Health-related quality of life in subjects with HCV/HIV coinfection: results from ACTG 5178 study.

TitleHealth-related quality of life in subjects with HCV/HIV coinfection: results from ACTG 5178 study.
Publication TypeJournal Article
Year of Publication2012
AuthorsKemmer N, Hua L, Andersen JW, Chung RT, Butt AA, Sherman KE
Corporate AuthorsACTG 5178 Study Team
JournalJ Viral Hepat
Volume19
Issue11
Pagination792-800
Date Published2012 Nov
ISSN1365-2893
KeywordsAntiviral Agents, Coinfection, Depression, Drug Therapy, Combination, Female, Hepatitis C, HIV Infections, Humans, Interferon-alpha, Liver Cirrhosis, Male, Polyethylene Glycols, Quality of Life, Recombinant Proteins, Ribavirin, Treatment Outcome
Abstract

Although health-related quality of life (HRQOL) is diminished in HCV/HIV, the relationship between virologic response and maintenance therapy with HRQOL in this population is unknown. ACTG 5178 was a phase 2, randomized trial, with three steps - Step 1: all subjects received pegylated interferon (PEG-IFN)/ribavirin (P/R) for 12 weeks. Step 2: subjects who failed to achieve early viral response (EVR) were randomized to PEG-IFN or observational control for an additional 72 weeks. Step 3: subjects with EVR from step 1 continued on P/R for a total of 72 weeks with 24 weeks follow-up off-therapy. HRQOL, symptom distress and depression levels were measured at multiple time points. In step 1 (n = 329), there was a significant decline in HRQOL in all dimensions. In step 3 (n = 169), the overall HRQOL and three of its eight dimensions (general health, role function and pain score) were increased, and achievement of sustained virologic response was associated with increased general health and cognitive function. In step 2 (n = 85), there was no significant change in HRQOL and no significant difference between groups (PEG-IFN vs observational control). There was a significant decline in HRQOL during the initial 12 weeks of therapy. Thereafter, the HRQOL profile differed for subjects with EVR vs without EVR. Maintenance therapy with PEG-IFN had no impact on the HRQOL.

DOI10.1111/j.1365-2893.2012.01609.x
Alternate JournalJ. Viral Hepat.
PubMed ID23043386
PubMed Central IDPMC3468910
Grant ListDK078772 / DK / NIDDK NIH HHS / United States
K24 DK070528 / DK / NIDDK NIH HHS / United States
K24 DK070528 / DK / NIDDK NIH HHS / United States
K24 DK070528-09 / DK / NIDDK NIH HHS / United States
K24 DK078772 / DK / NIDDK NIH HHS / United States
K24 DK078772-06 / DK / NIDDK NIH HHS / United States
P30 AI050410 / AI / NIAID NIH HHS / United States
U01 AI038858 / AI / NIAID NIH HHS / United States
U01 AI038858-09 / AI / NIAID NIH HHS / United States
U01 AI068634 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States
U01 AI068636-05S1 / AI / NIAID NIH HHS / United States
U01 AI38858 / AI / NIAID NIH HHS / United States
UL1 RR024160 / RR / NCRR NIH HHS / United States
UM1 AI068634 / AI / NIAID NIH HHS / United States
UM1 AI068634-07 / AI / NIAID NIH HHS / United States