Are the current doses of ARV correct. Richard Elion MD Associate Adjunct Clinical Professor of Medicine Johns Hopkins School of Medicine

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1 Are the current doses of ARV correct Richard Elion MD Associate Adjunct Clinical Professor of Medicine Johns Hopkins School of Medicine

2 Can we lower doses of HIV meds safely? Consensus Panel in Alexandria VA 2010 convened Key Factors defined as Preserving the initial arv regimen with extended durability and low toxicity Dosing schedules, adherence and favorable resistance profiles

3 Crawford, K, Ripin, D. et al,lancet 2012

4

5 Different Strategies to lower drug costs and decrease toxicities Lower dose of a specific drug ( efavirenz) Boosted PI with different doses of both PI and booster Use two class regimens ( dolutegravir/rilpivarine) Use monotherapy and then add drugs as needed ( Boosted PI monotherapy) Change frequency of meds (FOTO)

6 Precision Dose Reduction of Efavirenz Pros: Improve neurocognitive function Improve tolerability Improve prescribing of generic efavirenz Many patients on efavirenz Extend role of efavirenz as first-line agent Reduce drug cost Inform drug interactions Impetus to co-formulate >50% of patients eligible to dose reduce Cons: Increase number of pills Selective non-adherence Copays Requires genotyping Virologic control Most would dose reduce

7 ENCORE1: EFV 400 vs 600 mg QD + TDF/FTC in Treatment-Naive Pts Randomized, double-blind, noninferiority study Primary endpoint: HIV-1 RNA < 200 c/ml at Wk 96 Stratified by screening HIV-1 RNA vs > 100,000 c/ml and study site Wk 96 ART-naive pts with HIV-1 RNA 1000 c/ml, CD4+ cell count > 50 to < 500 cells/mm 3, CrCl 50 ml/min (N = 630) EFV 400 mg QD + TDF/FTC 300/200 mg QD (n = 321) EFV 600 mg QD + TDF/FTC 300/200 mg QD (n = 309) Carey D, et al. Glasgow HIV Abstract O421.

8 Encore1: Primary Endpoint - Non-Inferiority EFV400 % EFV600 % at Week 48 Difference (95%CI) P ITT (-2.1, 5.8) 0.36 <10 5 strata (-2.7, 6.8) (-5.3, 8.6) 0.64 NC=F (-0.8, 9.4) 0.10 <10 5 strata (-0.9, 12.1) (-6.1, 10.2) 0.63 PP (-1.5, 3.3) 0.47 <10 5 strata (-1.5, 4.0) (-4.1, 4.8) 1.00 Favors EFV Difference in Percentage of Participants with pvl <200 Copies/mL Favors EFV400

9 Encore1: Efavirenz Adverse Events Proportion of Participants (Percentage) CNS Psychiatric Rash Gastrointestinal Respiratory Hepatotoxicity EFV400 EFV EFV400 (N=321) EFV600 (N=309) P Number (%) Patients Stopping Drug Due to Related AE 6 (1.9) 18 (5.8) 0.010

10 Estimated C min by CYP2B6 Haplotype (516G T, 983T C, 15582C T) Holzinger et al, Pharmacogenet Genom 2012; 22:858

11 Cost Effectiveness Modeling of Efavirenz Dose Reduction by CYP2B6 Genotype Schackman et al (manuscript in preparation)

12 Cost Effectiveness of Efavirenz Dose Reduction based on CYP2B6 Genotype Dosing efavirenz by CYP2B6 genotype is cost-effective vs. standard care. Even if generic efavirenz available. Even if virologic response to lower dose regimens decreased from 84% to 70%. Results not sensitive to: genotype test cost likelihood of early discontinuation for toxicity quality of life effect and cost of efavirenz toxicity leading to treatment discontinuation proportion of population eligible for lower dose mean age mean CD4 count Schackman et al (manuscript in preparation)

13 Studies with PI agents POWER 1- showed that Darunavir 800mg/100 rtv was superior in qd lower doses of DRV Atazanvir 300 mg with 100 mg RTV vs 50 mg RTV was inferior ( similar to DRV)

14 Dual ART with LPV/RTV + 3TC Compared to Triple Therapy with LPV/RTV + 2NRTIs: GARDEL Study Phase 3, randomized, international, controlled, open-label 48-week study ARV-naïve patients > 18 yrs, HIV RNA > 1000 c/ml No IAS-USA defined NRTI or PI resistance at screening* HBs Ag negative (N=426) Stratified by screening HIV-1 RNA (< or > 100,000 copies/ml) Wk 24 Interim analysis Dual Therapy (DT): LPV/r 400/100 mg BID + 3TC 150 mg BID (n = 217) Triple Therapy (TT): LPV/r 400/100 mg BID + 3TC or FTC and a third investigator-selected NRTI in fixed-dose combination (n=209) Wk 48 Primary endpoint Cahn P, et al. Lancet Infect Dis. 2014;14(7): ; Cahn P, et al. EACS Abstract LBPS7/6.

