HIV and HCV Update for the Pharmacist

Transcript HIV and HCV Update for the Pharmacist

HIV and HCV Update for the Pharmacist – June 2014

John J. Faragon, PharmD, BCPS, AAHIV-P Regional Pharmacy Director, NY/NJ AETC Pharmacist, Albany Medical Center

Objectives

• Discuss recent guidelines changes for HIV infection • Using patient cases, discuss the role of sofosbuvir and simeprevir in HIV/HCV co infection • Review consensus guidelines for managing HIV/HCV coinfection 2

DHHS Guidelines Update 2014: Recommended Regimens in ARV Naives Regardless of Baseline CD4 and Viral Load

NNRTI – Based Regimen Efavirenz/tenofovir/emtricitabine (AI) PI – Based Regimens: Atazanavir/ritonavir + tenofovir/emtrictiabine (AI) Darunavir/ritonavir + tenofovir/emtricitabine (AI) INSTI – Based Regimens: Dolutegravir plus abacavir/lamivudine – ONLY if patient HLA-B*5701 negative (AI) Dolutegravir plus tenofovir/emtricitabine (AI) Elvitegravir/cobicistat/tenofovir/emtricitabine – ONLY if pre-ART CrCl >70ml/min (AI) Raltegravir plus tenofovir/emtricitabine (AI)

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf. Accessed 5/2/14

DHHS Guidelines Initial Recommended Regimens - 2014

Atripla 1/day Reyataz/Norvir/Truvada 3/day Prezista/Norvir/Truvada 3/day

DHHS Guidelines Initial Recommended Regimens - 2014

Isentress (BID)/Truvada 3/day Tivicay/Truvada OR Epzicom OR 2/day Stribild 1/day

DHHS Guidelines Update 2014: Recommended Regimens, ARV Naives, ONLY if Pre ART Viral Load <100,000 copies/ml

NNRTI – Based Regimen Efavirenz + abacavir/lamivudine – ONLY if patient HLA-B*5701 negative (AI) Rilpivirine/tenofovir/emtricitabine – ONLY if patient has CD4 count>200 cells/mm 3 (AI) PI – Based Regimens: Atazanavir/ritonavir + abacavir/lamivudine (AI) – ONLY if patient is HLA-B*5701 negative

DHHS Guidelines Update 2014 Alternative Regimens in ARV Naives

PI – Based Regimen Darunavir/ritonavir + abacavir/lamivudine – ONLY for patients who are HLA-B*5701 negative (BII) Lopinavir/ritonavir (once or twice daily) plus abacavir/lamivudine – ONLY for patients who are HLA-B*5701 negative (BI) Lopinavir/ritonavir (once or twice daily) plus tenofovir/emtricitabine (BI) INSTI – Based Regimens: Raltegravir + abacavir/lamivudine – ONLY for patients who are HLA-B*5701 negative

Preferred NRTI Backbones in Pregnancy – DHHS Perinatal Guidelines, March 2014

Preferred NRTI Backbones

Abacavir/lamivudine Tenofovir/emtricitabine or lamivudine Zidovudine/lamivudine Available as fixed dose combination, once daily dosing. Do NOT use in patients testing positive for HLAB*5701 Available as fixed dose combination, once daily dosing. Tenofovir may cause renal impairment Available as fixed dose combination. Most experience in pregnancy to date, but twice daily adminstration, and potential for hematologic toxicity Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/PerinatalGL.pdf. Accessed 5/2/14

Preferred PI, NNRTI Regimens in Pregnancy – DHHS Perinatal Guidelines, March 2014

Preferred PI Regimens

Atazanavir/ritonavir + preferred dual NRTI backbone Lopinavir/ritonavir + preferred dual NRTI backbone Once daily administration Twice daily administration. Once daily dosing not recommended in pregnancy. May need to increase dosage in 3 rd trimester

Preferred NNRTI Regimens

Efavirenz + preferred dual NRTI backbone initiated AFTER first 8 weeks of pregnancy Teratogenicity in primates. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/PerinatalGL.pdf. Accessed 5/2/14

Current Medications for HCV

 Older Medications  Pegylated Interferon – PegIntron or Pegasys  Ribavirin  Older Direct Acting Antivirals   Boceprevir (Victrelis) Telaprevir (Incivek)  New Direct Acting Antivirals   Simeprevir (Olysio) Sofosbuvir (Sovaldi)

