Lay summary
The expensiveness of Harvoni® 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 similar cure rate for patients with chronic hepatitis C.
Generic ledipasvir-sofosbuvir for patients with chronic hepatitis C: a real-life observational study
Qing-Lei Zeng , Guang-Hua Xu†, Ji-Yuan Zhang†, Wei Li†, Da-Wei Zhang, Zhi-Qin Li, Hong-Xia Liang, Chun-Xia Li, Zu-Jiang Yu
Abstract
Background & aims
Few patients from developing countries can afford brand name direct-acting antiviral agents for treatment of 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 12 weeks of generic ledipasvir-sofosbuvir with or without ribavirin for Chinese genotype 1b HCV-infected patients.
Few patients from developing countries can afford brand name direct-acting antiviral agents for treatment of 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 12 weeks of generic ledipasvir-sofosbuvir with or without ribavirin for Chinese genotype 1b HCV-infected patients.
Methods
In this open-labelled observational study, 63 cirrhotic (group 1) and 65 non-cirrhotic (group 2) patients were administered generic ledipasvir-sofosbuvir plus 1,000-1,200 mg of ribavirin daily for 12 and 8 weeks, respectively; and 64 non-cirrhotic patients (group 3) received ledipasvir-sofosbuvir for 8 weeks. The primary efficacy endpoint was undetectable HCV RNA at week 12 (SVR12) after cessation of therapy. Safety and pharmacokinetic data were collected.
In this open-labelled observational study, 63 cirrhotic (group 1) and 65 non-cirrhotic (group 2) patients were administered generic ledipasvir-sofosbuvir plus 1,000-1,200 mg of ribavirin daily for 12 and 8 weeks, respectively; and 64 non-cirrhotic patients (group 3) received ledipasvir-sofosbuvir for 8 weeks. The primary efficacy endpoint was undetectable HCV RNA at week 12 (SVR12) after cessation of therapy. Safety and pharmacokinetic data were collected.
Results
One hundred and eighty-seven patients completed treatment, and the latest undetectable HCV RNA was observed in three cirrhotic patient 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.
One hundred and eighty-seven patients completed treatment, and the latest undetectable HCV RNA was observed in three cirrhotic patient 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.
Conclusion
This study first demonstrated that 8 or 12 weeks of generic ledipasvir-sofosbuvir with or without ribavirin are safe and effective for patients with genotype 1b HCV infection.
This study first demonstrated that 8 or 12 weeks of generic ledipasvir-sofosbuvir with or without ribavirin are safe and effective for patients with genotype 1b HCV infection.
Of Interest
Link To Articles On This Blog - HCV Generics
AASLD 2016
Generic sofosbuvir-based therapy under performs in real-world setting, but is use of suboptimal regimens the reason?
Michael Carter
Published:09 December 2016
Generic sofosbuvir-based combinations may not perform as well as therapy based on branded sofosbuvir-containing regimens, according to result of a study conducted in Qatar and presented to the recent 2016 AASLD Liver Meeting. People treated with generics were less likely to have a sustained virological response 12-weeks post treatment (SVR12) and were also more likely to experience an adverse event, compared to people who received branded drugs.
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