15 Dual ART with LPV/RTV + 3TC Non-inferior to Triple Therapy with LPV/RTV + 2NRTIs: Results from GARDEL Percent of Patients (%) Viral Load < 50 copies/ml at week 48 (ITTe) P =.171, difference +4.6% (CI 95%: -2.2% to 11.8%) Week 88.3% 83.7% Dual ART Triple ART Dual ART: LPV/r BID + 3TC BID (n=217) Triple ART: LPV/r BID + 3TC or FTC + NRTI (n=209) Primary endpoint: % of patients with HIV-1 RNA< 50 copies/ml in an ITT-exposed analysis at 48 weeks (FDA snapshot algorithm). Cahn P, et al. Lancet Infect Dis. 2014;14(7): ; Cahn P, et al. EACS Abstract LBPS7/6.

16 NRTI-Sparing Strategy of DRV/R + RAL vs DRV/r + TDF/FTC in ARV-Naive: NEAT Study HIV-infected pts, > 18 yrs, with no previous ART, HIV RNA > 1000 c/ml CD4 < 500/mm 3 HBs Ag negative CrCl > 60 ml/min No resistance mutations n =401 1:1* n =404 DRV/r 800/100 mg QD + RAL bid DRV/r qd + TDF/FTC qd Wk 96 Primary endpoint: time to virologic or clinical failure (6 components) Virological Clinical Change of treatment before W32 because of insufficient virologic response HIV-1 RNA 50 c/ml at W32 HIV-1 RNA 50 c/ml at any time after W32 Death due to any cause Any new or recurrent AIDS defining event Any new serious non AIDS defining event *Randomization stratified by country and participation in virology/immunology substudy. HIV-1 RNA reduction < 1 log10 c/ml by W18* or HIV-1 RNA 400 c/ml at W24, confirmed by subsequent measurement* Confirmed by the Endpoint Review Committee. Raffi F, et al. Lancet. 2014;384(9958):

17 NEAT Study: Primary Endpoint at Week 96 by Baseline Characteristics Primary Endpoint at Wk 96: Adjusted Difference Estimate (95% CI) RAL TDF/FTC RAL + DRV/r TDF/FTC + DRV/r Overall n = % 13.7 % Baseline HIV-1 RNA < 100,000 c/ml n = % 7 % > 100,000 c/ml n = % 27 % p = 0.09* Baseline CD4+ < 200/mm 3 n = % 21.3 % > 200/mm 3 n = % 12.2 % p = 0.02* * Test for homogeneity Raffi F, et al. Lancet. 2014;384(9958):

18 NEAT Study: Virological Failure During Follow-Up and Resistance Data RAL + DRV/r (n=401) TDF/FTC + DRV/r (n=404) Protocol-defined virological failure (PDVF), n Number of PDVF who met criteria for genotype testing (HIV RNA > 500 copies/ml at or after W32) Number of patients with single unconfirmed value of HIV RNA > 500 copies/ml at or after wk 32 (meeting criteria for genotype testing) Genotype done, n 28/36 13/15 Major resistance mutations, n 5 0 NRTI 1 (K65R) 0 PI 0 0 INI 5 (N155H)* - *1 additional patient with T97A Protocol-defined virological failure change of any component of the initial randomised regimen before W32 because of confirmed insufficient virological response, defined as HIV-1 RNA reduction < 1 log 10 copies/ml by W18 or HIV-1 RNA 400 copies/ml at W24 ; failure to achieve virological response by W32 (confirmed HIV-1 RNA 50 copies/ml at W32) ; confirmed HIV-1 RNA 50 copies/ml at any time after W32 According to the protocol, genotypic testing was carried out by local laboratories when patients had a single VL > 500 copies/ml at or after W32. Raffi F, et al. Lancet. 2014;384(9958):

19 PROTEA: Switch to DRV/RTV ± 2 NRTIs for Stably Suppressed Pts on First-line ART Multicenter, randomized, open-label phase IIIb study Primary endpoint: HIV-1 RNA < 50 c/ml at Wk 48 (ITT; FDA Snapshot) Average duration of initial ARV regimen: 5.5 yrs Stratified by HCV status Wk 48 HIV-infected pts virologically suppressed (HIV-1 RNA < 50 c/ml) on first-line ART; CD4+ nadir > 100 cells/mm 3 (N = 273) DRV 800 mg QD + RTV 100 mg QD (n = 137) DRV 800 mg QD + RTV 100 mg QD + 2 NRTIs* (n = 136) *Investigator-selected dual combination of either ABC, 3TC, ZDV, TDF, or FTC. Antinori A, et al. Glasgow HIV Abstract O423A. Clarke A, et al. Glasgow HIV Abstract O423B.

