Comparative Antiviral Efficacy of Generic Sofosbuvir versus Brand Name Sofosbuvir with Ribavirin for the Treatment of Hepatitis C
Joint Authors
Tang, Lydia
Kottilil, Shyam
Kamat, M.
Shukla, A.
Vora, M.
Shah, S.
Kalal, Chetan Ramesh
Source
Interdisciplinary Perspectives on Infectious Diseases
Issue
Vol. 2018, Issue 2018 (31 Dec. 2018), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2018-10-01
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Background.
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.
Method.
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.
Results.
Sustained virologic response was 72.4% versus 75.7% (p=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).
Conclusion.
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.
American Psychological Association (APA)
Tang, Lydia& Kamat, M.& Shukla, A.& Vora, M.& Kalal, Chetan Ramesh& Kottilil, Shyam…[et al.]. 2018. Comparative Antiviral Efficacy of Generic Sofosbuvir versus Brand Name Sofosbuvir with Ribavirin for the Treatment of Hepatitis C. Interdisciplinary Perspectives on Infectious Diseases،Vol. 2018, no. 2018, pp.1-9.
https://search.emarefa.net/detail/BIM-1175877
Modern Language Association (MLA)
Tang, Lydia…[et al.]. Comparative Antiviral Efficacy of Generic Sofosbuvir versus Brand Name Sofosbuvir with Ribavirin for the Treatment of Hepatitis C. Interdisciplinary Perspectives on Infectious Diseases No. 2018 (2018), pp.1-9.
https://search.emarefa.net/detail/BIM-1175877
American Medical Association (AMA)
Tang, Lydia& Kamat, M.& Shukla, A.& Vora, M.& Kalal, Chetan Ramesh& Kottilil, Shyam…[et al.]. Comparative Antiviral Efficacy of Generic Sofosbuvir versus Brand Name Sofosbuvir with Ribavirin for the Treatment of Hepatitis C. Interdisciplinary Perspectives on Infectious Diseases. 2018. Vol. 2018, no. 2018, pp.1-9.
https://search.emarefa.net/detail/BIM-1175877
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1175877