PLoS ONE (Jan 2020)

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

  • Gregory D Huhn,
  • Moti Ramgopal,
  • Mamta K Jain,
  • Federico Hinestrosa,
  • David M Asmuth,
  • Jihad Slim,
  • Deborah Goldstein,
  • Shauna Applin,
  • Julie H Ryu,
  • Shuping Jiang,
  • Stephanie Cox,
  • Moupali Das,
  • Thai Nguyen-Cleary,
  • David Piontkowsky,
  • Bill Guyer,
  • Lorenzo Rossaro,
  • Richard H Haubrich

DOI
https://doi.org/10.1371/journal.pone.0224875
Journal volume & issue
Vol. 15, no. 1
p. e0224875

Abstract

Read online

IntroductionGuidelines advocate the treatment of HCV in all HIV/HCV co-infected individuals. The aim of this randomized, open-label study (ClinicalTrials.gov identifier: NCT02707601; https://clinicaltrials.gov/ct2/show/NCT02707601) was to evaluate the safety/efficacy of ledipasvir/sofosbuvir (LDV/SOF) 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.MethodsParticipants with HIV-1 RNA ResultsOf 150 participants, 148 received ≥1 dose of HIV study drug and 144 received LDV/SOF (72 in each F/TAF group; 83% GT1a, 94% HCV treatment-naïve, 12% cirrhotic). Overall, SVR12 was 97% (95% confidence interval: 93-99%). Black race did not affect SVR12. Of four participants not achieving SVR12, one had HCV relapse, one had HCV virologic non-response due to non-adherence, and two missed the post-HCV Week 12 visit. Of 148 participants, 96% receiving E/C/F/TAF and 95% receiving R/F/TAF maintained HIV suppression at Week 24; no HIV resistance was detected. No participant discontinued LDV/SOF or E/C/F/TAF due to adverse events; one participant discontinued R/F/TAF due to worsening of pre-existing hypercholesterolemia. Renal toxicity was not observed in either F/TAF regimen during LDV/SOF co-administration. In conclusion, high rates of HCV SVR12 and maintenance of HIV suppression were achieved with LDV/SOF and F/TAF-based regimens.ConclusionThis study supports LDV/SOF co-administered with an F/TAF-based regimen in HIV-1/HCV-GT1 co-infected patients.