Challenges with Older DAA

     Telaprevir (Incivek)  Rash – Black Box Warning   Anemia – Worse than Pegylated interferon + Ribavirin alone Needs interferon and ribavirin – brings all ADRs with it too Anorectal adverse events challenging Only for Genotype 1 – ie not pangenotypic Response guided therapy/stopping rules Drug Interactions complex, especially when treating co-infection  Large pull burden (6/day), TID, now BID frequency

Challenges with Older DAA

     Boceprevir (Victrelis)   Dygeusia –Anemia – Worse than Pegylated interferon + Ribavirin alone Needs interferon and ribavirin – brings all ADRs with it too 4 week lead in period Only for Genotype 1 – ie not pangenotypic Response guided therapy/stopping rules Drug Interactions complex, especially when treating co-infection  Large pull burden (12/day), TID frequency

Contraindicated medications with boceprevir and telaprevir

Contraindicated With BOC [1] Contraindicated With TVR [2,3] Drug Class

Alfuzosin Alfuzosin Alpha 1-adrenoreceptor antagonist Anticonvulsants Antimycobacterials Ergot derivatives GI motility agents Herbal products HMG CoA reductase inhibitors Oral contraceptives Neuroleptic PDE5 inhibitor Sedatives/hypnotics Carbamazepine, phenobarbital, phenytoin Rifampin Dihydroergotamine, ergonovine, ergotamine, methylergonovine Cisapride St John’s wort Lovastatin, simvastatin Drospirenone Pimozide Sildenafil or tadalafil when used for tx of pulmonary arterial HTN Triazolam; orally administered midazolam Carbamazepine, phenobarbital, phenytoin Rifampin Dihydroergotamine, ergonovine, ergotamine, methylergonovine Cisapride St John’s wort Lovastatin, simvastatin N/A Pimozide Sildenafil or tadalafil when used for tx of pulmonary arterial HTN Triazolam; orally administered midazolam 1. Boceprevir [package insert]. 2013. 2. Telaprevir [package insert]. 2013., 3. www.hep-druginteractions.org

Concurrent Medication Atazanavir/ritonavir (Reyataz®/Norvir®) Darunavir/ritonavir (Prezista®/Norvir®) Fosamprenavir/ritonavir (Lexiva®/Norvir®) Lopinavir/ritonavir (Kaletra®) Efavirenz (Sustiva®) Etravirine (Intelence®) Rilpivirine (Edurant®) Tenofovir (Viread®) Raltegravir (Isentress®) Elvitegravir (in Stribild®) Dolutegravir (Tivicay®) Maraviroc (Selzentry®) Boceprevir allowed No No No, not studied to date Telaprevir allowed Yes No No No No Yes, reduced etravirine levels reported Yes Yes Yes ??

No Yes, increase TLV dose to 1125mg Q8H Yes Yes Yes, monitor renal fx Yes Yes Yes Yes, MRV 150mg BID Yes Yes, MRV 150mg BID

Telaprevir Boceprevir Simeprevir Faldapravir ABT-450 Daclatasvir Ledipasvir ABT- 267 Sofosbuvir ABT-333

   

Simeprevir FDA Approved November 22, 2013

FDA Panel recommended approval October 24, 2013, formal approval November 22, 2013 Recommend approval of simeprevir, an HCV NS3/4A protease inhibitor, in combination with pegylated interferon/ribavirin 150 mg once-daily for use by genotype 1 hepatitis C patients, either treatment-naive or prior non-responders, with food No dosage recommendations for East Asian ancestry subjects Janssen Research and Development. FDA Advisory Committee Recommends Approval of Simeprevir for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients. Press release. October 24, 2013.

www.olysio.com. Accessed June 4, 2014.

Simeprevir Key Points

     Q80K mutation screening will be important  GT1a polymorphism   Substantial reduction in SVR rates if present at baseline Pre-treatment screening recommended Serious photosensitivity reactions have been observed during combination therapy  Use sun protection measures and limit sun exposure. Consider discontinuation if a photosensitivity reaction occurs. Rash has been observed during combination therapy Discontinue OLYSIO if severe rash occurs. Caution in Sulfa allergic, simeprevir is a sulfonamide Hyperbilirubinemia also reported Janssen Research and Development. FDA Advisory Committee Recommends Approval of SimeQ*)previr for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients. Press release. October 24, 2013.

www.olysio.com. Accessed June 4, 2014.

