title: HIV Coinfected Have Similar SVR Rates as HCV Monoinfected With DAAs: It's Time to End Segregation and Integrate HIV Patients Into HCV Trials.
abstract: Phase 3 trials of direct acting antiviral drugs (DAAs) for hepatitis C virus (HCV) excluded patients coinfected with human immunodeficiency virus (HIV). After approval, small trials were done in HIV-HCV coinfected patients. The status quo results in delayed access to DAAs for HIV coinfected patients, a group with more rapid progression of liver disease. This article reviews all approved DAAs and compares sustained virological response (SVR) rates in the HIV coinfected with those in the HCV monoinfected treated with the same regimen for the same HCV genotype. SVR rates in HCV genotype 1 to 4 are virtually identical in the HIV co-infected as in the HCV monoinfected, regardless of whether the regimens contain interferon. Because HIV coinfection does not affect SVR rates or toxicity with DAA-containing therapy, excluding HIV coinfected patients from clinical trials of DAA-containing anti-HCV therapy is discriminatory and unnecessary. Rather, HIV coinfection is one of many comorbidities that occur in some patients with HCV infection.
authors.affiliation: Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada.
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Shafran
mesh_terms: D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D060085:Coinfection / Q000188:drug therapy / Q000453:epidemiology / Q000821:virology; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D016174:Hepacivirus / Q000187:drug effects; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology / Q000821:virology; D006801:Humans
chemical_list: D000998:Antiviral Agents
keywords: HCV; HIV; HIV exceptionalism; clinical trials