Disclosures. Update on HIV Drug Therapy: A Case based Discussion. Case # 1: Dr. Grant has received grant support from BMS, Gilead, Janssen, and Viiv

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1 Disclosures Update on HIV Drug Therapy: A Case based Discussion Dr. Grant has received grant support from BMS, Gilead, Janssen, and Viiv Philip Grant Assistant Professor Division of Infectious Diseases Stanford University Case # 1: 214 ARVs 27 years old man CD4 : 45 cells/µl Viral load: 95, copies/ml Dx : Anxiety disorder: Effexor NRTI Abacavir Didanosine Emtricitabine Lamivudine Stavudine Tenofovir NNRTI Delavirdine Efavirenz Etravirine Nevirapine (XR) Rilpivirine PI Atazanavir Darunavir Fosamprenavir Indinavir Lopinavir Nelfinavir Fusion Inhibitors Enfuvirtide CCR5 Antagonists Maraviroc Asthma: Albuterol prn, Fluticasone Chronic diarrhea Prefers one pill once daily option Which one? Zidovudine Ritonavir Saquinavir Tipranavir Boosters Cobicistat* Ritonavir INSTI Dolutegravir Elvitegravir* Raltegravir * with EVG/TDF/FTC

2 NNRTI DHHS 213 Guidelines: What to Start Boosted PI INSTI Preferred Regimens EFV/TDF/FTC ATV/r+ TDF/FTC DRV/r + TDF/FTC RAL + TDF/FTC EVG/COBI/TDF/FTC DTG + ABC/3TC DTG + TDF/FTC Alternative Regimens EFV + ABC/3TC* RPV /TDF/FTC or RPV + ABC/3TC* ATV/r + ABC/3TC* DRV/r+ ABC/3TC* FPV/r + (TDF/FTC or ABC/3TC* ) LPV/r + (TDF/FTC or ABC/3TC* ) RAL + ABC/3TC *In HLA-B*571 negative patients with baseline HIV-1 RNA < 1, copies/ml. RPV is not recommended in patients with baseline HIV-1 RNA > 1, copies/ml. EVG/COBI/TDF/FTC should not be started in patients with an estimated CrCl < 7 ml/min. IAS-USA 212 Guidelines: What to Start NNRTI Boosted PI INSTI Recommended Regimens Alternative Regimens EFV/TDF/FTC or NVP + (TDF/FTC or ABC/3TC* ) EFV + ABC/3TC* RPV/TDF/FTC or RPV + ABC/3TC* ATV/r + (TDF/FTC or ABC/3TC* ) DRV/r + TDF/FTC RAL + TDF/FTC DRV/r + ABC/3TC LPV/r + (TDF/FTC or ABC/3TC* ) RAL + ABC/3TC* EVG/COBI/TDF/FTC *In HLA-B*571 negative patients with baseline HIV-1 RNA < 1, copies/ml. Avoiding the use of ABC or LPV/RTV might be considered for patients with or at high risk of cardiovascular disease. DHHS Guidelines. February 213. Thompson MA, et al. JAMA. 212;38: Initial Therapy Options: Key Differences Between DHHS and IAS-USA DTG (with ABC/3TC or TDF/FTC) IAS-USA [1] DHHS [2] No guidance Recommended EVG/COBI/FTC/TDF Alternative Recommended ABC/3TC (with EFV or ATV/RTV) NVP (with ABC/3TC or TDF/FTC) Recommended (provided HIV- 1 RNA < 1k copies/ml) Alternative Alternative Other Which therapy would you choose? A) EFV/FTC/TDF B) ATV/r/FTC/TDF C) DRV/r/FTC/TDF D) RAL/FTC/TDF E) RPV/FTC/TDF F) EVG/COBI/FTC/TDF 1. Thompson MA, et al. JAMA. 212;38: DHHS Guidelines. February 213.

