SynthesisInternational journal of clinical pharmacy2015
Meta-analysis of the efficacy and safety of sofosbuvir for the treatment of hepatitis C virus infection.
Synthesis in International journal of clinical pharmacy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Efficacy and safety of sofosbuvir in the treatment of hep C among patients on hemodialysis: a systematic review and meta-analysis.Scientific reports · 2020Pooled it
- Cardiac Harms of Sofosbuvir: Systematic Review and Meta-Analysis.Drug safety · 2018Pooled it
- Efficacy and safety of sofosbuvir plus daclatasvir in hemodialysis patients with genotype 1b or 2a hepatitis C virus infection: a single-arm, prospective real-world study.Frontiers in medicine · 2025Article
- Real-world Safety and Effectiveness of 24-week Sofosbuvir and Ribavirin Treatment in Patients Infected with Rare Chronic Hepatitis C Virus Genotypes 3, 4, 5, or 6 in Japan.Internal medicine (Tokyo, Japan) · 2023Observational
- What is needed to achieve HCV microelimination among HIV-infected populations in Andalusia, Spain: a modeling analysis.BMC infectious diseases · 2020Article
- Implementation of a pharmaceutical care program for patients with hepatitis C treated with new direct-action antivirals.International journal of clinical pharmacy · 2019Article
- Scaling-up HCV prevention and treatment interventions in rural United States-model projections for tackling an increasing epidemic.Addiction (Abingdon, England) · 2018Article
- Behavioural, not biological, factors drive the HCV epidemic among HIV-positive MSM: HCV and HIV modelling analysis including HCV treatment-as-prevention impact.International journal of epidemiology · 2017Article
- Economic evaluation of pegylated interferon plus ribavirin for treatment of chronic hepatitis C in Thailand: genotype 1 and 6.BMC gastroenterology · 2016Article
- Ombitasvir, paritaprevir, ritonavir, dasabuvir and ribavirin in cirrhosis after complete destruction of hepatocellular carcinoma.World journal of gastroenterology · 2016Article
- A critical appraisal of statistical pitfalls and clinical relevance of meta-analysis involving hepatitis C virus and sofosbuvir.International journal of clinical pharmacy · 2015Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHepatitis C virus infection is a worldwide health problem and one of the leading causes of cirrhosis and hepatocellular carcinoma. Recently, sofosbuvir was introduced to the therapeutic arsenal against this virus, thereby paving the way for all-oral regimen. Aims of the review This study aimed to systematically analyze the efficacy and safety of sofosbuvir for the treatment of hepatitis C virus infection.
methodPubMed and EMBASE database searches were conducted using "sofosbuvir" as the search term. Phase III clinical studies retrieved from the two databases and resources posted on the Drug@FDA and ClinicalTrials.gov websites were evaluated with regard to outcomes of the efficacy and safety analyses of the drug.
resultsEight Phase III clinical studies compared the efficacy and safety of sofosbuvir. When sofosbuvir replaced peginterferon which was used in the previous standard regimen, a superior sustained virologic response, as defined by a viral RNA load less than the lower limit of quantification 12 weeks after cessation of therapy, was obtained (74.3 vs. 66.7%, p < 0.05). The response improved even more (90.8 vs. 66.7%, p < 0.0001) when sofosbuvir was used as an add-on therapy to the standard regimen. The overall odds ratio to achieve the response in the sofosbuvir-containing arm of the eight clinical studies was 3.66 times greater (95% CI 3.00-4.46) than that of the standard regimen arm. During the eight clinical studies, adverse events were observed in 83.61 and 87.22% of the patients in the sofosbuvir and non-sofosbuvir arms, respectively, with the most frequent events being mild central nervous system symptoms such as fatigue, headache, and asthenia.
conclusionsSofosbuvir was safe and effective in the treatment of hepatitis C virus genotype 1, 2, 3, or 4 infections. However, the lack of persistence of the sustained virologic response beyond the study duration and long-term safety concerns need to be addressed in future studies.
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Registered trials
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