title: Direct-acting antivirals in hepatitis C virus (HCV)-infected and HCV/HIV-coinfected patients: real-life safety and efficacy.
abstract: Clinical trials of all-oral direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection reported high response rates in HCV/HIV coinfection, similar to those obtained in HCV monoinfection. We evaluated the safety and efficacy of these regimens in a clinical practice setting.
  
  
  
  In this prospective observational study, all the HCV-monoinfected and HCV/HIV-coinfected patients undergoing HCV treatment with all-oral DAA regimens in a routine clinical setting from December 2014 to December 2015 were included in the analysis. Sustained virological response 12 weeks after the end of therapy (SVR12) and reported adverse events (AEs) were evaluated. Resistance-associated variants (RAVs) were analysed in a subgroup of patients at baseline and at the time of viral rebound in those with virological failure.
  
  
  
  One-hundred and nine patients (51 HCV-infected and 58 HCV/HIV-coinfected) were enrolled in the study. Sixty per cent had cirrhosis and 52% were pegylated interferon and ribavirin (pegIFN/RBV)-experienced. Thirty-six per cent received ombitasvir + paritaprevir/ritonavir + dasabuvir, 25% sofosbuvir + daclatasvir, 16% sofosbuvir + simeprevir, 17% sofosbuvir + ribavirin and 6% sofosbuvir + ledipasvir; ribavirin was used in 57% of subjects. The SVR12 rate was 91% and 96% in HIV-infected and uninfected patients, respectively (P = 0.44). The 4-week HCV viral decline was similar in the two groups. RAVs were found at baseline in 23 of 49 patients and did not affect SVR12. No predictors of SVR12 were identified in our cohort.
  
  
  
  Treatment with all-oral DAA combinations of patients infected with HCV and with HCV/HIV under real-life conditions led to high and similar rates of SVR12. Moreover, the historical factors associated with a sustained virological response to pegIFN/RBV were not predictive of the response to all-oral DAAs.
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Milazzo
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Lai
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Calvi
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Ronzi
authors.affiliation: Clinical Microbiology Virology and Diagnosis of Bioemergency, L. Sacco University Hospital, Milan, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Micheli
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Binda
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: A L
authors.initials: AL
authors.lastname: Ridolfo
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Gervasoni
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Galli
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Antinori
authors.affiliation: Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, Milan, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Sollima
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D060085:Coinfection / Q000188:drug therapy*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents
keywords: direct-acting antivirals; hepatitis C virus kinetics; hepatitis C virus polymorphisms; hepatitis C virus/HIV coinfection