Ledipasvir and Sofosbuvir in the Treatment of Early Hepatitis C Virus Infection in HIV-Infected Men

Abstract

Background: Treatment of HIV-infected men during early hepatitis C virus (HCV) infection with interferon results in a higher cure rate with a shorter duration of treatment than during chronic HCV infection. We recently demonstrated that this phenomenon applied to interferon-free treatment as well, curing most participants with short-course sofosbuvir and ribavirin. Due to the significantly higher potency of the ledipasvir/sofosbuvir (LDV/SOF) combination, we hypothesized that we would be more successful in curing early HCV infections using a shorter course of LDV/SOF than that used for treating chronic HCV infections.

Methods: We performed a prospective, open-label, consecutive case series study of 8 weeks of LDV/SOF in HIV-infected men with early genotype 1 HCV infection. The primary end point was aviremia at least 12 weeks after completion of treatment.

Results: We treated 25 HIV-infected men with early sexually acquired HCV infection with 8 weeks of LDV/SOF, and all 25 (100%) were cured. Twelve (48%) reported sexualized drug use with methamphetamine.

Conclusions: Eight weeks of LDV/SOF cured all 25 HIV-infected men with early HCV infection, including those who were actively using drugs. Based on these results, we recommend treatment of newly HCV-infected men during early infection, regardless of drug use, to both take advantage of this 8-week treatment and to decrease further HCV transmission among this group of men.

Keywords: HIV-infected men who have sex with men (MSM); acute HCV; enhanced treatment responsiveness; sexualized methamphetamine drug use.

Figure 1.

Trajectory of HCV VL from first measurement through initiation of treatment of 25 HIV-infected men with early hepatitis C infection. For each participant, the first-measured HCV VL (log₁₀-transformed) is denoted by a right tack (⊢), and the HCV VL at treatment initiation is denoted by an arrowhead, with the points connected by a line, labeled corresponding to Table 2. The points are placed along the y-axis corresponding to the magnitude of the VL, and along the x-axis corresponding to the time after clinical onset of HCV infection that the VL was obtained. Most participants had their first HCV VL obtained after their date of clinical onset; hence most first points are to the right of the x-axis origin. The horizontal dotted line represents the lower limit of quantification of the HCV VL test. For the purposes of the figure, HCV VL below this threshold were assigned a value of 1.0 log₁₀ IU/mL. Abbreviations: ALT, alanine aminotransferase; HCV, hepatitis C virus; VL, viral load.