NEW DRUGS FOR THE TREATMENT OF HEPATITIS C. Marcella Honkonen, PharmD, BCPS AzPA Annual Convention. Sunday, June 29 th, 2014 (1:15-2:15)

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1 NEW DRUGS FOR THE TREATMENT OF HEPATITIS C Marcella Honkonen, PharmD, BCPS AzPA Annual Convention. Sunday, June 29 th, 2014 (1:15-2:15)

2 Objectives Determine initial treatment options for patients with HCV infection Discuss retreatment options in patients who fail initial therapy Describe monitoring needs for patients who are on or have completed therapy

3 Global Prevalence of HCV Region Prevalence (%) Estimated number of people infected East Asia 3.7 >50 million South Asia 3.4 >50 million North Africa/Middle East 3.6 >15 million South-East Asia 2 >11 million Western Europe 2.4 >10 million West sub-saharan Africa 2.8 >8.4 million Eastern Europe 2.9 >6.2 million East sub-saharan Africa 2 >6.1 million North America 1.3 >4.4 million Central Latin America 1.6 >3.4 million

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5 Populations with Increased Risk Persons who inject drugs Recipients of infected blood products or invasive procedures in health-care facilities with inadequate infection control practices Children born to mothers infected with HCV People with sexual partners who are HCV-infected People with HIV infection People who have used intranasal drugs People who have had tattoos or piercings

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8 Patient Case 57 year old female presented with diarrhea x 2 days treated and discharged from hospital PMH: Diabetes type 2, Hypertension, Depression SH: IVDA (heroin), last use unknown Meds: Metformin, Glipizide, Lisinopril, Fluoxetine Allergies: Sulfa (rash) Diagnosis: Acute HepC infection She presents to your clinic Genotype and mutations pending Negative for HIV, HepA, and HepB

9 Patient Case What is true regarding the treatment for her Hepatitis C infection? She should not be treated since she currently (possibly) uses IV heroin She should not be treated because she has depression She should not be treated with a regimen containing the new agent simeprevir because of her sulfa allergy She could possibly be treated with a regimen containing the new agent sofosbuvir

10 To Treat or Not to Treat? IDSA/AASLD Guidelines Coming Soon based on 3/21/2014 update WHO April 2014 Guidelines

11 New Drug Options for HepC New Options Boceprevir (Victrelis) 5/2011 Telaprevir (Incivek) 5/2011 Simeprevir (Olysio) 11/2013 Sofosbuvir (Sovaldi) 12/2013 Standard of Care PEG interferon Ribavirin MANY agents in the pipeline!

12 OLD Standard of Care Peginterferon Weekly dosing - Subcutaneous injections Serious adverse events - Neuropsychiatric disorders (boxed warning), bone marrow suppression, hemolytic anemia, flu-like symptoms Treatment duration - 48 weeks to one year (monotherapy) Drug-Drug interactions - Decreases serum concentrations of CYP2C9 and CYP2D6 substrates Monitoring - Pregnancy, TSH, CBC, LFTs, bilirubin, LDH, Triglycerides, glucose/hba1c, ECG Ribavirin Daily dosing - Taken with food Serious adverse events - Hemolytic anemia, depression, leukopenia, neutropenia, alopecia, pruritus, rash Treatment duration - 24 to 48 weeks Drug-Drug interactions - NRTIs (didanosine, zidovudine), Live influenza vaccine Monitoring - Pregnancy, CBC, TSH, ANC, ECG

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15 Site of Drug Action Accessed April 2014.

16 Fallen Out of Favor Boceprevir Three times daily dosing - To be taken with food Higher rates of serious adverse events - Anemia, neutropenia, rash Longer treatment duration - 24 to 48 weeks Drug-Drug interactions - CYP3A4 substrate and inhibitor Frequency of monitoring - CBC at 2, 4, 8, 12 weeks and as clinically indicated Telaprevir Twice daily dosing - To be taken with fatty meal Higher rates of serious adverse events - Rash including boxed warning for SJS, TEN, and DRESS; anemia, nephropathy Longer treatment duration - 24 to 48 weeks Drug-Drug interactions - CYP3A4 substrate and inhibitor Frequency of monitoring - CBC, electrolytes, serum creatinine, TSH, bilirubin, liver enzymes, uric acid at 2, 4, 8, 12 weeks and as clinically indicated - Hydration status, urine output, signs of dehydration

17 Sofosbuvir (Sovaldi) Administration Prodrug Daily with or without food Adverse effects Fatigue, rash, nausea, anemia Treatment duration 12 to 24 weeks Drug-Drug interactions Substrate of P-glycoprotein Avoid use of tenofovir, oxcarbazepine, modafinil, St Johns Wort Monitoring Bilirubin, LFTs, serum creatinine at baseline and when clinically indicated

18 Simeprevir (Olysio) Administration Daily with food Contains sulfonamide moiety Adverse effects Rash, nausea, increased bilirubin, phototoxicity Treatment duration Drug-Drug interactions CYP3A4 substrate Inhibits CYP1A2 and P-glycoprotein Monitoring Bilirubin, LFTs, uric acid at baseline and when clinically indicated

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20 Out with the Old and In with the New??? Not Quite Yet

