Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir

Abstract

Objective: As the treatment of hepatitis C virus (HCV) infection has evolved to directly acting antiviral agents, the impact of these directly acting antiviral-only regimens on improving adherence to HCV treatment in HIV/HCV coinfected populations has not been evaluated. The study compared adherence to ledipasvir/sofosbuvir (LDV/SOF) in HCV monoinfected and HIV/HCV coinfected individuals.

Design: Adherence was measured from participants in two phase 2 open-label studies (NCT01805882 and NCT01878799).

Methods: HCV treatment-naive, genotype 1 study individuals [HCV monoinfected participants (N = 20) and HIV/HCV coinfected participants, antiretroviral untreated (N = 13) or on combination antiretroviral therapy (N = 37)] were treated with LDV (90 mg) and SOF (400 mg) administered as one tablet once daily for 12 weeks. Adherence was measured using three tools: medication event monitoring system cap, pill count, and patient report.

Results: Participants were predominately African American (83%) and male (73%), with a median age of 59 years. Participants had prompt HCV viral load decline and high adherence rates (97 ± 0.5% by medication event monitoring system). Participant adherence decreased significantly from early (baseline week 4) as compared with late (weeks 8-12) in therapy in all three groups - HCV monoinfected (P = 0.01), HIV/HCV antiretroviral untreated (P = 0.02), and HIV/HCV antiretroviral treated participants (P = 0.01).

Conclusion: Adherence to LDV/SOF in this urban population was high and comparable between HCV monoinfected and HIV/HCV coinfected participants regardless of antiretroviral use.

Fig. 1.. High adherence to ledipasvir/sofosbuvir in hepatitis C virus (HCV) monoinfected and HIV/HCV coinfected participants regardless of antiretroviral use.

(a) High rates of adherence was measured by MEMSCaps, pill count, and patient report, however, adherence as measured by MEMSCaps was significantly less than adherence as measured by patient report in all the three groups. (b) Although adherence as measured by MEMSCaps was high over the course of the 12-week treatment, adherence significantly declined over the course of treatment in all three patient groups from weeks 4 to 12: HCV monoinfected P = 0.01, HIV/HCV antiretroviral untreated P = 0.02, and HIV/HCV antiretroviral treated P = 0.01. MEMS, medication event monitoring system.