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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.

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Presentation on theme: "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."— Presentation transcript:

1 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

2 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

3 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

4 Reyataz/Norvir/Truvada Prezista/Norvir/Truvada Atripla 3/day 1/day DHHS Guidelines Initial Recommended Regimens - 2014 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.

5 Isentress (BID)/Truvada 3/day Tivicay/Truvada OR Epzicom 2/day Stribild 1/day OR DHHS Guidelines Initial Recommended Regimens - 2014 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.

6 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 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

7 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 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

8 Preferred NRTI Backbones in Pregnancy – DHHS Perinatal Guidelines, March 2014 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 NRTI Backbones Abacavir/lamivudineAvailable as fixed dose combination, once daily dosing. Do NOT use in patients testing positive for HLAB*5701 Tenofovir/emtricitabine or lamivudineAvailable as fixed dose combination, once daily dosing. Tenofovir may cause renal impairment Zidovudine/lamivudineAvailable as fixed dose combination. Most experience in pregnancy to date, but twice daily adminstration, and potential for hematologic toxicity

9 Preferred PI, NNRTI Regimens in Pregnancy – DHHS Perinatal Guidelines, March 2014 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 Regimens Atazanavir/ritonavir + preferred dual NRTI backbone Once daily administration Lopinavir/ritonavir + preferred dual NRTI backbone 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.

10 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)

11 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

12 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

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

14 Concurrent MedicationBoceprevir allowedTelaprevir allowed Atazanavir/ritonavir (Reyataz®/Norvir®)NoYes Darunavir/ritonavir (Prezista®/Norvir®)No Fosamprenavir/ritonavir (Lexiva®/Norvir®) No, not studied to dateNo Lopinavir/ritonavir (Kaletra®)No Efavirenz (Sustiva®)No Yes, increase TLV dose to 1125mg Q8H Etravirine (Intelence®) Yes, reduced etravirine levels reported Yes Rilpivirine (Edurant®)Yes Tenofovir (Viread®)YesYes, monitor renal fx Raltegravir (Isentress®)Yes Elvitegravir (in Stribild®) ??Yes Dolutegravir (Tivicay®) Yes Maraviroc (Selzentry®)Yes, MRV 150mg BID

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

16 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.

17 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.

18 Simeprevir Key Points Duration of Treatment with Simeprevir, peg-interferon alfa, ribavirin Simeprevir, peg- interferon alfa + ribavirin Peg-interferon alfa + ribavirin Total treatment duration Naïve, prior relapser, including cirrhosis First 12 weeksAdditional 12 weeks 24 weeks Prior non-responders, including cirrhosis First 12 weeksAdditional 36 weeks 48 weeks 18 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 Stopping Rules Week 4, > 25IU/mLDiscontinue simeprevir, peg-interferon and ribavirin Week 12, > 25IU/mLDiscontinue peg-interferon alfa and ribavirin (simeprevir complete at week 12) Week 24, > 25IU/mLDiscontinue peg-interferon alfa and ribavirin

19 Simeprevir with PEG/RBV, GT 1 HIV/HCV CoInfection Design 19 Dieterich D et al. CROI 2014; Abst 24 Treatment naïve or Prior relapser Prior partial or Null responder SMV + PR Follow-upPR Follow-up PR 12 24 36 48 60 72 RGT Primary Analysis

20 Simeprevir + PEG/R,GT1 HIV/HCV CoInfection: SVR 12 Results, ITT 20 Dieterich D et al. CROI 2014; Abst 24 p<0.001

21 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

22 Medications to Avoid with Simeprevir Medication and or ClassRationale for Avoiding with Simeprevir Anticonvulsants - carbamazepine, oxcarbazepine, phenobarbital, phenytoin  Co-administration with these medications is likely to reduce concentrations of simeprevir and lead to reduced simeprevir efficacy. Co-administration not recommended. Antibiotics – clarithromycin, erythromycin, telithromycin  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. Antifungals – fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole  Co-administration with these medications is likely to increase concentrations of simeprevir due to CYP3A4 inhibition from the antifungals. Co-administration not recommended. Antimycobacterials – rifampin, rifabutin, rifapentine  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

23 Medications to Avoid with Simeprevir Medication and or ClassRationale for Avoiding with Simeprevir Corticosteroids – dexamethasone  Co-administration with dexamethasone is likely to decrease concentrations of simeprevir and lead to reduced simeprevir efficacy. Co-administration not recommended. Propulsive – cisapride  Co-administration with cisapride may result in increased concentrations of cisapride leading to potential cardiac arrhythmias. Herbal products – Milk Thistle, St. John’s Wort  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

24 Simeprevir and HIV Medications Concurrent MedicationRecommendation HIV Protease Inhibitors All HIV PIs  Significant increases or decreases in simeprevir levels expected when used with any HIV protease inhibitor, when used with or without ritonavir. Co-administration not recommended HIV Non Nucleoside Reverse Transcriptase Inhibitors Efavirenz (Sustiva®), Etravirine (Intelence®), Nevirapine (Viramune®)  Significant reductions in simeprevir levels and reduced simeprevir efficacy due to CYP3A4 induction. Co- administration not recommended. Rilpivirine (Edurant®)  Concurrent use at standard doses acceptable. www.nynjaetc.org

25 Simeprevir and HIV Medications Concurrent MedicationRecommendation HIV Integrase Strand Transfer Inhibitors Dolutegravir (Tivicay®)  Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of simeprevir. Elvitegravir (contained in Stribild®)  Significant increase in simeprevir levels expected when used with a cobicistat containing regimen. Co-administration not recommended. Raltegravir (Isentress®)  Concurrent use at standard doses acceptable. HIV Entry Inhibitors Maraviroc (Selzentry®)  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

26 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.