21 Available Regimens Sofosbuvir 400 mg daily Simeprevir 150 mg daily Genotype 1, Treatment Naïve Duration PEG Ribavirin <75kg:1000 mg 75kg: 1200 mg Duration weeks weeks weeks - +/- 12 weeks weeks weeks weeks weeks* *This regimen may be less effective compared to sofosbuvir plus simeprevir, especially in patients with cirrhosis Not recommended for genotype 1, treatment naïve PEG/ribavirin for 24 to 48 weeks Telaprevir or boceprevir based regimens Monotherapy with PEG, ribavirin, or a direct-acting agent (DAA)

22 Available Regimens Sofosbuvir 400 mg daily Simeprevir 150 mg daily Genotype 2, Treatment Naïve Duration PEG Ribavirin <75kg:1000 mg 75kg: 1200 mg Duration weeks weeks Not recommended for genotype 2, treatment naïve PEG/ribavirin for 24 weeks Telaprevir, boceprevir, or simeprevir based regimens Monotherapy with PEG, ribavirin, or DAA

23 Available Regimens Sofosbuvir 400 mg daily Simeprevir 150 mg daily Genotype 3, Treatment Naïve Duration PEG Ribavirin <75kg:1000 mg 75kg: 1200 mg Duration weeks weeks weeks weeks Not recommended for genotype 3, treatment naïve PEG/ribavirin for 24 to 48 weeks Telaprevir, boceprevir, or simeprevir based regimens Monotherapy with PEG, ribavirin, or DAA

24 Available Regimens Sofosbuvir 400 mg daily Simeprevir 150 mg daily Genotype 4, Treatment Naïve Duration PEG Ribavirin <75kg:1000 mg 75kg: 1200 mg Duration weeks weeks weeks weeks weeks weeks Not recommended for genotype 4, treatment naïve PEG/ribavirin for 48 weeks Telaprevir or boceprevir based regimens Monotherapy with PEG, ribavirin, or DAA

25 Available Regimens Sofosbuvir 400 mg daily Simeprevir 150 mg daily Genotype 5 or 6, Treatment Naïve Duration PEG Ribavirin <75kg:1000 mg 75kg: 1200 mg Duration weeks weeks weeks Not recommended for genotype 5 or 6, treatment naïve Telaprevir or boceprevir based regimens Monotherapy with PEG, ribavirin, or DAA

26 Patient Case (continued) 57 year old female presented with diarrhea x 2 days treated and discharged from hospital PMH: Diabetes type 2, Hypertension, Depression SH: IVDA (heroin), last use unknown Meds: Metformin, Glipizide, Lisinopril, Fluoxetine Allergies: Sulfa (rash) Results from genotyping Genotype 1a Q80K mutation Found to have significant fibrosis Do you want to treat her? If so, What is her preferred regimen? How does the Q80K mutation impact her treatment?

27 What is the Q80K Mutation? Naturally occurring NS3-4A protease polymorphism In the United States People with genotype 1a have a high prevalence for the Q80K mutation Effects the outcome of patients treated with a simeprevir-based regimen Baseline testing for Q80K recommended

28 Effect of the Q80K Mutation

29 Patient Case Treatment Options Sofosbuvir 400 mg daily Simeprevir 150 mg daily Genotype 1, Treatment Naïve Duration PEG Ribavirin <75kg:1000 mg 75kg: 1200 mg Duration weeks weeks weeks - +/- 12 weeks weeks weeks weeks weeks* *This regimen may be less effective compared to sofosbuvir plus simeprevir, especially in patients with cirrhosis Which regimen do you recommend?

30 Considerations for Retreatment Relapsers and Non-Responders

31 Retreatment - Definitions Relapser Achieved undetectable levels after first course of therapy, and relapsed Treatment similar to treatment naïve Non-responder Null responders HCV RNA levels declined less than 2 log 10 IU/mL by week 12 Partial responders Those with greater than 2 log 10 IU/mL whose virus remained detectable up to 24 weeks or end of treatment

32 Retreatment Options for Non-Responders Genotype Sofosbuvir 400 mg daily Simeprevir 150 mg daily Duration PEG Ribavirin <75kg:1000 mg 75kg: 1200 mg Duration weeks - +/- 12 weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks weeks 5 or weeks weeks

33 Review of Assessment Questions

34 Question 1 Which factor plays a role in determining the treatment duration for hepatitis C? Cirrhosis Genotype Virologic response I only II only I and II only I and III only I, II, and III

35 Question 2 Which anti-viral regimen would be appropriate for a treatment-naïve HCV genotype 1 patient who is eligible to receive interferon? Boceprevir plus RBV plus PEG Sofosbuvir plus RBV plus PEG Sofosbuvir plus simeprevir plus PEG Sofosbuvir plus teleprevir plus PEG

36 Question 3 Which adverse reaction is MOST likely to occur secondary to sofosbuvir therapy? Anemia Depression Polyuria Thrombocytopenia

37 Questions & Discussion

38 References WHO. Guidelines for the screening, care and treatment of persons with hepatitis C infection. April IDSA, AASLD, IAS-USA. Recommendations for testing, managing, and treating hepatitis C. Revised March 21, 2014.

39 NEW DRUGS FOR THE TREATMENT OF HEPATITIS C Marcella Honkonen, PharmD, BCPS AzPA Annual Convention. Sunday, June 29 th, 2014 (1:15-2:15)

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