International Journal of Clinical Pharmacy

, Volume 37, Issue 5, pp 698–708 | Cite as

Meta-analysis of the efficacy and safety of sofosbuvir for the treatment of hepatitis C virus infection

  • Hye Jin Yang
  • Ju Yeon Ryoo
  • Bong Kyu YooEmail author
Review Article


Background Hepatitis 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. Method PubMed 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 websites were evaluated with regard to outcomes of the efficacy and safety analyses of the drug. Results Eight 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. Conclusions Sofosbuvir 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.


Adverse events Hepatitis C virus Peginterferon Sofosbuvir Sustained virologic response 



The authors thank Mr. Juno Yoo and Editage for their English editing service.


This study was not supported by any external funding.

Conflicts of interest

The authors have no conflicts of interest to disclose.


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Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2015

Authors and Affiliations

  1. 1.College of PharmacyGachon UniversityIncheonKorea

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