President for Liver Disease Therapeutics at Gilead. "These data strongly support the clinical potential of this oral combination HCV therapy, and we're looking forward to advancing the development of GS 9190 and GS 9256."
About Study 196-0112
This Phase IIa, randomized, open-label trial is evaluating GS 9190 and GS 9256 in combination (n=16), and with RBV (n=15) or with RBV/Peg-IFN (n=15). The trial enrolled treatment-naive adults with chronic HCV genotype 1 for a 28-day course of treatment. The primary outcome measures of the trial are the percentage of subjects achieving RVR, defined as HCV RNA < 25 IU/mL at Day 28, as well as the incidence of treatment-related side effects and adverse events.
Patients in the two-drug arm of the study received GS 9190 (40 mg twice daily) and GS 9256 (75 mg twice daily). Patients in the three-drug arm received a regimen of GS 9190, GS 9256 and RBV (1,000-1,200 mg total daily dose, administered twice daily), and patients in the four-drug arm also received Peg-IFN (180 g, injected once per week). In the final analysis, one patient in the four-drug arm was excluded due to a protocol violation. A median maximal decline from baseline HCV RNA of 4.1 log10 IU/mL was observed in patients receiving the two-drug combination of GS 9190 and GS 9256. The addition of RBV and RBV/Peg-IFN enhanced these responses, with median maximal RNA declines of 5.1 log10 IU/mL and 5.7 log10 IU/mL, respectively.
GS 9190 and GS 9256 were generally well tolerated. The majority of adverse events were Grade 1 or 2 in severity and resolved with continued treatment. The most common adverse events observed in each of the three arms were headache, diarrhea and nausea. Some patients taking the three-drug combination also experienced fatigue and insomnia, and some patients taking the four-drug combination experienced influenza-like illness, fatigue, myalgia and cough. There were two serious adverse events including one case of bursitis and a hospitalization for vasovagal collapse (fainting), which was attributed to gastroenteritis and occurred in a patient who continued therapy and achieved RVR. Elevations in bilirubin were observed across all three study arms, the majority of which were Grade 1 or 2 in severity and none of which resulted in study drug discontinuation.
Additional Gilead HCV Pipeline Research
In addition to Study 196-0112, data from seven additional studies will be presented at The Liver Meeting highlighting the clinical profile of the company's other HCV pipeline candidates, including another protease inhibitor, GS 9451, and a novel NS5A inhibitor, GS 5885. Gilead's HCV pipeline now includes seven unique molecules spanning six therapeutic classes with different mechanisms of action. Five of these compounds are currently in clinical trials, and two are slated to enter human clinical studies early next year.
In a Phase I three-day dose-ranging study (Study 169-0103), GS 9451 was found to be highly potent in terms of anti-HCV activity and demonstrated a long plasma half-life with once-daily dosing potential (Abstract #820). GS 9451 was tested among 33 patients with HCV genotype 1a (GT1a) or 1b (GT1b). GT1a patients received GS 9451 at 60 mg, 200 mg and 400 mg once-daily doses, and the median maximal decline from baseline in HCV RNA was 0.88, 3.2 and 3.6 log10 IU/mL, respectively. GT1b patients received GS 9451 at a 200 mg once-daily dose, and the median maximal reduction was 3.5 log10 IU/mL. The median half-life of GS 9451 at these doses ranged from 14 to 17 hours, which will allow for once-daily dosing. Treatment-emergent adverse events were generally mild to moderate. Adverse events occurring in at least two patients at any dose were headache (n=7) and dyspepsia (n=2).
Gilead also presented the first Phase I data on a novel NS5A inhibitor for HCV (Study 256-0101), GS 5885, which suggest that this compound also has once-daily dosing potential (Abstract #1883). In preclinical studies, GS 5885 demonstrated low picomolar potency and a favorable safety and pharmacokinetic profile. The clinical safety profile of GS 5885 was assessed in an escalating, single oral dose trial in 54 healthy volunteers (randomized 8:2 to receive GS 5885 versus placebo). The compound was dosed under fasted conditions at 3 mg, 10 mg, 30 mg (under fasted and fed conditions), 60 mg and 100 mg, and was well tolerated, with no serious adverse events and no treatment-emergent grade 3/4 laboratory abnormalities for one week after a single dose. Adverse events were few and generally mild, and included headache, dizziness, myalgia, dysmenorrhea and contact dermatitis from electrocardiogram (ECG) leads. GS 5885 exposure was proportional over the dosing range and produced a mean terminal half-life of 37 to 45 hours, demonstrating potential for once-daily dosing.
