Chen-Hua Liu1,2,3, Chun-Jen Liu1,2,4, Tung-Hung Su1,2, Hung-Chih Yang1,2,5, Chun-Ming Hong6, Tai-Chung Tseng7, Pei-Jer Chen1,2,4, Ding-Shinn Chen1,2,8, Jia-Horng Kao1,2,4. 1. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. 2. Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. 3. Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan. 4. Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. 5. Department of Microbiology, National Taiwan University College of Medicine, Taipei, Taiwan. 6. Department of Traumatology, National Taiwan University Hospital, Taipei, Taiwan. 7. National Taiwan University Hospital, Jinshan Branch, New Taipei City, Taiwan. 8. Genomics Research Center, Academia Sinica, Taipei, Taiwan.
Abstract
BACKGROUND AND AIM: The real-world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) remain limited for East Asian hepatitis C virus genotype 1b (HCV-1b) patients. The study aimed to evaluate the antiviral responses of PrOD-based regimens for HCV-1b patients in Taiwan. METHODS: The study performed a retrospective analysis of 103 HCV-1b patients receiving PrOD with or without ribavirin (RBV) for 12 weeks. Data were analyzed to assess the on-treatment and off-therapy HCV viral load and on-treatment adverse events. The pre-specified characteristics related to sustained virologic response 12 weeks off therapy (SVR12 ) were compared. RESULTS: At treatment week 4, 100 of 102 patients (98.0%) had serum HCV RNA level < 25 IU/mL. The SVR12 was achieved in 101 of 103 patients (98.1%, [95% confidence interval: 93.2-99.5%]). All except one (99.0%) patients tolerated treatment well without treatment interruption. One cirrhotic patient discontinued treatment at week 1 due to hepatic decompensation. Twenty-four patients (23.3%) had ≥ grade 2 elevation in total bilirubin levels, and 21 of them (87.5%) had indirect type hyperbilirubinemia. The stratified SVR12 rates were comparable in terms of sex, age, body mass index, prior treatment experience, hepatitis B virus surface antigen status, RBV usage, baseline and week 2 viral load, renal function, and hepatic fibrosis stage. CONCLUSIONS: Paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without RBV are efficacious and generally well tolerated for treatment of HCV-1b patients in Taiwan.
BACKGROUND AND AIM: The real-world effectiveness and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) remain limited for East Asian hepatitis C virus genotype 1b (HCV-1b) patients. The study aimed to evaluate the antiviral responses of PrOD-based regimens for HCV-1b patients in Taiwan. METHODS: The study performed a retrospective analysis of 103 HCV-1b patients receiving PrOD with or without ribavirin (RBV) for 12 weeks. Data were analyzed to assess the on-treatment and off-therapy HCV viral load and on-treatment adverse events. The pre-specified characteristics related to sustained virologic response 12 weeks off therapy (SVR12 ) were compared. RESULTS: At treatment week 4, 100 of 102 patients (98.0%) had serum HCV RNA level < 25 IU/mL. The SVR12 was achieved in 101 of 103 patients (98.1%, [95% confidence interval: 93.2-99.5%]). All except one (99.0%) patients tolerated treatment well without treatment interruption. One cirrhotic patient discontinued treatment at week 1 due to hepatic decompensation. Twenty-four patients (23.3%) had ≥ grade 2 elevation in total bilirubin levels, and 21 of them (87.5%) had indirect type hyperbilirubinemia. The stratified SVR12 rates were comparable in terms of sex, age, body mass index, prior treatment experience, hepatitis B virus surface antigen status, RBV usage, baseline and week 2 viral load, renal function, and hepatic fibrosis stage. CONCLUSIONS:Paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without RBV are efficacious and generally well tolerated for treatment of HCV-1b patients in Taiwan.