April 16, 2014
This article was reported by NAM aidsmap.
NAM aidsmap reported on a study of a co-formulation of sofosbuvir and ledipasvir for treating HIV-positive individuals who also were coinfected with the genotype 1 hepatitis C virus (HCV). In their trial, Anu Osinusi of the U.S. National Institute of Allergy and Infectious Diseases and colleagues treated the HIV/HCV-coinfected individuals with once-daily fixed-dose combination of sofosbuvir (Sovaldi) and the NS5A inhibitor ledipasvir (400/90 milligrams). Researchers divided patients into two groups based on HIV treatment status. One group contained 13 individuals who were not on antiretrovirals (ARV), and the other group contained 37 people who had been on ARVs for at least eight weeks.
All participants received the sofosbuvir/ledipasvir combination for 12 weeks. They showed undetectable HCV RNA by the fourth week of treatment and had continued virological response at the end of treatment. Results show that the combination treatment led to sustained viral response (SVR) for all patients. The patients who were not taking ARVs achieved SVR 12 (which is considered a cure), while those on ARVs achieved SVR 4. Data are still being collected on this group. The drug was safe and well-tolerated with no serious adverse effects or early discontinuation for adverse effects. The most common side effects were headache, fatigue, pain, nausea, diarrhea, and constipation.
The full report, "Use of Sofosbuvir/Ledipasvir Fixed Dose Combination for Treatment of HCV Genotype-1 in Patients Coinfected With HIV," was presented at the 49th Annual Meeting of the European Association for the Study of the Liver, Abstract 014, London, 2014.