Based on the results of the studies presented at The Liver Meeting, Gilead is advancing its HCV pipeline with three new studies slated for initiation before the end of 2010. The first is a Phase IIb clinical trial of GS 9190 and GS 9256 administered with the current standard of care, evaluating the potential to reduce the required duration of HCV therapy (including RBV/Peg-IFN) from 48 to 16 weeks. Similarly, a second Phase IIb trial will assess GS 9190 plus GS 9451 and the current standard of care. Finally, Gilead will be initiating a drug interaction study of GS 5885 in preparation for a Phase IIb study of GS 5885 plus a protease inhibitor and the current standard of care.
GS 9190, GS 9256, GS 9451 and GS 5885 are investigational products and have not yet been determined safe or efficacious in humans.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
Gilead's Investigational Hepatitis C Compounds GS 9190 and GS 9256 in Combination with Standard of Care Therapies Achieve Substantial Viral Suppression in Phase II Study
-- Compounds Among the Company's Seven HCV Pipeline Candidates Spanning Six Therapeutic Classes --
BOSTON, Oct 30, 2010 (BUSINESS WIRE) -- Gilead Sciences, Inc today announced data from a Phase IIa study showing that its investigational compounds GS 9190 and GS 9256, used in conjunction with current standard of care therapies, produced substantial suppression of the hepatitis C virus (HCV) within 28 days of treatment. The findings are being presented Monday, November 1, during a latebreaker oral session (#LB-1) at the 61st annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2010) in Boston.
"Patients with chronic hepatitis C urgently need new and better treatment options, particularly combination therapies involving antiviral drugs that employ multiple mechanisms of action to eradicate the virus," said the study's principal investigator, Stefan Zeuzem, MD, JW Goethe University Hospital, Frankfurt, Germany. "The data presented today support the continued clinical evaluation of GS 9190 and GS 9256 in combination with other hepatitis C therapies and provide additional clinical insight into the effect of ribavirin in the absence of interferon."
More than seven million people in industrialized countries are chronically infected with HCV, and as many as three million Americans have the disease. The current standard of care in HCV therapy is the oral antiviral ribavirin (RBV), administered in combination with peg-interferon (Peg-IFN), which is delivered via injection and achieves a sustained therapeutic response in only 40-55 percent of patients with HCV genotype 1, the most common form of HCV in the Americas and Europe.(1)
Gilead's three-arm Phase IIa trial (Study 196-0112) evaluated the safety and efficacy of GS 9190, an oral polymerase inhibitor, in combination with GS 9256, an oral protease inhibitor, when used as: 1) a dual antiviral therapy alone; 2) a three-drug regimen with RBV; or 3) a four-drug regimen with RBV and Peg-IFN. The study found that the all-oral regimen of GS 9190, GS 9256 and RBV produced substantial viral suppression, with a median maximal decline from baseline in HCV RNA of 5.1 log10 IU/mL during 28 days of treatment. Among patients given the four-drug regimen of GS 9190, GS 9256, RBV and Peg-IFN, 100 percent (14/14 patients) achieved Rapid Virologic Response (RVR) (HCV RNA < 25 IU/mL) at day 28, with 93 percent (13/14 patients) achieving undetectable viral levels (HCV RNA < 10 IU/mL). No virologic breakthroughs were observed in this arm.
"Oral combinations of multiple antiviral agents are expected to become the new standard of care for patients with hepatitis C, and our ultimate goal and vision is to develop a potent and well-tolerated fixed-dose combination product that will eliminate the need for peg-interferon," said John McHutchison, MD, Senior Vice President for Liver Disease Therapeutics at Gilead. "These data strongly support the clinical potential of this oral combination HCV therapy, and we're looking forward to advancing the development of GS 9190 and GS 9256."
About Study 196-0112
This Phase IIa, randomized, open-label trial is evaluating GS 9190 and GS 9256 in combination (n=16), and with RBV (n=15) or with RBV/Peg-IFN (n=15). The trial enrolled treatment-naive adults with chronic HCV genotype 1 for a 28-day course of treatment. The primary outcome measures of the trial are the percentage of subjects achieving RVR, defined as HCV RNA < 25 IU/mL at Day 28, as well as the incidence of treatment-related side effects and adverse events.
