The ART of Managing Drug-Drug Interactions in Patients with HIV
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1 The ART of Managing Drug-Drug Interactions in Patients with HIV Bradley L. Smith, Pharm.D. Pharmacy Grand Rounds December 19, MFMER slide-1
2 Presentation Objectives Describe the HIV life cycle and how antiretroviral medications work to suppress viral replication Identify drug-drug interactions with common antiretroviral medications Recognize appropriate management strategies for drug-drug interactions in HIV patients 2017 MFMER slide-2
3 Presentation Abbreviations ART Antiretroviral Therapy AUC Area under the curve CD4 Cluster of differentiation 4 CCR5 C-C chemokine receptor 5 CXCR4 C-X-C chemokine receptor 4 DHHS Department of Health and Human Services DVT Deep vein thrombosis H2RAs Histamine-2 Receptor Antagonist INSTIs Integrase Inhibitors mrna messenger RNA NNRTIs Non-Nucleoside Reverse Transcriptase Inhibitors NRTIs Nucleoside Reverse Transcriptase Inhibitors PIs Protease Inhibitors P-gp P-glycoprotein PPIs Proton Pump Inhibitors vdna viral DNA vrna viral RNA RT reverse transcriptase 2017 MFMER slide-3
4 HIV Life Cycle Fusion and Entry CD4 CCR5 or CXCR4 Viral Nucleocapsid Extracellular Intracellular 2017 MFMER slide-4
5 Current Antiretroviral Medications Fusion Inhibitor (1) Enfuvirtide (T-20) CCR-5 Inhibitors (1) Maraviroc (MVC) CD4 CCR5 or CXCR4 Extracellular Intracellular 2017 MFMER slide-5
6 HIV Life Cycle Transcription and Integration Nucleus HIV RT Host DNA vrna vdna Integrase 2017 MFMER slide-6
7 HIV Life Cycle Transcription and Integration HIV RT vrna vdna NRTIs (7) Abacavir (ABC) Didanosine (ddi) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4t) Tenofovir (TDF) Zidovudine (AZT, ZDV) NNRTIs (5) Efavirenz (EFV) Etravirine (ETV) Nevirapine (NVP) Rilpivirine (RPV) Delavirdine (DLV) 2017 MFMER slide-7
8 HIV Life Cycle Transcription and Integration INSTIs (3) Dolutegravir (DTG) Elvitegravir (EVG) Raltegravir (RAL) Host DNA Nucleus Integrase vdna 2017 MFMER slide-8
9 HIV Life Cycle Transcription and Integration Protease Transcription to viral mrna Host DNA Nucleus Protease Protease Polyprotein Protease Integrase Transcription to vrna Integrated HIV DNA 2017 MFMER slide-9
10 HIV Life Cycle Cell Exit 2017 MFMER slide-10
11 HIV Life Cycle Transcription and Integration Polyprotein Protease PIs (9) Atazanavir (ATV) Darunavir (DRV) Fosamprenavir (FPV) Lopinavir/r (LPV/r) Ritonavir (RTV) Tipranavir (TPV) Indinavir (IDV) Nelfinavir (NFV) Saquinavir (SQV) 2017 MFMER slide-11
12 Current Antiretroviral Medications Fusion Inhibitor (1) Enfuvirtide (T-20) NRTIs (7) Abacavir (ABC) Didanosine (ddi) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4t) Tenofovir (TDF) Zidovudine (AZT, ZDV) CCR-5 Inhibitors (1) Maraviroc (MVC) NNRTIs (5) Efavirenz (EFV) Etravirine (ETV) Nevirapine (NVP) Rilpivirine (RPV) Delavirdine (DLV) INSTIs (3) Dolutegravir (DTG) Elvitegravir (EVG) Raltegravir (RAL) PIs (9) Atazanavir (ATV) Darunavir (DRV) Fosamprenavir (FPV) Lopinavir/r (LPV/r) Ritonavir (RTV) Tipranavir (TPV) Indinavir (IDV) Nelfinavir (NFV) Saquinavir (SQV) 2017 MFMER slide-12
