SAN FRANCISCO, CA—In treatment-naïve patients co-infected with hepatitis C genotype 1–4 and HIV infection, treatment with sofosbuvir + peginterferon alfa-2a/ribavirin for 12 weeks was highly effective in the sustained virologic response (SVR) rate, a pilot trial presented at IDWeek 2013 has found.
“Sofosbuvir was well tolerated, in patients taking a wide variety of HIV antiretroviral regimens,” noted Maribel Rodriguez-Torres, MD, Gastroenterology, Fundacion de Investigacion, Rio Piedras, PR.
HIV and HCV co-infection increases the rate of fibrosis, cirrhosis, hepatocellular carcinoma, and overall mortality in HCV-infected people. Past studies have shown that the standard of care, pegylated interferon (PEG)/ribavirin results in a sustained virologic response of 27–40%. Sofosbuvir, a NS5B nucleoside inhibitor has been able to demonstrate safety and efficacy in HCV-mono-infected patients.
“However, HIV/HCV co-infected patients are in need of safe and effective HCV treatments without the risk for resistance and that can be given with antiretroviral treatment (ART),” she added. Thus Dr. Rodriguez-Torres and colleagues initiated a single-center, open-label, single-arm trial assessing the safety and efficacy of a 12-week course of sofosbuvir + pegylated interferon (Pegasys; Genentech)/ribavirin for the treatment of patients with chronic HCV coinfected with HIV.
Investigators included 23 HCV treatment-naïve patients with a HCV genotype between 1 and 4 and no cirrhosis. Patients were given oral sofosbuvir 400mg once daily plus weight-based ribavirin 1000–1200mg/day and subcutaneous peginterferon alfa-2a 180μg/week for 12 weeks. All participants were required to be on a stable antiretroviral regimen for >8 weeks with HIV RNA suppression and have a CD-4 T-cell count >200cells/mm3.
The primary efficacy end point was the proportion of patients with SVR 12 weeks after the end of treatment (SVR12). The primary safety and tolerability endpoint included the effect on HIV RNA and CD4 T-cell counts/percentages.
Among the patients in this study, 18 (78%) were male; 8 (35%) were black; 15 had a HCV genotype 1a, 4 with genotype 1b, 1 with genotype 2b, 2 with genotype 3a, and 1 with genotype 4a/4b/4c. Five patients (22%) had the IL28b CC genotype.
All patients were on a stable antiretroviral treatment regimen, which comprised of tenofovir/emtricitabine plus one of the following: efavirenz (n=7; 30%); ritonavir/atazanavir (n=5; 22%); raltegravir (n=6; 26%); ritonavir/darunavir (n=4; 17%); or rilpivirine (n=1; 4%).
“Most patients had rapid on-treatment HCV RNA suppression; 23/23 (100%) had a week 2 HCV RNA below the limit of quantification, and there was no HIV virologic breakthrough at follow-up Week 4,” Dr. Rodriguez-Torres reported. HCV RNA suppression continued throughout the study with 91% of patients (21/23) achieving SVR at week 12. The most frequently reported adverse events were anemia (n=12; 52%) and fatigue (n=8; 35%).
Researchers observed a low risk of HIV virologic breakthrough with sofosbuvir plus pegylated interferon/ribavirin therapy. “SVR12 rates were similar to those seen with this regimen in hepatitis C virus mono-infected patients,” Dr. Rodriguez-Torres noted.