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HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based

Gregory D Huhn1, Moti Ramgopal2, Mamta K Jain3

  • 1Ruth M Rothstein CORE Center, Chicago, IL, United States of America.

Plos One
|January 30, 2020
PubMed

Insights

This study shows that ledipasvir/sofosbuvir (LDV/SOF) is safe and effective for treating Hepatitis C Virus (HCV) in patients co-infected with HIV. High rates of sustained virologic response (SVR12) were achieved with co-administration of LDV/SOF and elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or rilpivirine/F/TAF (R/F/TAF).

Area of Science:

  • Infectious Diseases
  • Hepatology
  • Virology

Background:

  • Guidelines recommend Hepatitis C Virus (HCV) treatment for all HIV/HCV co-infected individuals.
  • HIV-1/HCV co-infection presents unique challenges in treatment management and efficacy.
  • Ledipasvir/sofosbuvir (LDV/SOF) is a direct-acting antiviral agent for HCV treatment.

Purpose of the Study:

  • To evaluate the safety and efficacy of LDV/SOF when co-administered with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or rilpivirine/F/TAF (R/F/TAF) in HIV-1/HCV co-infected participants.
  • To assess the rates of sustained virologic response (SVR12) for HCV and the maintenance of HIV suppression.
  • To determine the safety profile of the co-administered regimens, including adverse events and potential toxicities.

Main Methods:

  • A randomized, open-label study (NCT02707601) enrolled participants with HIV-1 RNA <50 copies/mL and chronic HCV genotype 1.
  • Participants were randomized to switch to E/C/F/TAF or R/F/TAF, followed by 12 weeks of LDV/SOF if HIV suppression was maintained.
  • The primary endpoint was SVR12, defined as HCV virologic response 12 weeks after LDV/SOF completion.

Main Results:

  • An overall SVR12 rate of 97% was achieved in 144 participants who received LDV/SOF.
  • 96% of participants on E/C/F/TAF and 95% on R/F/TAF maintained HIV suppression at Week 24, with no detected HIV resistance.
  • No participants discontinued LDV/SOF or E/C/F/TAF due to adverse events; renal toxicity was not observed.

Conclusions:

  • LDV/SOF co-administered with F/TAF-based regimens (E/C/F/TAF or R/F/TAF) demonstrates high efficacy for HCV treatment in HIV-1/HCV co-infected patients.
  • The combination regimens are safe and well-tolerated, supporting the maintenance of HIV suppression.
  • These findings support current guidelines advocating for HCV treatment in all HIV/HCV co-infected individuals.
Abstract

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