Berkan-Kawińska Aleksandra, Piekarska Anna, Berak Hanna, Mazur Włodzimierz, Garlicki Aleksander, Tudrujek-Zdunek Magdalena, Lorenc Beata, Dybowska Dorota, Socha Łukasz, Parfieniuk-Kowerda Anna, Flisiak Robert
Department of Infectious Diseases and Hepatology, Medical University of Lodz, Łódź, Poland.
Hospital for Infectious Diseases, Warsaw Medical University, Warsaw, Poland.
Clin Exp Hepatol. 2024 Sep;10(3):165-169. doi: 10.5114/ceh.2024.141752. Epub 2024 Jul 29.
To assess the real-life efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in HIV/HCV- positive patients treated with bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF).
Patients were evaluated in terms of their baseline biochemical characteristics, which included platelet count, serum creatinine and bilirubin levels, alanine transaminase (ALT) activity, international normalized ratio (INR) and Model for End-Stage Liver Disease (MELD) score.The efficacy endpoint was the achievement of a sustained virologic response at posttreatment week 12 (SVR12), defined as undetectable HCV RNA 12 weeks after the scheduled end of therapy.
No significant differences in baseline patient characteristics between the two study groups were observed. Patients treated with sofosbuvir/velpatasvir (SOF/VEL) were more often treatment-naïve, but the difference was not statistically significant (96.0% vs. 86.8% in GLE/PIB group, = 0.0629). Prevalence of genotype 3 was higher in the group treated with GLE/PIB (36.9% vs. 21.8% in SOF/VEL group, = 0.183382), while genotype 1 was more frequent in patients treated with SOF/VEL (55.4% vs. 44.7% in GLE/PIB group, = 0.348202), but again it did not prove to be statistically significant. SVR12 rates reached 78.9% and 80.2% for GLE/PIB and SOF/VEL, respectively, in ITT analysis, and 100% and 98.8%, respectively, in modified intent-to-treat (mITT) analysis.
The study showed that real-life results of direct acting antiviral (DAA) therapy with GLE/PIB or SOF/VEL did not differ significantly in HIV/HCV-coinfected patients treated with B/FTC/TAF. Both regimens allowed encouraging SVR12 rates and treatment safety to be achieved, as well as tolerability, which was also comparable between the study groups.
评估 glecaprevir/pibrentasvir(GLE/PIB)在接受比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺(B/FTC/TAF)治疗的 HIV/HCV 阳性患者中的实际疗效和安全性。
根据患者的基线生化特征进行评估,这些特征包括血小板计数、血清肌酐和胆红素水平、丙氨酸转氨酶(ALT)活性、国际标准化比值(INR)和终末期肝病模型(MELD)评分。疗效终点是治疗后第 12 周实现持续病毒学应答(SVR12),定义为预定治疗结束后 12 周 HCV RNA 检测不到。
两个研究组之间患者的基线特征未观察到显著差异。接受索磷布韦/维帕他韦(SOF/VEL)治疗的患者初治比例更高,但差异无统计学意义(GLE/PIB 组为 96.0%,SOF/VEL 组为 86.8%,P = 0.0629)。GLE/PIB 治疗组中基因 3 型的患病率更高(GLE/PIB 组为 36.9%,SOF/VEL 组为 21.8%,P = 0.183382),而接受 SOF/VEL 治疗的患者中基因 1 型更常见(GLE/PIB 组为 44.7%,SOF/VEL 组为 55.4%,P = 0.348202),但同样未证明具有统计学意义。在意向性分析(ITT)中,GLE/PIB 和 SOF/VEL 的 SVR12 率分别达到 78.9%和 80.2%,在改良意向性分析(mITT)中分别为 100%和 98.8%。
该研究表明,在接受 B/FTC/TAF 治疗的 HIV/HCV 合并感染患者中,GLE/PIB 或 SOF/VEL 直接抗病毒(DAA)治疗的实际结果无显著差异。两种治疗方案均能实现令人鼓舞的 SVR12 率、治疗安全性以及耐受性,且研究组之间的耐受性也相当。