Drug Interactions in HIV/HCV coinfection

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1 HIV/HCV Drug Interactions Case Based Discussion John J. Faragon, PharmD, BCPS, AAHIVP Regional Pharmacy Director, NY/NJ AETC HIV Pharmacist, Albany Medical Center 1

2 Drug Interactions in HIV/HCV coinfection 125 HIV/HCV-coinfected people taking antiretrovirals, academic center, Denver, CO ARV interactions assessed with four possible DAA combinations: SIM/SOF, SOF/LDV, SOF/DAC, 3D Interactions rated as severe (unsafe and contraindicated), moderate (requiring additional monitoring and/or dose adjustments), and no significant interactions (safe with no dose adjustments required) 70% could have moderate or severe interactions with one of four common direct-acting antiviral (DAA) regimens for HCV 20% of patients who needed to switch antiretrovirals because of certain DAA interactions could not switch because of antiretroviral resistance Langness J, et al. 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. May 26-28, Washington, DC. Abstract 18 Results ARV Regimens 101 (81%) were taking tenofovir 50 (40%) a protease inhibitor 44 (35%) raltegravir 20 (16%) efavirenz Prescribed ARV regimens proved most likely to pose a risk of severe interactions if prescribed with: SIM/SOF (64%), followed by 3D (40.8%), and SOF/LDV (9.6%) No severe interactions were anticipated with SOF/DCV. Prescribed ARV regimens leading to a moderate or severe interaction if prescribed with: SIM/SOF 70%, 3D 64%, SOF/LDV 61%, SOF/DCV 47% Langness J, et al. 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. May 26-28, Washington, DC. Abstract 18 2

3 Results/Conclusions 35 patients prescribed SOF/LDV 2 subjects were taking ARVS contraindicated with SOF/LDV 17 subjects had moderate interactions between ARVs and SOF/LDV 16 subjects had no interactions with SOF/LDV. Of 17 people with potential moderate interactions, 10 switched ARVs 7 continued original ARVS upon SOF/LDV initiation ARV salvage regimen (2 people) Adherence problems and low viremia (3 people) Preferred to stay on their antiretroviral regimen (2 people) HIV resistance via genotype, phenotype, and/or Phenosense in all 35 people prescribed SOF/LDV 7 of 35 could not change their antiretrovirals because of resistance 5/7 did not have significant interactions between their antiretrovirals and SOF/LDV, while 2 had moderate interactions. The researchers concluded that potential moderate or severe interactions between DAAs and antiretrovirals are common in HIV/HCV-coinfected people and noted that "without a choice in DAA selection, many patients will require a change of antiretroviral therapy or increased monitoring. Langness J, et al. 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy. May 26-28, Washington, DC. Abstract 18 Case 3

4 HIV/HCV Co-infected Case 45 year old male, African American patient PMH HIV infection, Hypertension, Hyperlipidemia, COPD, GERD HCV Genotype 1b, never treated Pertinent Labs HCV Fibrosure A2F2, VL 9.6 million HIV <40 copies/ml, CD4 416 cells/mm 3 AST 62, ALT 54, Albumin 4.2, Platelets , Tbili 2.0 CrCL >60 ml/min HIV/HCV Co-infected Case Medications Atazanavir/ritonavir + tenofovir/emtricitabine Metoprolol 25mg twice daily Rosuvastatin 10mg daily at bedtime Omeprazole 40mg daily Tiotropium one puff daily Ferrous Sulfate 325mg daily Albuterol 2 puffs every 6 hours as needed Hydrocodone/APAP 7.5/325 2 every 6 hours as needed 4

