PMID- 20622678
OWN - NLM
STAT- MEDLINE
DCOM- 20101008
LR  - 20220414
IS  - 1944-7884 (Electronic)
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 55
IP  - 2
DP  - 2010 Oct
TI  - Women experience higher rates of adverse events during hepatitis C virus therapy 
      in HIV infection: a meta-analysis.
PG  - 170-5
LID - 10.1097/QAI.0b013e3181e36420 [doi]
AB  - BACKGROUND: In HIV/ hepatitis C virus (HCV) coinfection, adverse events (AEs) 
      during HCV therapy account for 12%-39% of treatment discontinuations. It is 
      unknown whether sex influences complications. METHODS: Meta-analysis to study the 
      effect of sex and other predictors of AEs in 3 randomized trials, ACTG 5071, 
      APRICOT, and ANRSHCO2-RIBAVIC of Interferon (IFN) and Pegylated IFN (PEG), both 
      with and without Ribavirin, in HIV/HCV coinfection. Primary endpoints were AEs 
      requiring treatment discontinuation (AETD) or first dose modification (AEDM). 
      Multi-covariate stratified logistic regression was used to study predictors and 
      assess interactions with sex. RESULTS: Twenty-one percent of 1376 subjects were 
      women; 61% had undetectable HIV RNA; 14% were antiretroviral (ARV) therapy naive 
      at entry; median CD4 was 485 cells per cubicmillimeter. Seventeen percent had an 
      AETD and 50% AEDM; women had more AETD than men (24% vs. 16% P = 0.003) and AEDM 
      (61% vs. 48% P < 0.0001). AETD and AEDM occurred earlier in women; but the types 
      of AETD and AEDM were similar between sexes. Seventy-four percent of AETDs and 
      49% of AEDMs involved constitutional AEs; 18% of AETD depression; and 26% of AEDM 
      neutropenia. We identified interactions with sex and body mass index (BMI) (P = 
      0.04, continuous) and nonnucleoside reverse transcriptase inhibitor (P = 0.03); 
      more AETDs were seen in men with lower BMI (P = 0.01) and in women on 
      nonnucleoside reverse transcriptase inhibitors (P = 0.009). More AEDMs were seen 
      with PEG [odds ratio (OR) = 2.07]; older age (OR = 1.48 per 10 years); decreasing 
      BMI (OR = 1.04 per kg/m); HCV genotype 1, 4 (OR = 1.31); Ishak 5, 6 (OR = 1.42); 
      decreasing Hgb (OR = 1.23 per g/dL); and decreasing absolute neutrophil count 
      (1.04 per 500 cells/mm). Interactions between sex and ARV-naive status (P = 
      0.001) and zidovudine (P = 0.001) were identified: There were more AEDMs in 
      ARV-naive women (P = 0.06) and ARV-experienced men (P = 0.001) and higher AEDMs 
      in women with zidovudine (P = 0.0002). CONCLUSIONS: Although there was no 
      difference in type of AE, AETD and AEDM were more frequent and occurred earlier 
      in women. In women, ARV regimen may be an important predictor of AETDs during HCV 
      therapy and should be explored as a predictor of AEs in HIV/HCV coinfection 
      trials.
