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Sovaldi ™ - Sofosbuvir
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Sovaldi ™ - Sofosbuvir

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  1. Sovaldi™ - Sofosbuvir Manufacturer: Gilead Sciences, Inc. FDA Approval Date: December 6, 2013

  2. Sovaldi™ - SofosbuvirClinical Application • Indications: • Genotypes 1-4 chronic HCV • Hepatocellular carcinoma • HCV/HIV co-infection • Place in therapy: • Considered first-line therapy for patients with HCV in combination with ribavirin and peg-interferon

  3. Sovaldi™ - SofosbuvirClinical Application • Contraindications: • Pregnancy and use in male partners of pregnant women • All contraindications applicable to ribavirin and peg-interferon • Warnings and Precautions • Use with potent P-gp inducers • Pregnancy when used with ribavirin or peg-interferon • Use as monotherapy

  4. Sovaldi™ - SofosbuvirClinical Application • Pregnancy: • Category B • Category X when used in combination with ritonavir or peg-interferon/ribavirin • Lactation: • Excretion in breast milk is unknown; use is not recommended

  5. Sovaldi™ - SofosbuvirDrug Facts • Pharmacology: • Directly acts on HCV to inhibits HCV NS5B RNA-dependent RNA polymerase, an enzyme essential for viral replication and acts as a chain terminator

  6. Sovaldi™ - SofosbuvirDrug Facts

  7. Sovaldi™ - SofosbuvirDrug Interactions • Drug Interactions – Precipitant Drugs: • P-gp/ABCB1 inducers  • P-gp/ABCB1 inhibitors  • Anticonvulsants (carbamazepine, phenytoin and phenobarbital)  • Antimycobacterials (rifabutin, rifampin, rifapentine)  • St. John’s Wort  • Tipranazvir/Ritonavir 

  8. Sovaldi™ - SofosbuvirAdverse Effects

  9. Sovaldi™ - SofosbuvirMonitoring Parameters • Efficacy Monitoring: • HCV-RNA at baseline, during treatment, at the end of treatment and during follow-up when clinically indicated • Toxicity Monitoring: • Bilirubin, liver enzymes and serum creatinine at baseline ad periodically when clinically indicated • Pretreatment and monthly pregnancy tests up to 6 months following therapy

  10. Sovaldi™ - SofosbuvirPrescription Information • Dosing: 400mg daily with contaminant ribavirin with/without peg-interferon alfa • Cost: $33,600 for #28 • Source: www.uptodate.com • Accessed 2/26/2014

  11. Sovaldi™ - SofosbuvirLiterature Review • Pooled analysis of two multicenter trials • NEUTRINO Trial • Single-group, open-label study • SOF/PEG/RBV in genotypes 1, 4, 5 and 6 • FISSION Trial • Randomized, open-label, active-control study • SOF/RBV x12w vs. PEG/RBV x24 w in genotypes 2 and 3 Lawitz, E et al. NEJM. 2013; 368:1878-87.

  12. Sovaldi™ - SofosbuvirLiterature Review • Objective • Evaluate the safety and efficacy of 12 weeks of regimens containing sofosbuvir in previously untreated patients with HCV • Primary Endpoint • Sustained virologic response – HCV RNA undetectable 12 weeks after the end of treatment Lawitz, E et al. NEJM. 2013; 368:1878-87.

  13. Sovaldi™ - SofosbuvirLiterature Review NEUTRINO FISSION N = 499 • N = 327 Lawitz, E et al. NEJM. 2013; 368:1878-87.

  14. Sovaldi™ - SofosbuvirLiterature Review Lawitz, E et al. NEJM. 2013; 368:1878-87.

  15. Sovaldi™ - SofosbuvirLiterature Review Lawitz, E et al. NEJM. 2013; 368:1878-87.

  16. Sovaldi™ - SofosbuvirLiterature Review Lawitz, E et al. NEJM. 2013; 368:1878-87.

  17. Sovaldi™ - SofosbuvirLiterature Review Lawitz, E et al. NEJM. 2013; 368:1878-87.

  18. Sovaldi™ - SofosbuvirLiterature Review Lawitz, E et al. NEJM. 2013; 368:1878-87.

  19. Sovaldi™ - SofosbuvirLiterature Review Lawitz, E et al. NEJM. 2013; 368:1878-87.

  20. Sovaldi™ - SofosbuvirLiterature Review • Conclusions • Sofosbuvir/Peg-Interferon/Ribavirin had high efficacy in patients with genotypes 1 and 4 HCV • Sofosbuvir/Ribavirin is non-inferior to Peg-Interferon/Ribavirin in patients with genotypes 2 and 3 HCV • AASLD and IDSA recommend sofosbuvir containing regimens as first line in all HCV genotypes Lawitz, E et al. NEJM. 2013; 368:1878-87.

  21. Sovaldi™ - SofosbuvirSummary • Novel agent designed to target NS5B RNA-dependent RNA polymerase of the hepatitis C virus • Indicated for the treatment of HCV and NOW considered first line in patients with HCV regardless of the genotype in combination with ribavirin and peg-interferon alfa • Dose is 400mg daily and is NOT to be used as monotherapy • HCV-RNA should be monitor at baseline and periodically throughout tx to assess efficacy • Fatigue and headache are the most common side effects

  22. Sovaldi™ - SofosbuvirReferences • http://www.sovaldi.com • Sovaldi Package Insert. Gilead. Dec. 2013. • Lawitz, E et al. Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection. The New England Journal of Medicine. 2013; 368:1878-87. • Sovaldi. Lexicomp Drug Information. Accessed through UpToDate. Accessed on February 21, 2014. • Sovaldi. Micromedex DRUGDEX website. Accessed on February 21, 2014.