13 Common Antiretroviral Regimens NRTIs Abacavir (ABC) Emtricitabine (FTC) Lamivudine (3TC) Tenofovir (TDF) Zidovudine (AZT, ZDV) Backbone PIs Atazanavir (ATV) Darunavir (DRV) Ritonavir (RTV) Enhancers Cobicistat (COBI) One Additional Agent NNRTIs Efavirenz (EFV) Etravirine (ETV) Rilpivirine (RPV) INSTIs Dolutegravir (DTG) Elvitegravir (EVG) Raltegravir (RAL) 2017 MFMER slide-13
14 Pharmacokinetic Boosting Agents Cobicistat (COBI) Ritonavir (RTV) No activity against HIV Less drug interactions P-gp inhibitor 3A4 substrate 3A4, 2D6 inhibitor HIV activity (PI) More drug interactions P-gp substrate and inhibitor 3A4, 2D6 substrate 3A4, 2D6 inhibitor 1A2, 2C8, 2C9, 2C19, UGT 1a1 inducer 2017 MFMER slide-14
15 Single-Tablet Regimens Positively Aware 2017 HIV Drug Chart MFMER slide-15
16 How many medication targets are there in the HIV life cycle? A) Three B) Four C) Five D) Six 2017 MFMER slide-16
17 Assessment of ART-related Drug Interactions 2017 MFMER slide-17
18 Assessment of Drug Interactions Tertiary drug sources interaction checkers University of Liverpool site Only checks interactions with ART 2017 DHHS HIV Guidelines Table 17 - Mechanisms of Antiretroviral-Associated Drug Interactions Table 18 ART Drug Interactions by class 2017 MFMER slide-18
19 DHHS HIV Guidelines: Mechanisms of Antiretroviral-Associated Drug Interactions DTG Dolutegravir COBI Cobicistat EVG Elvitegravir RTV Ritonavir RAL Raltegravir ATV Atazanavir HIV/AIDS Treatment Guidelines MFMER slide-19
20 DHHS HIV Guidelines: ART Drug Interactions by Class TPV/r Tipranavir/ritonavir ATV/c Atazanavir/cobicistat DRV/c Darunavir/cobicistat RTV Ritonavir HIV/AIDS Treatment Guidelines MFMER slide-20
21 Management of ART-related drug interactions 2017 MFMER slide-21
22 Patient Case #1 56 year old female Admitted for community acquired pneumonia Past Medical History: HIV Osteopenia Current medications include: Complera (RPV/TDF/FTC) once daily at bedtime Calcium 600mg/Vitamin D3 800IU two tablets daily Medicine Service orders: Continue home medications Pantoprazole 40mg once daily Levofloxacin 500mg once daily RPV Rilpivirine TDF Tenofovir FTC Emtricitiabine 2017 MFMER slide-22
23 Stomach Acid and Antiretrovirals Boosted- Atazanavir (ATV/c or ATV/r) Antacids: ATV 2 hours before or 1 to 2 hours after H2RAs: ATV at least 10 hours after Famotidine < 20mg BID PPIs: PPI at least 12 hours before Omeprazole 20mg Rilpivirine (RPV) Antacids: Give 2 hours before or 4 hours after RPV H2RAs: Give 12 hours before or 4 hours after RPV PPIs: Contraindicated 2017 MFMER slide-23
24 Polyvalent Cations and Antiretrovirals Dolutegravir (DTV) Elvitegravir (EVG) Raltegravir (RAL) Calcium Aluminum Magnesium Iron Zinc Chelation 2017 MFMER slide-24
25 Antiretrovirals Requiring Food Darunavir (DRV) Etravirine (ETR) Atazanavir (ATV) DAR 2 E 2 you to eat that Elvitegravir (EVG) Rilpirivine (RPV) Ritonavir (RTV) tablet 2017 MFMER slide-25
