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New Treatment for Hep C

New Treatment for Hep C. Prabhdeep Sidhu Candidate PharmD 2015 Western University of Health Sciences Mar 28, 2014. Objectives. Discuss epidemiology of Hepatitis C Explain testing and diagnosis Describe current treatments Explain new medication Sovaldi Identify place in treatment

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New Treatment for Hep C

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  1. New Treatment for Hep C Prabhdeep Sidhu Candidate PharmD 2015 Western University of Health Sciences Mar 28, 2014

  2. Objectives • Discuss epidemiology of Hepatitis C • Explain testing and diagnosis • Describe current treatments • Explain new medication Sovaldi • Identify place in treatment • Compare Sovaldi with other treatment plans

  3. Patient Case • AJ is 45 year old male African American patient who got diagnosed with Hepatitis C genotype 2. AJ has a past medical history of DM and is taking metformin and glipizide. Pt also has a history of IVDU and stopped using drugs 5 years ago. Pt is experiencing fatigue and low in energy from past few months. Resident physician wants to start AJ on Sovaldi and asking for pharmacist’s receommendation.

  4. Hepatitis C • Symptoms • Acute • Mostly asymptomatic • Chronic • Persistent fatigue • Nausea • Poor appetite • Transmission • Caused by infection with Hepatitis C virus • Spread through exposure to infected blood • Sharing needles to inject drugs • Blood transfusions (before 1992)

  5. Hepatitis C • Approximately 3.2 million people infected with HCV • Risk groups • Injection drug users • Recipient of blood products prior to 1992 • Chronic haemodialysis patients • Persons with HIV infection • Children born to HCV infected mothers

  6. Testing Recommendations • Persons born from 1945 through 1965 • Persons injecting illegal drugs • Recipients of blood transfusions prior to 1992 • Long term haemodialysis patients • Persons with HIV infection

  7. Diagnosis • Screening tests for antibody to HCV • RNA polymerase chain reaction • Quantitative test to detect amount of virus

  8. Current Treatments • For genotype 1 (duration varies on treatment response) • Peg interferon and Ribavirin • Plus Boceprevir or Telaprevir • For genotype 2 or 3 ( 24 weeks) • Peg interferon Plus Ribavirin

  9. Sovaldi (Sofosbuvir) • Nucleotide analogue inhibitor of hepatitis C virus NS5B polymerase enzyme • 400 mg tablet • Once daily • Approved Dec 2013

  10. Mechanism of Action • HCV NS5B RNA dependent RNA polymerase • Essential for viral replication • Sovaldi is a prodrug which undergoes intracellular metabolism to active form uridine analog triphospahte • Gets incorporated into viral RNA and acts as a chain terminator

  11. Pharmacokinetics

  12. Adverse Effects • Common • Rash (18%) • Diarrhea (12%) • Nausea (34%) • Anemia (6%) • Serious • Pancytopenia (<1%) • Increased bilirubin levels (3%) • Depression (<1%)

  13. Monitoring • Detect viral load • Improvement in signs and symptoms of Hepatitis C • In female patients and female partners of male patients, perform pregnancy test before initiating treatment and monthly thereafter, and for 6 months after discontinuing treatment

  14. CI and DDI • CI • Pregnancy – Category B • DDI • Carbamazepine • Fosphenytoin • Oxcarbazepine • Phenytoin • Rifampin • St. John’s wort

  15. Place in treatment • Genotype 1 • Sovaldi + Peg interferon + Ribavirin for 12 weeks • Genotype 2 • Sovaldi + Ribavirin for 12 weeks • Genotype 3 • Sovaldi + Ribavirin for 24 weeks

  16. Treatment comparison • NEUTRINO trial – single group open label trial

  17. Treatment comparison • FISSION trial – randomized open label active- control groups

  18. Treatment comparison • Cost • Peg- interferon + Ribavirin for 24 weeks = 23,002 • Sovaldi + Ribavirin for 12 weeks = 101, 195

  19. Pros &Cons • Pros - • Oral Administration • Once daily dosing • Shorter treatment duration • Cons – • Increase in cost of treatment • Long term data not available

  20. Recommendation for AJ • Peg-interferon 180 mcg once weekly for 24 weeks • Ribavirin 400 mg twice daily for 24 weeks

  21. References • Hepatitis C information for health professionals. Retrieved on Mar 24, 2014 from http://www.cdc.gov/hepatitis/HCV/index.htm • Sovaldi Lexi-comphttp://online.lexi.com.proxy.westernu.edu/lco/action/doc/retrieve/docid/patch_f/4884323Accessed on Mar 27, 2014. • Lawitz E. et al. Sofosbuvir for previously untreated chronic hepatitis C infection. The New England Journal of Medicine 2013; 368:1878-1887

  22. Thank You

  23. Questions

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