title: Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study.
abstract: BACKGROUND
  A safe, simple, effective, and pan-genotypic regimen to treat hepatitis C virus (HCV) infection in patients coinfected with human immunodeficiency virus type 1 (HIV-1) remains a medical need. We assessed the efficacy and safety of the NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir for HCV in patients coinfected with HIV-1.
  
  
  METHODS
  This phase 3, open-label, single-arm study at 17 sites in the United States enrolled patients with HCV of any genotype and HIV-1 coinfection, including those with compensated cirrhosis. All patients received sofosbuvir-velpatasvir once daily for 12 weeks. The primary endpoint was sustained virologic response 12 weeks after treatment (SVR12). Efficacy and safety were assessed in all patients receiving at least 1 dose of treatment.
  
  
  RESULTS
  Of 106 patients, 91 (86%) were men, 48 (45%) were black, and 19 (18%) had cirrhosis. SVR12 was achieved by 101 of 106 (95% [95% confidence interval {CI}, 89%-99%]) patients: 74 of 78 (95% [95% CI, 87%-99%]) with genotype 1; all 11 (100% [95% CI, 72%-100%]) with genotype 2; 11 of 12 (92% [95% CI, 62%-100%]) with genotype 3; and all 5 (100% [95% CI, 48%-100%]) with genotype 4. All 19 patients with cirrhosis had SVR12. Two patients relapsed, 2 were lost to follow-up, and 1 withdrew consent. Two discontinued treatment due to adverse events and 2 had serious adverse events. The most common adverse events were fatigue (25%), headache (13%), upper respiratory tract infection (8%), and arthralgia (8%).
  
  
  CONCLUSIONS
  Sofosbuvir-velpatasvir for 12 weeks was safe and provided high rates of SVR12 in patients coinfected with HCV and HIV-1.
  
  
  BACKGROUND
  NCT02480712.
authors.affiliation: Division of Infectious Diseases, Denver Health and Hospital Authority, Colorado.
authors.forename: David
authors.initials: D
authors.lastname: Wyles
authors.affiliation: James J. Peters Veterans Affairs Medical Center, Bronx.|Icahn School of Medicine at Mount Sinai, New York City, New York.
authors.forename: Norbert
authors.initials: N
authors.lastname: Bräu
authors.affiliation: Institute of Human Virology, University of Maryland, Baltimore.
authors.forename: Shyam
authors.initials: S
authors.lastname: Kottilil
authors.affiliation: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance.
authors.forename: Eric S
authors.initials: ES
authors.lastname: Daar
authors.affiliation: Ruane Medical and Liver Health Institute, Los Angeles, California.
authors.forename: Peter
authors.initials: P
authors.lastname: Ruane
authors.affiliation: Emory University, Atlanta, Georgia.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Workowski
authors.affiliation: University of California, San Francisco.
authors.forename: Anne
authors.initials: A
authors.lastname: Luetkemeyer
authors.affiliation: CORE Center, Cook County Health and Hospitals System and Rush University Medical Center, Chicago, Illinois.
authors.forename: Oluwatoyin
authors.initials: O
authors.lastname: Adeyemi
authors.affiliation: Massachusetts General Hospital and Harvard Medical School, Boston.
authors.forename: Arthur Y
authors.initials: AY
authors.lastname: Kim
authors.affiliation: Gilead Sciences, Foster City, California.
authors.forename: Brian
authors.initials: B
authors.lastname: Doehle
authors.affiliation: Gilead Sciences, Foster City, California.
authors.forename: K C
authors.initials: KC
authors.lastname: Huang
authors.affiliation: Gilead Sciences, Foster City, California.
authors.forename: Erik
authors.initials: E
authors.lastname: Mogalian
authors.affiliation: Gilead Sciences, Foster City, California.
authors.forename: Anu
authors.initials: A
authors.lastname: Osinusi
authors.affiliation: Gilead Sciences, Foster City, California.
authors.forename: John
authors.initials: J
authors.lastname: McNally
authors.affiliation: Gilead Sciences, Foster City, California.
authors.forename: Diana M
authors.initials: DM
authors.lastname: Brainard
authors.affiliation: Gilead Sciences, Foster City, California.
authors.forename: John G
authors.initials: JG
authors.lastname: McHutchison
authors.affiliation: Duke University, Durham, North Carolina.
authors.forename: Susanna
authors.initials: S
authors.lastname: Naggie
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Mark
authors.initials: M
authors.lastname: Sulkowski
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002219:Carbamates / Q000009:adverse effects / Q000627:therapeutic use*; D060085:Coinfection; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006526:Hepatitis C / Q000150:complications* / Q000188:drug therapy*; D006576:Heterocyclic Compounds, 4 or More Rings / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069474:Sofosbuvir / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D001562:Benzimidazoles; D001578:Benzopyrans
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D006576:Heterocyclic Compounds, 4 or More Rings; D000069474:Sofosbuvir; C000604171:velpatasvir; D001562:Benzimidazoles; D001578:Benzopyrans
keywords: ASTRAL-5; HCV-HIV coinfection; hepatitis C virus; sofosbuvir; velpatasvir