HIV Treatment: What to Start
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1 HIV Treatment: What to Start Joel Gallant, MD, MPH Johns Hopkins University School of Medicine ACTHIV 2011: A State-of-the-Science Conference for Frontline Health Professionals
2 Learning Objectives Upon completion of this presentation, learners should be better able to: Assess current guidelines for selection of initial antiretroviral regimens, including the advantages and disadvantages of each Appraise the drugs and regimens currently being investigated in phase III clinical trials and their potential role in practice
3 Off-Label Disclosure The following off-label/investigational uses will be discussed in this presentation: Investigational agents: elvitegravir, cobicistat, rilpivirine, S/GSK Investigational coformulations using investigational and approved agents
4 Case A 30 year old accountant is referred to you by his dentist, who found oral thrush on exam. He is found to be HIV+ with a CD4 count of 83 and a viral load of 192,000 Genotype shows pan-susceptible virus He does not have chronic hepatitis B or C. Renal function, liver enzymes, and fasting lipid profile are normal He does not use illicit drugs. He has no chronic medical conditions except HTN, well controlled on an ARB He says he is ready to start ART. He has no preferences about regimen
5 Case What would you do now? 1. Defer ART until he has seen an adherence counselor and has kept several follow-up appointments 2. Start 2 NRTIs plus EFV 3. Start 2 NRTIs plus a boosted PI 4. Start 2 NRTIs plus RAL 5. Start an NRTI-sparing regimen
6 DHHS (2009) & IAS-USA Guidelines (2010): Preferred Initial Regimens Preferred Agents for First-Line Therapy (AI recommendations) NRTIs TDF/FTC Plus a third agent NNRTI EFV Boosted PI ATV/r DRV/r INSTI RAL Thompson MA, et al. JAMA. 2010;304;
7 Other regimens categories (DHHS) Alternative (BI) Acceptable (CI) Acceptable but more definitive data are needed (CIII) May be acceptable but should be used with caution (CI-III) Not recommended
8 Choosing the Initial Regimen: The 4 Questions EFV, a boosted PI, or RAL? If a boosted PI, which one? Which NRTI backbone? Something else?
9 Question 1: EFV vs. PI/r vs. RAL? EFV PROS Gold standard for virologic efficacy Easiest regimens (1-2 pills/d) Minimal long-term toxicity PK forgiving of missed doses CONS CNS side effects Teratogenicity Genetic barrier: resistance with interruption Poorer CD4 response than with other classes
10 Question 1: EFV vs. PI/r vs. RAL? EFV PI/r PROS Gold standard for virologic efficacy Easiest regimens (1-2 pills/d) Minimal long-term toxicity PK forgiving of missed doses As effective as EFV (ATV/r in ACTG 5202) Less resistance with failure Preferred in pregnancy CONS CNS side effects Teratogenicity Genetic barrier: resistance with interruption Poorer CD4 response than with other classes Greater pill burden GI side effects
11 Question 1: EFV vs. PI/r vs. RAL? EFV PI/r RAL PROS Gold standard for virologic efficacy Easiest regimens (1-2 pills/d) Minimal long-term toxicity PK forgiving of missed doses As effective as EFV (ATV/r in ACTG 5202) Less resistance with failure Preferred in pregnancy As effective as EFV with better tolerability (STARTMRK) Lipid neutral (vs. EFV, PI/r) CONS CNS side effects Teratogenicity Genetic barrier: resistance with interruption Poorer CD4 response than with other classes Greater pill burden GI side effects No long-term data Twice-daily dosing Resistance risk similar to EFV Expensive
12 Case The patient wants a once-daily regimen and says he can t afford the time to adjust to EFV side effects. What do you choose? 1. 2 NRTIs + LPV/r 2. 2 NRTIs + DRV/r 3. 2 NRTIs + ATV/r 4. Convince him to take EFV 5. 2 NRTIs plus once-daily RAL