5 What regimen(s) would be an option for our case? A. Sofosbuvir + Riba for 12 weeks B. Ledipasvir/Sofosbuvir for 8 weeks C. 3D, without ribavirin for 12 weeks D. All of the above Sofosbuvir + Riba for 12 weeks 24% Ledipasvir/Sofosbuvir for % 3D, without ribavirin for % 29% All of the above HIV/HCV Co-Infection, GT1b Recommended Daily fixed-dose ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for treatment-naive patients, IA rating Daily fixed-dose paritaprevir (150 mg)/ritonavir (100 mg)/ ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks (no cirrhosis) OR 24 weeks (cirrhosis) is recommended for treatment-naive patients, IA rating Daily sofosbuvir (400 mg) plus simeprevir (150 mg) with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 12 weeks (no cirrhosis) OR 24 weeks (cirrhosis) is recommended for treatment-naive patients, IIa, B rating 5

6 Provider selects 3D Regimen. What HIV meds regimen can be used with 3D? A. Darunavir/ritonavir + tenofovir/emtricitabine B. Elvitegravir/cobicistat/ tenofovir/emtricitabine C. Rilpivirine/tenofovir/ emtricitabine D. None of the above Darunavir/ritonavir + tenofo... 25% Elvitegravir/cobicistat/ teno... 20% Rilpivirine/tenofovir/ emtric... 33% 22% None of the above HCV Classes and Medications NS3/4a Protease Inhibitor Paretaprevir with ritonavir NS5A Inhibitor ombitasvir NS5B Polymerase Inhibitor dasabuvir 6

7 3DAA Regimen FDA Approved Population Treatment Duration Genotype 1a, non cirrhotic Genotype 1a, cirrhotic Genotype 1b, non cirrhotic Genotype 1b, cirrhotic Ombitasvir/paretaprevir/ritonavir + dasabuvir + RBV Ombitasvir/paretaprevir/ritonavir + dasabuvir + RBV Ombitasvir/paretaprevir/ritonavir + dasabuvir Ombitasvir/paretaprevir/ritonavir + dasabuvir + RBV Avoid in hepatic decompensation Take with food without regard to fat or content No dose change in renal impairment, no data in dialysis Fatigue, nausea, pruritis, rash, insomnia, asthenia Product Information, Viekera Pak. AbbVie December weeks 24 weeks 12 weeks 12 weeks 3D Metabolism Medication HCV Mechanism of Action Route of Metabolism and Drug Interaction Potential Ombitasvir NS5a inhibitor Metabolized via amide hydrolysis, and then oxidative metabolism Paritaprevir NS3/4a protease inhibitor Metabolized via CYP3A4, and to a lesser extent CYP3A5 Ritonavir Dasabuvir Not active against HCV, ritonavir acts as a pharmacokinetic booster for paritaprevir Non-nucleoside NS5b polymerase inhibitor Metabolized via CYP3A4, and to a lesser extent CYP2D6 Metabolized via CYP2C8, and to a lesser extent CYP3A4 Product Information, Viekera Pak. AbbVie December

8 3D Acceptable HIV Medications Concurrent Medication Recommendation and Clinical Comment Atazanavir/ritonavir (Reyataz /Norvir ) When using atazanavir with ombitasvir/paritaprevir/ritonavir and dasabuvir, give atazanavir without supplemental ritonavir in the morning. Take atazanavir at the same time as ombitasvir/paritaprevir/ritonavir to allow for appropriate PK boosting of atazanavir. Raltegravir (Isentress ) Concurrent use at standard doses appropriate. Dolutegravir (Tivicay ) Concurrent use at standard doses appropriate. Abacavir (Ziagen ) Emtricitabine (Emtriva ) Lamivudine (Epivir ) Tenofovir (Viread ) Stavudine (Zerit ) Concurrent use at standard doses acceptable. While only tenofovir/emtricitabine was allowed in co-infection studies of ombitasvir/paritaprevir/ritonavir with dasabuvir, these other medications are unlikely to interact. Product Information, Viekera Pak. AbbVie December 2014, Menon R et al. Reported by Jules Levin 16 th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy Washington D.C., May 26-28, D and Dolutegravir Menon R et al. Reported by Jules Levin 16 th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy Washington D.C., May 26-28,

