Disclosures. Goals. US DHHS Guidelines: 1 st Line Therapy. Antiretroviral Therapy Initiation:

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1 Disclosures Antiretroviral Therapy Initiation: From Guidelines to Practice: ART 101 Medical Management of AIDS & Hepatitis December 8, 2017 Research grant support from Gilead Sciences for ongoing work in East Africa related to antiretroviral delivery Research grant support from NIH, CDC, PEPFAR Vivek Jain, M.D., M.A.S. Associate Professor of Medicine Division of HIV, Infectious Diseases & Global Medicine San Francisco General Hospital University of California, San Francisco Goals US DHHS Guidelines: 1 st Line Therapy Working proficiency in selecting initial ART regimens Review DHHS first line & alternate regimens Pros and cons, considerations/choices Many updates from last year Will not focus on: In-depth ART pharmacology HIV drug resistance 2-drug or Nucleoside-sparing regimens ART for pediatric or pregnant patients Drugs in development but not yet FDA approved 45 minutes lots to cover! Recommended regimens are those with demonstrated durable virologic efficacy, favorable tolerability and toxicity profiles, and ease of use. Adapted Footnotes: a 3TC may be substituted for FTC, or vice versa b and TDF are two forms of tenofovir approved by the FDA. has fewer bone and kidney toxicities than TDF, while TDF is associated with lower lipid levels. Safety, cost, and access are among the factors to consider when choosing between these drugs. c RAL can be given as 400 mg BID or 1200 mg (two 600-mg tablets) once daily. d Several other NRTI-limiting treatment strategies are under investigation. e LPV/r plus 3TC: only PI/3TC regimen with 48-week RCT data in ART-naïve patients Yellow = October 2017 updates These regimens are effective and tolerable, but have some disadvantages when compared with the regimens listed above, or have less supporting data from randomized clinical trials. However, in certain clinical situations, one of these regimens may be preferred. US DHHS ART Guidelines October 17, 2017 Update 1

2 U.S. DHHS Guideline Update: October, 2017 FDA-Approved ARVs, 2017 Initial Regimens for Most People DTG/ABC/3TC Only if HLB57-01 negative DTG + (TDF/FTC or /FTC) EVG/cobi + (TDF/FTC or /FTC) RAL + (TDF/FTC or /FTC) Two organizational comments: DRV moved out of first line list in 2017 Guidelines don t emphasize vs. TDF Initial Regimens in Certain Clinical Situations (DRV/RTV or DRV/cobi) + (TDF/FTC or /FTC) (DRV/cobi or DRV/RTV) + ABC/3TC Only if HLB57-01 negative (ATV/cobi or ATV/RTV) + (TDF/FTC or /FTC) (ATV/cobi or ATVRTV) + ABC/3TC Only if HLAB57 negative and VL<100,000 EFV + (TDF/FTC or /FTC) RPV + (TDF/FTC or /FTC) Only if VL<100,000 & CD4+ >200 RAL/ABC/3TC Only if HLAB57 negative and VL<100,000 Adapted from: US DHHS ART Guidelines October 17, 2017 Update NRTI (nucleoside analogs) Tenofovir alafenamide Tenofovir TDF Abacavir ABC Emtricitabine FTC Lamivudine 3TC Stavudine D4T Didanosine DDI Zalcitabine DDC Zidovudine ZDV (non-nucleosides) RPV Etravirine ETR EFV Nevirapine NVP Delavirdine DLV Integrase Inhibitors Dolutegravir DTG Elvitegravir EVG Raltegravir RAL Inhibitors Darunavir DRV Atazanavir ATV Ritonavir RTV Cobicistat Cobi Lopinavir LPV Fosamprenavir FPV Amprenavir APV Tipranavir TPV Nelfinavir NFV Saquinavir SQV Indinavir IDV CCR5 Inhibitors Maraviroc MVC Fusion Inhibitors Enfuvirtide T-20 ARVs in Common Use, 2017 Basic Initial Regimen Composition NRTI (nucleoside analogs) Tenofovir alafenamide Tenofovir TDF Abacavir ABC Emtricitabine FTC Lamivudine 3TC (non-nucleosides) RPV Etravirine ETR EFV Integrase Inhibitors Dolutegravir DTG Elvitegravir EVG Raltegravir RAL Inhibitors Darunavir DRV Atazanavir ATV Ritonavir RTV Cobicistat Cobi Previously: 2x NRTI TDF/FTC or ABC/3TC + EFV RPV or PI r/atv r/drv or RAL EVG DTG Currently: 2x NRTI /FTC or TDF/FTC or ABC/3TC + DTG RAL (EVG) or PI r/drv 2