13 Question 2: Which Boosted PI? PI/r PROS CONS ATV/r Superior to LPV/r at 96 wks (CASTLE) Lowest pill burden (2/d) Gastric acid requirement Food requirement Jaundice & scleral icterus
14 Question 2: Which Boosted PI? PI/r PROS CONS ATV/r Superior to LPV/r at 96 wks (CASTLE) Lowest pill burden (2/d) Gastric acid requirement Food requirement Jaundice & scleral icterus DRV/r Superior to LPV/r (VL>100K, ARTEMIS) Better tolerability and less hyperlipidemia (vs. LPV/r) No gastric acid issues (vs. ATV/r) Food requirement Rash
15 Question 2: Which Boosted PI? PI/r PROS CONS ATV/r Superior to LPV/r at 96 wks (CASTLE) Lowest pill burden (2/d) Gastric acid requirement Food requirement Jaundice & scleral icterus DRV/r Superior to LPV/r (VL>100K, ARTEMIS) Better tolerability and less hyperlipidemia (vs. LPV/r) No gastric acid issues (vs. ATV/r) LPV/r Coformulated No food restrictions Preferred for pregnancy Food requirement Rash Requires 200 mg/d of RTV Metabolic toxicity GI side effects Risk of MI in D:A:D
16 Question 2: Which Boosted PI? PI/r PROS CONS ATV/r DRV/r LPV/r Superior to LPV/r at 96 wks (CASTLE) Lowest pill burden (2/d) Superior to LPV/r (VL>100K, ARTEMIS) Better tolerability and less hyperlipidemia (vs. LPV/r) No gastric acid issues (vs. ATV/r) Coformulated No food restrictions Preferred for pregnancy Least expensive Gastric acid requirement Food requirement Jaundice & scleral icterus Food requirement Rash Requires 200 mg/d of RTV Metabolic toxicity GI side effects Risk of MI in D:A:D FPV/r No food restrictions 700/100 mg BID dose: no advantage over LPV/r 1400/100 mg QD dose: not as well studied as other PI/r options
17 Case Which NRTI backbone do you choose? 1. TDF/FTC 2. ABC/3TC (after HLA B*5701 testing) 3. AZT/3TC 4. I would us an NRTI-sparing regimen
18 Question 3: Which NRTI Backbone? NRTIs PROS CONS TDF/FTC Best backbone with EFV Only studied backbone with RAL Preferred for HBV coinfection Renal toxicity Possible increased risk with PIs Bone density?
19 Question 3: Which NRTI Backbone? NRTIs PROS CONS TDF/FTC Best backbone with EFV Only studied backbone with RAL Preferred for HBV coinfection Renal toxicity Possible increased risk with PIs Bone density? ABC/3TC Lack of renal toxicity Need for HLA B*5701 screening to avoid ABC HSR Inferior to TDF/FTC with VL >100,000 Increased risk of MI? ACTG 5202 safety/tolerability data
20 Abacavir and Cardiovascular Risk Conflicting data from multiple cohort studies and clinical trials If there is an increased risk: it is greatest in patients with multiple cardiovascular risk factors pathogenesis unknown, but not due to metabolic factors Inflammation, endothelial function, platelet reactivity/function? Cardiovascular risk of untreated HIV probably greater than risk of any specific drug Daar E, et al. CROI Abstract 59LB.
21 Tenofovir and Renal Risk TDF can cause two types of nephrotoxicity: Glomerular: decreased kidney function Tubular: Fanconi s syndrome, phosphate wasting Low risk, especially with initial therapy or when combined with EFV Boosted PIs increase tenofovir levels and may increase nephrotoxicity, though incidence has been low in trials of 1 st line therapy Tubular toxicity not detected by creatinine alone. Look for glycosuria, proteinuria, phosphate wasting
22 Which NRTI Backbone? TDF/FTC Kidney disease HLA B*5701 negative, VL <100,000, low CV risk ABC/3TC
23 Which NRTI Backbone? HLA B*5701 positive, high CV risk, (VL>100,000?) TDF/FTC Kidney disease NRTI-sparing regimen? ABC/3TC
24 ACTG 5202: ABC/3TC vs. TDF/FTC Primary Virologic Endpoint (High VL Stratum at DSMB Action) N=797; median (25 th, 75th) follow-up = 60 weeks (28, 84) Time to Virologic Failure Time to Safety Endpoint TDF/FTC (26 events) ABC/3TC (57 events) Log rank test p-value= HR (95% CI) 2.33 (1.46,3.72) Sax PE, et al. NEJM 2009; 361:
