Clinical experience with dolutegravir/abacavir/lamivudine in HIV-HCV co-infected patients treated with a sofosbuvir-based regimen-safety and efficacy

HIV Clin Trials. 2016 Nov;17(6):242-245. doi: 10.1080/15284336.2016.1248625.

Abstract

Background: There is no known reason to suspect an adverse drug interaction between dolutegravir-based antiretroviral therapy and sofosbuvir, simeprevir, or ledipasvir. There is a paucity of clinical data for this combination.

Methods: Prospective, open-label study of patients with HIV well controlled on dolutegravir, abacavir, and lamivudine, who were co-infected with HCV genotype 1, and required therapy with simeprevir plus sofosbuvir or sofosbuvir/ledipasvir single-tablet regimen (STR) for 12 weeks. The two primary endpoints were percentage of patients achieving sustained virologic response (SVR) at 12 weeks post-treatment and percentage of patients with a HIV-1 viral load <50 copies/ml at end of the combination therapy.

Results: Twenty-eight subjects were enrolled from August 2014 to September 2015. Thirteen patients were treated with simprevir plus sofosbuvir, and 15 subjects were treated with sofosbuvir/ledipasvir. 23 genotype 1a, and 5 genotype 1b were included. Nineteen were treatment naïve, and 2 patients had compensated cirrhosis. The mean age was 59 years (95% CI 58.21-59.78 years). The mean age was 59 years (95% CI: 58.21-59.78 years), and 25 patients were black. Out of the 28 patients who completed this study, SVR 12 was achieved in 27 of 28 patients (96%, 95% CI 89.6-100.0%), and all patients had an HIV virus load <50 copies/ml at week 12 of therapy, for an intent-to-treat rate of 100%. No patients ended therapy secondary to adverse events.

Conclusion: Our study suggests a good safety and efficacy for the combination of a dolutegravir, abacavir, and lamivudine with sofosbuvir-based DAA therapy.

Keywords: Antiretroviral therapy; Coinfection; HIV–HCV; Ledipasvir; Simeprevir; Sofobuvir.

Publication types

  • Clinical Trial

MeSH terms

  • Antiretroviral Therapy, Highly Active* / adverse effects
  • CD4 Lymphocyte Count
  • Coinfection*
  • Dideoxynucleosides / administration & dosage
  • Drug Therapy, Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV Infections / virology
  • HIV-1
  • Hepacivirus / genetics
  • Hepatitis C / drug therapy*
  • Hepatitis C / virology
  • Heterocyclic Compounds, 3-Ring / administration & dosage
  • Humans
  • Lamivudine / administration & dosage
  • Male
  • Middle Aged
  • Oxazines
  • Piperazines
  • Pyridones
  • Sofosbuvir / administration & dosage
  • Sofosbuvir / adverse effects
  • Sofosbuvir / therapeutic use*
  • Treatment Outcome
  • Viral Load

Substances

  • Dideoxynucleosides
  • Heterocyclic Compounds, 3-Ring
  • Oxazines
  • Piperazines
  • Pyridones
  • Lamivudine
  • dolutegravir
  • Sofosbuvir
  • abacavir