title: Clinical experience with dolutegravir/abacavir/lamivudine in HIV-HCV co-infected patients treated with a sofosbuvir-based regimen-safety and efficacy.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Our study suggests a good safety and efficacy for the combination of a dolutegravir, abacavir, and lamivudine with sofosbuvir-based DAA therapy.
authors.affiliation: a Department of Infectious Disease, Saint Michaels Medical Center , New York Medical College , Newark , NJ , USA.
authors.forename: Tamara M
authors.initials: TM
authors.lastname: Johnson
authors.affiliation: a Department of Infectious Disease, Saint Michaels Medical Center , New York Medical College , Newark , NJ , USA.
authors.forename: Raymund
authors.initials: R
authors.lastname: Sison
authors.affiliation: b Department of Research , Saint Michael's Medical Center , Newark , NJ , USA.
authors.forename: James P
authors.initials: JP
authors.lastname: Fallon
authors.affiliation: b Department of Research , Saint Michael's Medical Center , Newark , NJ , USA.
authors.forename: Prerak P
authors.initials: PP
authors.lastname: Shukla
authors.affiliation: a Department of Infectious Disease, Saint Michaels Medical Center , New York Medical College , Newark , NJ , USA.
authors.forename: Sristi
authors.initials: S
authors.lastname: Bhattarai
authors.affiliation: b Department of Research , Saint Michael's Medical Center , Newark , NJ , USA.
authors.forename: Herbert
authors.initials: H
authors.lastname: Galang
authors.affiliation: b Department of Research , Saint Michael's Medical Center , Newark , NJ , USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Habeeb
authors.affiliation: a Department of Infectious Disease, Saint Michaels Medical Center , New York Medical College , Newark , NJ , USA.
authors.forename: Jihad
authors.initials: J
authors.lastname: Slim
mesh_terms: D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D060085:Coinfection; D015224:Dideoxynucleosides / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006575:Heterocyclic Compounds, 3-Ring / Q000008:administration & dosage; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D000099227:Abacavir; D000099226:Dolutegravir
chemical_list: D015224:Dideoxynucleosides; D006575:Heterocyclic Compounds, 3-Ring; D019259:Lamivudine; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D000069474:Sofosbuvir; D000099227:Abacavir; D000099226:Dolutegravir
keywords: Antiretroviral therapy; Coinfection; HIV–HCV; Ledipasvir; Simeprevir; Sofobuvir