Evidence map›Paper›PMID 27822881›Full record

Trial reportIndian journal of gastroenterology : official journal of the Indian Society of Gastroenterology2016

Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in "real-life" cohort.

Rajiv Mehta, Mayank Kabrawala, Subhash Nandwani, Rini Tekriwal, Payal Nandaniya, Mrunal Shah, Vishwa Bhayani

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Chronic Hepatitis C: Do Generics Work as Well as Branded Drugs?Journal of clinical and experimental hepatology · 2017
    Review
  6. Treatment of chronic genotype-3 hepatitis C virus infection using direct-acting antiviral agents: An Indian experience.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2017
    Article
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.

Rajiv MehtaDepartment of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India. rmgastro@yahoo.com.
Mayank KabrawalaDepartment of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India.
Subhash NandwaniDepartment of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India.
Rini TekriwalDepartment of Physiology, Government Medical College, Majuragate, Surat, 395 001, India.
Payal NandaniyaDepartment of Physiology, Government Medical College, Majuragate, Surat, 395 001, India.
Mrunal ShahDepartment of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India.
Vishwa BhayaniDepartment of Gastroenterology, Surat Institute of Digestive Sciences, Ring Road, Surat, 395 002, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe safety and efficacy of sofosbuvir-based treatment (sofosbuvir and ribavirin with or without pegylated interferon-α) for hepatitis C virus (HCV) infection has been established in clinical trials. However, there is limited data regarding safety and efficacy of sofosbuvir-based treatment for HCV infection in a "real-life" cohort. We describe our experience with sofosbuvir-based treatment for HCV infection in a real-life cohort.

methodsThis was a prospective, nonrandomized and observational study at a tertiary care centre in Surat, India. The primary end-point was proportion of the study patients who achieved a sustained virological response 12 weeks after cessation of treatment (SVR 12). Secondary end-points of the study include SVR 4, virological relapse and appearance of adverse events.

resultsA total of 107 patients with chronic HCV who received sofosbuvir-based treatment were included in the study. During study period, two patients died due to severity of liver complications. Hence, overall rate of SVR 4 and SVR 12 was 98.1 % (n = 103/105) and 94.3 % (n = 99/105), respectively. Among 67 patients with HCV genotype-3 infection, the SVR 12 rate was 92.5 % (n = 62/67), and among 38 patients with HCV genotype-1 infection, the rate of SVR 12 was 97.4 % (n=37/38). A total of 32 (29.9 %) patients reported adverse events during the course of sofosbuvir-based treatment. None of the patient discontinued treatment due to adverse event.

conclusionsSofosbuvir-based treatment is safe and efficacious in clinical practice in Indian patients with HCV genotype-1 and genotype-3 infection.

Indexed as

AdultAntiviral AgentsCohort StudiesDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis C, ChronicHumansInterferon-alphaMaleMiddle AgedRibavirinSofosbuvirTreatment OutcomeAntiviral AgentsInterferon-alphaRibavirinSofosbuvirDirect acting antiviralsHepatitis CPegylated interferonRibavirinSofosbuvir

Identifiers

PMID27822881

What OpenQuestion holds

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Registered trials

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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.