Patients in the two-drug arm of the study received GS 9190 (40 mg twice daily) and GS 9256 (75 mg twice daily). Patients in the three-drug arm received a regimen of GS 9190, GS 9256 and RBV (1,000-1,200 mg total daily dose, administered twice daily), and patients in the four-drug arm also received Peg-IFN (180 g, injected once per week). In the final analysis, one patient in the four-drug arm was excluded due to a protocol violation. A median maximal decline from baseline HCV RNA of 4.1 log10 IU/mL was observed in patients receiving the two-drug combination of GS 9190 and GS 9256. The addition of RBV and RBV/Peg-IFN enhanced these responses, with median maximal RNA declines of 5.1 log10 IU/mL and 5.7 log10 IU/mL, respectively.
GS 9190 and GS 9256 were generally well tolerated. The majority of adverse events were Grade 1 or 2 in severity and resolved with continued treatment. The most common adverse events observed in each of the three arms were headache, diarrhea and nausea. Some patients taking the three-drug combination also experienced fatigue and insomnia, and some patients taking the four-drug combination experienced influenza-like illness, fatigue, myalgia and cough. There were two serious adverse events including one case of bursitis and a hospitalization for vasovagal collapse (fainting), which was attributed to gastroenteritis and occurred in a patient who continued therapy and achieved RVR. Elevations in bilirubin were observed across all three study arms, the majority of which were Grade 1 or 2 in severity and none of which resulted in study drug discontinuation.
Additional Gilead HCV Pipeline Research
In addition to Study 196-0112, data from seven additional studies will be presented at The Liver Meeting highlighting the clinical profile of the company's other HCV pipeline candidates, including another protease inhibitor, GS 9451, and a novel NS5A inhibitor, GS 5885. Gilead's HCV pipeline now includes seven unique molecules spanning six therapeutic classes with different mechanisms of action. Five of these compounds are currently in clinical trials, and two are slated to enter human clinical studies early next year.
In a Phase I three-day dose-ranging study (Study 169-0103), GS 9451 was found to be highly potent in terms of anti-HCV activity and demonstrated a long plasma half-life with once-daily dosing potential (Abstract #820). GS 9451 was tested among 33 patients with HCV genotype 1a (GT1a) or 1b (GT1b). GT1a patients received GS 9451 at 60 mg, 200 mg and 400 mg once-daily doses, and the median maximal decline from baseline in HCV RNA was 0.88, 3.2 and 3.6 log10 IU/mL, respectively. GT1b patients received GS 9451 at a 200 mg once-daily dose, and the median maximal reduction was 3.5 log10 IU/mL. The median half-life of GS 9451 at these doses ranged from 14 to 17 hours, which will allow for once-daily dosing. Treatment-emergent adverse events were generally mild to moderate. Adverse events occurring in at least two patients at any dose were headache (n=7) and dyspepsia (n=2).
Gilead also presented the first Phase I data on a novel NS5A inhibitor for HCV (Study 256-0101), GS 5885, which suggest that this compound also has once-daily dosing potential (Abstract #1883). In preclinical studies, GS 5885 demonstrated low picomolar potency and a favorable safety and pharmacokinetic profile. The clinical safety profile of GS 5885 was assessed in an escalating, single oral dose trial in 54 healthy volunteers (randomized 8:2 to receive GS 5885 versus placebo). The compound was dosed under fasted conditions at 3 mg, 10 mg, 30 mg (under fasted and fed conditions), 60 mg and 100 mg, and was well tolerated, with no serious adverse events and no treatment-emergent grade 3/4 laboratory abnormalities for one week after a single dose. Adverse events were few and generally mild, and included headache, dizziness, myalgia, dysmenorrhea and contact dermatitis from electrocardiogram (ECG) leads. GS 5885 exposure was proportional over the dosing range and produced a mean terminal half-life of 37 to 45 hours, demonstrating potential for once-daily dosing.
Based on the results of the studies presented at The Liver Meeting, Gilead is advancing its HCV pipeline with three new studies slated for initiation before the end of 2010. The first is a Phase IIb clinical trial of GS 9190 and GS 9256 administered with the current standard of care, evaluating the potential to reduce the required duration of HCV therapy (including RBV/Peg-IFN) from 48 to 16 weeks. Similarly, a second Phase IIb trial will assess GS 9190 plus GS 9451 and the current standard of care. Finally, Gilead will be initiating a drug interaction study of GS 5885 in preparation for a Phase IIb study of GS 5885 plus a protease inhibitor and the current standard of care.
