Sofosbuvir: Game Changer for the Treatment of Hepatitis C

Transcription

1 Sofosbuvir: Game Changer for the Treatment of Hepatitis C Leslie Dixon, Pharm.D. Managed Care Drug Policy Resident Scott & White Health Plan Temple, TX Learning Objectives May 30, 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

2 Hepatitis C virus (HCV): disease course and demographic trends 1

3 HCV Medications Interferon α- 2 + Ribavirin ("PEG/RBV") Boceprevir and Telaprevir Approval Year Mechanism of Action 2001 Interferons macrophage phagocytosis and lymphocyte cytotoxicity Ribavirin inhibits replication of RNA and DNA viruses 2011 Prevent viral proteases from cleaving nonstructural proteins into replication complex Sofosbuvir 2013 Decoy substrate for HCV RNA polymerase (NS5B portion); chain terminator SVR Rate for Genotype 1 (upper limit) Side Effects 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 70% PEG/RBV side effects Dysguesia Severe rash Neutropenia Photosensitivity 90% Fatigue Headache Nausea NEUTRINO trial: Sofosbuvir for HCV Genotype 1 2

4 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 3

5 PHOTON- 1 trial: Sofosbuvir for HCV Genotype 1 Genotype 1: HIV- HCV Co- Infected Sofosbuvir: Game Changer for Patients 4

6 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 5

7 References AASLD and IDSA. Recommendations for Testing, Managing, and Treating Hepatitis C. Available at Accessed May 28, Birnkrant D. [Sovaldi] Division Director s Summary Review. CDER Application No Orig1s000. November 27, Available at Accessed 5/22/14. Birnkrant D. FDA Introductory Remarks: Sofosbuvir NDA , October 25, 2013: Silver Spring, Maryland. Available at visorycommittee/ucm pdf. Accessed May 23, CDER Guidance to Industry, Chronic Hepatitis C Virus Infection: Developing Direct Acting Antiviral Drugs for Treatment. Draft guidance, October Available at pdf. Accessed May 18, Connelly S. [Sofosbuvir] Cross- Discipline Team Leader Review. CDER Application No Orig1s000. November 8, Available at Orig1s000CrossR.pdf. Accessed May 26, C. Everett Koop Institute, Dartmouth Medical School. Hepatitis C: An Epidemic for Anyone. Available at Accessed May 18, Darrow JJ, et al. New FDA Breakthrough- Drug Category Implications for Patients. NEJM 2014; 370: Dugum M. Cleveland Clinic Journal of Medicine 2014; 81(3): FDA Guidance for Industry: Chronic Hepatitis C Virus Infection: Developing Direct- Acting Antiviral Drugs for Treatment. October Available at pdf. Accessed May 18, FDA. Novel New Drugs 2013 Summary; January Available at Accessed 5/23/14. Florian, et al. [Sovaldi] Addendum to FDA Clinical Pharmacology and Biopharmaceutics Review, Application No sOrig1s000, November 22, Available at Accessed May 24, Jacobson IM, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. NEJM 2013; 368: ; Suppl. App., p. 23. Japsen B. At $1,000 A Pill, Hepatitis C Drug Sovaldi Rattles Medicaid Programs. Forbes. Available at hepatitis- pill- sovaldi- rattles- medicaid- programs/. Accessed May 28, 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 Jun 15;381(9883):

8 Lawitz E, et al. [NEUTRINO] Sofosbuvir for previously untreated chronic hepatitis C infection. NEJM 2013 May 16; 368(20): and supplementary appendix pp Lexicomp Online, Lexi- Drugs, Hudson, Ohio: Lexi- Comp, Inc.; 2014; May 29, 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, Available at Accessed May 22, Sears D. Strategies for Implementing New CDC Guidelines for HCV in Baby Boomers Texas Viral Hepatitis Summit Available at Texas- Viral- Hepatitis- Summit.doc. Accessed May 24, Smith BD, et al. Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During MMWR; August 17, 2012/61(RR04);1-18. Sovaldi Clinical Studies [Promotional Materials]. Foster City, CA: Gilead, Sovaldi [package insert]. Foster City, CA: Gilead; Staton T. Express Scripts assembling anti- Sovaldi coalition to shut out Gilead hep C drug. FiercePharma. Available at scripts- assembling- anti- sovaldi- coalition- shut- out- gilead- hep- c- dru/ #ixzz337cwcnkC. Accessed May 28, Ura A. Cost of New Drug Complicates Access for Inmates and the Poor. NYT May 24, Available at of- new- drug- complicates- access- for- inmates- and- the- poor.html?_r=0. Accessed May 28, World Health Organization. Guidelines for the Screening, Care and Treatment of Persons With Hepatitis C Infection. April Available at c- guidelines/en/. Accessed May 29,