You are here
Ledipasvir/Sofosbuvir for 6 Weeks in HIV-Infected Patients With Acute HCV Infection
Jürgen K. Rockstroh1; Sanjay Bhagani2; Robert H. Hyland3; Chohee Yun3; Wei Zhang3; Diana M. Brainard4; John G. McHutchison4; Patrick Ingiliz5; Thomas Lutz6; Mark Nelson7
1Medizinische Univsklinik, Bonn, Germany;2Royal Free Hosp, London, United Kingdom;3Gilead Scis, Inc, Foster City, CA, USA;4Gilead Sciences, Foster City, CA, USA;5Cntr for Infectiology, Berlin, Germany;6Infektiologikum, Frankfurt/Main, Frankfurt, Germany;7Chelsea and Westminster Hosp NHS Fndn Trust, London, UK
There is no currently approved treatment for acute HCV infection. Guidelines recommend 24 weeks of therapy with interferon (IFN) and ribavirin in HIV coinfected individuals who are diagnosed with acute HCV. Shorter duration therapy with all-oral agents may offer a better-tolerated more efficacious alternative. Here we evaluated the safety, tolerability and efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed dose combination for 6 weeks in genotype 1 or 4 HIV-infected patients with acute HCV infection.
Patients with an acute HCV infection of <24 weeks duration as per NEAT AHC guidelines were included. Patients were required to either be receiving HIV antiretroviral (ARV) therapy with HIV RNA <200 copies/mL, or not be receiving any treatment for HIV with no plans to start therapy. Enrollment of patients with active illicit drug use was permitted. Patients with acute opportunistic infections or HBV co-infection were excluded. The primary endpoint was sustained viral response defined as HCV RNA.
Twenty-six patients were enrolled. All were male, the majority were Caucasian (92%), IL28B non-CC (54%), and receiving ARV therapy (96%). The median baseline HCV RNA was 5.4 log10 IU/mL. Nineteen (73%) patients had HCV genotype 1a infection and 7 (27%) had genotype 4 infection. All patients completed therapy. 22/26 (85%) achieved SVR4. Four (15%) patients relapsed. There was a strong relationship between baseline HCV RNA and treatment outcome (Figure). All patients (21/21) with baseline HCV RNA <9 million IU/mL achieved SVR4. Treatment was safe and well tolerated. Twenty two of 26 (85%) patients had an adverse event; the majority being mild or moderate. One patient had serious adverse events related to a motor vehicle accident and illicit drug use. No patients discontinued, died or experienced HIV rebound. Post treatment week 12 data will be presented.
LDV/SOF for 6 weeks is effective and well tolerated in HIV-infected patients with acute HCV infection who have a baseline HCV RNA <9 million. Acutely HCV-infected patients with a higher viral load should be considered for longer duration of therapy.