GS 9190, GS 9256, GS 9451 and GS 5885 are investigational products and have not yet been determined safe or efficacious in humans.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
Saturday, November 20, 2010
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
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
Friday, November 19, 2010
NEWSMAX.com lists the Top 10 Hepatitis Treatment Centers...
I'm sure Newsmax, being the fair balanced news source it is *cough* has very good intentions with this top 10 list of centers that treat Hepatitis C. However, they don't reveal to us regular folks on what the criteria is to get in the Top 10. Outcomes? Patient satisfaction? quality of clinical research? High-dollar Republican campaign contributions? Anyway, it is what it is - Chris
Hepatitis C: Top 10 Treatment Centers
Tuesday, November 16, 2010 12:00 PM
Hepatitis C is a viral liver disease that may include pain in the liver or abdominal area, and jaundice like symptoms where both the white of the eyes and the skin turn yellow. Hepatitis may cause the urine to appear dark in color while stools appear pale. The disease is also marked by fatigue, confusion, and irritability.
Other symptoms during the onset of the infection include a loss of appetite, diarrhea, nausea, and vomiting. Some chronic Hepatitis C cases have symptoms of sleep disturbance, itchy skin, vomiting blood, hallucination, edema or fluid retention, and swelling of the abdomen, legs, and face.
The top ten treatment centers for Hepatitis C are:
1. Gastroenterology Associates of East Bay Medical Group, Berkeley, California
2. Atlanta Gastroenterology Associates, Atlanta, Georgia
3. Idaho Gastroenterology Associates, Meridian, Idaho
4. Johns Hopkins University, Baltimore, Maryland
5. Carolinas Center for Liver Diseases, Charlotte, North Carolina
6. Baylor University Medical Center, Dallas, Texas
7. Wisconsin Center for Advanced Research, Milwaukee, Wisconsin
8. University of Massachusetts Memorial Medical Center, Worcester, Massachusetts
9. Washington Hospital Center, Washington, District of Columbia
10. University of Miami Center for Liver Diseases, Miami, Florida
Hepatitis C: Top 10 Treatment Centers
Tuesday, November 16, 2010 12:00 PM
Hepatitis C is a viral liver disease that may include pain in the liver or abdominal area, and jaundice like symptoms where both the white of the eyes and the skin turn yellow. Hepatitis may cause the urine to appear dark in color while stools appear pale. The disease is also marked by fatigue, confusion, and irritability.
Other symptoms during the onset of the infection include a loss of appetite, diarrhea, nausea, and vomiting. Some chronic Hepatitis C cases have symptoms of sleep disturbance, itchy skin, vomiting blood, hallucination, edema or fluid retention, and swelling of the abdomen, legs, and face.
The top ten treatment centers for Hepatitis C are:
1. Gastroenterology Associates of East Bay Medical Group, Berkeley, California
2. Atlanta Gastroenterology Associates, Atlanta, Georgia
3. Idaho Gastroenterology Associates, Meridian, Idaho
4. Johns Hopkins University, Baltimore, Maryland
5. Carolinas Center for Liver Diseases, Charlotte, North Carolina
6. Baylor University Medical Center, Dallas, Texas
7. Wisconsin Center for Advanced Research, Milwaukee, Wisconsin
8. University of Massachusetts Memorial Medical Center, Worcester, Massachusetts
9. Washington Hospital Center, Washington, District of Columbia
10. University of Miami Center for Liver Diseases, Miami, Florida
Thursday, November 18, 2010
Medivir/Tibotec's TMC435 looking good in partial and non-responders....
This should get interesting in terms of revenue streams - Medivir is developing TMC435 with Tibotec who will market the drug in the US. Tibotec has marketing rights for Telaprevir everywhere except North America and the Far East. Telaprevir will be out first, depending on how things go with the European regulatory folks. How Tibotec prioritizes TMC435 development with Telaprevir marketing abroad is unclear. Looks like a darn good drug though. Good numbers and QD dosing.
