Ke Y C, Li L H, Hu F Y, Lan Y, He Y Z, Chen X J, Tang X P, Cai W P, Lu R C, He Y, Li H Q
Department of Infectious Diseases, Eighth People's Hospital, Guangzhou 510060, China.
Research Institution, Eighth People's Hospital, Guangzhou 510060, China.
Zhonghua Gan Zang Bing Za Zhi. 2018 Apr 20;26(4):282-287. doi: 10.3760/cma.j.issn.1007-3418.2018.04.010.
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. 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. 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). 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.
探讨聚乙二醇化α干扰素（Peg-INFα）联合利巴韦林（RBV）治疗人类免疫缺陷病毒（HIV）感染患者慢性丙型肝炎的最佳疗程。进行了一项多中心前瞻性研究。研究对象分为两组：HIV/HCV合并感染组（A组，n = 158）和HCV单感染对照组（B组，n = 60）。所有招募的患者均接受标准的Peg-INFα加RBV治疗。A组根据CD4(+)细胞计数分为3个亚组：A1亚组，79例，CD4(+)计数> 350个细胞/μl，在联合抗逆转录病毒治疗（cART）前接受抗HCV治疗；A2亚组，45例，CD4(+)计数在200至350个细胞/μl之间，在能够耐受cART后才开始抗HCV治疗；A3亚组，34例，CD4(+)计数< 200个细胞/μl，先给予cART，当CD4(+)计数> 200个细胞/μl时开始抗HCV治疗。比较两组和3个亚组的抗HCV疗效。对正态分布和方差齐性数据进行统计分析采用t检验，计数资料采用χ(2)检验。对非正态数据采用Mann-Whitney U检验。采用单因素方差分析（ANOVA）比较多组数据，随后采用SNK法。多组独立样本采用非参数检验。各组和各亚组之间年龄和基线HCV RNA水平无显著差异（P > 0.05）。通过意向性分析（ITT），A组完全早期病毒学应答（cEVR）率为75.3%（119/158），治疗结束时病毒学应答（eTVR）率为68.4%（108/158），持续病毒学应答（SVR）率为48.7%（77/158）；B组cEVR率为93.3%（56/60），eTVR率为90.0%（54/60），SVR率为71.7%（43/60）；A组的治疗指标低于B组（P≤0.05）。通过符合方案分析（PP），A组cEVR率[75.2%（88/112）]仍低于B组[93.3%（56/60）]，但两组eTVR率和SVR率比较无显著差异（P > 0.05）。通过ITT分析比较各亚组（A1、A2和A3）的疗效，cEVR率分别为78.5%（62/79）、75.6%（34/45）和67.6%（23/34）；eTVR率分别为68.4%（54/79）、80.0%（36/45）和52.9%（18/34）；SVR率分别为41.8%（33/79）、64.4%（29/45）和44.1%（15/34）。A2亚组的eTVR率明显高于A3亚组，A2亚组的SVR率在统计学上高于A1亚组（P≤0.05）。然而，通过PP分析，各亚组的治疗指标无显著差异（P > 0.05）。HIV-HCV合并感染患者使用Peg-INFα-2a加RBV的抗HCV疗效优于HCV单感染患者。HIV-HCV合并感染患者开始抗HCV治疗的最佳时机是CD4(+)计数> 200个细胞/μl时。
