ABSTRACT
Objective@#To investigate the optimal duration of pegylated-alpha interferon (Peg-INFα) combined with ribavirin (RBV) in treating chronic hepatitis C infection in human immunodeficiency virus (HIV)-infected patients.@*Methods@#A multicenter prospective study was conducted. The study subjects were divided into two groups; HIV/HCV co-infections (Group A, n = 158) and control with HCV-monoinfections (Group B, n = 60). All recruited patients received standard Peg-INFα plus RBV therapy. Group A was divided into 3 subgroups according to CD4+ cell counts: A1 subgroup, 79 cases, CD4+ counts > 350 cells /μl, who received anti-HCV before combination antiretroviral therapy(cART); A2 subgroup, 45 cases, CD4+ counts between 200 and 350 cells/μl, who did not start anti-HCV until they could tolerate cART well; A3 subgroup, 34 cases, CD4+ counts < 200 cells /μl, cART was administered first, and anti-HCV therapy was started when CD4+ counts > 200 cells/μl. The anti-HCV efficacy of two groups and 3 subgroups were compared. Statistical analysis for normal distribution and homogeneity of variance data was calculated by t-test and the counting data was analyzed by χ 2 test. The Mann-Whitney U test was used for non-normal data. A one-way analysis of variance (ANOVA) was used for the comparison of multiple groups, followed by SNK method. Multiple independent samples were used for non-parametric tests.@*Results@#There was no significant difference in age and baseline HCV RNA levels between groups and subgroups (P > 0.05). By an intent-to-treat (ITT) analysis, in Group A, the ratio of complete early virological response (cEVR) rate was 75.3% (119/158), the ratio of end of treatment virological response (eTVR) rate was 68.4% (108/158), and the ratio of sustained virological response (SVR) rate was 48.7% (77/158); in Group B, the ratio of cEVR rate was 93.3% (56/60), the ratio of eTVR rate was 90.0% (54/60), and the ratio of SVR rate was 71.7% (43/60); The therapeutic index of Group A were lower than those of Group B (P≤0.05). By per-protocol (PP) analysis, the ratio of cEVR rate in Group A [75.2% (88/112)] was still lower than that in Group B [93.3% (56/60)], but no significant differences were found in the ratio of eTVR rate and SVR rate between 2 groups (P > 0.05). Comparing the efficacy of subgroups (A1, A2 and A3) by ITT analysis, the ratios of cEVR rate were respectively 78.5% (62/79), 75.6% (34/45) and 67.6% (23/34); the ratios of eTVR rate were respectively 68.4%(54/79), 80.0%(36/45)and 52.9%(18/34); and the ratios of SVR rate were respectively 41.8%(33/79), 64.4%(29/45)and 44.1%(15/34). The ratio of eTVR in subgroup A2 was obviously higher than that in subgroup A3 and the ratio of SVR in subgroup A2 was statistically higher than that of subgroup A1(P≤0.05). However, by PP analysis, no significant differences of the therapeutic indexes were found among the respective subgroups (P > 0.05).@*Conclusion@#HIV-HCV co-infected patients would have better anti-HCV efficacy with Peg-INFα-2a plus RBV than HCV- monoinfected patients. The best time for initiating anti-HCV therapy in HIV-HCV co-infected patients is when CD4+ counts 200 cells/ μl.
ABSTRACT
ObjectiveTo investigate the efficacy of highly active antiretroviral therapy (HAART) for HIV/HCV co-infection patients. MethodsA randomized and double blinded trial was conducted in sixty-three HIV/HCV co-infected patients ( group A) and 62 HIV infected patients ( group B). The group A (study group) was further divided into A1, A2, A3 subgroups randomly by Spw-Pb network data system, and were given three different HAART regimens based on nevirapine (NVP), efavirenz (EFV) and lopinavir/ritonavir(LPV/r), respectively. CD4+ T lymphocyte counts, HIV virus load, glutamate-pyruvate transaminase (ALT) were detected at baseline and at the endpoint of study (48 weeks). SPSS 13.0 was used for statistical analysis. One-way ANOVA and LSD-t tests were performed. ResultsAfter 48 weeks treatment, HIV RNA became negative in 59 patients of group A (59/63, 93.7％ ), while that in group B was 61 (61/62, 98.4％ ) (x2 =0. 159, P ＞ 0.05 ). CD4+ T lymphocyte count in group A was (208 ± 77 )/μL, which was significantly lower than that in group B (263 ± 78)/μL (t =-2. 759, P = 0. 008 ).ALT level in group A was (57 ±49)U/L, which was significantly higher than in group B (31 ± 14) U/L (t = 2. 027, P = 0.047). CD4 + T lymphocyte count in group A3 was significantly higher than that in A1 (t=-2. 191, P =0.045), while ALT level in A1 was much higher than that in subgroups A2 and A3 ( t = 2.568 and 2.478, P ＜ 0. 05 ). The incurrence of drug-induced hepatitis in HIV/HCV co-infected group was much higher than that in HIV infected group (55.5％ vs. 27.4％, x2 = 10. 182, P = 0.001 ).ConclusionsHCV co-infection in HIV patients shows no impact on virological response to HAART, but the immunological response is poorer.Hepatotoxicity is common among patients receiving HAART, especially those who are receiving NVP containing regimens. LPV/r based regimens are recommend for HIV/HCV coinfected patients.