Department of Gastroenterology & Hepatology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.
Swiss Med Wkly. 2010 Jul 19;140:w13055. doi: 10.4414/smw.2010.13055. eCollection 2010.
BACKGROUND/AIMS: Treatment of chronic HCV infection has become a priority in HIV+ patients, given the faster progression to end-stage liver disease. The primary endpoint of this study was to evaluate and compare antiviral efficacy of Peginterferon alpha 2a plus ribavirin in HIV-HCV co-infected and HCV mono-infected patients, and to examine whether 6 months of therapy would have the same efficacy in HIV patients with favourable genotypes 2 and 3 as in mono-infected patients, to minimise HCV-therapy-related toxicities. Secondary endpoints were to evaluate predictors of sustained virological response (SVR) and frequency of side-effects.
Patients with genotypes 1 and 4 were treated for 48 weeks with Pegasys 180 microg/week plus Copegus 1000-1200 mg/day according to body weight; patients with genotypes 2 and 3 for 24 weeks with Pegasys 180 microg/week plus Copegus 800 mg/day.
132 patients were enrolled in the study: 85 HCV mono-infected (38: genotypes 1 and 4; 47: genotypes 2 and 3), 47 HIV-HCV co-infected patients (23: genotypes 1 and 4; 24: genotypes 2 and 3). In an intention-to-treat analysis, SVR for genotypes 1 and 4 was observed in 58% of HCV mono-infected and in 13% of HIV-HCV co-infected patients (P = 0.001). For genotypes 2 and 3, SVR was observed in 70% of HCV mono-infected and in 67% of HIV-HCV co-infected patients (P = 0.973). Undetectable HCV-RNA at week 4 had a positive predictive value for SVR for mono-infected patients with genotypes 1 and 4 of 0.78 (95% CI: 0.54-0.93) and of 0.81 (95% CI: 0.64-0.92) for genotypes 2 and 3. For co-infected patients with genotypes 2 and 3, the positive predictive value of SVR of undetectable HCV-RNA at week 4 was 0.76 (95%CI, 0.50-0.93). Study not completed by 22 patients (36%): genotypes 1 and 4 and by 12 patients (17%): genotypes 2 and 3.
Genotypes 2 or 3 predict the likelihood of SVR in HCV mono-infected and in HIV-HCV co-infected patients. A 6-month treatment with Peginterferon alpha 2a plus ribavirin has the same efficacy in HIV-HCV co-infected patients with genotypes 2 and 3 as in mono-infected patients. HCV-RNA negativity at 4 weeks has a positive predictive value for SVR. Aggressive treatment of adverse effects to avoid dose reduction, consent withdrawal or drop-out is crucial to increase the rate of SVR, especially when duration of treatment is 48 weeks. Sixty-one percent of HIV-HCV co-infected patients with genotypes 1 and 4 did not complete the study against 4% with genotypes 2 and 3.
背景/目的：鉴于 HIV 阳性患者向终末期肝病的更快进展，慢性 HCV 感染的治疗已成为 HIV 阳性患者的当务之急。本研究的主要终点是评估和比较聚乙二醇干扰素 alpha 2a 加利巴韦林在 HIV-HCV 合并感染和 HCV 单感染患者中的抗病毒疗效，并研究在 HIV 患者中，6 个月的治疗方案对有利基因型 2 和 3 的患者是否与单感染患者具有相同的疗效，以最大程度减少 HCV 治疗相关的毒性。次要终点是评估持续病毒学应答（SVR）的预测因素和不良反应的频率。
基因型 1 和 4 的患者接受 Pegasys 180 mcg/周联合 Copegus 1000-1200 mg/天（根据体重）治疗 48 周；基因型 2 和 3 的患者接受 Pegasys 180 mcg/周联合 Copegus 800 mg/天治疗 24 周。
本研究共纳入 132 例患者：85 例 HCV 单感染（38 例：基因型 1 和 4；47 例：基因型 2 和 3），47 例 HIV-HCV 合并感染患者（23 例：基因型 1 和 4；24 例：基因型 2 和 3）。在意向治疗分析中，基因型 1 和 4 的 HCV 单感染患者中 SVR 为 58%，HIV-HCV 合并感染患者为 13%（P = 0.001）。对于基因型 2 和 3，HCV 单感染患者 SVR 为 70%，HIV-HCV 合并感染患者为 67%（P = 0.973）。第 4 周时 HCV-RNA 不可检测对基因型 1 和 4 的 HCV 单感染患者 SVR 的阳性预测值为 0.78（95%CI：0.54-0.93），对基因型 2 和 3 的阳性预测值为 0.81（95%CI：0.64-0.92）。对于基因型 2 和 3 的合并感染患者，第 4 周时 HCV-RNA 不可检测的 SVR 阳性预测值为 0.76（95%CI，0.50-0.93）。22 例患者（36%）未完成研究：基因型 1 和 4；12 例患者（17%）：基因型 2 和 3。
基因型 2 或 3 可预测 HCV 单感染和 HIV-HCV 合并感染患者的 SVR 可能性。聚乙二醇干扰素 alpha 2a 加利巴韦林 6 个月的治疗在基因型 2 和 3 的 HIV-HCV 合并感染患者中的疗效与单感染患者相同。第 4 周时 HCV-RNA 阴性对 SVR 具有阳性预测值。积极治疗不良反应以避免剂量减少、同意书撤回或脱落对于提高 SVR 率至关重要，尤其是在治疗持续时间为 48 周时。基因型 1 和 4 的 61%的 HIV-HCV 合并感染患者未完成研究，而基因型 2 和 3 的患者为 4%。
Zotero 插件