Prevalence of HCV coinfection in HIV-infected individuals in Nigeria and characterization of HCV genotypes.

BACKGROUND: Coinfection with hepatitis C virus (HCV) in individuals infected with HIV is associated with a higher incidence of liver injury, hepatic decompensation, and decreased survival time than that seen in an HIV-monoinfected population. While prevalence studies on HIV/HCV coinfection have been performed in the U.S. and in some European countries, little is known about coinfection rates in Africa. DESIGN: Retrospectively collected specimens from 146 confirmed HIV-positive individuals in Nigeria who had access to antiretroviral therapy (ART) were tested for HCV RNA, using the VERSANT HCV RNA qualitative assay (TMA), and, if HCV RNA-positive, for HCV genotype using the VERSANT HCV genotype assay (LiPA). RESULTS: Twelve out of the 146 individuals tested (8.2%) were HCV positive. Nine of the 12 HCV-positive individuals were infected with HCV genotype 1 (five 1a, three 1b, one non-subtypable) and three were infected with HCV genotype 2 (all non-subtypable). Coinfected individuals were more likely to be male, older, and have lower CD4+ cell counts than HIV-monoinfected individuals, although none of the differences reached statistical significance. CONCLUSION: The results highlight the potential public health impact of HCV infection in Nigeria, where anti-HCV testing is generally not performed in HIV-infected populations or in most blood transfusion centers.

Multicenter evaluation of the VERSANT HCV RNA qualitative assay for detection of hepatitis C virus RNA.

We report the results of a multicenter evaluation of a new assay for the detection of hepatitis C virus (HCV) RNA in human serum or plasma based on transcription-mediated amplification (HCV TMA). Analysis of combined data obtained from 15 independent sites, including 4 sites in the United States and 11 in Europe, by using preproduction kits showed a limit of detection of 9.8 IU/ml and an overall mean specificity of 97.9%. In addition, assay runs and samples were valid consistently (97.8% of assay runs and 98.0% of specimen results). Of the 15 sites that participated in the multicenter evaluation, 2 subsequently carried out additional performance studies with production kits in support of the assay's registration in France. Comparison of the findings from these two sites during the multicenter evaluation and during the registration studies showed an overall improvement in assay performance. A statistically significant (P < 0.001) improvement was achieved for both specificity and specimen validity in the registration studies, which were 99.4 and 98.1%, respectively. Combined data from the two sites showed a lower limit of detection of approximately 2.4 IU/ml and an improved assay validity of 100%, although the sample size was too small to show statistical significance at the 0.05 level. In summary, the performance characteristics of HCV TMA indicate that this assay is a reliable tool for the detection of HCV RNA in serum or plasma. Improvement in assay performance has been demonstrated with refinement of assay reagents, instrumentation, and operator experience.