Phase 3 Data Raise Hopes for All-Oral Hepatitis C Regimen

New results from numerous clinical trials of direct-acting antivirals against hepatitis C presented at the ACG2013 meeting point to more effective regimens within a year.

In a plenary session highlighting the most important new data presented at the American College of Gastroenterology annual conference, three international teams released the results of large phase 3 trials showing superior efficacy, safety, and convenience for the new wave of direct-acting oral agents against the hepatitis C virus. The data raise the possibility of the first all-oral regimens for chronic hepatitis C, which may be available within a year.

The regimens include:

1. Faldaprevir, a protease inhibitor with once-daily dosing. Added to an interferion + ribavirin regiment, faldaprevir achieved viral cure for about 80% of treatment-arm patients at 12 weeks, compared with 52% of patients receiving only interferon/ribavirin plus placebo (P <.0001); 88% of patients treated with faldaprevir were well enough to stop all treatment at week 24.

2. Sofosbuvir:  In four separate trials, the use of sofosbuvir, with or without interferon, was associated with marked improvement in SVR12 rates (sustained virological response at 12 weeks) for most tested subtypes of infection.

3. Experimental protease inhibitors ABT-450/r, ABT-267, and/or ABT-333 (direct-acting antiviral agents, or DAAs) used in interferon-free regimens, with our without ribavirin-the Aviator Trial: Overall, SVR12 was 98.7% in treatment-naive patients, and 93.3% in non-responders to previous treatment. Twelve-week regimens were as effective as 24-week regimens.

For more details see:  Breakthrough at ACG 2013: Oral-Only Treatment for Chronic Hepatitis C
by Jeffrey Hertzberg MD
ConsultantLive, October 17, 2013

See also:  New Antivirals for Hepatitis C: Four Basic Facts
by Arun Jesudian MD
Musculoskeletal Network, June 4, 2013

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