27 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 27 www.solvadi.com. Accessed June 4, 2014. HCV Mono-infected and HCV/HIV Co-infected TreatmentDuration Genotype 1 or 4Sofosbuvir + PEG-interferon + ribavirin 12 weeks Genotype 2Sofosbuvir + ribavirin12 weeks Genotype 3Sofosbuvir + ribavirin24 weeks

28 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.

29 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

30 PHOTON-1 Trial in HIV/HCV Co-infection 30 Open-label, phase 3 study of sofosbuvir plus weight- based ribavirin in coinfection, genotypes 1, 2 or 3. Naggie S et al. CROI 2014; Abst 26. GT1, Naive GT2/3, Naive SOF + RBV, n=114 SOF + RBV, n=68 SOF + RBV, n=41 GT2/3, Experienced SVR 12 SVR 24 Week 0 12 24 36 48

31 PHOTON-1: Results 31Naggie S et al. CROI 2014; Abst 26

32 PHOTON-1: Results  Allowable ARVs: NRTIs, atazanavir/r, darunavir/r, rilpivirine & raltegravir  Most virologic failures had relapse  No sofosbuvir resistance seen 32 Naggie S et al. CROI 2014; Abst 26

33 PHOTON-1 Adverse Events 33 Naggie S et al. CROI 2014; Abst 26 Patients, % AEs24 Weeks SOF+RBV(n=155)12 Weeks SOF+RBV(n=68) Fatigue3935 Insomnia1521 Headache1413 Nausea1518 Diarrhea119 Irritability10 URI12 Grade 3-4 AEs1210 Serious AEs67 Treatment DC due to AEs34 Death01

34 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

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

36 Sofosbuvir and HIV Medications Concurrent MedicationRecommendation 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

37 Sofosbuvir and HIV Medications Concurrent MedicationRecommendation HIV Integrase Strand Transfer Inhibitors Dolutegravir (Tivicay®)  Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of sofosbuvir. Elvitegravir (contained in Stribild®)  Concurrent use at standard doses acceptable. Interactions not expected based upon metabolism of sofosbuvir. Raltegravir (Isentress®)  Concurrent use at standard doses acceptable. HIV Entry Inhibitors 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

38 COSMOS Study Design 38 Lawitz, etal. 49 th EASL, April 9-13, 2014. 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 SMV+SOF+RBVPost-treatment follow-up SMV+SOF + RBV SMV+SOF Randomized 2:1:2:1 Arm1 Arm2 Arm 3 Arm 4 12 24 36 48

39 COSMOS, Baseline Characteristics 39 Lawitz, etal. 49 th EASL, April 9-13, 2014. CharacteristicSMV/SOF+ RBV 24 weeks n=30 SMV/SOF 24 weeks n=16 SMV/SOF + RBV 12 weeks n=27 SMV/SOF 12 weeks n=14 Total n=87 Male, %7044747167 White/African American97/381/1993/786/1491/9 Hispanic, Latino1031191417 Median Age58 5758 Median BMI2829273228 GT 1a7775827978 GT 1a, Q80K4842363040 Median HCV VL6.36.66.7 6.6 Null Responders5750565054 IL28B, non CC7388857179 Cirrhosis4363415047

40 COSMOS, SVR 12 (ITT) Results 40 Lawitz, etal. 49 th EASL, April 9-13, 2014. 24 weeks 12 weeks Overall 28/30 16/1625/27 13/14 82/87

41 www.hcvguidelines.org Released 1/29/14!

42 HIV/HCV Co-Infection, GT1 PreferredAlternative 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

43 HIV/HCV Co-Infection, GT2 PreferredAlternative All patients, regardless of treatment history: SOF + RBV(WB) x 12 weeks 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

44 HIV/HCV Co-Infection, GT3 PreferredAlternative All patients, regardless of treatment history: SOF + RBV(WB) x 24 weeks 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

45 HIV/HCV Coinfection, GT4 PreferredAlternative All patients, regardless of treatment history: IFN eligible: SOF + PEG/RBV(WB) x 12 weeks IFN ineligible: SOF + RBV(WB) x 24 weeks None Not Recommended: PEG/RBV x 48 weeks, any regimen with TVR or BOC www.hcvguidelines.org

46 HIV/HCV Coinfection, GT 5,6 PreferredAlternative All patients, regardless of treatment history: SOF + PEG/RBV(WB) x 12 weeks None Not Recommended: PEG/RBV x 48 weeks, any regimen with TVR, BOC, or SMV www.hcvguidelines.org

47 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

48 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

49 Investigational HCV Medications

50 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

51 Select HIV/HCV Resources

52 www.hcvguidelines.org Released 1/29/14!

53 www.nynjaetc.org

54 CLICK HERE

55 www.nynjaetc.org CLICK HERE

56 NY/NJ AETC – www.nynjaetc.org

57

58 www.hep-druginteractions.org

59 NY/NJ AETC – www.nynjaetc.org

60


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