Department of Gastroenterology and Hepatology, Federal Research Center for Nutrition, Biotechnology and Food Safety, Kashirskoe shosse, 21, Moscow, 115446, Russian Federation.
Clinical and Diagnostic Department, Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases, Krasnoyarsk, Russian Federation.
Clin Drug Investig. 2018 Mar;38(3):239-247. doi: 10.1007/s40261-017-0606-0.
BACKGROUND AND OBJECTIVES: The efficacy of < 12 weeks of hepatitis C virus (HCV) treatment in patients co-infected with HCV and human immunodeficiency virus type 1 (HIV-1) has not been established. We assessed the efficacy and safety of ledipasvir-sofosbuvir for 8 weeks in HCV mono-infected and HCV/HIV-1 co-infected patients.
We enrolled patients mono-infected with genotype 1 HCV or co-infected with HCV and HIV-1 who were HCV treatment-naive and did not have cirrhosis. HCV/HIV-1 co-infected patients were either not receiving antiretroviral treatment and had a CD4 T-cell count > 500 cells/mm or were receiving a protocol-approved antiretroviral regimen for ≥ 8 weeks (or ≥ 6 months for abacavir-containing regimens) and had HIV-1 RNA < 50 copies/mL and a CD4 T-cell count > 200 cells/mm. Patients received ledipasvir-sofosbuvir (90/400 mg) once daily for 8 weeks. The primary efficacy endpoint was sustained virologic response 12 weeks after treatment discontinuation (SVR12).
The SVR12 rate was 100% (67/67) for HCV mono-infected patients and 97% (57/59) for HCV/HIV-1 co-infected patients. Two patients relapsed by the week 4 post-treatment visit. Overall, the most common adverse events were headache (52%) and upper abdominal pain (26%). There were no serious adverse events or treatment discontinuations due to adverse events. No HCV/HIV-1 co-infected patients receiving antiretroviral treatment experienced HIV virologic rebound, and no clinically meaningful changes in CD4 T-cell counts were observed in any co-infected patient.
Non-cirrhotic, treatment-naive patients with genotype 1 HCV mono-infection and HCV/HIV-1 co-infection achieved high rates of SVR12 with 8 weeks of treatment with ledipasvir/sofosbuvir. ClinicalTrials.gov identifier: NCT02472886.
尚未确定在合并感染丙型肝炎病毒（HCV）和人类免疫缺陷病毒 1（HIV-1）的患者中，<12 周 HCV 治疗的疗效。我们评估了 ledipasvir-索磷布韦在 HCV 单感染和 HCV/HIV-1 合并感染患者中治疗 8 周的疗效和安全性。
我们招募了 HCV 基因型 1 单感染或 HCV/HIV-1 合并感染且未合并肝硬化的初治患者。HCV/HIV-1 合并感染患者未接受抗逆转录病毒治疗且 CD4 T 细胞计数>500 个细胞/mm³，或正在接受方案批准的抗逆转录病毒治疗方案治疗≥8 周（或对于含阿巴卡韦的方案治疗≥6 个月），且 HIV-1 RNA<50 拷贝/mL 和 CD4 T 细胞计数>200 个细胞/mm³。患者接受 ledipasvir-索磷布韦（90/400mg）每日 1 次，治疗 8 周。主要疗效终点是治疗结束后 12 周持续病毒学应答（SVR12）。
HCV 单感染患者的 SVR12 率为 100%（67/67），HCV/HIV-1 合并感染患者的 SVR12 率为 97%（57/59）。2 例患者在治疗后第 4 周时复发。总体而言，最常见的不良反应是头痛（52%）和上腹痛（26%）。无严重不良事件或因不良事件而停药。接受抗逆转录病毒治疗的 HCV/HIV-1 合并感染患者均未出现 HIV 病毒学反弹，任何合并感染患者的 CD4 T 细胞计数均无临床意义的变化。
无肝硬化、初治的基因型 1 HCV 单感染和 HCV/HIV-1 合并感染患者接受 ledipasvir/sofosbuvir 治疗 8 周，SVR12 率高。临床试验注册号：NCT02472886。