9 3D and HIV Medications Raltegravir YES Dolutegravir YES Atazanavir YES, stop extra ritonavir Tenofovir/emtricitabine YES Abacavir/lamivudine - YES Efavirenz NO, poor tolerability, LFTs Darunavir NO, lower troughs Lopinavir/ritonavir NO, lower paritaprevir Either an interaction likely or no data with other meds Product Information, Viekera Pak. AbbVie December 2014, HIV/HCV Co-infected Case Medications Atazanavir/ritonavir + tenofovir/emtricitabine Metoprolol 25mg twice daily Rosuvastatin 10mg daily at bedtime Omeprazole 40mg daily Tiotropium one puff daily Ferrous Sulfate 325mg daily Albuterol 2 puffs every 6 hours as needed Hydrocodone/APAP 7.5/325 2 every 6 hours as needed 9

10 What medications should be avoided with 3D regimen? A. Inhaled fluticasone 42% B. Ethinyl estradiol C. All statins 29% D. Omeprazole E. A and B only 9% 17% 3% Inhaled fluticasone Ethinyl estradiol All statins Omeprazole A and B only Viekera Pak Contraindicated Meds Medication and or Class Alpha 1-antagonist (alfluzosin) Anticonvulsants (carbamazepine, phenytoin, phenobarbital) Antifungal (voriconazole) Antihyperlipidemic (gemfibrozil) Antimycobacterial (rifampin) Beta adrenoceptor agonist (long acting salmeterol) Corticosteroids (inhaled or nasal fluticasone) Ergot derivatives (ergotamine, dihydroergotamine, ergonovine, methylergonovine) Ethinyl estradiol containing products (Oral contraceptives) Herbal therapy (St. Johns Wort) HMG-CoA reductase inhibitors (lovastatin, simvastatin) Neuroleptic (pimozide) Phosphodiesterase-5 inhibitor (sildenafil in Pulmonary Arterial Hypertension Sedative/hypnotics (oral midazolam, triazolam) Product Information, Viekera Pak. AbbVie December 2014, 10

11 3D Meds Requiring Adjustment Medication and or Class Recommendation and Clinical Comment Antiarrythmics (amiodarone, bepredil, disopyramide, flecainide, lidocaine, mexilitine, Caution with concurrent use. Therapeutic concentration monitoring recommended if available when used with ombitasvir/paritaprevir/ritonavir and dasabuvir. propafenone, quinidine Antifungal (ketoconazole) When using ketoconazole with ombitasvir/paritaprevir/ritonavir and dasabuvir, the dose of ketoconazole should not exceed 200mg daily. Calcium channel blocker (amlodipine) Consider dosage reduction for amlodipine; monitor closely for hypotension. Diuretic (furosemide) Possible increase in furosemide levels; monitor closely based upon response. HMG-CoA reductase inhibitors (atorvastatin, pravastatin and rosuvastatin) Increase in atorvastatin, pravastatin and rosuvastatin likely requiring dosage limitations. Do not exceed atorvastatin 20mg, pravastatin 40mg, or rosuvastatin 10mg with concurrent use of ombitasvir/paritaprevir/ritonavir and dasabuvir. Immunosuppressants (cyclosporine, tacrolimus) See Label Product Information, Viekera Pak. AbbVie December 2014, 3D Medications Requiring Adjustments Medication and or Class Narcotic analgesics (buprenorphine/naloxone, metahdone) Hydrocodone Phosphodiesterase-5 inhibitor (when used for erectile dysfunction) Proton pump inhibitor (omeprazole) Recommendation and Clinical Comment No dosage adjustment is required, however monitoring for sedation is appropriate. Hydrocodone levels nearly double, consider dosage reduction If patients receiving sildenafil for erectile dysfunction, recommended dose is 25mg maxiumum in a 48 hour period. In patients receiving tadalafil for erectile dysfunction, recommended dose is 10mg maximum in a 72 hour period. In patients receiving vardenafil for erectile dysfunction, recommended dose is 2.5mg Monitor for decreased efficacy of omeprazole. Consider increasing omeprazole dose in patients not well controlled. Do not exceed omeprazole 40mg daily. Sedative/hypnotic (alprazolam) Monitor for excess sedation. Decrease in alprazolam dose can be considered based upon response. Product Information, Viekera Pak. AbbVie December 2014, 11