Simeprevir Key Points

Duration of Treatment with Simeprevir, peg-interferon alfa, ribavirin Naïve, prior relapser, including cirrhosis Simeprevir, peg interferon alfa + ribavirin First 12 weeks Peg-interferon alfa + ribavirin Additional 12 weeks Prior non-responders, including cirrhosis First 12 weeks Additional 36 weeks Simeprevir Stopping Rules Week 4, > 25IU/mL Week 12, > 25IU/mL Week 24, > 25IU/mL Total treatment duration 24 weeks 48 weeks Discontinue simeprevir, peg-interferon and ribavirin Discontinue peg-interferon alfa and ribavirin (simeprevir complete at week 12) Discontinue peg-interferon alfa and ribavirin

Janssen Research and Development. FDA Advisory Committee Recommends Approval of SimeQ*)previr for Combination Treatment of Genotype 1 Chronic Hepatitis C in Adult Patients. Press release. October 24, 2013.

www.olysio.com. Accessed June 4, 2014. 18

Simeprevir with PEG/RBV, GT 1 HIV/HCV CoInfection Design

Treatment naïve or Prior relapser RGT SMV + PR SMV + PR Prior partial or Null responder SMV + PR PR PR Primary Analysis Follow-up Follow-up PR Follow-up 12 24 36 48 60 72 Dieterich D et al. CROI 2014; Abst 24 19

Simeprevir + PEG/R,GT1 HIV/HCV CoInfection: SVR 12 Results, ITT

100 80 74 p<0.001

79 87 70 p<0.001

57 60 40 29 20 0 0 Overall Naives Dieterich D et al. CROI 2014; Abst 24 0 Relapsers 0 Partial Null 5 20

Drug Interactions Considerations

 Simeprevir  Mild inhibitor of CYP1A2 activity and intestinal CYP3A4  Does not affect hepatic CYP3A4 activity   Inhibits OATP1B1/3 and P-glycoprotein Multiple drug interactions expected www.hcvguidelines.org

Medications to Avoid with Simeprevir

Medication and or Class Anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antibiotics – clarithromycin, erythromycin, telithromycin Antifungals – fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole Antimycobacterials – rifampin, rifabutin, rifapentine Rationale for Avoiding with Simeprevir  Co-administration with these medications is likely to reduce concentrations of simeprevir and lead to reduced simeprevir efficacy. Co-administration not recommended.

   Co-administration with these medications is likely to increase concentrations of either simeprevir or the antibiotic due to CYP3A4 and P-glycoprotein (P-gp) inhibition. Co-administration not recommended. Co-administration with these medications is likely to increase concentrations of simeprevir due to CYP3A4 inhibition from the antifungals. Co-administration not recommended. Co-administration with these medications is likely to reduce concentrations of simeprevir and lead to reduced simeprevir efficacy. Co-administration not recommended. www.nynjaetc.org

Medications to Avoid with Simeprevir

Medication and or Class Corticosteroids – dexamethasone Propulsive – cisapride Herbal products – Milk Thistle, St. John’s Wort Rationale for Avoiding with Simeprevir  Co-administration with dexamethasone is likely to decrease concentrations of simeprevir and lead to reduced simeprevir efficacy. Co-administration not recommended.  Co-administration with cisapride may result in increased concentrations of cisapride leading to potential cardiac arrhythmias.   Co-administration with milk thistle is likely to increase concentrations of simeprevir. Co-administration not recommended. Co-administration with St. John’s Wort is likely to reduce concentrations of simeprevir leading to reduced simeprevir efficacy, due to intestinal P-glycoprotein (P-gp) induction associated with St. John’s Wort.

www.nynjaetc.org

Simeprevir and HIV Medications

Concurrent Medication Recommendation HIV Protease Inhibitors All HIV PIs used with or without ritonavir. Co-administration not recommended HIV Non Nucleoside Reverse Transcriptase Inhibitors Efavirenz (Sustiva®),  Significant reductions in simeprevir levels and reduced Etravirine (Intelence®), Nevirapine (Viramune®)  Significant increases or decreases in simeprevir levels expected when used with any HIV protease inhibitor, when simeprevir efficacy due to CYP3A4 induction. Co administration not recommended.

