sofosbuvir:++gamechanger+ forthetreatmentof...
TRANSCRIPT
Sofosbuvir: Game Changer for the Treatment of
Hepatitis C
Leslie Dixon, Pharm.D. Managed Care Drug Policy Resident Scott & White Health Plan Temple, TX
May 30, 2014
Learning Objectives
1. Describe Hepatitis C patient demographics 2. Discuss the evidence for sofosbuvir in Hepatitis C genotype 1 patients 3. State sofosbuvir’s place in therapy according to the AASLD 4. List several ways in which sofosbuvir is a game changer for patients, insurers, and
dispensing pharmacists
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Hepatitis C virus (HCV): disease course and demographic trends
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HCV Medications Approval Year Mechanism of Action
SVR Rate for Genotype 1 (upper limit) Side Effects
Interferon α-‐2 + Ribavirin ("PEG/RBV")
2001 • Interferons ↑ macrophage phagocytosis and lymphocyte cytotoxicity
• Ribavirin inhibits replication of RNA and DNA viruses
50% Anemia (may require transfusion) Flu-‐like sx
Anxiety, depression, memory loss, acute psychoses, suicidal ideation Hearing loss, seizures, vision loss, coma Renal, cardiac, pulmonary failure Autoimmune disease
MI, angina, stroke
Hair loss, rash, photosensitivity Injection site pain
Boceprevir and Telaprevir
2011 Prevent viral proteases from cleaving nonstructural proteins into replication complex
70% ↑ PEG/RBV side effects Dysguesia Severe rash Neutropenia Photosensitivity
Sofosbuvir 2013 Decoy substrate for HCV RNA polymerase (NS5B portion); chain terminator
90% Fatigue Headache Nausea
NEUTRINO trial: Sofosbuvir for HCV Genotype 1
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NEUTRINO trial: Sofosbuvir for HCV Genotype 1
Genotype 1 patients who had failed prior therapies have been waiting for a drug like Sofosbuvir, but NEUTRINO only studied treatment naïve patients
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PHOTON-‐1 trial: Sofosbuvir for HCV Genotype 1
Genotype 1: HIV-‐HCV Co-‐Infected
Sofosbuvir: Game Changer for Patients
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Sofosbuvir: Game Changer for Insurers
Number of sofosbuvir prescriptions expected to increase significantly
Gilead has negotiated a price break with Egypt. A 12-‐week course of sofosbuvir will cost $900
Sofosbuvir: Game Changer for Dispensing Pharmacists
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References
AASLD and IDSA. Recommendations for Testing, Managing, and Treating Hepatitis C. Available at www.hcvguidelines.org. Accessed May 28, 2014.
Birnkrant D. [Sovaldi] Division Director’s Summary Review. CDER Application No. 204671Orig1s000. November 27, 2013. Available at www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000SumR.pdf. Accessed 5/22/14.
Birnkrant D. FDA Introductory Remarks: Sofosbuvir NDA 204671, October 25, 2013: Silver Spring, Maryland. Available at www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM375285.pdf. Accessed May 23, 2014.
CDER Guidance to Industry, Chronic Hepatitis C Virus Infection: Developing Direct Acting Antiviral Drugs for Treatment. Draft guidance, October 2013. Available at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf. Accessed May 18, 2014.
Connelly S. [Sofosbuvir] Cross-‐Discipline Team Leader Review. CDER Application No. 204671Orig1s000. November 8, 2013. Available at www.accessdata.fda.gov/drugsatfda_docs/nda/2013/ 204671Orig1s000CrossR.pdf. Accessed May 26, 2014.
C. Everett Koop Institute, Dartmouth Medical School. Hepatitis C: An Epidemic for Anyone. Available at www.epidemic.org/theFacts/hepatitisC/hepatitisC.php. Accessed May 18, 2014.
Darrow JJ, et al. New FDA Breakthrough-‐Drug Category – Implications for Patients. NEJM 2014; 370:1252-‐1258.