20 HIV-1 RNA < 50 c/ml (%) PROTEA: Virologic Response at ITT: -8.7% (-1.8% to -15.5%) 118/ 129/ n/n = n/n = DRV/RTV DRV/RTV + 2 NRTIs HIV-1 RNA < 50 c/ml (%) Wk Nadir CD4+ Count Nadir CD4+ Count < 200 cells/mm cells/mm 3 No difference in efficacy between treatment arms in switch included analysis that classified pts with viral suppression at Wk 48 after reintensification or second switch as virologic responders / / 30 DRV/RTV DRV/RTV + 2 NRTIs 91/ / 106 DRV/RTV DRV/RTV + 2 NRTIs Antinori A, et al. Glasgow HIV Abstract O423A. Clarke A, et al. Glasgow HIV Abstract O423B. Reproduced with permission.

21 PROTEA: Adverse Events Event, n (%) DRV + RTV (n = 137) DRV + RTV + 2 NRTIs (n = 136) Serious AEs 9 (6.6) 5 (3.7) Deaths* 1 (0.7) 0 All AEs 96 (70.1) 83 (61) Grade 3/4 AEs 7 (5.1) 3 (3.7) Psychiatric AEs 10 (7.3) 9 (6.6) Nervous system AEs 13 (9.5) 14 (10.3) *1 pt with myocardial infarction judged to be unrelated to treatment. Antinori A, et al. Glasgow HIV Abstract O423A. Clarke A, et al. Glasgow HIV Abstract O423B. Reproduced with permission.

22 Summary of 2-Drug Studies Results of 3 fully powered studies released in last yr GARDEL: LPV/RTV + 3TC noninferior to LPV/RTV + 2 NRTIs NEAT: DRV/RTV + RAL with more virologic failures at high HIV-1 RNA and/or low CD4+ cell count than DRV/RTV + TDF/FTC MODERN: DRV/RTV + MVC inferior to DRV/RTV + TDF/FTC Results underscore critical role of 3TC (or FTC) as part of initial therapy

23 Raltegravir PK/PD Curves display variability

24 LATTE Study: Induction/Maintenance with Long-Acting Oral Formulations (Rilpivirine and Cabotegravir) Oral Induction Phase Oral Maintenance Phase** HIV ART-naive HIV RNA > 1,000 c/ml, CD4+ cell count > 200 cells/mm3 1:1:1:1 Randomization Stratified by VL and NRTI (N = 243) CAB 10 mg QD + 2 NRTIs * CAB 30 mg QD + 2 NRTIs * CAB 60 mg QD + 2 NRTIs * CAB 10 mg QD + RPV 25 mg QD CAB 30 mg QD + RPV 25 mg QD CAB 60 mg QD + RPV 25 mg QD EFV + 2 NRTIs * EFV + 2 NRTIs D1 Week primary analysis CAB=cabotegravir. *Investigator-selected NRTIs: ABC/3TC (38% to 39% across arms) or TDF/FTC (61% to 62% across arms). **Patients receiving cabotegravir eligible for maintenance phase if HIV-1 RNA < 50 copies/ml at Wk 20. Margolis D, et al. CROI Abstract 554LB; Margolis D, et al. CROI Abstract 91LB.

25 LATTE Study: Treatment Outcomes of Maintenance Population at Wk 48 (primary endpoint) Outcome at Week 48 CAB 10 mg n=52 CAB 30 mg n=53 CAB 60 mg n=55 CAB total n=160 EFV Control n=47 Virologic success 48 (92%) 48 (91%) 53 (96%) 149 (93%) 44 (94%) Virologic failure 3 (6%) 5 (9%) 1 (2%) 9 (6%) 2 (4%) Data in window not <50 c/ml 3 (6%) 3 (6%) 1 (2%) 7 (4%) 1 (2%) Discontinued for lack of efficacy (2%) Change in ART 0 2 (4%) 0 2 (1%) 0 No virologic data at Week 48 1 (2%) 0 1 (2%) 2 (1%) 1 (2%) Discontinued due to AE 1 (2%) 0 1 (2%) 2 (1%) 1 (2%) In maintenance population, virologic success rates similar across CAB arms and CAB arms and EFV Margolis D, et al. CROI Abstract 91LB.

