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.
We performed a retrospective chart review from 2014 - 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)
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 - 1430 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.
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.
M. Al Obaidi,
B. Dang, None
B. Barnett, None