25 Patients (%) PROGRESS: LPV/r + RAL vs LPV/r + NRTIs in ART-Naive Patients Randomized, open-label, multicenter phase III trial in ART-naive pts with VL> * LPV/r+ RAL * VL < 40 (ITT-TLOVR) 84.8% 83.2% LPV/r 400/100 mg BID + RAL 400 mg BID (n = 101) vs 60 * Difference: -1.6% (95% CI: -12.0% to 8.8%) LPV/r 400/100 mg BID + TDF/FTC (n = 105) Relatively low mean baseline VL: 4.25 log * *Statistically significant difference between arms: Wks 2, 4, 8 P <.002 Wk 16 P = Wks Similar CD4 gain at Wk 48 LPV/r + RAL: 215 Reynes J, et al. AIDS Abstract MOAB0101. Graphic used with permission. LPV/r + NRTIs: 245
26 Potential New First-Line Options CCR5 inhibitor-containing regimens Quad : elvitegravir/cobicistat/tdf/ftc Cobicistat as PI booster, including possible coformulations Dolutegravir (including coformulation with ABC/3TC) Rilpivirine, including coformulation with TDF/FTC
27 What about maraviroc? MVC PROS R5 virus more likely with early/initial therapy Very well tolerated Greater CD4 count than with EFV High barrier to resistance CONS No long-term data Twice-daily dosing Studied only with ZDV/3TC Requires baseline tropism testing Complex dosing
28 HIV-1 RNA < 50 copies/ml at Wee k 48 (%) MERIT: Reanalysis With Enhanced Sensitivity Phenotypic Tropism Assay 15% of patients reclassified from R5 to D/M at screening when retested with enhanced sensitivity phenotypic tropism assay 100 Noninferiority criteria (rates of HIV-1 RNA < 50 copies/ml) met when D/M patients excluded EFV + ZDV/3TC MVC + ZDV/3TC Overall By Baseline HIV-1 RNA (copies/ml) MERIT MERIT-ES MERIT MERIT-ES < 100, ,000 < 100, , n= Cooper DA, et al. J Infect Dis. 2010;201:
29 Determination of Viral Tropism Phenotypic assay used in clinical trials involving CCR5 antagonists to determine viral tropism [1,2] Genotyping of env V3 loop may be an alternative to phenotyping [3,4] Less costly and faster, though some assays inferior to phenotypic assay [5] Genotypic [6] and phenotypic [7] assays available for determining tropism from PBMC proviral DNA 1. Gulick RM, et al. N Engl J Med. 2008;359: Cooper DA, et al. J Infect Dis. 2010;201: Harrigan PR, et al. IAS Abst WELBA McGovern R, et al. CROI Abs Wilkin TJ, et al. ICAAC Abs. H-932a. 5. Swenson LC, et al. J Acquir Immun Defic Syndr. 2010;54: Toma J, et al. ICAAC Abs H-921.
30 Potential New Options CCR5 inhibitor-containing regimens Quad : elvitegravir/cobicistat/tdf/ftc Cobicistat as PI booster, including possible coformulations Dolutegravir (including coformulation with ABC/3TC) Rilpivirine, including coformulation with TDF/FTC
31 HIV-1 RNA < 50 c/ml (%) Cobicistat-Boosted EVG + FTC/TDF vs. EFV/FTC/TDF in Naive Pts: Phase II trial Cobicistat (GS-9350, COB): investigational CYP3A inhibitor (boosting agent) Elvitegravir (EVG): investigational integrase inhibitor ART-naive pts with CD4 50, VL 5000, no NRTI, NNRTI or PI resistance (N = 71) Wk 24 primary endpoint analysis Wk 48 EVG/COB/FTC/TDF (n = 48) EFV/FTC/TDF (n = 23) EVG/COB/FTC/TDF EFV/FTC/TDF ITT, M = F Wk 24 stratum-weighted difference: +5% (95% CI: -11.0% to 21.1%) Wk Cohen C, et al. CROI Abstract 58LB. Reproduced with permission.
32 Potential New Options CCR5 inhibitor-containing regimens Quad : elvitegravir/cobicistat/tdf/ftc Cobicistat as PI booster, including possible coformulations Dolutegravir (including coformulation with ABC/3TC) Rilpivirine, including coformulation with TDF/FTC
33 HIV-1 RNA < 50 c/ml (%) Cobicistat-Boosted ATV Virologic Efficacy Similar to ATV/r in Naive Pts Phase II study comparing cobicistat (GS-9350) vs RTV as boosting agent for atazanavir ART-naive pts with CD4 50,VL 5000 no NRTI, NNRTI or PI resistance (N = 79) Wk 24 primary endpoint Wk COB Boosted ATV + FTC/TDF (n = 50) RTV-Boosted ATV + FTC/TDF (n = 29) COB RTV Wk 24 stratum-weighted difference: -1.9% (95% CI: -18.4% to 14.7%) Wk ITT, M = F Cohen C, et al. CROI Abstract 58LB. Reproduced with permission.