3 Suicidality in Patients Treated With EFV Containing Regimens Retrospective analysis of ACTG clinical trials in which pts were randomized to EFVcontaining or EFV free regimens Suicidality identified using prespecified Medical Dictionary for Regulatory Activities codes and blinded data review Study No standardized questionnaire querying suicidal ideation or attempts Enrollment Period A A A A EFV Regimens (n = 3241) EFV + ZDV/3TC/ABC EFV + ZDV/3TC EFV + 3TC + NRTI EFV + LPV/RTV EFV + ZDV/3TC EFV + TDF/FTC EFV + TDF/FTC EFV + ABC/3TC Mollan K, et al. IDWeek 213. Abstract 432. EFV Free Regimens (n = 291) Median Follow up, Wks EFV EFV Free ZDV/3TC/ABC 145 (48*) 144 (48*) LPV/RTV + 3TC + NRTI ATV + ddi EC + FTC 184 (87) 184 (87) ATV/RTV + TDF/FTC ATV/RTV + ABC/3TC Risk of Suicidality Increased in Pts Treated With EFV Containing Regimens Treatment with EFV associated with increased risk of suicidality Absolute risk is small (NNH=226) Probability EFV EFV free HR: 2.28 (95% CI ; P =.6) 47 events/5817 PY (8.8/1 PY) 15 events/499 PY (3.66/1 PY) Wks to Suicidality Mollan K, et al. ID Week 213. Abstract 432. Reproduced with permission. Risk of attempted or completed suicide also associated with EFV (HR: 2.58; 95% CI:.94 to 7.6; P =.6) EFV also associated with increased risk of death from injury, substance use, or unknown causes Multivariate Analysis of Factors Associated With Suicidality in ACTG Clinical Trials Variable HR (95% CI) P Value Randomly assigned EFV 2.15 ( ).1 Age category, yrs.4 < ( ) 1.69 ( ) 1. (reference) Hx IDU 2.18 ( ).2 Psychiatric hx or psychoactive rx 3.9 ( ) <.1 Suicidality at CROI 214 British Columbia group reported steep decline in suicide rates with current rates in HIVinfected 3 times that of general population EFV associated with suicide in univariate but not multivariate analysis BMS review of FDA data showed no increased rate of suicide with EFV ACTG A5257 CROI 214 Randomized comparison of ATV/r vs. DRV/r vs. RAL (all combined with TDF/FTC) (n=189) 96 week results showed Similar time to VF (13% vs. 15% vs. 1%) Tolerability discontinuations greater with ATV/r (16% vs. 5% vs. 1%) RAL superior to both PIs for tolerability/vf endpoint

4 ECHO/THRIVE: Rilpivirine Noninferior to Efavirenz Through Wk 48 HIV-1 RNA < 5 c/ml at Wk 96 (ITT-TLOVR) n = Δ: 2.% (95% CI: 2. to 6.) RPV 682 EFV Pooled Data Cohen CJ, et al. AIDS. 213;27: More virologic failures with RPV vs EFV: 9% vs 5% Development of mutations more common with RPV vs. EFV E138K mutation with RPV cross-resistance with ETR Discontinuation for AEs more common with EFV vs. RPV: 8% vs. 3% RPV superior to EFV at VL<1K (9% vs. 84%) but inferior for VL>1K Open-Label STaR Trial: RPV/TDF/FTC Non-inferior to EFV/TDF/FTC at Wk 48 RPV/TDF/FTC non-inferior to EFV/TDF/FTC in overall population and in pts with baseline HIV-1 RNA > 1, c/ml RPV/TDF/FTC superior to EFV/TDF/FTC in pts with baseline HIV-1 RNA 1, c/ml RPV/TDF/FTC (n = 394) n/n = Δ: 4.1% (95% CI: 1.1 to 9.2) / / 392 All Pts Δ : 7.2% (95% CI: ) / / 25 VL 1k Cohen C, et al. Glasgow 212. Abstract O425. Δ : 1.8% (95% CI: 11.1 to 7.5) / / 142 VL > 1k EFV/TDF/FTC (n = 392) Post Hoc Analysis / 98 96/ 117 VL > 1k 5k 72 26/ / 25 VL > 5k Summary of Results From Phase III Studies of RPV vs EFV More virologic failures with RPV, especially with VL> 1k [1,2] Difference reduced in open-label study, suggesting importance of adherence, food effect [2] DHHS: RPV is not recommended in patients with pretreatment HIV-1 RNA > 1, copies/ml; higher rate of virologic failures reported in patients with pre-art CD4+ count < 2 cells/mm 3 who were treated with RPV + 2 NRTIs [3] RPV resistance mutation (E138K) causes cross-resistance with ETR [1,2] Fewer drug discontinuations with RPV than EFV [1,2] Fewer rash, CNS events; better lipids [1,2] Summary of Results From Tx-Naive Phase III Studies of EVG/COBI/TDF/FTC Virologic outcomes noninferior to EFV/TDF/FTC and ATV/RTV + TDF/FTC Activity sustained in high VL stratum 2% failed with resistance, usually to both NRTIs and EVG Adverse events vs EFV: fewer CNS, rash events; better lipids; more nausea vs ATV/RTV: less jaundice Small, rapid increase in serum creatinine related to inhibition of tubular secretion of creatinine 5 pts (.7% of total) developed tubulopathy, likely from TDF 1. Cohen CJ, et al. AIDS. 213;27: Cohen C, et al. Glasgow 212. Abstract O DHHS Guidelines. February 213.

