Evidence map›Paper›PMID 32042516›Full record

ArticleCureus2020

Efficacy and Safety of Sofosbuvir-Velpatasvir combination in Hepatitis C Virus-infected Pakistani Patients without Cirrhosis or with Compensated Cirrhosis: A Prospective, Open-label Interventional Trial.

Nazish Butt, Iltaf Muhammad, Attique Abou Bakr, Zaheer Akhtar, Mashhood Ali, Sharib Syed Muhammad, Neeta Maheshwary

Open access · diamondAbstract read
In one paragraph

Article in Cureus, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 25% of its field
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

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. 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 at 7 institutions in 2 countries.

Nazish ButtGastroenterology, Jinnah Postgraduate Medical Centre, Karachi, PAK.
Iltaf MuhammadGastroenterology, Hayatabad Medical Complex, Peshawar, PAK.
Attique Abou BakrGastroenterology, Jinnah Hospital, Lahore, PAK.
Zaheer AkhtarGastroenterology, Gulab Devi Hospital, Lahore, PAK.
Mashhood AliGastroenterology, Pakistan Institute of Medical Sciences, Islamabad, PAK.
Sharib Syed MuhammadClinical Research, Hilton Pharma (Pvt.) Ltd., Karachi, PAK.
Neeta MaheshwaryClinical Research, Hilton Pharma (Pvt.) Ltd., Karachi, PAK.
Aga Khan University Hospital · PKHayatabad Medical Complex · PKJinnah Postgraduate Medical Center · PKLiaquat National Hospital · PKPakistan Institute of Medical Sciences · PKUniversity of Karachi · PKXLAB (Slovenia) · SI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background In Pakistan, there is a paucity of published clinical data regarding the efficacy of sofosbuvir-velpatasvir in the management of patients with hepatitis C without cirrhosis or with compensated cirrhosis. Methods A prospective, open-label, multicenter, interventional trial was conducted in patients with hepatitis C without cirrhosis or with compensated cirrhosis. Hepatitis C patients without cirrhosis or with compensated cirrhosis were screened, and 133 patients were enrolled in the study. They received sofosbuvir 400 mg plus velpatasvir 100 mg combination once daily for 12 weeks. Patients were followed up for six months after the start of therapy. Hepatitis C viral load was assessed at baseline, at week 12, and after 24 weeks following the start of the treatment. The trial was prospectively registered with the Iranian Registry of Clinical Trials (IRCT) with the identification number IRCT20170614034526N4. Results Among enrolled patients, 79 were male, and 54 were female. Ninety-five (71.4%) patients were without cirrhosis, and 38 had compensated cirrhosis. Patients without cirrhosis had a mean age of 45.90 ±10.99 years, and patients with compensated cirrhosis had a mean age of 52.60 ±12.29 years. As per the intention-to-treat analysis, all patients without cirrhosis and 35 (92.1%) patients with compensated cirrhosis achieved undetectable viral load hepatitis C virus (HCV) ribonucleic acid (RNA) of <15 IU/mL at 12 weeks from the start of treatment. Eighty-six (90.5%) patients without cirrhosis achieved sustained virologic response 12 weeks after the end of therapy. Patients with compensated cirrhosis experienced more adverse events (31.5%) than patients without cirrhosis (20.15%). Conclusion Direct-acting antiviral therapy using sofosbuvir and velpatasvir combination is effective and safe in HCV patients without cirrhosis and patients with compensated cirrhosis.

Indexed as

hepatitis cliver cirrhosispakistansofosbuvir-velpatasvirsustained virologic response

Identifiers

PMID32042516
PMCPMC6996271
OpenAlexW2997407255

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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.