PMID- 26839044
OWN - NLM
STAT- MEDLINE
DCOM- 20161007
LR  - 20220330
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 38
IP  - 2
DP  - 2016 Feb
TI  - Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with 
      Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison.
PG  - 404-12
LID - S0149-2918(16)00002-3 [pii]
LID - 10.1016/j.clinthera.2015.12.017 [doi]
AB  - PURPOSE: Our aim was to compare the efficacy and tolerability of daclatasvir plus 
      sofosbuvir (DCV+SOF) versus SOF plus ribavirin (SOF+R) in patients coinfected 
      with HIV and hepatitis C virus (HCV). METHODS: A systematic literature review of 
      Phase III clinical trials identified 2 trials of SOF+R-PHOTON-1 (A Phase 3, 
      Open-Label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin 
      in Chronic Genotype 1, 2 and 3 Hepatitis C Virus [HCV] and Human Immunodeficiency 
      Virus [HIV] Co-Infected Subjects) and PHOTON-2 (A Phase 3, Open-Label Study to 
      Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic 
      Genotype 1, 2, 3 and 4 Hepatitis C Virus [HCV] and Human Immunodeficiency Virus 
      [HIV] Co-Infected Subjects) suitable for comparison with the trial of DCV+SOF in 
      patients coinfected with HIV and HCV-ALLY-2 (A Phase 3 Evaluation of Daclatasvir 
      Plus Sofosbuvir in Treatment-naive and Treatment-experienced Chronic Hepatitis C 
      [Genotype 1, 2, 3, 4, 5, or 6] Subjects Coinfected With Human Immunodeficiency 
      Virus [HIV]). Individual patient data from ALLY-2 were available; published 
      summary data were extracted and pooled for the PHOTON trials. To adjust for 
      cross-trial differences, ALLY-2 patients were subject to the inclusion and 
      exclusion criteria reported in the PHOTON trials and were weighted to match all 
      available summary baseline characteristics reported in both PHOTON trials. 
      Sustained virologic response at week 12 post-treatment (SVR12) discontinuation 
      due to adverse events (AEs) and rates of AEs were compared. FINDINGS: The SVR12 
      rate was significantly higher among patients treated with DCV+SOF (n = 91) than 
      among those treated with SOF+R (n = 455) both before (96.7% vs 84.6%; P = 0.002) 
      and after (99.9% vs 84.6%; P < 0.001) adjusting for baseline characteristics. 
      After adjustment, compared with patients treated with SOF+R, patients receiving 
      DCV+SOF had a significantly lower rate of discontinuation due to AEs and 
      significantly lower rates of the following specific AEs: cough, diarrhea, 
      insomnia, nasopharyngitis, upper respiratory tract infection, and hemoglobin <10 
      g/dL. IMPLICATIONS: After adjustment for cross-trial differences in baseline 
      characteristics, DCV+SOF was associated with a significantly higher SVR12 rate 
      and lower rate of discontinuation due to AEs than SOF+R in patients coinfected 
      with HIV and HCV.
CI  - Copyright (c) 2016 Elsevier HS Journals, Inc. All rights reserved.
FAU - Swallow, Elyse
AU  - Swallow E
AD  - Analysis Group, Inc., Boston, Massachusetts. Electronic address: 
      elyse.swallow@analysisgroup.com.
FAU - Song, Jinlin
AU  - Song J
AD  - Analysis Group, Inc., Boston, Massachusetts.
FAU - Yuan, Yong
AU  - Yuan Y
AD  - Bristol-Myers Squibb, Princeton, New Jersey.
FAU - Kalsekar, Anupama
AU  - Kalsekar A
AD  - Bristol-Myers Squibb, Princeton, New Jersey.
FAU - Kelley, Caroline
AU  - Kelley C
AD  - Analysis Group, Inc., Boston, Massachusetts.
FAU - Peeples, Miranda
AU  - Peeples M
AD  - Analysis Group, Inc., Boston, Massachusetts.
FAU - Mu, Fan
AU  - Mu F
AD  - Analysis Group, Inc., Boston, Massachusetts.
FAU - Ackerman, Peter
AU  - Ackerman P
AD  - Bristol-Myers Squibb, Wallingford, Connecticut.
FAU - Signorovitch, James
AU  - Signorovitch J
AD  - Analysis Group, Inc., Boston, Massachusetts.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20160203
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Imidazoles)
RN  - 0 (Pyrrolidines)
RN  - 49717AWG6K (Ribavirin)
RN  - HG18B9YRS7 (Valine)
RN  - LI2427F9CI (daclatasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Antiviral Agents/therapeutic use
MH  - Carbamates
MH  - Clinical Trials, Phase III as Topic
MH  - Coinfection
MH  - Drug Therapy, Combination
MH  - Genotype
MH  - HIV Infections/*drug therapy
MH  - Hepacivirus/genetics
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Imidazoles/*therapeutic use
MH  - Pyrrolidines
MH  - Ribavirin/*therapeutic use
MH  - Sofosbuvir/*therapeutic use
MH  - Valine/analogs & derivatives
OTO - NOTNLM
OT  - HIV
OT  - daclatasvir
OT  - hepatitis C
OT  - matching-adjusted indirect comparison
OT  - ribavirin
OT  - sofosbuvir
EDAT- 2016/02/04 06:00
MHDA- 2016/10/08 06:00
CRDT- 2016/02/04 06:00
PHST- 2015/08/25 00:00 [received]
PHST- 2015/12/22 00:00 [revised]
PHST- 2015/12/31 00:00 [accepted]
PHST- 2016/02/04 06:00 [entrez]
PHST- 2016/02/04 06:00 [pubmed]
PHST- 2016/10/08 06:00 [medline]
AID - S0149-2918(16)00002-3 [pii]
AID - 10.1016/j.clinthera.2015.12.017 [doi]
PST - ppublish
SO  - Clin Ther. 2016 Feb;38(2):404-12. doi: 10.1016/j.clinthera.2015.12.017. Epub 2016 
      Feb 3.