Rilpivirine (Edurant®)  Concurrent use at standard doses acceptable. www.nynjaetc.org

Simeprevir and HIV Medications

Concurrent Medication Recommendation HIV Integrase Strand Transfer Inhibitors Dolutegravir (Tivicay®)  Concurrent use at standard doses acceptable. Interactions Elvitegravir (contained in Stribild®)  not expected based upon metabolism of simeprevir.

Significant increase in simeprevir levels expected when used with a cobicistat containing regimen. Co-administration not Raltegravir (Isentress®) HIV Entry Inhibitors Maraviroc (Selzentry®)   recommended.

Concurrent use at standard doses acceptable.

Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of simeprevir.

HIV Nucleoside/Nucelotide Reverse Transcriptase Inhibitors All NRTIs  Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of simeprevir. www.nynjaetc.org

Sofosbuvir FDA Approved, December 6, 2013

 FDA Panel recommended approval October 25, 2013  Recommendation covers both use with interferon-based therapy for treatment naive people with HCV genotypes 1 or 4  Also use in dual therapy with ribavirin for people with easier-to-treat HCV genotypes 2 or 3 - the first approved interferon-free regimen Gilead Sciences. FDA Advisory Committee Supports Approval of Gilead’s Sofosbuvir for Chronic Hepatitis C Infection. Press release. October 25, 2013. www.solvadi.com. Accessed June 4, 2014.

Sofosbuvir Key Points

  Indication  NS5B nucleotide polymerase inhibitor for the treatment of chronic HCV as a component of combination anitiviral treatment regimen 400 mg tablet, once daily dosing, with no food restrictions

HCV Mono-infected and HCV/HIV Co-infected Genotype 1 or 4 Treatment Duration 12 weeks Genotype 2 Genotype 3 Sofosbuvir + PEG-interferon + ribavirin Sofosbuvir + ribavirin Sofosbuvir + ribavirin 12 weeks 24 weeks

www.solvadi.com. Accessed June 4, 2014.

Sofosbuvir Key Points

 Sofosbuvir + ribavirin ALONE for 24 weeks can be considered for GT1 if intolerant to interferon   No dosage recommendation can be made in patients with severe renal impairment or ESRD – up to 20 fold increase in SOF metabolite Contraindications – Monotherapy, also ribavirin birth defects www.solvadi.com. Accessed June 4, 2014.

Sofosbuvir Key Points

   Adverse Events  Headache and fatigue most common  Anemia and insomnia, nausea when adding peginterferon + ribavirin Additional info  HIV/HCV coinfection studied, also data on patients with HCC awaiting liver transplantation studied Drug Interactions  Intestinal PGP inducers likely to reduce levels –ie rifampin, St Johns Wort www.solvadi.com. Accessed June 4, 2014

PHOTON-1 Trial in HIV/HCV Co-infection

• Open-label, phase 3 study of sofosbuvir plus weight based ribavirin in coinfection, genotypes 1, 2 or 3.

Week 0 12 24 36 48 GT1, Naive SOF + RBV, n=114 GT2/3, Naive SOF + RBV, n=68 GT2/3, Experienced SOF + RBV, n=41 Naggie S et al. CROI 2014; Abst 26.

SVR 12 SVR 24 30

PHOTON-1: Results

Naggie S et al. CROI 2014; Abst 26 31

PHOTON-1: Results

   Allowable ARVs: NRTIs, atazanavir/r, darunavir/r, rilpivirine & raltegravir Most virologic failures had relapse No sofosbuvir resistance seen Naggie S et al. CROI 2014; Abst 26 32

PHOTON-1 Adverse Events

Patients, % AEs Fatigue Insomnia Headache Nausea Diarrhea Irritability URI Grade 3-4 AEs Serious AEs Treatment DC due to AEs Death 24 Weeks SOF+RBV(n=155) 39 15 14 15 6 3 0 11 10 12 12 12 Weeks SOF+RBV(n=68) 35 21 13 18 7 4 1 9 10 12 10