12 HIV/HCV Co-infected Case Medications Atazanavir/ritonavir + tenofovir/emtricitabine Metoprolol 25mg twice daily Rosuvastatin 10mg daily at bedtime Omeprazole 40mg daily Tiotropium one puff daily Ferrous Sulfate 325mg daily Albuterol 2 puffs every 6 hours as needed Hydrocodone/APAP 7.5/325 2 every 6 hours as needed Case 12

13 HIV/HCV Co-infected Case 56 year old male, African American patient PMH HIV infection, Hypertension, GERD, mild asthma, prior GI bleed HCV Genotype 1a, never treated Pertinent Labs HCV F2 by biopsy, 1997, VL 3.8 million HIV <40 copies/ml, CD4 416 cells/mm 3 AST 30, ALT 26, Albumin 3.2, Platelets , Tbili 0.5 CrCL >60 ml/min HIV/HCV Co-infected Case Medications Daruanvir/ritonavir 800/100 once daily Raltegravir 400mg BID Tenofovir/emtricitabine once daily Omeprazole 40mg daily Losartan 100mg daily Albuterol MDI prn Oxycodone 10mg prn Provider wants to initiate ledipasvir/sofosbuvir 13

14 HIV/HCV Co-Infection, GT1a Recommended Daily fixed-dose ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is recommended for treatment-naive patients, IA rating Daily fixed-dose paritaprevir (150 mg)/ritonavir (100 mg)/ ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) and weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 12 weeks (no cirrhosis) OR 24 weeks (cirrhosis) is recommended for treatment-naive patients, IA rating Daily sofosbuvir (400 mg) plus simeprevir (150 mg) with or without weight-based RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) for 12 weeks (no cirrhosis) OR 24 weeks (cirrhosis) is recommended for treatment-naive patients, IIa, B rating HCV Classes and Medications NS5A Inhibitor Ledipasvir NS5B Polymerase Inhibitor Sofosbuvir 14

15 Ledipasvir/Sofosbuvir FDA Approved, October 2014 FDC, 90mg/400mg - One tablet daily for HCV GT1, no food requirement NOT FDA approved for HIV/HCV coinfection No dosing in CrCl<30ml/min Patient Population Treatment naïve, with or without cirrhosis Treatment experienced without cirrhosis Treatment experienced with cirrhosis Treatment naïve, without cirrhosis, baseline viral load less than 6 million IU/ml Recommended Treatment Duration 12 weeks 12 weeks 24 weeks Consider 8 weeks Harvoni PI, Weeks of Sofosbuvir/ledipasvir can be used in co-infection, if patient has a HCV viral load <6 million IU/ml. A. True B. False 51% 49% True False 15

16 Relapse Rates Overall and by Baseline Viral Load, ION3 Patients, n (%) LDV/SOF 8 weeks N=215 8 Weeks 12 Weeks LDV/SOF+RBV 8 weeks N=216 LDV/SOF 12 weeks N=216 Overall SVR12 94% (202/215) 93% (201/216) 96% (208/216) Overall Relapse Rate 5% (11/215) 4% (9/216) 1% (3/216) SVR by baseline VL HCV RNA < 6M IU/mL 97% (119/123) 96% (133/138) 96% (126/131) HCV RNA 6M IU/mL 90% (83/92) 87% (68/78) 96% (82/85) Relapse Rates by baseline VL HCV RNA < 6M IU/mL 2% (2/123) 2% (3/137) 2% (2/131) HCV RNA 6M IU/mL 10% (9/92) 8% (6/77) 1% (1/85) SVR by baseline VL HCV RNA < 10M IU/mL 96% (156/163) 94% (160/171) 96% (160/166) HCV RNA 10M IU/mL 88% (9/92) 91% (41/45) 96% (48/50) Relapse Rates by baseline VL HCV RNA < 10M IU/mL 3% (5/163) 4% (7/169) 1% (2/166) HCV RNA 10M IU/mL 12% (6/52) 4% (2/45) 2% (1/50) HARVONI [PI]. Gilead Sciences, Inc. Foster City, CA October 2014Kowdley K, EASL, 2014, O56, Kowdley K, et al. N Engl J Med 2014;370: , Data on File, Gilead Sciences The use of darunavir/ritonavir was allowed in the ION4 study. A. True B. False 62% 38% True False 16