5 GI Symptoms and Stribild In randomized comparison of EVG vs. EFV, 21% vs. 14% with nausea (p<.5) Similar rates as to ATV/r (2% vs. 19%) Efficacy of initial combination antiretroviral therapy for HIV-1: a meta-analysis Frederick J. Lee 1, Janaki Amin 2, Andrew Carr 1 Centre for Applied Medical Research, St Vincent s Hospital 1 Kirby Institute, University of New South Wales 2 Sydney, Australia 7 th IAS Conference on HIV Pathogenesis, Treatment & Infection July 213, Kuala Lumpur, Malaysia Efficacy By DHHS regimen DHHS recommendation Preferred Alternative Other Groups, n Participants, n 5,677 8,556 25,891 Follow-up, weeks (SD) 99 (41) 86 (35) 77 (37) ART efficacy, %(SD) 75 (8) 65 (7) 55 (17) ART cessation, %(SD) 2 (8) 25 (8) 27 (12) adverse events patient decision virological failure other Efficacy By DHHS regimen TDF+FTC/3TC plus Groups, n Participants, n Follow-up, weeks Efficacy, % (SD) EFV 14 2, (8) ATV/r 9 1, (7) DRV/r (N.A.) RAL (8) Similar efficacy across DHHS- Preferred regimens, although trend to superior efficacy with raltegravir

6 ART Meta-analysis Key Findings Virologic suppression improving over the years Increased rates of VF with VL>1, c/ml TDF/FTC improved rates of suppression vs. ABC/3TC ( +7.6, P =.3) Case # 1 Complera Viral load below 4 copies/ml at 12 months Well tolerated Pill burden not associated with outcomes Which Patients for RPV/TDF/FTC? Which Patients for EVG/COBI/TDF/FTC/? Considerations in Favor Coformulated/1 pill daily Superior vs. EFV at lower VL [1] Fewer CNS adverse events than EFV [2] Considerations Against Less effective at high BL VL [2] (not recommended at high VL and low CD4+) and lower levels of adherence [3] Food requirement [4] Restricted use with PPIs or H2 blockers [4] High risk of resistance and cross resistance with other NNRTIs at VF [2] Considerations in Favor Co-formulated/1 pill dally Once-daily INSTI regimen Non-inferior to EFV and ATV/RTV across HIV-1 RNA, CD4+ strata [1,2] Fewer CNS AEs than EFV [1] Considerations Against Mild nausea/diarrhea High risk of resistance at VF [1-4] Cross resistance with RAL [5] Drug drug interactions [6] Concerns about monitoring renal function with COBI [6] 1. Cohen C, et al. Glasgow 212. Abstract O Cohen C, et al. AIDS. 213;27: DHHS Guidelines. February TDF/FTC/RPV [package insert]. 1. Zolopa A, et al. J Acquir Immune Defic Syndr. 213;63: Rockstroh J, et al. J Acquir Immune Defic Syndr. 213;62: Sax PE, et al. Lancet. 212;379: DeJesus E, et al. Lancet. 212;379: DeJesus E, et al. IAS 27. Abstract TUPEB TDF/FTC/EVG/COBI [package insert].

7 Individualizing First-line Therapy: Specific Circumstances Circumstance No genotype High HIV 1 RNA Renal disease Dyslipidemia CV risk factors Pregnancy Chronic HBV infection Decreased BMD Concerns about CNS effects Agents Use boosted PI Caution with ABC (except no signal when combine with DTG), RPV Caution with TDF, ATV/r; monitoring complicated with COBI and DTG RAL, DTG, RPV most lipid neutral Association with ABC, ddi, LPV/r in some studies No data for DRV/r, INSTIs, MVC Preferred: ZDV/3TC + NVP, LPV/r, or ATV/r EFV can be used after first 5 6 wks Preferred TDF + 3TC or FTC Alternative is entecavir Caution with TDF; boosted PIs Caution with EFV for at least first months Case # 2 Male, 32 years old Dx 23 Crystal meth addiction Intermittent poor adherence h/o Stroke + CHF + GERD (on lansoprazole) On DRV/r/FTC/TDF since 21 No h/o VF Case # 2 Creatinine increased to 1.8 mg/dl Patient with mild GI upset which he attributes to ritonavir HLA B571: negative Trofile DNA CCR5 only using virus Would you change therapy Options: 1.No change in therapy 2.RAL/LPV/r 3.RAL/ABC/3TC 4.DTG/ABC/3TC 5.DTG/TDF/FTC 6.DRV/r/ABC/3TC Case # 2

