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• W2077000000 abstract "To the Editor: Hepatitis C virus (HCV) genotype and load are the strongest predictors of sustained virologic response in HIV-infected patients treated for HCV infection with peginterferon and ribavirin.1 A high level of HCV replication could explain the lower virologic response rate to anti-HCV therapy in HIV-coinfected patients. The impact of antiretroviral therapy on HCV load has been evaluated after the introduction of combination antiretroviral therapy (cART). Most studies showed that HCV load did not decrease during the first months of antiretroviral treatment2-5 and could even increase significantly (at least 0.5 log10) in some patients.4,5 Some authors have suggested that introduction of cART could yield a significant decrease in HCV load after 12 months of successful antiretroviral treatment,6 leading to HCV clearance in some cases.7,8 These studies were limited by their small sample size or a short follow-up period (no longer than 1 year), however. We describe here the change in plasma HCV load during the first 24 months after initiation of a protease inhibitor (PI)-containing antiretroviral regimen in 112 HCV-HIV-coinfected patients enrolled in the Agence Nationale de Recherches sur le SIDA (ANRS) CO8 APROCO-COPILOTE cohort. The ANRS CO8 APROCO-COPILOTE cohort is a prospective observational cohort in France that describes the effects of PI regimens in the context of routine care. A total of 1281 patients infected with HIV-1 and naive to PIs were enrolled from May 1997 to June 1999 at the time they initiated treatment with a PI-containing regimen. Data were recorded at baseline, after 1 and 4 months of PI therapy, and then every 4 months. Patients were eligible for inclusion in the study if they were HCV infected, defined as having positive serum antibodies to HCV by an enzyme-linked immunoassay (ELISA) third-generation test (Ortho HCV 3.0 ELISA, Monolisa antiHCV; Sanofi Diagnostics Pasteur, Paris, France) and detectable plasma HCV RNA by a sensitive polymerase chain reaction (PCR) technique (Cobas Amplicor HCV 2.0; Roche Diagnostics, Branchburg, NJ). Patients who had received previous anti-HCV treatment without documented virologic response at least 6 months before inclusion could be included. They were not eligible for analysis if they were receiving anti-HCV treatment during the follow-up period. Plasma samples were evaluated at baseline and after 4, 12, and 24 months of PI therapy in a single laboratory. Samples were stored at −80°C before HCV quantification, which used Versant HCV RNA 3.0 (Bayer Diagnostics, Eragny, France). If the HCV load was lower than the level of detection (3200 copies/mL or 615 IU/mL), HCV clearance was checked using a sensitive test (Cobas TaqMan HCV [sensitivity of 15 IU/mL]; Roche Diagnostics). To take into account intrinsic variability of quantitative assays and intraindividual variations, a decrease or increase in plasma HCV load was defined as a change between baseline and 24 months of >0.5 log10 (ie, 3-fold). The following potential determinants of plasma HCV load were considered for statistical analysis: age, gender, HIV transmission group, AIDS stage at baseline, HCV genotype, type of PI initially prescribed, and duration of PI therapy. The association between potential determinants and plasma HCV load at month 24 was studied by a linear regression model adjusted for plasma HCV load at initiation of PI therapy to take into account potential regression to the mean. Data were analyzed with SAS software, version 8 (SAS Institute, Cary, NC). Among the 1281 patients included in the cohort, 293 (23%) were HCV-antibody positive; 112 patients had available plasma samples after 24 months of PI therapy and were eligible for the current analysis (Table 1). At baseline, the plasma HCV load did not differ significantly according to age, gender, duration of HIV infection, CD4 T-lymphocyte count, plasma HIV-1 RNA level, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values, and HCV genotype. There was no significant change of median plasma HCV load over time (see Table 1). Among the 112 patients, 29 (28%) had a significant increase in plasma HCV load and 22 (20%) had a significant decrease at month 24, whereas 61 (52%) patients had no significant variation in plasma HCV load. Evolution of HIV RNA level and CD4 T-lymphocyte count did not significantly differ between these 3 groups. There was also no difference according