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HCV antibody seroconversion in a U.S.
HIV-infected male clinical trials population
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Reported by Jules Levin
AASLD Nov 2 2009, Boston, MA
"Irrespective of perceived risk, all HIV+ persons should be screened annually with HCV Ab"
From Jules: authors show HIV+ men are getting infected with HCV without injection drug use, sp apparently sex is a risk factor. However, the study also reflects that Guidelines do not recommend HCV antibody testing on a repeated regular bases because these men in this study were not diagnosed. So, we are NOT diagnosing men with HIV who are getting HCV-infected either sexually or by IDU or other means so the authors recommend annual HCV antibody testing in all HIV+ individuals; and this should be for both men & women because it also appears that the risk for sexual transmission from an HCV Ab+ man to a women sexually is higher among HIV+ individuals
Marisa Holubar1, Lynn E. Taylor1, Kunling Wu2, Ronald J. Bosch2, Kenneth H. Mayer1, Karen T. Tashima1
1Department of Medicine, Brown University, Providence, RI 2Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA
The authors have no disclosures to report
Background
Outbreaks of sexually transmitted HCV infection have been reported among HIV+ MSM in Europe, Australia, New York and California. Whether this is occurring across the U.S. is unknown.
Methods
We evaluated determinants of HCV Ab seroconversion incidence among HIV+ male participants of the AIDS Clinical Trial Group (ACTG) Longitudinal Linked Randomized Trials (ALLRT) cohort.
ACTG, funded by the DHHS, NIAID and the NIH,1 was founded in 1987 and is the largest HIV clinical trials organization in the world.
ALLRT is a prospective cohort study of HIV+ subjects previously randomized into ACTG parent studies. Initiated in 2000 , ALLRT examines long-term immunologic, virologic, pharmacologic and clinical outcomes associated with HAART. ALLRT excludes ACTG parent studies with a primary focus other than treatment-related outcomes or with results not amenable to cross-protocol
comparisons. From 2000-2007, 62% of eligible ACTG participants enrolled in ALLRT.2 Standardized visits in ALLRT occur every 16 weeks with individual outcomes assessed at different intervals.
We determined HCV seroconversion incidence from 1996-2008.
HCV Ab testing at ALLRT entry began in 2002 with re-testing every 96 weeks added in 2006. 17 ACTG parent studies also performed HCV Ab testing from 1996-2002 with re-testing at different intervals. We included results from parent ACTG trials and ALLRT data.
To control for variable Ab follow-up times and increased surveillance after 2002, date of seroconversion was re-assigned as halfway between the date of the last negative and first positive HCV Ab. We evaluated associations with self-reported (previously, 5.3% or currently, 0.5%) IDU, time-varying CD4+ cell count and HIV RNA using multivariate Poisson regression. No sexual or non-IDU risk factor data was available.
Because of the variability of HCV Ab re-testing in ACTG parent protocols, subjects had different lengths of follow-up, with 47% contributing >4 years of person-time.
Conclusions & Recommendations
Incident HCV infection is occurring in an older, well-educated U.S. HIV+ male population despite engagement in care with HAART, primarily through non-parenteral means
75% seroconverted in the absence of IDU
HCV Ab development was not related to immune reconstitution
Irrespective of perceived risk, all HIV+ persons should be screened annually with HCV Ab
REFERENCES
1US Department of Health and Human Services, National Institute of Allergy and Infectious Disease, National Institute of Health - Division of AIDS
2Smurzynski, et al. (2008) AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT): Rationale, Design, and Baseline Characteristics. HIV Clin Trials 9(4):268-281
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