26 Antiretrovirals Requiring Food Antiretroviral Rilpivirine (RPV) Atazanavir (ATV) Darunavir (DRV) Elvitegravir/cobicistat (EVG/c) Patient Friendly Answer 400 calories 10 grams fat Food Requirement 400k kcal 13 g fat kcal g fat kcal g fat kcal 20-50% fat Rilpivirine [package insert]. Gilead Sciences, Inc. March 2, 2016 Atazanavir [package insert]. E.R. Squibb & Sons, L.L.C. September 24, 2015 Darunavir [package insert]. Janssen Products LP. June 8, 2015 Stribild [package insert]. Gilead Sciences, Inc. February 29, MFMER slide-26
27 Patient Case #1 56 year old female Admitted for community acquired pneumonia Past Medical History: HIV Osteopenia Current medications include: Complera (RPV/TDF/FTC) once daily at bedtime Calcium 600mg/Vitamin D3 800IU two tablets daily Medicine Service orders: Continue home medications Pantoprazole 40mg once daily Levofloxacin 500mg once daily RPV Rilpivirine TDF Tenofovir FTC Emtricitiabine 2017 MFMER slide-27
28 Which is an appropriate recommendation for the management of this patient? A) Complera (RPV/TDF/FTC) may be given at bedtime during hospital admission B) Pantoprazole may be used for stress ulcer prophylaxis C) Ensure spacing of antiretroviral by at least 4 hours before calcium or 2 hours after D) A and C E) All of the above RPV Rilpivirine TDF Tenofovir FTC Emtricitiabine 2017 MFMER slide-28
29 Patient Case #2 61 year old male patient Admitted due to right lower extremity DVT Patient on therapeutic enoxaparin Orders for transition to oral anticoagulation Social history: Smokes 1 pack per day Current medication list includes Lisinopril 10mg once daily Tivicay (DTG) 50mg once daily Prezcobix (DRV/r) 800mg/150mg once daily Truvada (TDF/FTC) 300mg/200mg once daily DTG = Dolutegravir DRV/r = Darunavir/ritonavir TDF = Tenofovir FTC = Emtricitabine 2017 MFMER slide-29
30 Anticoagulation and Antiretrovirals ART Apixaban Dabigatran Rivaroxaban Warfarin PIs (Boosted) Not recommended Not recommended Not recommended PI/r: warfarin possible apixaban 50% Consider alternative Consider alternative Monitor INR closely COBI Not recommended No recommended Not recommended or warfarin possible apixaban 50% Monitor INR closely NNRTIs EFV, ETR, NVP: Consider alternative EFV, NVP, RPV: No adjustment ETR: Consider alternative EFV, ETR, NVP: Consider alternative RPV: Good or warfarin possible Monitor INR closely EFV = Efavirenz ETR = Etravirine NVP = Nevirapine RPV = Rilpivirine 2017 MFMER slide-30
31 ART Smoking Cessation and Antiretrovirals PIs (Boosted) Nicotine Replacement Varenicline Bupropion Recommended Recommended Bupropion dose COBI Recommended Recommended or bupropion possible NNRTIs Recommended Recommended Bupropion dose 2017 MFMER slide-31
32 Patient Case #2 61 year old male patient Admitted due to right lower extremity DVT Patient on therapeutic enoxaparin Orders for transition to oral anticoagulation Social history: Smokes 1 pack per day Current medication list includes Lisinopril 10mg once daily Tivicay (DTG) 50mg once daily Prezcobix (DRV/r) 800mg/150mg once daily Truvada (TDF/FTC) 300mg/200mg once daily DTG = Dolutegravir DRV/r = Darunavir/ritonavir TDF = Tenofovir FTC = Emtricitabine 2017 MFMER slide-32
33 What is your recommendation for an oral anticoagulant? A) Apixaban 10 mg twice daily for 7 days then 5 mg twice daily B) Dabigatran 150 mg twice daily C) Rivaroxaban 15 mg twice daily for 21 days then 20 mg once daily D) Warfarin 5 mg once daily adjusted per INR results E) Warfarin 3 mg once daily adjusted per INR results 2017 MFMER slide-33