3 NRTI s: Tenofovir-based Meds TDF/FTC (Truvada) /FTC (Descovy) Renal Concerns Bone Concerns Renal Profile NRTI s Decrease in egfr over time? Decrease in bone density? better? Bone Profile Risk of tubular toxicity/ Fanconi s syndrome? Concomitant increase risk of fracture? better? Lipid Profile worse? NRTI s: TDF/FTC (Truvada) TDF/FTC (Truvada): evidence supporting renal concerns? NRTI s: TDF/FTC (Truvada) TDF/FTC (Truvada): evidence for bone concerns? Slow, small magnitude decrement in egfr over time? Small risk of proximal tubular toxicity/ Fanconi s syndrome? TDF Other Generalized decrease in renal function TDF > Other agents; difference small Modest loss in Y1, less after that -10 egfr after 6Y TDF vs -9 Initial case reports Laprise CID 2013 A known low-level risk; forms the basis of monitoring Japanese cohort with larger decline in egfr with TDF vs. ABC Nishijima AIDS 2014 Large metaanalysis including RCTs: small difference, perhaps 3-4 ml/min egfr Cooper CID 2010 Issues: controversial topic observational study vs. RCT baseline egfr low body weight other renal risks use of r/pi other nephrotoxic meds Decrement in bone density after ART initiation Then stabilization Hip BMD Clinical significance of a 2-4% loss of BMD unclear No apparent evidence this translates to higher risk of fracture Spine BMD McComsey, JID,

4 NRTI s: /FTC (Descovy) NRTI s: /FTC (Descovy) (tenofovir alafenamide) Oral prodrug hydrolyzed to tenofovir in plasma Virologic noninferiority to TDF/FTC (data through 144 weeks) Plasma concentrations are 90% lower than TDF Intracellular concentrations much higher converted to tenofovirdiphosphate inside cells Evidence for improved renal profile? (Data through 144 weeks) Smaller changes in proteinuria by 4 measurements: egfr, urine prot./creat., RBP/creat., b2m/creat. Less decline in egfr: median drop in CrCl: -2.0 ml/min [ECF-] -7.5 ml/min [ECF-TDF] (p<0.001) Genvoya noninferior to Stribild: at Week 48: 92% VS [] vs. 90% [TDF] at Week 96: 87% VS [] vs. 85% [TDF] at Week 144, 84.2% [] vs. 80.0% [TDF] Fewer discontinuations due to renal dysfunction: 0 discontinuations [] vs.12 discontinuations [TDF] Similar AE profile, lipid effects Arribas J et al., JAIDS, 2017 Week 48 data: Sax PE et al., Study 104/111: Lancet, 2015 Week 96 data: Wohl D et al., Study 104/111: JAIDS, 2016 Week 144 data: Arribas J et al., Study 104/111: JAIDS, 2017 Also note: Can use for patients with egfr 30 whereas TDF for patients with egfr 60 Sax PE et al., Lancet, 2015, Wohl D et al., JAIDS, 2016, Arribas J et al., JAIDS, 2017 NRTI s: /FTC (Descovy) NRTI s: /FTC (Descovy) Lipid profile Evidence for improved bone profile? à (Data through 144 weeks) Drug interactions Lipid change from baseline to 144 weeks is worse in vs. TDF: Rifamycins Induce CYP3A4, P-gp, and BRCP Less drop in BMD Less drop in BMD Arribas J et al., JAIDS, 2017 Smaller pill size TDF Inhibit OATP1B1, OATP1B3 Total chol. é31 é13 Net effect of this unknown Smaller rise in PTH /FTC Stribild Do not co-administer rifamycins with HDL é6 é2 LDL é19 é6 with cobicistat TG é20 é12 a substrate of CYP3A4, P-gp, OATP1B1, and OATP1B3 Arribas J et al., JAIDS, 2017 Cobi inhibits these à boosts levels Compelling for some patients; less important to other patients TDF/FTC Genvoya Note: TDF associated with favorable lipid profile; is a move away from this favorable profile Thus, dose with cobi is 10mg not 25mg 4

