sofosbuvir (Sovaldi)
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Indications
- for use in combination with ledipasvir (Harvoni) for treatment of hepatitis C genotypes 1, 4, 5, or 6
- for use in combination with ribavirin for treatment of hepatitis C genotypes 2 & 3
- for use in combination with pegylated interferon & ribavirin for treatment of hepatitis C genotypes 1,4,5,6
- particularly useful for hepatitis C genotype 1
* FDA-approved for use in patients >- 12 years of age[16]
Dosage
- oral agent
- 12 weeks of therapy
- in combination with ledipasvir, 8 weeks of therapy[7]
- 95% effective in cirrhosis-free patients
- equally effective among previously untreated as well as previously treated patients, many with cirrhosis[11]
- 8 weeks of therapy equivalent to 12 weeks[7]
- cost effective for genotype 1 infection
- $12,825 more per quality-adjusted life year compared with standard of care[9]
- cost-effective for genotype 2 or 3 infection with cirrhosis or previous treatment with interferon[10]
- cost effective for genotype 1 infection
Storage
- store in orginal container
- original container has a desiccant[8]
Adverse effects
- headache, fatigue (when used in combination with ribavirin)
- also nausea, insomnia & anemia when used in combination with peginterferon-alfa)[5]
- may exacerbate hepatitis B infection[13][14]
- may cause liver injury & liver failure independent of hepatitis B[15]
Mechanism of action
- nucleotide polymerase inhibitor
Notes
- response rates (no detectable serum HCV RNA) at 24 weeks
- resistance to sofosbuvir did not develop in 2 studies[3]
- discontinuation of sofosbuvir only 1-2%[3]
- $84,000 for a 12-week course of treatment (2014)[6]
More general terms
Component of
- sofosbuvir/velpatasvir (Epclusa)
- sofosbuvir/velpatasvir/voxilaprevir (Vosevi)
- ledipasvir/sofosbuvir (Harvoni)
References
- ↑ Gane EJ et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med 2013 Jan 3; 368:34. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23281974
Poordad F et al. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med 2013 Jan 3; 368:45 PMID: https://www.ncbi.nlm.nih.gov/pubmed/23281975 - ↑ Sax PE HIV and ID Observations Simeprevir and Sofosbuvir Submitted to FDA - Clock Ticking on Boceprevir, Telaprevir, Even Interferon cited in: Physician's First Watch for April 11, 2013 Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org http://blogs.jwatch.org/hiv-id-observations/index.php/simeprevir-and-sofosbuvir-submitted-to-fda-clock-ticking-on-boceprevir-telaprevir-even-interferon/2013/04/10/?q=pfw-featured
- ↑ 3.0 3.1 3.2 Lawitz E et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013 Apr 23; <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23607594 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1214853
- ↑ 4.0 4.1 Osinusi A et al Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 in Patients With Unfavorable Treatment Characteristics. A Randomized Clinical Trial. JAMA. 2013;310(8):804-811 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23982366 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=1733720
- ↑ 5.0 5.1 FDA News Release: Dec. 6, 2013 FDA approves Sovaldi for chronic hepatitis C http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm
- ↑ 6.0 6.1 Physician's First Watch, March 25, 2014 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
- ↑ 7.0 7.1 7.2 Kowdley JV et al Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis. N Engl J Med. April 11, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24720702 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1402355
- ↑ 8.0 8.1 Prescriber's Letter 21(6): 2014 Oral Meds to Keep in Original Containers Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=300622&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 9.0 9.1 Najafzadeh M et al. Cost-effectiveness of novel regimens for the treatment of hepatitis C virus. Ann Intern Med 2015 Mar 17; 162:407. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25775313 <Internet> http://annals.org/article.aspx?articleid=2197177
Chhatwal J et al. Cost-effectiveness and budget impact of hepatitis C virus treatment with sofosbuvir and ledipasvir in the United States. Ann Intern Med 2015 Mar 17; 162:397. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25775312 <Internet> http://annals.org/article.aspx?articleid=2197176 - ↑ 10.0 10.1 Linas BP et al The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 Infection. Ann Intern Med. Published online 30 March 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25820703 <Internet> http://annals.org/article.aspx?articleid=2212248
Etzion O, Ghany MG A Cure for the High Cost of Hepatitis C Virus Treatment. Ann Intern Med. Published online 30 March 2015. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25820765 <Internet> http://annals.org/article.aspx?articleid=2212249 - ↑ 11.0 11.1 Afdhal N et al Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection. N Engl J Med. April 12, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24725238 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1316366
Afdhal N et al Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection. N Engl J Med. April 12, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24725239 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1402454
Poordad F et al ABT-450/r - Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis. N Engl J Med. April 12, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24725237 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1402869
Hoofnagle JH and Sherker JH Therapy for Hepatitis C - The Costs of Success. N Engl J Med. April 12, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24725236 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1401508 - ↑ Herper M. The Top Drug Launches Of All Time. Forbes. July 29, 2015 http://www.forbes.com/sites/matthewherper/2015/07/29/the-top-drug-launches-of-all-time
- ↑ 13.0 13.1 Collins JM et al. Hepatitis B virus reactivation during successful treatment of hepatitis C virus with sofosbuvir and simeprevir. Clin Infect Dis 2015 Oct 15; 61:1304. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26082511 <Internet> http://cid.oxfordjournals.org/content/61/8/1304
Balagopal A and Thio CL. Another call to cure hepatitis B. Clin Infect Dis 2015 Oct 15; 61:1307 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26082512 <Internet> http://cid.oxfordjournals.org/content/61/8/1307 - ↑ 14.0 14.1 FDA Drug Safety Communication: Oct 4, 2016 FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. http://www.fda.gov/Drugs/DrugSafety/ucm522932.htm
- ↑ 15.0 15.1 PERSPECTIVES FROM NEW ADVERSE EVENT REPORTS Institute for Safe Medication Practices. Jan 25, 2017 http://www.ismp.org/quarterwatch/pdfs/2016Q2.pdf
- ↑ 16.0 16.1 Kelley KJ, Sadoughi S, Sofair A FDA Approves Two Antivirals to Treat HCV in Pediatric Patients. Physician's First Watch, April 10, 2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
FDA News Release. April 7, 2017 FDA approves two hepatitis C drugs for pediatric patients. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551407.htm