Real World Experience of Sofosbuvir/Ledipasvir Therapy in HIV Patients Co-infected with HCV: A Retrospective Study

Abstract

Background. Direct acting antiretrovirals in clinical trials have high efficacy achieving sustained virologic response (SVR) in Hepatitis C virus (HCV) and human‐immunodeficiency virus (HIV) co‐infected patients. We aim to investigate real‐world HCV SVR outcome of ledipasvir/sofosbuvir therapy in the HIV population. Methods. We performed a retrospective chart review from 2014 to 2016 of patients with HCV/HIV coinfection who received ledipasvir/sofosbuvir in a freestanding HIV clinic. Demographic data collected includes: HCV genotype (Gt), Fib‐4 score, length of therapy (LOT), HIV viral load (VL), CD4+ cell count, antiretroviral therapy (ART), HCV RNA levels at baseline, 4 weeks, 8 weeks, end of therapy (EOT), and SVR at week 12 post‐treatment. Statistical analysis was performed using Stata version 14 (STATA Corp., Texas, USA). Results. A total of 94 patients were included. The mean age was 54 years‐old, 78% were male. Most patients (95%) had Gt 1 HCV infection (84% 1A, 11% 1B and 1% mixed), 4% Gt 4, and one patient had Gt 6; 24% of patients had compensated cirrhosis. Median LOT was 12 weeks. 95% of patients received 12 weeks, 4% 24 weeks, and 1% received 16 weeks of therapy. Most patients had undetectable HIV VL (77% with <20 copies/mL), while 23% had HIV VL range from 20 to 1,430 copies/mL. The mean CD4+ count was 639 cells/microliters (95% CI 567‐711). The most commonly used ARTs were efavirenz/emtricitabine/tenofovir (21%), followed by abacavir/dolutegravir/lamivudine (15%). SVR12 was achieved in 99% (93/94) of patients (100% in HCV treatment experienced). Of those patients, 86/91 achieved HCV VL <15 at week 4 and 80/82 at EOT. The mean Fib‐4 score at start of therapy was 2.33 with post‐therapy of 1.35. One patient (Gt 1A, F4, on FTC/TDF/RAL) failed therapy secondary to NS5a mutation (L31M/V) and was retreated with sofosubuvir/simeprevir for 12 weeks achieving SVR 12. Interestingly, 4 patients had undetectable HCV VL at EOT with post‐EOT HCV viremia (157‐4511 IU/mL) that resolved on its own on repeated testing. Conclusion. Our HCV real‐life experience with ledipasvir/sofosbuvir at a freestanding HIV clinic confirms the efficacy and safety reported in randomized clinical trials. NS5A mutation led to treatment failure in this heterogeneous group of patients.