5 and TDF Summary NRTI s: ABC/3TC (Epzicom) TDF/FTC (Truvada) /FTC (Descovy) ABC/3TC (Epzicom): Renal Concerns Bone Concerns Renal Profile ABC Hypersensitivity Cardiovascular Concerns Decrease in egfr over time? Decrease in bone density? better? Bone Profile Basic biology Polymorphism of HLAB57-01 allele 4-8% of overall population positive; 2-4% among African Americans ABC binds to HLA molecule, triggering HS reaction Theoretical basis for concern Enhanced platelet reactivity? Platelet aggregation? Promotes ischemic CV disease? Controversial Risk of tubular toxicity/ Fanconi s syndrome? Concomitant increase risk of fracture? better? Lipid Profile worse? Consider egfr, proteinuria, osteoporosis, and need for rifamycins in this decision HLA- B57-01 Testing Fully discriminative If positiveàabc contraindicated If negativeàabc safe Database studies are equivocal Do not clearly demonstrate MI risk Issues: controversial topic observational studies vs. RCTs other CV risks: accounted for? risks from other ARVs? duration of follow-up? what outcomes assessed? NRTIs for Patients with HBV For Hepatitis B positive patients: TDF/FTC: 2 active agents: good choice /FTC: 2 active agents also FDA approved for HBV+ patients; good choice Integrase Inhibitors ABC/3TC: only the 3TC is active if using ABC, typically combine with entecavir 5

6 Integrase Inhibitor Overview Dolutegravir (DTG) Most potent, highly efficacious Higher genetic barrier to resistance 50mg QD dosing, no booster Need BID if using with EFV, rifampin Tivicay (DTG 50mg) Caution: DTG AUC decreased if egfr<30 When use as ABC/3TC/DTG, only for egfr>50 Increased AUC with low, moderate, high fat meal Decreased absorption when polyvalent cations given (Ca+2, Mg+2, Fe+3, e.g.) à space DTG 2h before or 6h after these Caution: boosts metformin levels Inhibits OCT2 à inhibits tubular creatinine secretion, écr Side effects à discontinuation initially thought to be <2-3% in first year Curtis et al., HIV Clin Trials Headache, insomnia increasingly recognized 15% (85/556) Amsterdam patients stopped DTG: 6% (sleep), 4% (GI), 4% (malaise), 3% (psychological) 2% joint/tendon/muscle, 2% neurologic de Boer et al. AIDS Hypersensitivity/skin reactions uncommon (<1%) Integrase Inhibitors (cont d) Elvitegravir (EVG) Well-tolerated, strong efficacy 150 mg QD dosing Requires cobicistat (150mg QD) Lower genetic barrier to resistance Stribild (TDF 300/FTC 200/cobi 150/EVG 150) Genvoya ( 10/FTC 200/cobi 150/EVG 150) Raltegravir (RAL) Isentress (RAL 400 BID) Very well-tolerated, good potency/efficacy 400mg BID dosing Can dose at 1200mg QD (noninferior to 400mg BID) No boosting required Lower genetic barrier to resistance Hypersensitivity rare 1/866 patients had rash in EVG studies Isentress HD (RAL 600 x 2 QD) Hypersensitivity reaction (rare, mild) Even rarer: DRESS syndrome Ripamonti et al. AIDS Inhibitor Overview Inhibitors Darunavir (DRV/r) Highest potency; fewer side effects than other PIs; well tolerated Norvir: RTV 100 Prezista: DRV mg QD dosing (if no DRV mutations) concomitantly administer either RTV 100mg QD or cobicistat 150mg QD 600mg BID dosing (when DRV mutations present) concomitantly administer RTV 100mg BID (don t use cobicistat for boosting) Prezista: DRV 600 Side effects: overall low As with most PI s: GI side effects, skin rash (sulfa moiety) usually self limited, dyslipidemia, rare hepatotoxicity Advise take with food RTV 100 Unlike ATV: no hyperbilirubinemia; no spacing apart from H2-blockers; PPI s are ok Was in first line recommendations until latest update few weeks ago 6

