AI Article Synopsis
Article Abstract
Background & Aims: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
Lay Summary: 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.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jhep.2017.01.025 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Effectiveness of Ledipasvir-Sofosbuvir 12 Weeks After Hepatitis C Virus Genotype 1 Infection and the Factors Associated With Sustained Virologic Response: A Retrospective Study.
Cureus
August 2024
General Practice, School of Medicine, Ibb University, Ibb, YEM.
Background: The combination of ledipasvir and sofosbuvir (LDV/SOF) has been licensed to treat genotype 1 hepatitis C virus infection (HCV) with a 12-week regimen. However, there is scant data from Yemen regarding this combination regimen. Here, we investigate sustained virologic responses (SVR) 12 weeks after HCV treatment with LDV/SOF regimens and the factors that contribute to SVR failure.
View Article and Find Full Text PDFHepatitis C virus diversity and treatment outcomes in Benin: a prospective cohort study.
Lancet Microbe
July 2024
MRC-University of Glasgow Centre for Virus Research, Glasgow, UK; London School of Hygiene & Tropical Medicine, London, UK. Electronic address:
Background: 10 million people are chronically infected with the hepatitis C virus (HCV) in sub-Saharan Africa. The assessment of viral genotypes and treatment response in this region is necessary to achieve the WHO target of worldwide elimination of viral hepatitis by 2030. We aimed to investigate the prevalence of HCV genotypes and outcomes of treatment with direct-acting antiviral agents in Benin, a country with a national HCV seroprevalence of 4%.
View Article and Find Full Text PDFSeroprevalence and Genotype Diversity of Hepatitis C Virus in the Caribbean-A Review.
Trop Med Infect Dis
July 2023
Division of Gastroenterology, Hepatology, and Nutrition, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, 875 Ellicott Street, Suite 6089, Buffalo, NY 14203, USA.
Hepatitis C (HCV) continues to present a global public health challenge, with no vaccine available for prevention. Despite the availability of direct-acting antivirals (DAAs) to cure HCV, it remains prevalent in many regions including the Caribbean. As efforts are made to eliminate HCV from the region, existing barriers, such as the high cost of DAAs and lack of an established database of HCV cases within the Caribbean, must be addressed.
View Article and Find Full Text PDFNext-generation sequencing analysis of hepatitis C virus resistance-associated substitutions in direct-acting antiviral failure in South Korea.
Clin Mol Hepatol
April 2023
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Background/aims: We used next-generation sequencing (NGS) to analyze resistance-associated substitutions (RASs) and retreatment outcomes in patients with chronic hepatitis C virus (HCV) infection who failed direct-acting antiviral agent (DAA) treatment in South Korea.
Methods: Using prospectively collected data from the Korean HCV cohort study, we recruited 36 patients who failed DAA treatment in 10 centers between 2007 and 2020; 29 blood samples were available from 24 patients. RASs were analyzed using NGS.
Impact of list price changes on out-of-pocket costs and adherence in four high-rebate specialty drugs.
PLoS One
January 2023
Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.
Background: Insurers manage the cost of specialty medicines via rebates, however it is unclear if the savings are passed on to patients, and whether reducing rebates may lead to changes in patient out-of-pocket (OOP) costs and medication adherence. This study examined two drug classes to understand the impact of reducing list prices to net prices, via lower-priced national drug codes (NDCs) or authorized generics, on patient OOP costs and adherence.
Methods: This retrospective analysis assessed IQVIA PharMetrics ® Plus adjudicated medical and pharmacy claims for commercially insured patients.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!