By Frances Schwartzkopff - Nov 18, 2010
Medivir AB, the drugmaker competing to develop a new hepatitis C medicine, rose the most in four months in Stockholm trading after its drug reduced the virus to undetectable levels in patients who failed earlier treatment.
After 24 weeks, 86 percent of patients who had only partially responded to earlier treatment had undetectable virus levels after taking TMC435 alongside standard care, the Huddinge, Sweden-based company said in a study published today. That compared with undetectable levels in 19 percent of patients receiving a placebo. Shares rose as much as 9.2 percent.
Medivir is developing TMC435 with Tibotec Pharmaceuticals. The drugmaker, a unit of New Brunswick, New Jersey-based Johnson & Johnson, also is working simultaneously with Vertex Pharmaceuticals Inc. on a new hepatitis C drug.
Vertex, based in Cambridge, Massachusetts, plans to seek U.S. approval for its medicine, Telaprevir, by the end of the year.
Medivir, which still needs to conduct the last trial needed to seek regulatory approval, said 78 percent of patients who didn’t respond at all to initial treatment had undetectable virus levels after taking TMC435, almost twice as many as those who received a placebo.
The medication also led to undetectable virus levels in 94 percent of patients who had relapsed after receiving earlier care. That compared with 83 percent of patients taking a placebo. 462 patients participated in the 48-week study, with results taken half way through.
Medivir rose 8.5 kronor, or 6.8 percent, to 133.5 kronor at 12:54 p.m. local time. The advance gave the drugmaker a market value of 3.5 billion kronor ($511 million), its highest since December 2000.
By Frances Schwartzkopff - Nov 18, 2010
Medivir AB, the drugmaker competing to develop a new hepatitis C medicine, rose the most in four months in Stockholm trading after its drug reduced the virus to undetectable levels in patients who failed earlier treatment.
After 24 weeks, 86 percent of patients who had only partially responded to earlier treatment had undetectable virus levels after taking TMC435 alongside standard care, the Huddinge, Sweden-based company said in a study published today. That compared with undetectable levels in 19 percent of patients receiving a placebo. Shares rose as much as 9.2 percent.
Medivir is developing TMC435 with Tibotec Pharmaceuticals. The drugmaker, a unit of New Brunswick, New Jersey-based Johnson & Johnson, also is working simultaneously with Vertex Pharmaceuticals Inc. on a new hepatitis C drug.
Vertex, based in Cambridge, Massachusetts, plans to seek U.S. approval for its medicine, Telaprevir, by the end of the year.
Medivir, which still needs to conduct the last trial needed to seek regulatory approval, said 78 percent of patients who didn’t respond at all to initial treatment had undetectable virus levels after taking TMC435, almost twice as many as those who received a placebo.
The medication also led to undetectable virus levels in 94 percent of patients who had relapsed after receiving earlier care. That compared with 83 percent of patients taking a placebo. 462 patients participated in the 48-week study, with results taken half way through.
Medivir rose 8.5 kronor, or 6.8 percent, to 133.5 kronor at 12:54 p.m. local time. The advance gave the drugmaker a market value of 3.5 billion kronor ($511 million), its highest since December 2000.
Wednesday, November 17, 2010
Unmet needs spur innovative drug development for Hepatitis C...
Article I authored for TrendSlate blog.
Large, unmet needs in medicine have always spurred innovation in novel drug development. A textbook case of this can be found in the effort to fight Hepatitis C (HCV) infection. Hepatitis C is a blood borne virus that primarily affects the liver. The virus triggers an immune response – one that the virus almost always successfully evades– causing liver inflammation and scarring. Slowly, over a period of 20-30 years in most cases, the scarring can progress to decompensated cirrhosis, liver cancer and eventually liver failure. Lack of general knowledge regarding the disease in both the patient and healthcare provider population has created an environment of chronic underscreening, underdiagnosis and lack of proper treatment.
By the most conservative of estimates, researchers have put the worldwide number of HCV infected at 180 million, with 3 to 5 million here in the United States. With large portion of the infections occurring before the early 90’s when an effective technology came out to screen the blood donor pool, most of the burden of the disease sits squarely on the shoulders of those born between 1946 and 1964 – the baby boomer generation. Given that the progression of disease from infection to liver damage is roughly 20 years, there has been a correlating recent uptick in the worldwide incidence of liver disease. Without an effective therapy, experts expect a four fold increase in the incidence of Hepatitis C-related liver disease in the next 20 years. Inextricably linked are healthcare costs… a highly regarded 2009 forecast from the Milliman Consulting Group pegs an increase in healthcare costs from the current $30 billion to over $85 billion in 2027. Most of that burden is forecasted to fall in the lap of already-cash strapped government payors. That is one financial tidal wave to be avoided.