17 ION4 HIV/HCV Coinfection HIV Medications allowed included efavirenz, rilpivirine, raltegravir, all in combination with tenofovir/emtricitabine 48% on efavirenz 44% on raltegravir 9% on rilpivirine 12 weeks of ledipasvir/sofosbuvir used, small percentage of patients had documented cirrhosis. Naggie B, et al Conference on Retroviruses and Opportunistic Infections. Seattle, February 23-24, Abstract 152LB ION4 Results Overall SVR12 rate 96% Treatment naive and treatment-experienced patients (95% and 97%), and for people with and without cirrhosis (94% and 96%) responded the same 0% of patients who were found to have NS5A resistance-associated variants at baseline had a 94% cure rate (no NS5B resistant variants were detected). 10 people relapsed after the end of treatment 2 experienced treatment failure due to poor adherence 1 was lost to follow-up 1 died of an unrelated cause. Naggie B, et al Conference on Retroviruses and Opportunistic Infections. Seattle, February 23-24, Abstract 152LB 17

18 Results: SVR12 in Subgroups HIV-HCV (ION-4) Overall Male Sex Female Black Race Non-Black 1a HCV Genotype 1b 4 <800,000 Baseline HCV RNA (IU/mL) 800,000 Baseline BMI (kg/m 2) <30 30 CC IL28B CT TT No Cirrhosis Yes No Prior HCV Treatment Yes EFV + FTC + TDF ARV Regimen RAL + FTC + TDF RPV + FTC + TDF <350 Baseline CD4 (cells/μl) 350 LDV/SOF 12 Weeks, N= SVR12, % (95% CI) Statistically significant in multivariate analysis 38 HIV Meds/Regimens with LDV/SOF No Significant Interaction NRTIs Abacavir/lamivudine Tenofovir/emtricitabine NNRTIs Rilpivirine (if NOT on a proton pump inhibitor) INSTI Based Raltegravir Dolutegravir Product Information, Harvoni, 2014, DHHS Guidelines April 2015, Intl Workshop on Clin Pharm. Washington D.C., May 26-28,

19 Use of sofosbuvir/ledipasvir with RTV boosted PIs AND tenofovir will cause 62% A. An increase in PI levels B. An increase in sofosbvir levels C. An increase in tenofovir levels D. None of the above An increase in PI levels 7% An increase in sofosbvir levels 9% An increase in tenofovir levels 22% None of the above HIV Meds/Regimens with LDV/SOF Interaction Requiring Monitoring HIV Antiretrovirals HIV protease inhibitor with ritonavir and tenofovir Atazanavir/ritonavir Darunavir/ritonavir Lopinavir/ritonavir TDF levels increased with concurrent ledipasvir/sofosbuvir, and TDF levels increased with HIV protease inhibitors combined with ritonavir Consider alternative HCV or antiretroviral therapy IE abacavir/lamivudine in place of tenofovir/emtricitabine If co-administration required, monitor for tenofovirassociated renal adverse events. Efavirenz, emtricitabine, tenofovir Increase in tenofovir levels expected when used with ledipasvir and efavirenz. Ledipasvir levels reduced by 34% when ledipasvir/sofosbvir was combined with Atripla Monitor for tenofovir-associated renal adverse events in patients receiving ledipasvir/sofosbuvir concomitantly with efavirenz and tenofovir containing regimens Product Information, Harvoni, , DHHS Guidelines April 2015, 19

