Tang L, Kamat M, Shukla A, Vora M, Kalal C, Kottilil S, Shah S
Division of Clinical Care and Research, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.
Department of Hepatology, Institute of Liver Diseases, Hepato Pancreato Biliary Surgery and Transplant, Global Hospitals, Mumbai, India.
Interdiscip Perspect Infect Dis. 2018 Oct 1;2018:9124604. doi: 10.1155/2018/9124604. eCollection 2018.
Chronic hepatitis C infection is a major cause for liver failure and liver cancer and can be treated with highly effective all oral directly acting antiviral (DAA) drugs. Generic versions of these DAAs are available in India.
This was an open-label, single-center, prospective, nonrandomized observational study for the comparative safety and efficacy of generic versus brand name sofosbuvir with ribavirin therapy for chronic hepatitis C infection (all genotypes). Between December 2014 and December 2015, 66 patients received either generic sofosbuvir (400mg) or brand name SOLVALDI (400mg) with weight based ribavirin for 24 weeks in a single multispecialty hospital in Mumbai. Monitoring viral loads and safety labs was performed as per national guidelines.
Sustained virologic response was 72.4% versus 75.7% (=0.78) among patients treated with generics and SOVALDI, respectively. At 4 weeks on-treatment, approximately 90% of patients from both groups had undetectable or below the lower limit of quantification. Change in hemoglobin was comparable in both groups (p=0.26).
Generic versions of sofosbuvir reported in this study are safe and efficacious to treat hepatitis C. However, bioequivalency studies of all generic DAAs need to be performed before wider use of such drugs for the treatment of hepatitis C.
慢性丙型肝炎感染是肝衰竭和肝癌的主要病因，可用高效的全口服直接抗病毒药物（DAA）进行治疗。这些DAA的仿制药在印度有售。
这是一项开放标签、单中心、前瞻性、非随机观察性研究，旨在比较仿制药与品牌药索磷布韦联合利巴韦林治疗慢性丙型肝炎感染（所有基因型）的安全性和疗效。2014年12月至2015年12月期间，在孟买的一家单一多专科医院中，66例患者接受了仿制药索磷布韦（400mg）或品牌药索华迪（400mg）联合基于体重的利巴韦林治疗，疗程为24周。按照国家指南进行病毒载量和安全性实验室监测。
接受仿制药和索华迪治疗的患者的持续病毒学应答率分别为72.4%和75.7%（=0.78）。治疗4周时，两组中约90%的患者病毒载量不可检测或低于定量下限。两组血红蛋白的变化相当（p=0.26）。
本研究中报道的索磷布韦仿制药治疗丙型肝炎安全有效。然而，在更广泛地使用此类药物治疗丙型肝炎之前，需要对所有DAA仿制药进行生物等效性研究。