34 Patient Case #3 23 yo male patient newly diagnosed with HIV Patient is ready to begin antiretroviral therapy Past medical history: Asthma Seizures Social History Denies smoking, alcohol or illicit drug use Current medication list includes Fluticasone 110mcg 2 puffs twice daily Phenobarbital 100mg twice daily 2017 MFMER slide-34
35 Corticosteroids and Antiretrovirals Glucocorticoid metabolism via CYP3A4 Glucocorticoid accumulation RTV, COBI, PIs inhibit CYP3A4 RTV Ritonavir COBI Cobicistat 2017 MFMER slide-35
36 Corticosteroids and Antiretrovirals Case Age/Sex Antiretrovirals Corticosteroid 1 39/male TDF FTC DRV/r 2 12/female 3TC AZT LPV/r 3 15/male 3TC AZT DRV/r 4 48/female TDF FTC ATV/r Inhaled salmeterol/fluticasone Intranasal fluticasone Inhaled salmeterol/fluticasone Ophthalmic dexamethasone Injected triamcinolone epidural 3TC = Lamivudine DRV/r = Darunavir/ritonavir ATV/r = Atazanavir/ritonavir TDF = Tenofovir LPV/r = Lopinavir/ritonavir FTC = Emtricitabine AZT = Zidovudine Sadarangani S, et al. Interdiscip Perspect Infect Dis. 2014;2014: Azevedo L, et al. BMJ Case Rep 2015 Johnson SR et al. J Pediatr 2006;148: Rainsbury PG et al. Pediatr Infect Dis J 2017;36: MFMER slide-36
37 Corticosteroids and Antiretrovirals Alternative corticosteroid options Beclomethasone Flunisolide Alternative ART options NNRTIs INSTIs (RAL or DTG) If benefits outweigh risks, consider dose adjustment and monitor closely RAL = Raltegravir DTG = Dolutegravir 2017 MFMER slide-37
38 Anticonvulsants and Antiretrovirals Anticonvulsant Antiretroviral Action Carbamazepine PIs, RPV, EVG/c Contraindicated Phenytoin, Phenobarbital Lamotrigine, Valproic Acid ETR, RAL DTG PIs, RPV, EVG/c ETR, RAL, DTG PIs NNRTIs Avoid Increase DTG to 50mg twice daily Contraindicated Avoid Caution Okay Levetirectam safe to use with all antiretrovirals DTG = Dolutegravir RPV = Rilpivirine EVG/c = Elvitegravir/cobicistat ETR = Etravirine RAL = Raltegravir 2017 MFMER slide-38
39 Patient Case #3 23 yo male patient newly diagnosed with HIV Patient is ready to begin antiretroviral therapy Past medical history: Asthma Seizures Social History Denies smoking, alcohol or illicit drug use Current medication list includes Fluticasone 110mcg 2 puffs twice daily Phenobarbital 100mg twice daily 2017 MFMER slide-39
40 What would be an appropriate recommendation for therapy? A) Genvoya (EVG/COBI/FTC/TDF) once daily B) Atripla (EFV/FTC/TDF) once daily C) Prezcobix (DRV/r) once daily plus Descovy (TAF/FTC) once daily D) Triumeq (DTG/ABC/3TC) once daily plus Tivicay (DTG) 50mg once daily 2017 MFMER slide-40
41 Antiretroviral Drug Interactions Summary Resources for interactions DHHS Table 18 Cobicistat and Ritonavir Acid Suppression Atazanavir; Rilpivirine Food requirement DAR 2 E 2 you to eat that Warfarin safest anticoagulant Corticosteroids Use beclomethasone Levetiracetam no drug interactions 2017 MFMER slide-41
42 Questions & Discussion 2017 MFMER slide-42
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