SOF-based Regimens Offer New Options for Patients with HCV GT4
BOSTON, MA—The sofosbuvir/ribavirin, ledipasvir/sofosbuvir, and sofosbuvir/velpatasvir regimens “may offer important new therapeutic options” for patients with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection, according to an integrated analysis reported at The Liver Meeting® 2016.
Globally, GT4 HCV accounts for nearly 15% of all HCV infections and is the dominant genotype in Egypt and some regions of sub-Saharan Africa.
To provide an integrated analysis of safety and efficacy from 6 studies that evaluated sofosbuvir-based regimens in patients with HCV GT4, Tarik Asselah, MD, PhD, Service d'Hepatologie & INSERM, Hopital Beaujon, Clichy, France, and colleagues pooled data from 352 patients enrolled in phase 2 and 3 studies.
“The analysis included treatment-naive and treatment-experienced subjects with HCV GT4 infection, including subjects with compensated cirrhosis and HIV-1 co-infection,” Dr. Asselah said.
In the six studies, patients received sofosbuvir/ribavirin for 12 to 24 weeks (GS-US-334-0114 and GS-US-334-0138); ledipasvir/sofosbuvir for 12 weeks (ION-4, GS-US-337-1119, and SYNERGY; included HIV co-infection); or sofosbuvir/velpatasvir for 12 weeks (ASTRAL-1). Overall, 21% of patients had compensated cirrhosis.
For non-cirrhotic vs. cirrhotic patients, respectively, SVR12 rates were 78% and 53% with sofosbuvir/ribavirin; 93% and 100% ledipasvir/sofosbuvir, 92% and 88% for SOF/RBV 24 weeks; and 100% and 100% for sofosbuvir/velpatasvir.
Grade 3/4 adverse events were 5% in the sofosbuvir/ribavirin patients, 1% in ledipasvir/sofosbuvir patients, and 2% in sofosbuvir/velpatasvir patients.
The most commonly reported adverse events for the three treatment regiments were fatigue, headache, and nausea. There were no deaths.