Advances in HCV Therapy
Hepatitis C Treatments in Current Clinical Development
– Detailed Reference Guide
Treatment of chronic hepatitis C virus infection in the near future
2014 Pipeline Report
July 20, 2014 – HIV, HCV, and TB Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.
Visit www.PipelineReport.org to read the report online.
2013 Pipeline Report
"An impressive 26 new HCV drugs are being studied in phases II/III in at least 28 interferon-free
regimens, which are bringing the potential of faster, all-oral HCV cures rapidly toward approval
for the world’s 185 million people living with HCV"
HIV i-Base/Treatment Action Group 2013 Pipeline Report calls on leaders to get the best HIV, hepatitis C
virus (HCV), and tuberculosis drugs, diagnostics, and vaccines to the most people as quickly as possible
In the 2013 “HCV Treatment Pipeline,” Tracy Swan (TAG) notes that the “confluence of a robust HCV drug
pipeline, shortened regimens, and [shorter] posttreatment follow-up are extraordinary.
The new FDA breakthrough therapy designation may speed things up as well. By the end of 2014, [new HCV drugs]
from four different classes and fixed-dose combinations (FDCs) are likely to be approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), offering the potential for off-label mixing and matching.”
An impressive 26 new HCV drugs are being studied in phases II/III in at least 28 interferon-free regimens, which are bringing the potential of faster, all-oral HCV cures rapidly toward approval for the world’s 185 million people living with HCV.
Swan notes, however, that not all optimal combinations are being studied, with some sponsors preferring combinations
of their own proprietary compounds, while many sponsors take too long to study their new drugs in people coinfected
with HIV and HCV, and those with cirrhosis.
In her companion chapter, “Low- and Middle-Income Countries Defuse Hepatitis C, the ‘Viral Time Bomb,’” Karyn Kaplan (TAG) describes how a worldwide movement is forming to ensure that when new all-oral HCV cures are approved, that governments, health systems, and providers will be ready for them. Kaplan points to recent progress instigated by HCV activists in countries such as Egypt, Georgia, Thailand, and Ukraine.
Press release is available here.
Hepatitis C Drug Development Catapults Onward
HCV Treatments in Phase II and Phase III
The Best Combinations
Interferon-Free Regimens in Development for HCV Genotype 1
Interferon-Free Regimens in Development for HCV Genotypes 2, 3, & 4
Next in Line: Simeprevir, Faldaprevir, and Sofosbuvir
Without a PEG to Stand on: The Sofosbuvir Saga Goes on
Biting the (Magic) Bullet
Twinkle, Twinkle, Little (Lone) Star
AbbVie: All Hands on Deck
Bristol-Myers Squibb: All In!
(Genotype) 3 is the new 1
SVR in HCV Genotypes 2 and 3
Cirrhosis: From Frontier to Proving Ground
Faldaprevir plus PEG-IFN/RBV
Simeprevir plus PEG-IFN and RBV
From Excess to Access
Where Should All the Research Go?
Next Chapter: Low- and Middle-Income Countries Defuse Hepatitis C, the “Viral Time
2013 SVR Rates Update
Pipeline Oral HCV Drugs and Generic Global Access to DAAs: The Need to Mirror ARV Programs
By Simon Collins
From HIV i-Base July/August 2013
Predicted generic costs for ribavirin and four DAAs .......
Andrew Hill from Liverpool University and colleagues presented the first analysis of predicted generic costs for ribavirin and four DAAs that are currently in late phase development – daclatasvir, sofosbuvir, faldaprevir and simeprevir – based on compound properties including chemical structure, complexity of synthesis, daily dose etc, and then adapted manufacturing costs achieved by ARV access programmes from the Clinton Foundation and MSF......
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