Naggie S et al. CROI 2014; Abst 26 33

Drug Interactions Considerations

 Sofosbuvir  Substrate for P-glycoprotein and breast cancer resistance protein  Intracellular metabolism mediated by hydrolase and nucleotide phosphorylation pathways  Minimal drug interactions expected www.hcvguidelines.org

Medications to Avoid with Sofosbuvir

Medication and or Class Anticonvulsants – carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials – rifampin, rifabutin, rifapentin Rationale for Avoiding with Sofosbuvir  Co-administration with these medications is likely to reduce concentrations of sofosbuvir leading to reduced sofosbuvir efficacy. Co-administration not recommended.

 Co-administration with these medications is likely to reduce concentrations of sofosbuvir leading to reduced sofosbuvir efficacy due to intestinal P-glycoprotein (P-gp) induction from rifampin. Herbal products – St. John’s Wort  Co-administration with these medications is likely to reduce concentrations of sofosbuvir leading to reduced sofosbuvir efficacy due to intestinal P-glycoprotein (P-gp) induction associated with St. John’s Wort. www.nynjaetc.org

Sofosbuvir and HIV Medications

Concurrent Medication Recommendation HIV Protease Inhibitors All HIV PIs, with or without ritonavir, except tipranavir  Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of sofosbuvir. Tipranavir (Aptivus®)  Co-administration not recommended HIV Non Nucleoside Reverse Transcriptase Inhibitors All NNRTIs  Concurrent use at standard doses acceptable.

www.nynjaetc.org

Sofosbuvir and HIV Medications

Concurrent Medication Recommendation HIV Integrase Strand Transfer Inhibitors Dolutegravir (Tivicay®)  Concurrent use at standard doses acceptable. Interactions not Elvitegravir (contained in  expected based upon metabolism of sofosbuvir.

Concurrent use at standard doses acceptable. Interactions not Stribild®) Raltegravir (Isentress®) HIV Entry Inhibitors  expected based upon metabolism of sofosbuvir.

Concurrent use at standard doses acceptable.

Maraviroc (Selzentry®)  Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of sofosbuvir.

HIV Nucleoside/Nucleotide Reverse Transcriptase Inhibitors All NRTIs  Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of sofosbuvir.

www.nynjaetc.org

COSMOS Study Design

Arm1 SMV+SOF+RBV Post-treatment follow-up Randomized 2:1:2:1 Arm2 Arm 3 SMV+SOF SMV+SOF + RBV SMV+SOF Post-treatment follow-up Post-treatment follow-up Arm 4 Post-treatment follow-up

12 24 36 48 Cohort 1 – Metavir F0-F2, prior null responders Cohort 2 – Metavir F3-F4, prior null responders or naives Primary Endpoint: SVR12 Secondary Endpoints: RVR, Tx failure, relapse rate, safety Lawitz, etal. 49 th EASL, April 9-13, 2014 .

COSMOS, Baseline Characteristics

Characteristic Male, % White/African American Hispanic, Latino Median Age Median BMI GT 1a GT 1a, Q80K Median HCV VL Null Responders IL28B, non CC Cirrhosis

Lawitz, etal. 49 th EASL, April 9-13, 2014.

SMV/SOF+ RBV 24 weeks n=30 70 97/3 10 58 28 77 48 6.3

57 73 43 SMV/SOF 24 weeks n=16 44 81/19 31 58 29 75 42 6.6

50 88 63 SMV/SOF + RBV 12 weeks n=27 74 93/7 19 57 27 82 36 6.7

56 85 41 SMV/SOF 12 weeks n=14 71 86/14 14 58 32 79 30 6.7

50 71 50 Total n=87 67 91/9 17 58 28 78 40 6.6

54 79 47

COSMOS, SVR 12 (ITT) Results

100% 7 0 7 7 2 80% 60% 40% 93 100 93 93 95 20% 0% 28/30 SMV/SOF/RBV 16/16 SMV/SOF 24 weeks 25/27 SMV/SOF/RBV Lawitz, etal. 49 th EASL, April 9-13, 2014.

