PMID- 27477612
OWN - NLM
STAT- MEDLINE
DCOM- 20170802
LR  - 20180303
IS  - 1468-1293 (Electronic)
IS  - 1464-2662 (Linking)
VI  - 18
IP  - 4
DP  - 2017 Apr
TI  - Direct-acting antivirals in hepatitis C virus (HCV)-infected and 
      HCV/HIV-coinfected patients: real-life safety and efficacy.
PG  - 284-291
LID - 10.1111/hiv.12429 [doi]
AB  - OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
CI  - (c) 2016 British HIV Association.
FAU - Milazzo, L
AU  - Milazzo L
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
FAU - Lai, A
AU  - Lai A
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
FAU - Calvi, E
AU  - Calvi E
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
FAU - Ronzi, P
AU  - Ronzi P
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
FAU - Micheli, V
AU  - Micheli V
AD  - Clinical Microbiology Virology and Diagnosis of Bioemergency, L. Sacco University 
      Hospital, Milan, Italy.
FAU - Binda, F
AU  - Binda F
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
FAU - Ridolfo, A L
AU  - Ridolfo AL
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
FAU - Gervasoni, C
AU  - Gervasoni C
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
FAU - Galli, M
AU  - Galli M
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
FAU - Antinori, S
AU  - Antinori S
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
FAU - Sollima, S
AU  - Sollima S
AD  - Department of Biomedical and Clinical Sciences L. Sacco, University of Milan, 
      Milan, Italy.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20160801
PL  - England
TA  - HIV Med
JT  - HIV medicine
JID - 100897392
RN  - 0 (Antiviral Agents)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Antiviral Agents/*administration & dosage/*adverse effects
MH  - Coinfection/*drug therapy
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - HIV Infections/*complications/*drug therapy
MH  - Hepatitis C, Chronic/*complications/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Viral Load
OTO - NOTNLM
OT  - direct-acting antivirals
OT  - hepatitis C virus kinetics
OT  - hepatitis C virus polymorphisms
OT  - hepatitis C virus/HIV coinfection
EDAT- 2016/08/02 06:00
MHDA- 2017/08/03 06:00
CRDT- 2016/08/02 06:00
PHST- 2016/05/19 00:00 [accepted]
PHST- 2016/08/02 06:00 [pubmed]
PHST- 2017/08/03 06:00 [medline]
PHST- 2016/08/02 06:00 [entrez]
AID - 10.1111/hiv.12429 [doi]
PST - ppublish
SO  - HIV Med. 2017 Apr;18(4):284-291. doi: 10.1111/hiv.12429. Epub 2016 Aug 1.