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.
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Funding
This study was supported by The National Natural Science Foundation of China (No. 81601731).
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Yuanyuan Li, Linghua Li, and Jun Liu contributed equally as co-first authors. Fu-Sheng Wang contributed to the design of this study. All authors contributed to data collection, the interpretation of data, the drafting, and revision of this manuscript. The final version of this manuscript was approved by all authors.
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Yuanyuan Li, Linghua Li, Jun Liu, Da-Wei Zhang, Fang Zhao, Li Wang, Aizezi Mahemure, Ronghui Xie, Suyun Lei, Weiping Cai, Xicheng Wang, Zhanjun Shu, Xiejie Chen, Hui Wang, and Fu-Sheng Wang declared that there were no conflicts regarding funding or interest with this manuscript.
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This study protocol had been approved by the ethical committee of the Beijing 302 hospital and other institutions involved.
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Li, Y., Li, L., Liu, J. et al. Tolerable and curable treatment in HIV/HCV co-infected patients using anti-HCV direct antiviral agents: a real-world observation in China. Hepatol Int 12, 465–473 (2018). https://doi.org/10.1007/s12072-018-9891-9
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DOI: https://doi.org/10.1007/s12072-018-9891-9