13/14 SMV/SOF 82/87 SMV/SOF +/- RBV 12 weeks Overall Relapse Non VF SVR12 40

www.hcvguidelines.org

Released 1/29/14!

HIV/HCV Co-Infection, GT1

Preferred Alternative Treatment-naïve, prior PEG/RBV relapsers, IFN eligible:

SOF + PEG/RBV(WB) x 12 weeks

IFN ineligible:

SOF + RBV(WB) x 24 weeks SOF + SMV ± RBV(WB) x 12 weeks

Treatment experienced, prior PEG/RBV nonresponders, regardless of IFN eligibility:

SOF + SMV ± RBV(WB) x 12 weeks

Treatment-naïve, prior PEG/RBV relapsers, IFN eligible:

SMV x 12 weeks + PEG/RBV(WB) x 24 weeks

IFN ineligible:

None

Treatment experienced, prior PEG/RBV nonresponders

IFN eligible: SOF + PEG/RBV(WB) x 12 Weeks IFN ineligible: SOF + RBV(WB) x 24 Weeks

Not Recommended:

TVR + PEG/RBV x 24 or 48 weeks (RGT), BOC + PEG/RBV x 28 or 48 weeks (RGT) PEG/RBV x 48 weeks, SMV x 12 weeks + PEG/RBV x 48 wks www.hcvguidelines.org

HIV/HCV Co-Infection, GT2

Preferred All patients, regardless of treatment history:

SOF + RBV(WB) x 12 weeks

Alternative Treatment naive and prior PEG/RBV relapsers:

None

Treatment experienced, prior PEG/RBV Nonresponders:

IFN eligible: SOF + PEG/RBV(WB) X 12 Weeks IFN ineligible: None

Not Recommended:

PEG/RBV x 24-48 weeks, or any regimen with TVR, BOC, or SMV www.hcvguidelines.org

HIV/HCV Co-Infection, GT3

Preferred All patients, regardless of treatment history:

SOF + RBV(WB) x 24 weeks

Alternative Treatment naïve, PEG/RBV relapsers:

None

Treatment experienced, prior PEG/RBV Nonresponders:

IFN eligible: SOF + PEG/RBV(WB) X 12 weeks IFN ineligible: None

Not Recommended:

PEG/RBV x 24 - 48 weeks, Any regimen with TVR, BOC, or SMV www.hcvguidelines.org

HIV/HCV Coinfection, GT4

Preferred All patients, regardless of treatment history: Alternative

None IFN eligible: SOF + PEG/RBV(WB) x 12 weeks IFN ineligible: SOF + RBV(WB) x 24 weeks

Not Recommended:

PEG/RBV x 48 weeks, any regimen with TVR or BOC www.hcvguidelines.org

HIV/HCV Coinfection, GT 5,6

Preferred All patients, regardless of treatment history:

SOF + PEG/RBV(WB) x 12 weeks

Alternative

None

Not Recommended:

PEG/RBV x 48 weeks, any regimen with TVR, BOC, or SMV www.hcvguidelines.org

Standard Dosing

    Sofosbuvir – 400mg once daily Simeprevir – 150mg once daily Peg Interferon – 180mcg once weekly Ribavirin – weight based dosing  <75kg – 1000mg daily in divided doses  ≥75 kg – 1200mg daily in divided doses www.hcvguidelines.org

IFN Ineligible Definitions

       Intolerance to IFN Autoimmune hepatitis and other autoimmune disorders Hypersensitivity to PEG or any of its components Decompensated hepatic disease History of depression, or clinical features consistent with depression A baseline neutrophil count below 1500/ μL, a baseline platelet count below 90,000/ μL or baseline hemoglobin below 10 g/dL A history of preexisting cardiac disease www.hcvguidelines.org

Investigational HCV Medications

Select Investigational Medications

 All oral, interferon free likely in October 2014   Ledipasvir (FDC with sofosbuvir) ABT-450/ritonavir+ABT-267 (ombitasvir) (FDC) plus ABT-333 (dasabuvir) BID  Other meds moving forward (not all inclusive)     Daclatasvir + asunaprevir + BMS-791325 Faldaprevir MK-5172, MK-8742 GS-9669, GS-9451, GS-5816 50

HIV and HCV Update for the Pharmacist

Transcript HIV and HCV Update for the Pharmacist