The current treatment for Hepatitis C is arduous for both patient and provider, costly and comes with a largely insufficient cure rate, especially genotype 1, the most common genotype found in the United States. With a 50% cure rate at best (called ‘SVR’ or ‘Sustained Viral Response’), the current treatment of pegylated interferon and nucleoside analog ribavirin is also fraught with side events and tolerability issues that make it not unlike a 48 week endurance contest. Pegylated interferon works by stimulating the host immune response and ribavirin is thought to work by preventing relapse, although it’s exact mechanism of action is unknown. Using the two together means 48 weeks of flu-like symptoms, depression and fatigue. With 50% of patients not responding and/or tolerating this regimen, there is certainly a lot of room for improvement. This fact, coupled with a refocused FDA prioritizing reviews with an eye out for compounds that meet unmet disease states, make HCV an attractive target for intrepid drug developers.
From the scrappiest of the little Biopharma startups to the biggest of behemoth Big Pharma companies, there is plenty of innovation going in developing drugs to effectively treat HCV. As I’m typing this, there are currently over 120 compounds in all stages of development with new ones being added as others undoubtedly falter. Most of these new compounds fall under the umbrella of “STAT-C Drugs” or “Specifically Targeted Antiviral Therapy for Hepatitis C”, Unlike the non-specific method of action of pegylated interferon and ribavirin, STAT-C drugs are a new class of compounds that customized to target specific areas integral to the life cycle of Hepatitis C virus. The goal is to terminate that life cycle, thereby preventing viral replication.
Nearest to market are Vertex Pharmaceuticals and Merck with HCV protease inhibitors Telaprevir and Boceprevir respectively, due to hit the market at about the same time in 2011. Some experts even predict a dual FDA review which will surely test the mettle of both companies. It is fitting, however, that Vertex is amongst the leaders in STAT-C development. They fired the first shot in the equivalent of a drug development revolution when Vertex scientists first published the structure of the HCV protease in 1996 and then used computer-generated modeling to design molecules to bind to the protease. Unlike the HIV protease, HCV didn’t present a nice, big pocket to fit a molecule in. The binding site of the HCV protease was described as more of a “dent in a dinner plate”, making the design more difficult. That program created the Telaprevir molecule. Vertex did it again in 1998, identifying the 3D structure of the NS3 HCV Helicase. This, however, has been a less successful target than the protease. No doubt that both discoveries lead to a industry-wide gold rush in HCV drug development. The forecasted revenue for these two novel drugs? Between 2-3 billion by 2014 for Vertex’s Telaprevir alone, according to some market oracles.
In terms of competition, it looks as if both Vertex and Merck look to have the STAT-C market to themselves for two or three years. Both companies have additional STAT-C compounds in in the pipeline. Looming closely behind are companies like Roche, Bristol Meyers Squibb, Gilead, Boehringer Ingelheim and Tibotec with their own compounds and no shortage of capital to get them to market. Yet despite the leaps in drug development innovation for HCV, a big, yet unanswered question remains. All the trials with both Telaprevir and Boceprevir were done in combination with the current standard of care, pegylated interferon and ribavirin. The addition of either compound provided an average increase in SVR of around 20% and cut the duration of therapy by 50% compared to pegylated interferon and ribavirin alone. Both compounds added additional leverage in boosting the SVRs of patients that had been previously treated but were not cured as well as making significant inroads in populations that have significant genetic barriers to treatment success such as Hispanics and African Americans. A 20% increase in SVR in half the time is remarkable achievement. The fact remains however, that even 12-16 weeks of treatment may be rough to get through given the side effect baggage of pegylated interferon and ribavirin combined with the additional side effects of the new compounds. If a combination of better-tolerated STAT-C drugs can be robust enough to prevent viral resistance and breakthrough without the non-virus specific immune modulating effects of peyglated interferon and ribavirin, even more patients could be treated.