7 Inhibitor Overview RTV 100 ATV 300 Atazanavir (ATV/r) Good potency, generally well-tolerated, 300mg QD (+ RTV 100mg QD) Least effect on lipids of PI s bilirubin: sometimes cosmetic, sometimes beyond GERD: in ART-naïve patients: H2 blockers: give ATV 400QD 2h before or 10h after H2; give ATV300/RTV100 anytime PPI: use omeprazole 20 or equivalent (maximum) 12h before ATV Recommend take with food Recommend against combining ATV with PPI Not in first line recommended list s Overview (EFV) Sustiva: EFV 600 (RPV) Edurant: RPV 25 Etravirine (ETV) Intelence: ETR 200 x2 Potency well established QD Potency similar to EFV Lacks CNS side effects Less lipid effects Potency similar to EFV Less lipid effects Caution with depression Rare suicidality CNS side effects: insomnia, dreams Lipid effects Not in first line recommended list Lower efficacy when VL>100K or CD4<200 Requires 400 cal. meal H2 blocker: give 12h before or 4h after RPV PPI: avoid Not in first line recommended list BID drug (200mg BID) (data support 400mg QD) Not in first line recommended list Single Tablet Regimens 7

8 Single Tablet Co-Formulations Single Tablet Regimens NRTI Tenofovir Ritonavir NRTI Tenofovir Ritonavir Emtricitabine Descovy April, 2016 Atazanavir Emtricitabine Atazanavir Abacavir Lamivudine Epzicom 2004 Truvada 2004 Evotaz January, 2015 Prezcobix January, 2015 Darunavir Cobicistat Raltegravir Abacavir Lamivudine Atripla 2006 Darunavir Cobicistat Raltegravir Elvitegravir Elvitegravir Dolutegravir Dolutegravir Single Tablet Regimens Single Tablet Regimens NRTI Tenofovir Ritonavir NRTI Tenofovir Ritonavir Emtricitabine Atazanavir Emtricitabine Atazanavir Abacavir Darunavir Abacavir Darunavir Lamivudine Complera August, 2011 Cobicistat Raltegravir Lamivudine Odefsey March, 2016 Cobicistat Raltegravir Elvitegravir Elvitegravir Dolutegravir Dolutegravir 8

9 Single Tablet Regimens Single Tablet Regimens NRTI Tenofovir Ritonavir NRTI Tenofovir Ritonavir Emtricitabine Atazanavir Emtricitabine Atazanavir Abacavir Lamivudine Stribild August, 2012 Darunavir Cobicistat Raltegravir Abacavir Lamivudine Genvoya November, 2015 Darunavir Cobicistat Raltegravir Elvitegravir Elvitegravir Dolutegravir Dolutegravir Single Tablet Regimens U.S. DHHS Guideline Update: October, 2017 NRTI Emtricitabine Tenofovir Ritonavir Atazanavir Initial Regimens for Most People DTG/ABC/3TC Only if HLB57-01 negative Initial Regimens in Certain Clinical Situations (DRV/RTV or DRV/cobi) + (TDF/FTC or /FTC) Abacavir Darunavir DTG + (TDF/FTC or /FTC) (DRV/cobi or DRV/RTV) + ABC/3TC Only if HLB57-01 negative Lamivudine Triumeq August, 2014 Cobicistat Raltegravir Elvitegravir Dolutegravir EVG/cobi + (TDF/FTC or /FTC) RAL + (TDF/FTC or /FTC) Two organizational comments: DRV moved out of first line list in 2017 Guidelines don t emphasize vs. TDF (ATV/cobi or ATV/RTV) + (TDF/FTC or /FTC) (ATV/cobi or ATVRTV) + ABC/3TC Only if HLAB57 negative and VL<100,000 EFV + (TDF/FTC or /FTC) RPV + (TDF/FTC or /FTC) Only if VL<100,000 & CD4+ >200 RAL/ABC/3TC Only if HLAB57 negative and VL<100,000 Adapted from: US DHHS ART Guidelines October 17, 2017 Update 9

