A randomized controlled trial of highly active antiretroviral therapy versus highly active antiretroviral therapy and chemotherapy in therapy-naive patients with HIV-associated Kaposi sarcoma in South Africa.
A randomized controlled trial of highly active antiretroviral therapy versus highly active antiretroviral therapy and chemotherapy in therapy-naive patients with HIV-associated Kaposi sarcoma in South Africa.
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DOI：
10.1097/qai.0b013e318251aedd
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发表时间：
2012-06-01
期刊：
影响因子：
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通讯作者：
Coovadia HM
中科院分区：
文献类型：
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作者：
Mosam A;Shaik F;Uldrick TS;Esterhuizen T;Friedland GH;Scadden DT;Aboobaker J;Coovadia HM
撒哈拉以南非洲艾滋病毒相关KS（HIV-KS）的最佳方法尚不清楚。随着高效抗逆转录病毒疗法（HAART）在南非的大规模推广，我们假设HIV-KS的生存率将得到改善，并且除了HAART之外，化疗的管理将是可行的，并改善KS特异性结局。我们进行了一项随机、对照、开放标签试验，并进行了意向治疗分析。来自南非德班爱德华八世医院（一家公共部门三级转诊中心）的未经治疗的HIV-KS患者，但没有症状性内脏疾病或真菌性病变需要紧急化疗，随机接受HAART单药治疗或HAART+化疗（CXT）。HAART组接受司他夫定、拉米夫定和奈韦拉平（Triomune®）; CXT组接受Triomune® +博莱霉素、多柔比星和长春新碱（ABV），每3周一次。当ABV不可用时，口服依托泊苷（50-100 mg，第1-21天，28天为一个周期）替代。主要结果是HAART开始后12个月使用AIDS临床试验组标准的总体KS应答。次要比较包括：缓解时间、无进展生存期、总生存期、不良事件、艾滋病毒控制、CD 4重建、依从性和生活质量。59例受试者被随机分配至HAART组，53例被随机分配至CXT组。12-HAART组和CXT组的1个月总体KS应答率分别为39%和66%（差异27%; 95% CI 9%-43%，p=0.005）。12个月时，77%的患者存活（两组之间无生存差异，p=0.49），82%的患者HIV病毒载量<50拷贝/mL，两组之间无差异（p=0.47）;所有患者的CD 4计数和QOL指标均有所改善。HAART联合化疗在12个月内产生了更高的总体KS反应，而单独HAART在生存率和选择的发病率指标方面提供了类似的改善。在非洲，由于HIV和HHV-8的高流行率和有限的资源，HAART单独为HIV-KS患者提供了重要的益处。
The optimal approach to HIV-associated KS (HIV-KS) in sub-Saharan Africa is unknown. With large-scale rollout of highly active antiretroviral therapy (HAART) in South Africa, we hypothesized survival in HIV-KS would improve and administration of chemotherapy in addition to HAART would be feasible and improve KS-specific outcomes. We conducted a randomized, controlled, open-label trial with intention-to-treat analysis. Treatment-naïve patients from King Edward VIII Hospital, Durban, South Africa, a public-sector tertiary referral center, with HIV-KS, but no symptomatic visceral disease or fungating lesions requiring urgent chemotherapy, were randomized to HAART alone or HAART and chemotherapy (CXT). HAART arm received stavudine, lamivudine and nevirapine (Triomune®); CXT arm received Triomune® plus bleomycin, doxorubicin, and vincristine (ABV) every 3 weeks. When ABV was not available, oral etoposide (50-100 mg days 1-21 of a 28 day cycle) was substituted. Primary outcome was overall KS response using AIDS Clinical Trial Group criteria 12 months after HAART initiation. Secondary comparisons included: time to response, progression-free survival, overall survival, adverse events, HIV control, CD4 reconstitution, adherence and quality-of-life. 59 subjects were randomized to HAART, 53 to CXT. 12-month overall KS response was 39% in the HAART arm and 66% in the CXT arm (difference 27%; 95% CI 9%-43%, p=0.005). At 12 months, 77% were alive (no survival difference between arms, p=0.49), 82% had HIV viral load <50 copies/mL without difference between arms, (p=0.47); CD4 counts and QOL measures improved in all patients. HAART with chemotherapy produced higher overall KS response over 12 months, while HAART alone provided similar improvement in survival and select measures of morbidity. In Africa, with high prevalence of HIV and HHV-8 and limited resources, HAART alone provides important benefit in patients with HIV-KS.