A six-week course of hepatitis C (HCV) treatment with three oral medications yielded 95%-100% cure rates in a study presented by Anita Kohli, M.D., at the 21st Conference on Retroviruses and Opportunistic Infections (CROI 2014). The researchers suggested that such short-course treatment could be particularly beneficial to people with limited access to health care and difficulty with adherence, both in the U.S. and in resource-poor nations.
Current standard HCV treatment involves weekly injections for 12 weeks or longer and does not always cure the infection. Since many people with HCV have a history of injection drug use, treatment with needles is sometimes problematic. New direct-acting antiviral agents (DAAs) allow for needle-free HCV treatment and avoid the use of pegylated interferon, which often causes troublesome side effects.
The NIAID SYNERGY study enrolled 60 individuals living with HCV in Washington, D.C. About 70% were men, mostly African-American, and 70% had HCV subtype 1a, which is difficult to treat. However, none of the participants were coinfected with HIV or hepatitis B, and those suffering from cirrhosis were excluded from the two six-week arms of the study.
Study participants were randomized to one of three arms: dual therapy with sofosbuvir (Sovaldi)/ledipasvir for 12 weeks, or sofosbuvir/ledipasvir plus either GS-9669 (a non-nucleoside NS5B site 2 polymerase inhibitor) or GS-9451 (an NS3 protease inhibitor) for six weeks. Twelve-week post-treatment sustained virological response (SVR12), a measure of HCV cure, was between 95% (for those taking sofosbuvir/ledipasvir and GS-9669) and 100% (in the two other arms).
"Hepatitis C can be successfully and safely treated in six weeks using three direct acting agents with different mechanisms of action," the researchers concluded. "This short duration, simple therapy for HCV may prove relevant for the global elimination of hepatitis C, where uncomplicated, well-tolerated therapy is required to ensure adherence and minimize health care expenditures."
This study was designed as an eight-arm trial, with future arms enrolling patients with cirrhosis in the regimen that includes the NS3 protease inhibitor GS-9451 and evaluating a four-week regimen of three oral drugs.