10 Case 1 Case 1 51 year old man registering for care. VL = 41,000, CD4+ count = 682. Creatinine = 1.4, and egfr = 55 ml/min. LDL = 68. HLAB57-01 is negative. No other medical problems. Which regimen(s) would you offer? A) TDF/FTC (Truvada) + DTG B) /FTC (Descovy) + DTG C) ABC/3TC/DTG (Triumeq) D) TDF/FTC + RTV/DRV E) EVG/cobi//FTC (Genvoya) F) RAL + /FTC 51 year old man registering for care. VL = 41,000, CD4+ count = 682. Creatinine = 1.4, and egfr = 55 ml/min. LDL = 68. HLAB57-01 is negative. No other medical problems. Which regimen(s) would you offer? A) TDF/FTC (Truvada) + DTG à egfr is <70: avoid TDF B) /FTC (Descovy) + DTG à Fine choice C) ABC/3TC/DTG (Triumeq) à Fine choice B57 negative: eligible, and no major CV concerns. Triumeq for egfr>50. D) TDF/FTC + RTV/DRV à egfr is <70: would avoid RTV/PI + TDF combo E) EVG/cobi//FTC (Genvoya) à egfr is <70: favor unboosted F) RAL + /FTC à Fine choice but prefer potency/genetic barrier of DTG Case 2 Case 2 Same patient as Case 1, but lower egfr: 51 year old man registering for care. VL = 41,000, CD4+ count = 682. Creatinine = 1.6, and egfr = 31 ml/min. LDL = 68. HLAB57-01 is negative. No other medical problems. Which regimen would you offer? A) TDF/FTC (Truvada) + DTG B) /FTC (Descovy) + DTG C) ABC/3TC/DTG (Triumeq) D) TDF/FTC + RTV/DRV E) EVG/cobi//FTC (Genvoya) F) RAL + /FTC 51 year old man registering for care. VL = 41,000, CD4+ count = 682. Creatinine = 1.6, and egfr = 31 ml/min. LDL = 68. HLAB57-01 is negative. No other medical problems. Which regimen would you offer? A) TDF/FTC (Truvada) + DTG à egfr is <70: avoid TDF B) /FTC (Descovy) + DTG à egfr is >30: fine choice C) ABC/3TC/DTG (Triumeq) B57 negative: eligible. Some CV concerns with renal disease. Triumeq is for egfr>50. D) TDF/FTC + RTV/DRV à egfr is <70: avoid RTV/PI + TDF combo E) EVG/cobi//FTC (Genvoya) à With egfr<70, favor unboosted F) RAL + /FTC à Fine choice but prefer potency/genetic barrier of DTG 10

