Evidence map›Paper›PMID 30364048›Full record

ArticleInterdisciplinary perspectives on infectious diseases2018

Comparative Antiviral Efficacy of Generic Sofosbuvir versus Brand Name Sofosbuvir with Ribavirin for the Treatment of Hepatitis C.

L Tang, M Kamat, A Shukla, M Vora, C Kalal, S Kottilil, S Shah

Abstract read
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Article in Interdisciplinary perspectives on infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

L TangDivision of Clinical Care and Research, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.ORCID 0000-0001-8682-9220
M KamatDepartment of Hepatology, Institute of Liver Diseases, Hepato Pancreato Biliary Surgery and Transplant, Global Hospitals, Mumbai, India.
A ShuklaDepartment of Hepatology, Institute of Liver Diseases, Hepato Pancreato Biliary Surgery and Transplant, Global Hospitals, Mumbai, India.
M VoraDepartment of Hepatology, Institute of Liver Diseases, Hepato Pancreato Biliary Surgery and Transplant, Global Hospitals, Mumbai, India.
C KalalDepartment of Hepatology, Institute of Liver Diseases, Hepato Pancreato Biliary Surgery and Transplant, Global Hospitals, Mumbai, India.ORCID 0000-0002-5284-7890
S KottililDivision of Clinical Care and Research, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.ORCID 0000-0001-7471-0812
S ShahDepartment of Hepatology, Institute of Liver Diseases, Hepato Pancreato Biliary Surgery and Transplant, Global Hospitals, Mumbai, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic 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.

methodThis 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.

resultsSustained virologic response was 72.4% versus 75.7% (

conclusionGeneric 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.

Identifiers

PMID30364048
PMCPMC6188723

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.