Evidence map›Paper›PMID 36514327›Full record

ArticleHealth science reports2023

Efficacy of generic sofosbuvir with daclatasvir compared to sofosbuvir/ledipasvir in genotype 4 hepatitis C virus: A prospective comparison with historical control.

Hala Joharji, Delal Alkortas, Aziza Ajlan, Mohamed Ahmed, Hamad Al-Ashgar, Mohammed Al-Quaiz, Dieter Broering, Mohammed Al-Sebayel, Hussien Elsiesy, Faisal A Alkhail and 4 more

Open access · goldAbstract read
In one paragraph

Article in Health science reports, 2023. 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
0.7field-weighted citation impact, top 31% 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

6 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. A Bibliometric Analysis of the HCV Drug-Resistant Majority and Minority Variants.International journal of environmental research and public health · 2025
    Article
  3. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  4. Article
  5. Article
  6. 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

14 authors at 2 institutions in 1 country.

Hala JoharjiKing Faisal Specialist Hospital and Research Centre Organ Transplant Center of Excellence Riyadh Saudi Arabia.ORCID 0000-0002-4324-0683
Delal AlkortasKing Faisal Specialist Hospital and Research Centre Organ Transplant Center of Excellence Riyadh Saudi Arabia.
Aziza AjlanKing Faisal Specialist Hospital and Research Centre Organ Transplant Center of Excellence Riyadh Saudi Arabia.ORCID 0000-0002-5562-9928
Mohamed AhmedKing Faisal Specialist Hospital and Research Centre Organ Transplant Center of Excellence Riyadh Saudi Arabia.
Hamad Al-AshgarDepartment of Medicine King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia.
Mohammed Al-QuaizDepartment of Medicine King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia.
Dieter BroeringKing Faisal Specialist Hospital and Research Centre Organ Transplant Center of Excellence Riyadh Saudi Arabia.
Mohammed Al-SebayelLiver and Small Bowel Transplant and Hepatology Surgical Department King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia.
Hussien ElsiesyLiver and Small Bowel Transplant and Hepatology Surgical Department King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia.
Faisal A AlkhailLiver and Small Bowel Transplant and Hepatology Surgical Department King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia.
Waleed K Al-HamoudiLiver and Small Bowel Transplant and Hepatology Surgical Department King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia.
Edward De VolBiostatistics, Epidemiology and Science Computing Department King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia.
Epi Amirah AlmuhayshirBiostatistics, Epidemiology and Science Computing Department King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia.
Ahmed Al-JedaiKing Faisal Specialist Hospital and Research Centre Organ Transplant Center of Excellence Riyadh Saudi Arabia.
King Faisal Specialist Hospital & Research Centre · SAAlfaisal University · SA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and Aim: Management of genotype 4 hepatitis C virus (HCV) has shifted to interferon-free regimens with a high sustained virological response (SVR-12), especially with NS5B/NS5A inhibitor combinations such as sofosbuvir and ledipasvir (Sof-Led). The guidelines have recommended the combination of sofosbuvir and another NS5A inhibitor, daclatasvir, to manage HCV genotypes 1-3. However, its use was extended to genotype 4 HCV based on extrapolating evidence. Our aim is to assess the efficacy of generic sofosbuvir + branded daclatasvir (Sof-Dac) compared to the Sof-Led combination in treating genotype 4 HCV. Methods: This study is an open-label, 2-period, noninferiority study that compared patients receiving a combination of generic sofosbuvir 400 mg and daclatasvir 60 mg orally daily (Group 2) prospectively to a historical control (Group 1) that included patients who received a combination of sofosbuvir/ledipasvir 400/90 mg orally daily. The primary endpoint is the proportion of patients who achieved SVR-12. Results: The study included 111 patients in the (Sof-Led) Group 1 and 109 patients (Sof-Dac) Group 2. For the primary outcome, SVR-12 was achieved in 106 (95.5%) of the patients in Group 1 versus 108 (99.1%) in Group 2 ( Conclusion: Generic sofosbuvir combined with branded daclatasvir was safe and effective for treating genotype 4 HCV compared to Sof-Led. This combination may significantly reduce the cost burden, enabling a larger pool of treated patients. Office of research affairs at KFSHRC RAC# 2171 036.

Indexed as

cost savingdirect acting antiviralssustained virological responseviral hepatitis

Identifiers

PMID36514327
PMCPMC9731361
OpenAlexW4311825484

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.