Yuanyuan Li1, Linghua Li2, Jun Liu3, Da-Wei Zhang1, Fang Zhao4, Li Wang5, Aizezi Mahemure6, Ronghui Xie5, Suyun Lei5, Weiping Cai2, Xicheng Wang5, Zhanjun Shu6, Xiejie Chen2, Hui Wang7, Fu-Sheng Wang8. 1. Research and Treatment Center of Infectious Diseases, Beijing 302 Hospital, 100, Western 4th Ring Middle Road, Beijing, 100039, China. 2. Department of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou, 510060, China. 3. Kunming Third People's Hospital, Kunming, 650000, China. 4. Department of Infectious Disease, Shenzhen Third People's Hospital, Shenzhen, 518000, China. 5. Department of Infectious Diseases, Yunnan Provincial Hospital of Infectious Diseases, Kunming, 650300, China. 6. Xinjiang Uygur Autonomous Region Infectious Diseases Hospital, Uygur, Ürümqi, 830000, China. 7. Department of Infectious Disease, Shenzhen Third People's Hospital, Shenzhen, 518000, China. szwanghui810@163.com. 8. Research and Treatment Center of Infectious Diseases, Beijing 302 Hospital, 100, Western 4th Ring Middle Road, Beijing, 100039, China. fswang302@163.com.
Abstract
OBJECTIVE: No brand direct-acting antiviral agents (DAAs) are available for treatment of HIV-1/HCV co-infected patients in China. This study aimed to observe the therapeutic efficacy and safety of generic DAAs for affected Chinese patients. DESIGN: Real-world setting to elucidate whether DAAs were tolerated and effective in HIV-1/HCV co-infected patients. METHODS: 176 HIV-1/HCV co-infected patients received anti-HCV DAA treatment together with ART regimens for HIV infection. Among the 176 patients, 99 patients were treated with SOF + DCV ± RBV, 60 patients were treated with SOF + LDV ± RBV, and 17 patients received SOF + RBV ± Peg-IFN regimens, for 12 or 24 weeks, respectively. The primary endpoint was undetectable HCV RNA 12 weeks after therapy was completed (SVR12). Data pertaining to safety and adverse events were analyzed. RESULTS: 151/176 HIV-1/HCV co-infected patients finished the treatment and 12-week follow-up. SVR12 for the patients treated with regimens of SOF + DCV, SOF + DCV+RBV, SOF + Peg-IFN+RBV, SOF + RBV, SOF + LDV, and SOF + LDV+RBV for 12 or 24 weeks was 100% (75/75), 100% (11/11), 100% (14/14), 100% (2/2), 95.2% (40/42), and 100% (7/7), respectively. HIV-1/HCV co-infected patients with liver cirrhosis achieved well SRV12. Notably, there was no significant difference in adverse effects among patients with different baseline CD4+ T-cell count in those who received DAA regimens with or without Peg-IFN and RBV. CONCLUSION: We showed generic SOF + DCV and SOF + LDV regimens were well tolerated and with high efficiency. Patient's baseline CD4+ T-cell count did not exhibit significant difference in adverse effects.
OBJECTIVE: No brand direct-acting antiviral agents (DAAs) are available for treatment of HIV-1/HCV co-infected patients in China. This study aimed to observe the therapeutic efficacy and safety of generic DAAs for affected Chinese patients. DESIGN: Real-world setting to elucidate whether DAAs were tolerated and effective in HIV-1/HCV co-infected patients. METHODS: 176 HIV-1/HCV co-infected patients received anti-HCV DAA treatment together with ART regimens for HIV infection. Among the 176 patients, 99 patients were treated with SOF + DCV ± RBV, 60 patients were treated with SOF + LDV ± RBV, and 17 patients received SOF + RBV ± Peg-IFN regimens, for 12 or 24 weeks, respectively. The primary endpoint was undetectable HCV RNA 12 weeks after therapy was completed (SVR12). Data pertaining to safety and adverse events were analyzed. RESULTS: 151/176 HIV-1/HCV co-infected patients finished the treatment and 12-week follow-up. SVR12 for the patients treated with regimens of SOF + DCV, SOF + DCV+RBV, SOF + Peg-IFN+RBV, SOF + RBV, SOF + LDV, and SOF + LDV+RBV for 12 or 24 weeks was 100% (75/75), 100% (11/11), 100% (14/14), 100% (2/2), 95.2% (40/42), and 100% (7/7), respectively. HIV-1/HCV co-infected patients with liver cirrhosis achieved well SRV12. Notably, there was no significant difference in adverse effects among patients with different baseline CD4+ T-cell count in those who received DAA regimens with or without Peg-IFN and RBV. CONCLUSION: We showed generic SOF + DCV and SOF + LDV regimens were well tolerated and with high efficiency. Patient's baseline CD4+ T-cell count did not exhibit significant difference in adverse effects.
Entities:
Keywords:
Co-infected; Generic DAAs; HIV-1 patients; Hepatitis C; SOF
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