Mandorfer Mattias, Steiner Sebastian, Schwabl Philipp, Payer Berit A, Aichelburg Maximilian C, Lang Gerold, Grabmeier-Pfistershammer Katharina, Trauner Michael, Peck-Radosavljevic Markus, Reiberger Thomas
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna Vienna HIV & Liver Study Group.
Vienna HIV & Liver Study Group Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria.
J Infect Dis. 2015 Mar 1;211(5):729-35. doi: 10.1093/infdis/jiu516. Epub 2014 Sep 11.
The HIVCOBOC-RGT study (NCT01925183) was the first study to evaluate response-guided shortening of the duration of boceprevir (BOC)-based triple therapy in human immunodeficiency virus (HIV)/hepatitis C virus genotype 1-coinfected patients (HIV/HCV-GT1).
After 4 weeks of pegylated interferon-α-2a/ribavirin (PEGIFN/RBV) lead-in, patients with target-not-detectable HCV-RNA at week 8 (rapid virologic response; LI4W-W8UTND) received 24 weeks of BOC/PEGIFN/RBV (total: 28 weeks [W28]). Patients with target-detectable HCV-RNA at week 8 received 44 weeks of BOC/PEGIFN/RBV (total: 48 weeks [W48]).
Fourteen patients (67%) had LI4W-W8UTND and were eligible for the shortened W28 arm, while 7 (33%) patients were allocated to the W48 arm. No breakthrough or relapse occurred in the W28 arm, resulting in a sustained virologic response (SVR12TND) rate of 100% (12/12). In the W48 arm, the SVR12TND was 50% (3/6), with 3 patients meeting the futility rule at treatment week 12. The preliminary overall SVR12TND rate was 83% (15/18). Serious adverse events were observed in 5 (24%) patients, with 2 (10%) patients requiring surgical treatment of abscesses.
The majority of HIV/HCV-GT1 were eligible for response-guided shortening of treatment duration to W28 and all of these patients had a SVR12TND. If second-generation direct-acting antivirals are not available, W28 of BOC-based triple therapy may be recommended.
HIVCOBOC-RGT研究（NCT01925183）是首个评估在人类免疫缺陷病毒（HIV）/丙型肝炎病毒1型合并感染患者（HIV/HCV-GT1）中，基于波普瑞韦（BOC）的三联疗法的疗程能否根据反应进行缩短的研究。
在接受聚乙二醇化干扰素-α-2a/利巴韦林（PEGIFN/RBV）导入治疗4周后，第8周时丙型肝炎病毒核糖核酸（HCV-RNA）检测不到目标值的患者（快速病毒学应答；第4周-第8周未检测到目标值）接受24周的BOC/PEGIFN/RBV治疗（总计：28周[第28周]）。第8周时HCV-RNA检测到目标值的患者接受44周的BOC/PEGIFN/RBV治疗（总计：48周[第48周]）。
14例患者（67%）第4周-第8周未检测到目标值，符合进入疗程缩短至第28周组的条件，而7例（33%）患者被分配至第48周组。第28周组未发生突破或复发，持续病毒学应答（SVR12TND）率为100%（12/12）。在第48周组，SVR12TND为50%（3/6），3例患者在治疗第12周时符合无效标准。初步总体SVR12TND率为83%（15/18）。5例（24%）患者观察到严重不良事件，2例（10%）患者需要接受脓肿手术治疗。
大多数HIV/HCV-GT1患者符合根据反应将疗程缩短至第28周的条件，且所有这些患者均实现了SVR12TND。如果没有第二代直接作用抗病毒药物，可能推荐基于BOC的三联疗法治疗28周。