FAU - Bhattacharya, Debika
AU  - Bhattacharya D
AD  - University of California, Los Angeles, CA, USA. debikab@mednet.ucla.edu
FAU - Umbleja, T
AU  - Umbleja T
FAU - Carrat, F
AU  - Carrat F
FAU - Chung, R T
AU  - Chung RT
FAU - Peters, M G
AU  - Peters MG
FAU - Torriani, F
AU  - Torriani F
FAU - Andersen, J
AU  - Andersen J
FAU - Currier, J S
AU  - Currier JS
LA  - eng
GR  - P30-AI27763D/AI/NIAID NIH HHS/United States
GR  - K23 AI066983/AI/NIAID NIH HHS/United States
GR  - AI27661/AI/NIAID NIH HHS/United States
GR  - U01 AI046376/AI/NIAID NIH HHS/United States
GR  - AI27670/AI/NIAID NIH HHS/United States
GR  - 5K12HD01400/HD/NICHD NIH HHS/United States
GR  - K12 HD001400-02/HD/NICHD NIH HHS/United States
GR  - K24 AI056933-08/AI/NIAID NIH HHS/United States
GR  - DK078772/DK/NIDDK NIH HHS/United States
GR  - U01 AI069502/AI/NIAID NIH HHS/United States
GR  - K24 DK078772-01/DK/NIDDK NIH HHS/United States
GR  - K24 AI 56933/AI/NIAID NIH HHS/United States
GR  - M01 RR000096/RR/NCRR NIH HHS/United States
GR  - M01 RR000046/RR/NCRR NIH HHS/United States
GR  - AI46370/AI/NIAID NIH HHS/United States
GR  - U01 AI027661/AI/NIAID NIH HHS/United States
GR  - K24 DK078772/DK/NIDDK NIH HHS/United States
GR  - AI27675/AI/NIAID NIH HHS/United States
GR  - AI25868/AI/NIAID NIH HHS/United States
GR  - K24 AI056933/AI/NIAID NIH HHS/United States
GR  - U01 AI027670/AI/NIAID NIH HHS/United States
GR  - U01 AI025897/AI/NIAID NIH HHS/United States
GR  - AI25897/AI/NIAID NIH HHS/United States
GR  - RR00044/RR/NCRR NIH HHS/United States
GR  - M01 RR000044/RR/NCRR NIH HHS/United States
GR  - UM1 AI068634/AI/NIAID NIH HHS/United States
GR  - U01 AI046370/AI/NIAID NIH HHS/United States
GR  - AI046376/AI/NIAID NIH HHS/United States
GR  - K12 HD001400/HD/NICHD NIH HHS/United States
GR  - K23 AI066983A/AI/NIAID NIH HHS/United States
GR  - U01 AI027675/AI/NIAID NIH HHS/United States
GR  - P30 AI027763/AI/NIAID NIH HHS/United States
GR  - AI27659/AI/NIAID NIH HHS/United States
GR  - RR00096/RR/NCRR NIH HHS/United States
GR  - AI50410/AI/NIAID NIH HHS/United States
GR  - K23 AI066983-01A2/AI/NIAID NIH HHS/United States
GR  - AI068634/AI/NIAID NIH HHS/United States
GR  - U01 AI027659/AI/NIAID NIH HHS/United States
GR  - RR00046/RR/NCRR NIH HHS/United States
GR  - U01 AI068634/AI/NIAID NIH HHS/United States
GR  - P30 AI050410/AI/NIAID NIH HHS/United States
GR  - U01 AI025868/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Antiviral Agents)
RN  - 0 (Interferon alpha-2)
RN  - 0 (Interferon-alpha)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 49717AWG6K (Ribavirin)
RN  - 9008-11-1 (Interferons)
RN  - Q46947FE7K (peginterferon alfa-2a)
SB  - IM
MH  - Adult
MH  - Antiviral Agents/*adverse effects/therapeutic use
MH  - Female
MH  - HIV Infections/*complications/drug therapy
MH  - Hepatitis C/complications/*drug therapy
MH  - Humans
MH  - Interferon alpha-2
MH  - Interferon-alpha/*adverse effects/therapeutic use
MH  - Interferons/*adverse effects/therapeutic use
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Odds Ratio
MH  - Polyethylene Glycols/*adverse effects/therapeutic use
MH  - Recombinant Proteins
MH  - Ribavirin/*adverse effects/therapeutic use
MH  - Sex Factors
PMC - PMC2943974
MID - NIHMS213403
COIS- Conflicts of Interest: DB, TU, and FT report no conflicts of interest. JA has 
      served on the data safety monitoring board (DSMB) of Tibotec. FC was a consultant 
      for Roche, Glaxo-Smith Kline, Sanofi-Aventis, Novartis, received grants from 
      Roche, Glaxo-Smith Kline, Sanofi-Aventis and had travel expenses paid by Roche, 
      Glaxo-Smith Kline, Sanofi-Aventis, Novartis, and Schering-Plough. RTC has 
      received research support from Roche. JSC has received research grants from 
      Schering Plough, Merck, and Tibotec and has been on the Advisory Boards for BMS 
      and Merck (2008). MP has been a consultant for Roche, Merck, and Pharmasset.
EDAT- 2010/07/14 06:00
MHDA- 2010/10/12 06:00
PMCR- 2011/10/01
CRDT- 2010/07/13 06:00
PHST- 2010/07/13 06:00 [entrez]
PHST- 2010/07/14 06:00 [pubmed]
PHST- 2010/10/12 06:00 [medline]
PHST- 2011/10/01 00:00 [pmc-release]
AID - 10.1097/QAI.0b013e3181e36420 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2010 Oct;55(2):170-5. doi: 
      10.1097/QAI.0b013e3181e36420.