8 SPRING-2: Dolutegravir QD Noninferior to Raltegravir BID Through Wk 96 FLAMINGO: DTG + NRTIs Superior to DRV/r + NRTIs at Wk 48 HIV-1 RNA < 5 c/ml (%) DTG 5 mg QD (n = 411) RAL 4 mg BID (n = 411) NRTIs: investigator chosen ABC/3TC (4%) or TDF/FTC 6%) DTG noninferior to RAL at Wk 48 [1] and Wk 96 [2] Response similar with either NRTI pair and across VL strata Adverse events and discontinuation rates similar No resistance at VF with DTG vs. 1 subject with integrase resistance and 4 with NRTI resistance in RAL group Wk 48 Wk 96 Raffi F, et al. Lancet. 213;381: Raffi F, et al. IAS 213. Abstract TULBPE17. HIV-1 RNA < 5 c/ml at Wk 48 (%) Difference 7.1% (95% CI: +.9 to +13.2; P =.25) 9 83 DTG 5 mg DRV/RTV QD + 8/1 mg NRTIs QD + NRTIs (n = 242) (n = 242) Feinberg J, et al. ICAAC 213. Abstract H1464a. DTG superior to DRV/RTV (both with TDF/FTC or ABC/3TC) at Wk 48 primary efficacy endpoint VF: 2 pts (1%) on each arm No treatment-emergent resistance in either arm Treatment-related study discontinuation in 1% of DTG pts and 4% of DRV/RTV pts More diarrhea with DRV/RTV; more headache with DTG SINGLE: DTG + ABC/3TC Superior to EFV/TDF/FTC at Wk 48 HIV-1 RNA < 5 c/ml at Wk 48 (%) Difference 7.4% (95% CI: +2.5 to +12.3; P =.3) DTG 5 mg + ABC/3TC QD (n = 414) EFV/TDF/FTC QD (n = 419) DTG superior to EFV at Wk 48 primary efficacy endpoint 4% on each arm with protocoldefined VF Among pts with VF in EFV arm, 1 pt with NRTI and 4 with NNRTI resistance vs pts with resistance in DTG arm Treatment-related study discontinuation in 1% on EFV vs 2% on DTG CNS events and rash more common with EFV Summary of Results From Tx-Naive Phase III Studies of DTG DTG + NRTIs non-inferior to RAL + NRTIs; superior to DRV/r + NRTIs; DTG + ABC/3TC superior to EFV/TDF/FTC More drug discontinuations in EFV and DRV/r arms No DTG resistance mutations as yet detected with virologic failure in naïve patients DTG well tolerated with low rates of study drug discontinuation Fewer CNS and rash events compared with EFV Less diarrhea than DRV/r Small rapid increase in serum creatinine related to inhibition of tubular secretion of creatinine No drug-related renal events Walmsley S, et al. ICAAC 212. Abstract H-556b.

