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

International Journal of Clinical Pharmacy

Volumn 37, Issue 5, 2015, Pages 698-708

  Yang, Hye Jin ^a   Ryoo, Ju Yeon ^a   Yoo, Bong Kyu ^a  

^a Gachon University   (South Korea)

Author keywords

Adverse events; Hepatitis C virus; Peginterferon; Sofosbuvir; Sustained virologic response

Indexed keywords

LEDIPASVIR PLUS SOFOSBUVIR; PEGINTERFERON; PLACEBO; RIBAVIRIN; SOFOSBUVIR; VIRUS RNA; ANTIVIRUS AGENT;

ADD ON THERAPY; ANEMIA; ARTICLE; ASTHENIA; CELLULITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; COUGHING; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEVER; FRACTURE; HEADACHE; HEPATITIS C; HUMAN; INSOMNIA; META ANALYSIS; MULTICENTER STUDY (TOPIC); MYALGIA; NAUSEA; OSTEOMYELITIS; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RELAPSE; RHINOPHARYNGITIS; SYSTEMATIC REVIEW; THORAX PAIN; URINARY TRACT INFECTION; VIRUS LOAD; DRUG EFFECTS;

ANTIVIRAL AGENTS; HEPATITIS C; HUMANS; SOFOSBUVIR; VIRAL LOAD;

EID: 84943200197     PISSN: 22107703     EISSN: 22107711     Source Type: Journal    
DOI: 10.1007/s11096-015-0144-x     Document Type: Article

References (34)

1. Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011;17(2):107–15.
2. Nkontchou G, Ziol M, Aout M, Lhabadie M, Baazia Y, Mahmoudi A, et al. HCV genotype 3 is associated with a higher hepatocellular carcinoma incidence in patients with ongoing viral C cirrhosis. J Viral Hepat. 2011;18(10):e516–22.
3. Zeng QL, Zhang JY, Zhang Z, Wang LF, Wang FS. Sofosbuvir and ABT-450: terminator of hepatitis C virus? World J Gastroenterol. 2013;19(21):3199–206.
4. Alavian SM. Sofosbuvir has come out of the magic box. Hepat Mon. 2013;13(12):e16916.
5. Dugum M, O’Shea R. Hepatitis C virus: here comes all-oral treatment. Cleve Clin J Med. 2014;81(3):159–72.
6. Koff RS. The efficacy and safety of sofosbuvir, a novel, oral nucleotide NS5B polymerase inhibitor, in the treatment of chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2014;39(5):478–87.
7. Gentile I, Borgia F, Buonomo AR, Castaldo G, Borgia G. A novel promising therapeutic option against hepatitis C virus: an oral nucleotide NS5B polymerase inhibitor sofosbuvir. Curr Med Chem. 2013;20(30):3733–42.
8. Bhatia HK, Singh H, Grewal N, Natt NK. Sofosbuvir: a novel treatment option for chronic hepatitis C infection. J Pharmacol Pharmacother. 2014;5(4):278–84.
9. Pockros PJ. Nucleoside/nucleotide analogue polymerase inhibitors in development. Clin Liver Dis. 2013;17(1):105–10.
10. Marino Z, van Bommel F, Forns X, Berg T. New concepts of sofosbuvir-based treatment regimens in patients with hepatitis C. Gut. 2014;63(2):207–15.
11. Murakami E, Tolstykh T, Bao H, Niu C, Steuer HM, Bao D, et al. Mechanism of activation of PSI-7851 and its diastereoisomer PSI-7977. J Biol Chem. 2010;285(45):34337–47.
12. Asselah T, Marcellin P. Second-wave IFN-based triple therapy for HCV genotype 1 infection: simeprevir, faldaprevir and sofosbuvir. Liver Int. 2014;34(Suppl 1):60–8.
13. Herbst DA Jr, Reddy KR. Sofosbuvir, a nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus infection. Expert Opin Investig Drugs. 2013;22(4):527–36.
14. Clinicaltrials.gov (numbers: NCT01641640, NCT01497366, NCT01542788, NCT01604850, NCT01682720, NCT01701401, NCT01768286, NCT01851330). https://clinicaltrials.gov/. Accessed 16 Mar 2015.
15. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368(20):1878–87.
16. Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013;368(20):1867–77.
17. Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014;370(21):1993–2001.
18. Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370(20):1889–98.
19. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370(16):1483–93.
20. Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370(20):1879–88.
21. Chen J, Florian J, Carter W, Fleischer RD, Hammerstrom TS, Jadhav PR, et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology. 2013;144(7):1450–5.
22. Yoshida EM, Sulkowski MS, Gane EJ, Herring RW Jr, Ratziu V, Ding X, et al. Concordance of sustained virologic response 4, 12, and 24 weeks post-treatment with sofosbuvir-containing regimens for hepatitis C virus. Hepatology. 2015;61(1):41–5.
23. GILEAD Clinical Study Protocol. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214853/suppl_file/nejmoa1214853_protocol.pdf. Accessed 4 Dec 2014.
24. Averhoff FM, Glass N, Holtzman D. Global burden of hepatitis C: considerations for healthcare providers in the United States. Clin Infect Dis. 2012;55(suppl 1):S10–5.
25. Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol. 2006;45(4):529–38.
26. Ward RP, Kugelmas M. Using pegylated interferon and ribavirin to treat patients with chronic hepatitis C. Am Fam Physician. 2005;72(4):655–62.
27. American Association for the Study of Liver Diseases. Recommendations for testing, managing, and treating hepatitis C. http://hcvguidelines.org/fullreport. Accessed 4 Dec 2014.
28. European Association for the Study of the Liver (EASL). Recommendations on treatment of hepatitis C 2014. http://files.easl.eu/easl-recommendations-on-treatment-of-hepatitis-C/index.html. Accessed 4 Dec 2014.
29. Timm J, Roggendorf M. Sequence diversity of hepatitis C virus: implications for immune control and therapy. World J Gastroenterol. 2007;13(36):4808–17.
30. Zhu Y, Chen S. Antiviral treatment of hepatitis C virus infection and factors affecting efficacy. World J Gastroenterol. 2013;19(47):8960–73.
31. Soriano V, Vispo E, de Mendoza C, Labarga P, Fernandez-Montero JV, Poveda E, et al. Hepatitis C therapy with HCV NS5B polymerase inhibitors. Expert Opin Pharmacother. 2013;14(9):1161–70.
32. Goozner M. Why Sovaldi shouldn’t cost $84,000. Mod Healthc. 2014;44(18):26.
33. Hagan LM, Sulkowski MS, Schinazi RF. Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 hepatitis C virus in interferon-ineligible/intolerant individuals. Hepatology. 2014;60(1):37–45.
34. Support Path Program. http://www.mysupportpath.com/. Accessed 4 Dec 2014.