26 LATTE Study: Results Through 96 Wks Virologic suppression rates comparable with CAB + 2 NRTIs induction followed by CAB + RPV maintenance vs EFV + 2 NRTIs HIV-1 RNA < 50 copies/ml at 96 weeks (ITT-E) Pooled CAB arms: 76% EFV arm: 63% HIV-1 RNA < 50 copies/ml at 96 weeks (ITT-ME) Pooled CAB arms: 86% EFV arm: 83% Higher rate of discontinuation in EFV arm vs pooled CAB arms (34% vs 19%) CAB well tolerated with lower rates of discontinuation due to AEs vs EFV (2% to 7% vs 15%, respectively) Margolis D, et al. CROI Abstract 554LB.

27 Differences between efficacy of Raltegravir Overall and then compare By baseline viral load Eron, J. et al, Lancet, 2011

28 FOTO Study: Impact of Brief Interruption on Pill Fatigue and Costs Randomized, open-label 48-week study (n=60) Patients receiving efavirenz/ emtricitabine/tenofovir DF HIV RNA <50 copiers/ml Randomized groups FOTO: 5 days on, followed by 2 days off therapy each week for 48 weeks Daily: 7 days each week for 24 weeks Option to cross-over to FOTO arm at week 24 if HIV RNA <50 copies/ml Strong preference for FOTO regimen Maintained virologic suppression No virologic failure Projected to conserve cost compared with daily regimen HIV RNA <50 copies/ml (%) Outcomes FOTO Week (88-100) Week (82-98) CD 4 increase (cells/mm3) at week 24 Miss >1 dose in a 5-day period (%) Preferred FOTO regimen over Daily regimen (scale 1 [prefer daily] to 10 [prefer FOTO]) Daily 86 (73-99) Cohen C, et al. 5 th IAS Conference. Cape Town, Abstract MoPEB063.

29 Key Challenges Intrasubject variability (PD/PK impact) Human Behavior Timing with food, adherence, ddi

30 Comparison of adherence rates for hiv meds vs bp meds 865 HIV pos individuals who filled 1943 antiviral prescriptions between March 2012 and 2013 Adherence of 84.5% of population to meds, but only 40 % were adherent to 95% of meds, and greater adherence seen with single tablet FDC regimens Greater adherence seen with HIV meds then either BP or Mental Health meds Langness, J. et al. J Mang Care Spec Pharm 2014

31 Effect of Food Type on the Mean Rilpivirine Pharmacokinetic Profile Mean RPV Plasma Concentration (ng/ml) Standard breakfast Fasting conditions 200 High-fat breakfast Nutritional drink Kcal 0 Kcal 928 Kcal 300 Kcal Time (hours) Taking RPV with food increases RPV exposure by 40% compared to fasting Similar after a high-fat or standard breakfast. But less food effect on RPV exposure for the RPV/FTC/TDF STR vs. RPV single agent: Diff of Fasting vs. fed comparison: 16% with STR vs. 43% as RPV alone FDA Label: Recommended Dose: One tablet taken once daily with food Crauwels HM, et al. IWCPHIV Abstract P32; Ramanathan S, et al. HIV ; Glasgow, UK. P068 32

32 Concomitant Use of HIV Drugs and HCV Drugs for Treatment of HCV in HIV-Infected Adults (Cont d) HIV Drugs HCV Drugs SOF LDV/SOF 3D SMV RBV PegIFN SQV/r 3 X X TPV/r X X X X EFV 5 X X ETR X X NVP X X RVP X DTG? EVG/c/TDF/FTC X X X EVG (+ PI/r without COBI) Refer to recommendations specific to each PI/r RAL MVC X = ARV agents that can be used concomitantly; X = ARV agents not recommended;? = Data on PK interactions with the ARV drug are unavailable or insufficient to make a recommendation. 3D = Ombitasvir/paritaprevir/ritonavir + dasabuvir. 3. If PI/r [or ATV/c, DRV/c] is used with TDF, TDF concentrations are expected. If co-administration necessary, monitor for TDF-associated toxicities. Consider alternative HCV or ARV therapy to avoid increases in TDF exposures. If co-administration is necessary, monitor for TDF-associated adverse reactions. 5. If EFV used with TDF/FTC, monitor for TDF toxicity due to TDF concentrations

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