34 Cobicistat: AEs When Combined With EVG/FTC/TDF or ATV/r + TDF/FTC AEs, n (%) Grade 1-4 AEs related to randomized drug Cohen C, et al. CROI Abstract 58LB. EVG/COB/TDF /FTC (n = 48) EFV/FTC/TDF (n = 23) COB + ATV + FTC/TDF (n = 50) RTV + ATV TDF/FTC (n = 29) 17 (35) 13 (57) 10 (20) 7 (24) Abnormal dreams, nightmares 5 (10) 8 (35) 0 0 Dizziness 0 3 (13) 0 0 Fatigue 4 (8) 3 (13) 1 (2) 2 (7) Somnolence 2 (4) 2 (9) 0 0 Diarrhea 4 (8) 1 (4) 3 (6) 3 (10) Nausea 2 (4) 1 (4) 5 (10) 1 (3) Bilirubin, total /49 (82) 25 (86) Creatinine (grade 1) 1 (2) 0 6 (12) 0 D mean serum creatinine from BL to Wk 24, mg/dl D mean egfr from BL to Wk 24, ml/min
35 Potential New Options CCR5 inhibitor-containing regimens Quad : elvitegravir/cobicistat/tdf/ftc Cobicistat as PI booster, including possible coformulations Dolutegravir (including coformulation with ABC/3TC) Rilpivirine, including coformulation with TDF/FTC
36 HIV-1 RNA < 50 copies/ml (TLOVR), % SPRING-1: Virologic Response to S/GSK vs EFV at Wk mg dose chosen for phase III trial 96% 92% 90% 60% BL Wks CD4 count increases on 572 vs 116 on EFV No serious adverse events related to 572 Time to VL < 50 shorter for 572 than EFV (P <.001 for each comparison) mg mg mg EFV 600 mg Arribas J, et al. AIDS Abstract THLBB205. Graphic used with permission.
37 Potential New Options CCR5 inhibitor-containing regimens Quad : elvitegravir/cobicistat/tdf/ftc Cobicistat as PI booster, including possible coformulations Dolutegravir (including coformulation with ABC/3TC) Rilpivirine, including coformulation with TDF/FTC
38 Patients (%) Patients (%) Patients (%) ECHO, THRIVE: Rilpivirine vs EFV in Treatment-Naive Patients RPV EFV VL < 50 (ITT-TLOVR) at Wk VL < 50 at Wk 48 by BL VL 6.6 ( ) n = Pooled 346 ECHO THRIVE / 276/ 162/ 136/ Pooled ECHO 100, (-9.8 to +2.5) / / 167 THRIVE *P <.0001 for noninferiority at -12% margin. Cohen C, et al. AIDS Abstract THLBB206. Graphics used with permission / / 352 Pooled 125/ / 181 ECHO > 100, / / 171 THRIVE
39 Patients (%) ECHO, THRIVE: Treatment Failure, Resistance, and Adverse Events Treatment Failure in ECHO and THRIVE 15 RPV 12 EFV n = VF AE Resistance at Virologic Failure Wk 48 Outcome Rilpivirine (n = 686) Efavirenz (n = 682) Adverse Events and Discontinuation Wk 48 Outcome, % Rilpivirine (n = 686) Efavirenz (n = 682) P Value DC for AE Most Common AEs of Interest, % Any neurologic AE <.0001 Any psychiatric AE Any rash 3 14 <.0001 VF with resistance data, n No NNRTI or NRTI RAMs,% Emergent NNRTI RAM,% Most frequent NNRTI RAM E138K K103N 1 Emergent NRTI RAMs, % Most frequent NRTI RAM M184I M184V Cohen C, et al. AIDS Abstract THLBB206. Table used with permission.
40 Predictions (and questions) involving the future There will soon be new options for initial therapy TDF/FTC/RPV? Better tolerability, but efficacy and resistance concerns Quad? Phase III studies in progress. Concern about creatinine elevation Dolutegravir + ABC/3TC coformulation Attractive 1 st agent, but depends on what happens with earlier entries Use of ABC/3TC Boosted PIs will remain the best choice for patients with unreliable adherence Will cobicistat replace ritonavir?
41 Predictions (and questions) involving the future Generics: the wild card: Generic 3TC, EFV, SQV coming For the first time, preferred agents will be available as generics Will 3 rd party payers notice? Will coformulations no longer be covered? Will the bar be higher for development of new first-line agents? Need to show superior efficacy and/or safety rather than non-inferiority and improved convenience
42
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