Tuesday, July 9, 2013

2013 Pipeline Report - 28 HCV interferon-free regimens in development






Treatment Action Group 2013 Pipeline Report

At the 7th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention held in Kuala Lumpur, Malaysia the HIV i-Base/Treatment Action Group (Tag) released their comprehensive 2013 Pipeline Report. In the report both organizations advocate a global effort for national leaders and regulatory authorities to work together and expedite research needed to bring safe HIV, HCV and tuberculosis drugs to market.

For the HCV community, there is a particular article written by Tracy Swan from (Tag) which offers an update on the new HCV drugs currently in phases II/III trials.

The author writes:
"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"

2013 Pipeline Report - Hepatitis C Drug Development Catapults Onward 

Excerpt from the press release;
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.
The press release is available here

2013 "HCV Treatment Pipeline" - By Tracy Swan

Hepatitis C Drug Development Catapults Onward 
By Tracy Swan

Highlights:
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 - HCV Genotypes 2, 3, & 4
Cross-company Trials
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
HIV/HCV Coinfection
Faldaprevir plus PEG-IFN/RBV
Simeprevir plus PEG-IFN and RBV
From Excess to Access
Where Should All the Research Go?

Access the report here.........

Next Chapter:
Low-  and Middle-Income Countries Defuse Hepatitis C, the “Viral Time Bomb” 

Update
2013 SVR Rates




No comments:

Post a Comment