Chen-Hua Liu1,2,3, Tung-Hung Su1,2, Chun-Jen Liu1,2,4, Chun-Ming Hong1, Hung-Chih Yang1,2,5, Tai-Chung Tseng1,2, Pei-Jer Chen1,2,4, Ding-Shinn Chen1,2,6, 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. Genomics Research Center, Academia Sinica, Taipei, Taiwan.
Abstract
BACKGROUND AND AIM: Data regarding the comparative effectiveness and safety of sofosbuvir (SOF) in combination with ribavirin (RBV), daclatasvir (DCV), or ledipasvir (LDV) for hepatitis C virus genotype 2 (HCV-2) patients were limited. We aimed to evaluate the performance of these regimens in Taiwan. METHODS: One hundred eighty-seven HCV-2 patients with compensated liver diseases receiving SOF in combination with RBV (n = 82), DCV (n = 66), or LDV (n = 39) for 12 weeks were retrospectively enrolled. The effectiveness was determined by sustained virologic response 12 weeks off therapy (SVR12 ). The patient characteristics potentially related to SVR12 were compared. The safety profiles and laboratory abnormalities were assessed. RESULTS: The SVR12 rates were 93.9% (95% confidence interval [CI]: 86.5-97.4%), 98.5% (95% CI: 91.9-99.7%), and 100% (95% CI: 91.0-100%) in patients receiving SOF combined with RBV, DCV, and LDV, respectively. All patients tolerated treatment well. The stratified SVR12 rates were comparable regardless of baseline characteristics or week 4 viral decline among these regimens. Six (3.2%) patients had serious adverse events which were not related to treatment. The rates of fatigue, pruritus, and anemia tended to be higher in patients receiving RBV (22.0%, 19.5%, and 8.5%) combination than those receiving DCV (10.6%, 6.1%, and 1.5%) or LDV (10.3%, 5.1%, and 0%) combination. CONCLUSIONS: Sofosbuvir in combination with RBV, DCV, or LDV for 12 weeks is effective and well-tolerated for HCV-2 patients. Compared with DCV or LDV combination, the risks of fatigue, pruritus, and anemia are higher in patients receiving RBV combination.
BACKGROUND AND AIM: Data regarding the comparative effectiveness and safety of sofosbuvir (SOF) in combination with ribavirin (RBV), daclatasvir (DCV), or ledipasvir (LDV) for hepatitis C virus genotype 2 (HCV-2) patients were limited. We aimed to evaluate the performance of these regimens in Taiwan. METHODS: One hundred eighty-seven HCV-2patients with compensated liver diseases receiving SOF in combination with RBV (n = 82), DCV (n = 66), or LDV (n = 39) for 12 weeks were retrospectively enrolled. The effectiveness was determined by sustained virologic response 12 weeks off therapy (SVR12 ). The patient characteristics potentially related to SVR12 were compared. The safety profiles and laboratory abnormalities were assessed. RESULTS: The SVR12 rates were 93.9% (95% confidence interval [CI]: 86.5-97.4%), 98.5% (95% CI: 91.9-99.7%), and 100% (95% CI: 91.0-100%) in patients receiving SOF combined with RBV, DCV, and LDV, respectively. All patients tolerated treatment well. The stratified SVR12 rates were comparable regardless of baseline characteristics or week 4 viral decline among these regimens. Six (3.2%) patients had serious adverse events which were not related to treatment. The rates of fatigue, pruritus, and anemia tended to be higher in patients receiving RBV (22.0%, 19.5%, and 8.5%) combination than those receiving DCV (10.6%, 6.1%, and 1.5%) or LDV (10.3%, 5.1%, and 0%) combination. CONCLUSIONS:Sofosbuvir in combination with RBV, DCV, or LDV for 12 weeks is effective and well-tolerated for HCV-2patients. Compared with DCV or LDV combination, the risks of fatigue, pruritus, and anemia are higher in patients receiving RBV combination.