9 Which Patient for DTG? Interactions With Acid-Reducing Medications and Newer ARVs Considerations in Favor Once-daily INSTI without boosting Superior efficacy vs. EFV and DRV/r [1,2] Potentially less resistance at VF [1,3] Effective at high VL with both ABC/3TC and TDF/FTC [3] Well tolerated [1-3] Few drug drug interactions [4] Considerations Against Not yet available as coformulation Concerns about monitoring renal function [4] No guideline recommendation at this time ARV Antacids H2 Receptor Antagonists Proton Pump Inhibitors RPV [1] EVG/COBI TDF/FTC [1] DTG [2] Give antacids at least 2 hrs before or at least 4 hrs after RPV Separate EVG/COBI/ FTC/TDF and antacid administration by > 2 hrs DTG should be given 2 hrs before or 6 hrs after taking medications containing polyvalent cations Give H2 receptor antagonists at least 12 hrs before or at least 4 hrs after RPV No clinically relevant interactions No clinically relevant interactions Contraindicated No clinically relevant interactions No clinically relevant interactions 1. Walmsley S, et al. ICAAC 212. Abstract H-556b. 2. Feinberg J, et al. ICAAC 213. Abstract H- 1464a. 3. Raffi F, et al. Lancet. 213;381: Dolutegravir [package insert]. 1. DHHS Adult Guidelines. February Dolutegravir [package insert]. Interactions With First-line ART and Lipid-Lowering Therapy Antiretroviral Contraindicated Titrate Dose No Dose Adjustment RPV [1] EVG/COBI/TDF/ FTC [1] DTG [2] ATV/RTV [1] DRV/RTV [1] EFV [1] RAL [1] Lovastatin Simvastatin Lovastatin Simvastatin Lovastatin Simvastatin Atorvastatin Rosuvastatin Atorvastatin Rosuvastatin Atorvastatin Pravastatin Rosuvastatin Atorvastatin Simvastatin Pravastatin Rosuvastatin 1. DHHS Adult Guidelines. February Dolutegravir [package insert]. Pitavastatin Pitavastatin Mean Change From Baseline of Creatinine (mg/dl) SPRING-2: Changes in Serum Creatinine and Creatinine Clearance Change in Serum Creatinine, Mean ( SD) [1] Wk Change in CrCl, Mean ( SD) [2] Baseline (mg/ml): DTG.85 vs RAL.85 Baseline (ml/min): DTG 125 vs RAL 128 DTG increases serum creatinine by the benign inhibition of the organic cation transporter 2, which is responsible for tubular secretion of creatinine [3] 1. Raffi F, et al. Lancet. 213;381: Raffi F, et al. AIDS 212. Abstract THLBB4. 3. Koteff J, et al. Br J Clin Pharmacol. 213;75: Mean Change From Baseline (ml/min) DTG 5 mg QD (n = 411) RAL 4 mg BID (n = 411) BL Wk

10 Change From BL in Serum Creatinine (mg/dl; IQR) EVG/COBI/TDF/FTC vs EFV or ATV/RTV: Creatinine Changes BL EVG/COBI/TDF/FTC EFV/TDF/FTC Wks Cobicistat is associated with reduced active secretion of creatinine in the renal tubules leading to initial rises in creatinine levels EVG/COBI/TDF/FTC ATV/RTV + TDF/FTC BL Wks Special Considerations for Monitoring Renal Function Some drugs have an effect on creatinine including cimetidine, cobicistat, trimethoprim, EVG, and DTG Expected minor increases in creatinine and decreases in estimated CrCl during treatment with these agents do not reflect changes in egfr Baseline CrCl < 7: do not use EVG/COBI/TDF/FTC Stop if estimated CrCl < 5 (cannot adjust dose) Pts at risk of renal disease: monitor urine protein, glucose, serum phosphorus, and CrCl Confirmed rise in serum creatinine of >.4 mg/dl is considered significant Sax P, et al. Lancet. 212;379: DeJesus E, et al. Lancet. 212;379: years old male HIV+ Crystal meth + Dx 27 CD4 = 27 VL: 5, copies/ml Genotype: No resistance Case # 3 Case # 3 ARVs in January 28: NVP/TDF/FTC June 28: VL< 5 copies/ml; CD4 35 cells/µl Back on crystal meth in 29: 3/29: VL = 13,; CD4 25 Genotype: K65R, M184V, K13N, Y181C Lost to follow up

11 Case # 3 Case # 3 Back in the clinic July 212; Cr=1.3 Placed on DRV/r/FTC/TDF VL<4, CD4 count = 3. Creatinine Diarrhea ++ Chronic back pain Using Ibuprofen 8 mg TID x 1 year Which ARVs? A) DRV/r/ABC/3TC B) DRV/r/RAL C) DRV/r/RAL/ETR C) RAL/LPV/r D) DRV/r/MVC ANRS 139 : TRIO Study RAL/ETR/DRV/r Update on NRTI sparing regimens 9% (95%CI 85% to 96%) NRTIs prescribed: Median (range): 2 (1 4)

12 NRTIs for tx experienced patient OPTIONS Results No difference in regimen failure (include NRTIs 26% vs. 3% in omit NRTIs) Death higher in NRTI arm (6 vs. ; p<.1) MODERN Study ANRS Study

13 The End

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