20 HIV Meds/Regimens with LDV/SOF No Data but Interaction Unlikely HIV Antiretrovirals Maraviroc Etravirine Nevirapine Not studied. Interaction NOT expected Not studied. Interaction NOT expected Not studied. Interaction NOT expected Product Information, Harvoni, 2014, DHHS Guidelines April 2015, HIV Meds/Regimens to be AVOIDED LED/SOF CAN NOT OR WOULD NOT USE the following Tipranavir/ritonavir Elvitegravir/cobicistat/tenofovir/emtricitabine Product Information, Harvoni, 2014, DHHS Guidelines April 2015, 20

21 Ledipasvir/Sofosbuvir Medications to Avoid Antiarrythmics, Anticonvulsants/Antimycobacterials Amiodarone, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifampin, rifabutin HCV Products Simeprevir Coadministration not recommended. Coadministration not recommended. Herbal Supplements: St. John s wort (Hypericum perforatum) HMG-CoA Reductase Inhibitors: Rosuvastatin Coadministration not recommended. Coadministration not recommended. Harvoni PI, 2014, Ledipasvir/Sofosbuvir Medications with Dose Changes/Monitoring Acid Reducing Agents Antacids (Magnesium Separate antacids and sofosbuvir/ledipasvir and aluminum) administration by 4 hours. H2-receptor antagonists Administer simultaneously with or 12 hours apart from sofosbuvir/ledipasvir. Do not exceed doses comparable to famotidine 40 mg twice daily. Proton-pump inhibitors Doses comparable to omeprazole 20 mg or lower can be administered simultaneously with sofosbuvir/ledipasvir under fasted conditions. Antiarrhythmics Digoxin Coadministration of sofosbuvir/ledipasvir with digoxin may increase the concentration of digoxin. Monitor digoxin levels. Harvoni PI, 2014, 21

22 HIV/HCV Co-infected Case Medications Daruanvir/ritonavir 800/100 once daily Raltegravir 400mg BID Tenofovir/emtricitabine once daily Omeprazole 40mg daily Losartan 100mg daily Albuterol MDI prn Oxycodone 10mg prn DHHS Guidelines Update 2015: Recommended Regimens in ARV Naives PI Based Regimens: SIM/SOF SOF/LDV 3D Prezista/Norvir Truvada INSTI Based Regimens: SIM/SOF SOF/LDV 3D Triumeq Tivicay Truvada Stribild Isentress Truvada = Single Tablet Regimen 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 Accessed 4/27/15 22

23 DHHS Guidelines Update 2015: Alternative Regimens in ARV Naives PI Based Regimens: SIM/SOF SOF/LDV 3D Evotaz Truvada Reyataz Norvir Truvada Prezcobix Truvada or Epzicom Prezista Norvir Epzicom NNRTI SIM/SOF SOF/LDV 3D Atripla Complera = Single Tablet Regimen 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 Accessed 4/27/15 Pitfalls, HIV/HCV Co-infection Switches Tenofovir discontinuation If changing regimen, verify HBV infection is NOT present prior HBV flares can occur HIV resistance testing Need to review old genotype/phenotype to be sure new regimen is active Careful of prior NNRTI failures, ie K103N, M184V on a boosted PI, 2 NRTI and switching 3 drugs may not be enough 23

24 Resources for You Databases Issues Some over call interactions Entire class versus individual medications Some miss case reports, incomplete Always do a medline search ie: warfarin and lactulose on lexicomp Stick to reputable HIV driven references for first step to screen for interactions Variations in recommendations common 24

25 DHHS Guidelines, April 2015 DHHS Guidelines November

26 Updated April 2015! 26

27 3 Guides Posted on AETC Website Simeprevir/Sofosbuvir Ledipasvir/sofosbuvir Ombitasvir/paretaprevir/ritonavir + dasabuvir Available for printing NY/NJ AETC 27

28 NY/NJ AETC

29 NY/NJ AETC JUST UPDATED JUST UPDATED 29

30 30

31 70 31

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