The Journal of Practical Medicine ›› 2021, Vol. 37 ›› Issue (18): 2418-2422.doi: 10.3969/j.issn.1006⁃5725.2021.18.022

• Drugs and Clinic Practice • Previous Articles     Next Articles

A real ⁃ world clinical study of Danoprevir plus Sofosbuvir for chronic hepatitis C

FENG Kai*,HUANG Ping#,KE Liu,LONG Yingzi,YANG Xiaodong,LIN Chaoshuang.   

  1. The Third Affiliated Hospital of Sun Yat ⁃Sen University,Guangzhou 510500,China;# Lianjiang People′s Hospital,Lianjiang 524400,China

  • Online:2021-09-25 Published:2021-09-25
  • Contact: YANG Xiaodong E⁃mail:1503367141@qq.com;LIN Chaoshuang E⁃mail:lchaosh@mail. sysu.edu.cn

Abstract:

Objective All ⁃ oral direct ⁃ acting antiviral therapies are becoming the choice for hepatitis C (HCV)treatment. In this study,we aimed to evaluate the efficacy and safety of ritonavir ⁃ boosted danoprevir (DNVr)plus sofosbuvir±ribavirin(RBV)in the treatment of patients with HCV genotype 1,2,3 or 6,non⁃cirrhotic and compensated cirrhosis. Methods From July 2018 to December 2019,we registered 58 patients with HCV from the Third Affiliated Hospital of Sun Yat⁃Sen University,Kunming Third People′s Hospital,Liuzhou People′s Hospital and Guangzhou Eighth People′s Hospital. All patients were treated with DNVr plus sofosbuvir±ribavirin for 12 weeks and then followed up for 12 weeks. The primary endpoint was the rate of sustained virologic response at week 12 after the end of treatment(SVR12). The secondary endpoint was virologic response rate at end⁃of⁃treatment (EOT)and adverse event outcome. Results Of the 58 patients who were enrolled,5.2%(n = 3)had genotype 1a 43.1%(n = 25)had genotype 1b;17.2%(n = 10)had genotype 2a;5.2%(n = 3)had genotype 3a;8.6%(n = 5)had genotype 3b;and 20.7%(n = 12)had genotype 6a. There were 4 patients with compensated cirrhosis. All patients completed 12 weeks of treatment and ended with HCV RNA below the detection threshold(LLOQ < 15 IU/ML). Five patients did not complete the 12⁃week follow⁃up,and all 53 patients who completed the follow⁃up achieved a sustained virologic response(SVR12:100%). For patients with compensated cirrhosis,12 weeks of treatment with Danorelbine plus Sulfofovir plus Ribavirin,SVR12 was 100%(4/4)treatment and follow ⁃up. Only 5 patients had mild adverse events. Conclusions DNVr plus sofosbuvir± ribavirin provided 100%(53/53)SVR12 in patients with HCV genotype 1,2,3 or 6 were safe and were well tolerated.

Key words:

danoprevir, ritonavir, sofosbuvir, hepatitis C, sustained virologic response