Dugum M. Cleveland Clinic Journal of Medicine 2014; 81(3):159-‐172.
FDA Guidance for Industry: Chronic Hepatitis C Virus Infection: Developing Direct-‐Acting Antiviral Drugs for Treatment. October 2013. Available at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf. Accessed May 18, 2014.
FDA. Novel New Drugs 2013 Summary; January 2014. Available at www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM381803.pdf. Accessed 5/23/14.
Florian, et al. [Sovaldi] Addendum to FDA Clinical Pharmacology and Biopharmaceutics Review, Application No. 204671sOrig1s000, November 22, 2013. Available at www.accessdata.fda/gov/drugsatfda_docs/nda/2013/204671Orig1s000ClinPharmR.pdf. Accessed May 24, 2014.
Jacobson IM, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. NEJM 2013; 368:1867-‐77; Suppl. App., p. 23.
Japsen B. At $1,000 A Pill, Hepatitis C Drug Sovaldi Rattles Medicaid Programs. Forbes. Available at www.forbes.com/sites/brucejapsen/2014/04/28/pricey-‐hepatitis-‐pill-‐sovaldi-‐rattles-‐medicaid-‐programs/. Accessed May 28, 2014.
Kowdley KV, et al.Sofosbuvir with pegylated interferon alfa-‐2a and ribavirin for treatment-‐naïve patients with hepatitis C genotype-‐1 infection (ATOMIC): an open-‐label, randomised, multicentre phase 2 trial. Lancet. 2013 Jun 15;381(9883):2100-‐7.
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Lawitz E, et al. [NEUTRINO] Sofosbuvir for previously untreated chronic hepatitis C infection. NEJM 2013 May 16; 368(20):1878-‐87 and supplementary appendix pp. 1-‐59.
Lexicomp Online, Lexi-‐Drugs, Hudson, Ohio: Lexi-‐Comp, Inc.; 2014; May 29, 2014.
Massard J, et al. Natural history and predictors of disease severity in chronic hepatitis C. J Hepatology 2006; 44:S19-‐S24.
Mishra P. [Sovaldi] FDA Medical Review, September 6, 2013. Available at www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000MedR.pdf. Accessed May 22, 2014.
Sears D. Strategies for Implementing New CDC Guidelines for HCV in Baby Boomers. 2012 Texas Viral Hepatitis Summit 2012. Available at www.dshs.state.tx.us/hivstd/conference/2012/2012-‐Texas-‐Viral-‐Hepatitis-‐Summit.doc. Accessed May 24, 2014.
Smith BD, et al. Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945-‐1965. MMWR; August 17, 2012/61(RR04);1-‐18.
Sovaldi™ Clinical Studies [Promotional Materials]. Foster City, CA: Gilead, 2013.
Sovaldi™ [package insert]. Foster City, CA: Gilead; 2013.
Staton T. Express Scripts assembling anti-‐Sovaldi coalition to shut out Gilead hep C drug. FiercePharma. Available at www.fiercepharma.com/story/express-‐scripts-‐assembling-‐anti-‐sovaldi-‐coalition-‐shut-‐out-‐gilead-‐hep-‐c-‐dru/2014-‐04-‐08#ixzz337cwcnkC. Accessed May 28, 2014.
Ura A. Cost of New Drug Complicates Access for Inmates and the Poor. NYT May 24, 2014. Available at www.nytimes.com/2014/05/25/us/cost-‐of-‐new-‐drug-‐complicates-‐access-‐for-‐inmates-‐and-‐the-‐poor.html?_r=0 . Accessed May 28, 2014.
World Health Organization. Guidelines for the Screening, Care and Treatment of Persons With Hepatitis C Infection. April 2014. Available at www.who.int/hiv/pub/hepatitis/hepatitis-‐c-‐guidelines/en/. Accessed May 29, 2014.