Don’t think drug developers haven’t dreamed of ditching pegylated interferon and ribavirin. Many of the aforementioned companies are doing trials using their STAT-C regimens in combination both with and without pegylated interferon and ribavirin to explore the possibilities. Is it reasonable to think a virus that mutates so rapidly as to create every single possible mutation of itself every day be outwitted by drugs that target multiple points of the virus life cycle? The jury is still out. Vertex recently discontinued an arm in their trial pairing Telaprevir with a low dose of their non-nucleoside polymerase inhibitor VX-222 without pegylated interferon and ribavirin because some patients experienced viral breakthrough. In the higher dose arms, they paired Telaprevir plus VX-222 as well as pegylated interferon and ribavirin and at the time of the press release, those patients remained undetectable. Other trials with different combinations of drugs are currently progressing, so that particular question remains without a definitive answer.
Whatever the ultimate outcome for the STAT-C drugs, it’s clear that a significant milestone has been achieved in terms of drug development. Science and innovation are addressing a clear unmet need. We have an upcoming armory of novel compounds aimed at turning the $85 billion dollar tidal wave into a mere ripple by cutting the down the duration of therapy, increasing SVR and ultimately saving lives. Drugs will continue to improve as developers work to reduce adverse events, increase efficacy and make dosing more convenient. We’ll also witness dramatic shifts in the marketplace due to cost – how will the evolving managed care environment embrace the STAT-C drugs? What effects will STAT-C drugs have on utilization and provider reimbursement? How will patient assistance programs be designed? What role will support groups, community advocates and politics play in educating the masses on the disease and it’s treatment? What are the barriers to access to care? What about drug interactions and resistance profiles? What does HCV viral resistance mean? It is indeed a very exciting time for drug development, but definitely not for the faint of heart
Large, unmet needs in medicine have always spurred innovation in novel drug development. A textbook case of this can be found in the effort to fight Hepatitis C (HCV) infection. Hepatitis C is a blood borne virus that primarily affects the liver. The virus triggers an immune response – one that the virus almost always successfully evades– causing liver inflammation and scarring. Slowly, over a period of 20-30 years in most cases, the scarring can progress to decompensated cirrhosis, liver cancer and eventually liver failure. Lack of general knowledge regarding the disease in both the patient and healthcare provider population has created an environment of chronic underscreening, underdiagnosis and lack of proper treatment.
By the most conservative of estimates, researchers have put the worldwide number of HCV infected at 180 million, with 3 to 5 million here in the United States. With large portion of the infections occurring before the early 90’s when an effective technology came out to screen the blood donor pool, most of the burden of the disease sits squarely on the shoulders of those born between 1946 and 1964 – the baby boomer generation. Given that the progression of disease from infection to liver damage is roughly 20 years, there has been a correlating recent uptick in the worldwide incidence of liver disease. Without an effective therapy, experts expect a four fold increase in the incidence of Hepatitis C-related liver disease in the next 20 years. Inextricably linked are healthcare costs… a highly regarded 2009 forecast from the Milliman Consulting Group pegs an increase in healthcare costs from the current $30 billion to over $85 billion in 2027. Most of that burden is forecasted to fall in the lap of already-cash strapped government payors. That is one financial tidal wave to be avoided.
The current treatment for Hepatitis C is arduous for both patient and provider, costly and comes with a largely insufficient cure rate, especially genotype 1, the most common genotype found in the United States. With a 50% cure rate at best (called ‘SVR’ or ‘Sustained Viral Response’), the current treatment of pegylated interferon and nucleoside analog ribavirin is also fraught with side events and tolerability issues that make it not unlike a 48 week endurance contest. Pegylated interferon works by stimulating the host immune response and ribavirin is thought to work by preventing relapse, although it’s exact mechanism of action is unknown. Using the two together means 48 weeks of flu-like symptoms, depression and fatigue. With 50% of patients not responding and/or tolerating this regimen, there is certainly a lot of room for improvement. This fact, coupled with a refocused FDA prioritizing reviews with an eye out for compounds that meet unmet disease states, make HCV an attractive target for intrepid drug developers.
From the scrappiest of the little Biopharma startups to the biggest of behemoth Big Pharma companies, there is plenty of innovation going in developing drugs to effectively treat HCV. As I’m typing this, there are currently over 120 compounds in all stages of development with new ones being added as others undoubtedly falter. Most of these new compounds fall under the umbrella of “STAT-C Drugs” or “Specifically Targeted Antiviral Therapy for Hepatitis C”, Unlike the non-specific method of action of pegylated interferon and ribavirin, STAT-C drugs are a new class of compounds that customized to target specific areas integral to the life cycle of Hepatitis C virus. The goal is to terminate that life cycle, thereby preventing viral replication.
