title: Generic ledipasvir-sofosbuvir for patients with chronic hepatitis C: A real-life observational study.
abstract: Few patients from developing countries can afford brand name direct-acting antiviral agents for treating hepatitis C virus (HCV) infection, and controversy regarding the bioequivalence of generics exists. This study aimed to observe the safety and efficacy of 8 or 12weeks of generic ledipasvir-sofosbuvir with or without ribavirin for Chinese genotype 1b HCV-infected patients.
  
  
  
  In this open-labelled observational study, 63 cirrhotic (group 1) and 65 non-cirrhotic (group 2) patients were administered generic ledipasvir-sofosbuvir plus 1000-1200mg of ribavirin daily for 12 and 8weeks, respectively; and 64 non-cirrhotic patients (group 3) received ledipasvir-sofosbuvir for 8weeks. The primary efficacy endpoint was undetectable HCV RNA at week 12 (SVR12) after cessation of therapy. Safety and pharmacokinetic data were collected.
  
  
  
  One hundred and eighty-seven patients completed treatment, and the latest undetectable HCV RNA was observed in three patients with cirrhosis at week 5 during treatment. Intention-to-treat analysis revealed 96.8% (61/63), 96.9% (63/65), and 96.9% (62/64) of SVR12 rates in groups 1, 2, and 3, respectively. One patient in group 3 relapsed at post-treatment week 4. The regimens were generally well-tolerated. The most common adverse events were fatigue (17.8%), diarrhea (10.9%), and headache (9.9%). Four patients discontinued therapy due to diarrhea and vomiting. One patient from group 2 discontinued treatment on day 29 because of drug-unaffordability; fortunately, she achieved SVR12.
  
  
  
  This study demonstrated that 8 or 12weeks of generic ledipasvir-sofosbuvir with or without ribavirin are safe and effective for patients with genotype 1b HCV infection.
  
  
  
  The price of Harvoni® has led to restrictions and access limitations in many developing and even developed countries with limited healthcare budgets. Gilead approved generic ledipasvir-sofosbuvir costs far less than Harvoni® and presents a similar cure rate for patients with chronic hepatitis C.
authors.affiliation: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China. Electronic address: zengqinglei_pku@aliyun.com.
authors.forename: Qing-Lei
authors.initials: QL
authors.lastname: Zeng
authors.affiliation: Department of Infectious Diseases, The Affiliated Hospital of Yan'an University, Yan'an, Shaanxi Province, China.
authors.forename: Guang-Hua
authors.initials: GH
authors.lastname: Xu
authors.affiliation: Research and Treatment Center of Infectious Diseases, Beijing 302 Hospital, Beijing, China.
authors.forename: Ji-Yuan
authors.initials: JY
authors.lastname: Zhang
authors.affiliation: Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Henan Province, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.affiliation: Research and Treatment Center of Infectious Diseases, Beijing 302 Hospital, Beijing, China.
authors.forename: Da-Wei
authors.initials: DW
authors.lastname: Zhang
authors.affiliation: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.
authors.forename: Zhi-Qin
authors.initials: ZQ
authors.lastname: Li
authors.affiliation: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.
authors.forename: Hong-Xia
authors.initials: HX
authors.lastname: Liang
authors.affiliation: Department of Infectious Diseases, The Affiliated Hospital of Yan'an University, Yan'an, Shaanxi Province, China.
authors.forename: Chun-Xia
authors.initials: CX
authors.lastname: Li
authors.affiliation: Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China. Electronic address: johnyuem@zzu.edu.cn.
authors.forename: Zu-Jiang
authors.initials: ZJ
authors.lastname: Yu
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D002681:China; D016527:Drug Costs; D004359:Drug Therapy, Combination; D016568:Drugs, Generic / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000209:etiology; D008297:Male; D057193:Medical Tourism / Q000191:economics; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D012254:Ribavirin / Q000008:administration & dosage; D000069474:Sofosbuvir; D000072230:Sustained Virologic Response; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D016568:Drugs, Generic; D005449:Fluorenes; D012367:RNA, Viral; C000595958:ledipasvir, sofosbuvir drug combination; D012254:Ribavirin; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: Drugs; Generic; Hepatitis C; Ledipasvir; Sofosbuvir