11 Case 3 48 y.o. man, newly diagnosed last month, VL 105,000, CD4+ count = 487. Has history of hyperlipidemia (LDL = 140, Total cholesterol = 221), smokes 10 cigarettes/day, and has HBA1c = 7.1%. BUN/creatinine 14/1.2, egfr=73 ml/min, UA: 1+ protein. Which ART is optimal? A) TDF/FTC (Truvada) + DTG B) /FTC (Descovy) + DTG C) ABC/3TC/DTG (Triumeq) D) /FTC + RTV/DRV Case 3 48 y.o. man, newly diagnosed, VL 105,000, CD4+ = 487. Has hyperlipidemia (LDL = 140, Total cholesterol = 221), smokes 10 cigarettes/day, HBA1c = 7.1%, BUN/creatinine 14/1.2, egfr=73 ml/min, UA: 1+ protein. Which ART is optimal? A) TDF/FTC (Truvada) + DTG egfr>70 is ok, but with 1+ proteinuria, would favor over TDF B) /FTC (Descovy) + DTG OK choice, egfr>30, but already has proteinuria C) ABC/3TC/DTG (Triumeq) OK choice, egfr>50; but with CV risk factors (lipids/smoking/dm), balance CV risk with ABC vs. using in patient with proteinuria D) /FTC + RTV/DRV With cardiac and renal risk factors, avoid PI if possible Case 4 Case 4 34 y.o. woman, VL 23,000, CD Has chronic HBV: HBsAg+ HBsAb+ HBcAb+ HBV DNA = 6M IU/mL. HLAB57-01 negative. egfr=90.which regimen(s) would you offer? A) TDF/FTC (Truvada) + DTG B) /FTC (Descovy) + DTG C) ABC/3TC/DTG (Triumeq) D) TDF/FTC (Truvada) + RTV/DRV E) ABC/3TC (Epzicom) + RTV/DRV 34 y.o. woman, VL 23,000, CD Has chronic HBV: HBsAg+ HBsAb+ HBcAb+ HBV DNA+. HLAB57-01 negative. egfr=90.which regimen(s) would you offer? A) TDF/FTC (Truvada) + DTG B) /FTC (Descovy) + DTG à fine choice à fine choice C) ABC/3TC/DTG (Triumeq) à 3TC alone: would add entecavir D) TDF/FTC (Truvada) + RTV/DRV à OK, but prefer integrase > PI E) ABC/3TC (Epzicom) + RTV/DRV à Need entecavir with 3TC, and also would prefer integrase > PI 11

12 Case 5 Case 5 57 y.o. woman, VL=14K, CD4=390. DM2: A1c=8.0%, takes metformin at maximum 875mg TID dose + glipizide 5mg BID, egfr=90, UA with no protein. HLAB57 negative. Which ART regimen do you favor? A) TDF/FTC (Truvada) + DTG B) /FTC (Descovy) + DTG C) ABC/3TC/DTG (Triumeq) D) TDF/FTC/cobi/EVG (Stribild) E) /FTC + RAL F) ABC/3TC + RAL 57 y.o. woman, VL=14K, CD4=390. DM2: A1c=8.0%, takes metformin at maximum 850mg TID dose + glipizide 5mg BID, egfr=90, UA with no protein. HLAB57 negative. Which ART regimen do you favor? A) TDF/FTC (Truvada) + DTG B) /FTC (Descovy) + DTG Same as choice A C) ABC/3TC/DTG (Triumeq) Same as choice A D) TDF/FTC/cobi/EVG (Stribild) E) /FTC + RAL F) ABC/3TC + RAL Potentially ok; potentially not DTG boosts metformin à would need close monitoring as already on max dose (but might be ok) If need to reduce metformin, might have to add 2 nd med, or DM2 control may get worse egfr>70, no DDI*à fine choice, but prefer to avoid cobicistat if RAL possible egfr>30, no DDI*à fine choice Balance your view of RAL vs. DTG against DM control B57-negative, no DDI*, but this is listed as an other regimen: try to use something first line DDI = drugdrug interaction* Coming Soon & Relevant for ART Initiation Coming Soon & Relevant for ART Initiation Bictegravir//FTC (50/25/200) 1490 Study: B/F/ (n=327) vs. DTG + /FTC (n=330) Phase 3, double blind, PBO-matched study in ART naïve adults; non-inferiority design (with -12% margin) W48: VS 89% (B/F/) vs. 93% (DTG + /FTC), difference - 3.5% (95% CI -7.9% to +1.0%, p=0.12) 1489 Study: B/F/ (n=316) vs. DTG/ABC/3TC (n=315) Phase 3, double blind study in ART naïve adults; non-inferiority design (with -12% margin) W48: VS92.4% (B/F/) vs. 93% (Triumeq), difference -0.6% (95% CI -4.8% to +3.6%, p=0.78) FDA announcement expected Feb Sax PE et al., Lancet, 2017 Gallant, J et al., Lancet, 2017 Darunavir/cobi//FTC (800/150/10/200) AMBER Study (ART-naïve adults, randomized to D/C/F/ (n=362) vs. DRV/cobi + FTC/TDF (n=363) to W48 (double blind phase III non-inferiority trial, -10% margin) D/C/F/: 91.4% VS at Week 48 vs. DRV/cobi + TDF/FTC: 88.4% VS (+2.7%, 95% CI -1.6% to +7.1%; met noninferiority margin) EMERALD Ph. 3 switch study (in virally suppressed adults) also showed non-inferior maintenance of VS with D/C/F/ vs. control NDA application to FDA made; action date uncertain AMBER: Gallant, J et al., Abstract PS8/2, EACS 2017 Conference, October 2017 EMERALD: Orkin, C et al., Lancet HIV,