Nearest to market are Vertex Pharmaceuticals and Merck with HCV protease inhibitors Telaprevir and Boceprevir respectively, due to hit the market at about the same time in 2011. Some experts even predict a dual FDA review which will surely test the mettle of both companies. It is fitting, however, that Vertex is amongst the leaders in STAT-C development. They fired the first shot in the equivalent of a drug development revolution when Vertex scientists first published the structure of the HCV protease in 1996 and then used computer-generated modeling to design molecules to bind to the protease. Unlike the HIV protease, HCV didn’t present a nice, big pocket to fit a molecule in. The binding site of the HCV protease was described as more of a “dent in a dinner plate”, making the design more difficult. That program created the Telaprevir molecule. Vertex did it again in 1998, identifying the 3D structure of the NS3 HCV Helicase. This, however, has been a less successful target than the protease. No doubt that both discoveries lead to a industry-wide gold rush in HCV drug development. The forecasted revenue for these two novel drugs? Between 2-3 billion by 2014 for Vertex’s Telaprevir alone, according to some market oracles.
In terms of competition, it looks as if both Vertex and Merck look to have the STAT-C market to themselves for two or three years. Both companies have additional STAT-C compounds in in the pipeline. Looming closely behind are companies like Roche, Bristol Meyers Squibb, Gilead, Boehringer Ingelheim and Tibotec with their own compounds and no shortage of capital to get them to market. Yet despite the leaps in drug development innovation for HCV, a big, yet unanswered question remains. All the trials with both Telaprevir and Boceprevir were done in combination with the current standard of care, pegylated interferon and ribavirin. The addition of either compound provided an average increase in SVR of around 20% and cut the duration of therapy by 50% compared to pegylated interferon and ribavirin alone. Both compounds added additional leverage in boosting the SVRs of patients that had been previously treated but were not cured as well as making significant inroads in populations that have significant genetic barriers to treatment success such as Hispanics and African Americans. A 20% increase in SVR in half the time is remarkable achievement. The fact remains however, that even 12-16 weeks of treatment may be rough to get through given the side effect baggage of pegylated interferon and ribavirin combined with the additional side effects of the new compounds. If a combination of better-tolerated STAT-C drugs can be robust enough to prevent viral resistance and breakthrough without the non-virus specific immune modulating effects of peyglated interferon and ribavirin, even more patients could be treated.
Don’t think drug developers haven’t dreamed of ditching pegylated interferon and ribavirin. Many of the aforementioned companies are doing trials using their STAT-C regimens in combination both with and without pegylated interferon and ribavirin to explore the possibilities. Is it reasonable to think a virus that mutates so rapidly as to create every single possible mutation of itself every day be outwitted by drugs that target multiple points of the virus life cycle? The jury is still out. Vertex recently discontinued an arm in their trial pairing Telaprevir with a low dose of their non-nucleoside polymerase inhibitor VX-222 without pegylated interferon and ribavirin because some patients experienced viral breakthrough. In the higher dose arms, they paired Telaprevir plus VX-222 as well as pegylated interferon and ribavirin and at the time of the press release, those patients remained undetectable. Other trials with different combinations of drugs are currently progressing, so that particular question remains without a definitive answer.
Whatever the ultimate outcome for the STAT-C drugs, it’s clear that a significant milestone has been achieved in terms of drug development. Science and innovation are addressing a clear unmet need. We have an upcoming armory of novel compounds aimed at turning the $85 billion dollar tidal wave into a mere ripple by cutting the down the duration of therapy, increasing SVR and ultimately saving lives. Drugs will continue to improve as developers work to reduce adverse events, increase efficacy and make dosing more convenient. We’ll also witness dramatic shifts in the marketplace due to cost – how will the evolving managed care environment embrace the STAT-C drugs? What effects will STAT-C drugs have on utilization and provider reimbursement? How will patient assistance programs be designed? What role will support groups, community advocates and politics play in educating the masses on the disease and it’s treatment? What are the barriers to access to care? What about drug interactions and resistance profiles? What does HCV viral resistance mean? It is indeed a very exciting time for drug development, but definitely not for the faint of heart
Subscribe to:
Posts (Atom)
Posts
