title: 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens.
abstract: Highly effective hepatitis C virus (HCV) direct-acting antiviral therapies that do not require modification of human immunodeficiency virus (HIV) antiretroviral regimens are needed. We evaluated the efficacy and safety of daclatasvir + sofosbuvir (DCV + SOF) for 12 weeks by antiretroviral (ARV) regimen in HIV-HCV-coinfected patients.
  
  
  
  In the randomized, open-label ALLY-2 study, HIV-HCV-coinfected patients received 8 or 12 weeks of once-daily DCV 60 mg (dose-adjusted as-necessary for concomitant ARVs) + SOF 400 mg. Results were stratified by ARV class for the 151 patients who received 12 weeks of DCV + SOF.
  
  
  
  Fifty-one patients were HCV treatment experienced, 100 were treatment naive, 89% male and 33% black. HCV genotypes were: genotype 1a (GT1a; 69%), GT1b (15%), GT2 (8%), GT3 (6%), and GT4 (2%). Sustained virologic response 12 weeks post-treatment (SVR12) was 97% and was similar across ARV regimens (P = .774): protease inhibitor-based, 97% (95% confidence interval [CI], 90%-99.7%); nonnucleoside reverse transcriptase inhibitor-based, 100% (95% CI, 91%-100%); and integrase inhibitor based, 95% (95% CI, 83%-99.4%). SVR12 among patients receiving either tenofovir disoproxil fumarate or abacavir as part of their antiretroviral therapy regimen was 98% (95% CI, 93%-99.5%) and 100% (95% CI, 85%-100%), respectively. Age, gender, race, cirrhosis, HCV treatment history, GT , and baseline HCV RNA did not affect SVR12. No discontinuations were attributed to treatment-related adverse events.
  
  
  
  DCV + SOF x12 weeks is a highly efficacious, all-oral, pan-GT HCV treatment for HIV-HCV coinfected patients across a broad range of ARV regimens.
  
  
  
  NCT02032888.
authors.affiliation: University of California, San Francisco.
authors.forename: Anne F
authors.initials: AF
authors.lastname: Luetkemeyer
authors.affiliation: Tarrant County Infectious Disease Associates, Fort Worth, Texas.
authors.forename: Cheryl
authors.initials: C
authors.lastname: McDonald
authors.affiliation: Midway Immunology and Research Center, Fort Pierce, Florida.
authors.forename: Moti
authors.initials: M
authors.lastname: Ramgopal
authors.affiliation: Bristol-Myers Squibb, Lawrenceville.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Noviello
authors.affiliation: Bristol-Myers Squibb, Hopewell, New Jersey.
authors.forename: Rafia
authors.initials: R
authors.lastname: Bhore
authors.affiliation: Bristol-Myers Squibb, Wallingford, Connecticut.
authors.forename: Peter
authors.initials: P
authors.lastname: Ackerman
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002219:Carbamates; D060085:Coinfection / Q000188:drug therapy* / Q000821:virology; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1; D016174:Hepacivirus; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011759:Pyrrolidines; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D014633:Valine / Q000031:analogs & derivatives; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D011759:Pyrrolidines; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir
keywords: HIV-HCV; antiretroviral therapy; coinfection; daclatasvir; sofosbuvir