13 Coming Soon & Relevant for ART Initiation Dolutegravir + rilpivirine (Juluca) FDA approved 11/21/17 (two weeks ago) for maintenance for HIV therapy SWORD-1 & SWORD-2 Phase III switch studies: DTG/RPV 95% W48 vs. Control: 95% VS, difference -0.2% ( %) Data on ART-naïve patients not yet available Dolutegravir + 3TC GEMINI-1 & GEMINI-2: ongoing Phase III studies in ART-naïve individuals Summary / Principles Choosing the NRTI backbone: Consider TDF vs. Assess egfr, proteinuria, osteoporosis, importance of pill size Consider ABC vs. TDF/ Need HLAB57-01 test. Assess question/opinion of cardiac risk issues Goal is to use in most patients unless other issues prevail Consider prior history, drug intolerance, side effect, desire for singletablet regimen, drug interactions Assess PI and possibilities if needed: Consider dosing (QD vs. BID), desire for single tablet regimen, psychiatric history, lipid profile, GI issues, renal status, likelihood of strong adherence/genetic barrier Assess baseline VL and CD4 count Focus on DHHS recommended regimens References References (2) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services. Version: October 17, Available at: Accessed 11/1/17. Laprise C et al. Association between tenofovir exposure and reduced kidney function in a cohort of HIV-positive patients: results from 10 years of follow-up Clin Infect Dis. Feb;56(4): doi: /cid/cis937. PMID: Nishijima T et al. Long-term exposure to tenofovir continuously decrease renal function in HIV-1-infected patients with low body weight: results from 10 years of follow-up. AIDS Aug 24;28(13): doi: /QAD PMID: Cooper RD et al. Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients. Clin Infect Dis Sep 1;51(5): doi: / PMID: McComsey GA et al. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis Jun 15;203(12): doi: /infdis/jir188. PMID: Sax PE et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet Jun 27;385(9987): doi: /S (15)60616-X. PMID: Wohl D et al. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. JAIDS May 1;72(1): doi: /QAI PMID: Arribas JR et al. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide () vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. JAIDS Jun 1;75(2): doi: /QAI PMID: Curtis L et al. Dolutegravir: clinical and laboratory safety in integrase inhibitor-naive patients. HIV Clin Trials Sep-Oct;15(5): doi: /hct PMID: de Boer MG, et al. Intolerance of dolutegravir-containing combination antiretroviral therapy regimens in real-life clinical practice. AIDS Nov 28;30(18): PMID: Ripamonti D et al. Drug reaction with eosinophilia and systemic symptoms associated with raltegravir use: case report and review of the literature. AIDS Apr 24;28(7): doi: /QAD PMID: Sax PE et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US ): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet Nov 4;390(10107): doi: /S (17) PMID: Gallant J et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US ): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet Nov 4;390(10107): doi: /S (17) PMID: Gallant, J et al., Abstract PS8/2, EACS 2017 Conference, October 2017 Orkin C et al. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV Oct 5. pii: S (17) doi: /S (17) PMID: Lilbre JM et al. SWORD 1 & 2: Switch to DTG + RPV maintains virologic suppression through 48 weeks; a phase III study. Conference on Retroviruses and Opportunistic Infections,

14 Thank You! Happy to take any questions For questions after the conference: please me anytime 14

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