to the prescribed PI.TABLE 1: Characteristics of 112 HIV-HCV-Coinfected Patients Analyzed for the Evolution of Plasma HCV Load Over Time, ANRS C08 APROCO-COPILOTE CohortHCV clearance was reported in 4 (4%) of the 112 patients (95% confidence interval [CI]: 1.0 to 8.9). In 3 patients, the initial plasma HCV loads were 6.6, 6.1, and 5.3 log10, respectively. HCV RNA was undetectable at month 12 in 1 patient and at month 24 in the 2 others. In the fourth patient, baseline plasma HCV load was lower than the level of quantification but with a positive qualitative measurement. Clearance of HCV RNA was obtained as early as the first point of follow-up (month 4) and was confirmed later on (months 12 and 24). In contrast, among 29 patients with a significant increase in plasma HCV load, 3 had a baseline HCV load lower than the level of quantification with a positive qualitative test result. After initiation of cART, the plasma HCV load increased and remained persistently elevated during the entire follow-up period (5.3 to 6.0 log10). In our study, plasma HCV load did not vary significantly in patients receiving cART-containing PI over a 24 month-period. HCV clearance was obtained in 4% of patients. We were able to evaluate HCV load changes in a large population of patients during a longer period of follow-up than those of previous studies. We observed that most patients had no significant HCV load change during the 24 months of the study. Among others, HCV load increased or decreased significantly in 28% and 20%, respectively. It is highly plausible that the observed results are linked to the effect of regression to the mean rather than representing a true biologic variation.9 There was no association between HCV load variation and viroimmunologic parameters linked to HIV disease. As previously reported,7,8 we observed HCV clearance in 4% (95% CI: 1.0 to 8.9) of patients. Whether this represents spontaneous clearance or is linked to antiretroviral therapy cannot be solved. A CD4 cell response against HCV antigens (primarily core antigens) can be observed in peripheral blood mononuclear cells (PBMCs) in HCV-HIV-coinfected patients receiving cART. This response may be restored by cART, explaining the suppression of HCV RNA. Conversely, the HCV load strongly increased in 3 patients with an undetectable HCV load before initiation of cART. To our knowledge, such a phenomenon has never been described, although an increase in HCV load (more than 1 log10 copies/mL) has been reported.4 The increased number of cytotoxic T lymphocytes might cause immune-mediated lysis of HCV-infected cells, resulting in intracellular virus release. Alternatively, decreased HIV RNA levels could be associated with reduction in endogenous α-interferon, favoring an elevated HCV load.10 In summary, PI-containing cART is most often not associated with biologically significant changes in HCV load in the first 24 months after its initiation. Strong individual variations can be observed, however, ranging from a high increase in HCV load to HCV clearance. HCV-HIV-coinfected patients should receive specific treatment of their hepatitis C, preferably before starting cART. Didier Neau, MD, PhD* Pascale Trimoulet, MD† Edwige Pereira, MSc‡ Marie-Edith Lafon, MD, PhD† Anne Gervais, MD§ Jean-Marie Ragnaud, MD* Michel Dupon, MD* Jean-Luc Ecobichon, MD§ Geneviève Chêne, MD‡ François Raffi, MD, PhD∥ ANRS CO8 APROCO-COPILOTE Study Group *Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin Fédération des Maladies Infectieuses et Tropicales Bordeaux, France †Université Victor Segalen Bordeaux 2 Laboratoire de Virologie EA 2968 Bordeaux, France ‡INSERM, U593 Université Victor Segalen, ISPED Bordeaux, France §Laboratoire de Pathologie Infectieuse Faculté Xavier Bichat Paris, France ∥Université Nantes JE2437 Nantes, France ACKNOWLEDGMENTS The authors thank Dr. F. Huisse for providing all Versant HCV RNA 3.0 assays (Bayer Diagnostics) for HCV RNA quantitation used in this study. They also wish to thank technicians of the virology laboratory of the Bordeaux University Hospital for providing their assistance." @default.
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• W2077000000 title "Evolution of Plasma Hepatitis C Virus Load in Patients Coinfected by HIV and Hepatitis C Virus Started on a Protease Inhibitor-Containing Antiretroviral Regimen, Agence Nationale de Recherches sur le SIDA CO8 APROCO-COPILOTE Cohort" @default.
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