Optimizing the treatment

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1 PIs are the real world answer for: Optimizing the treatment Sergio Lo Caputo Malattie Infettive - Azienda Sanitaria Firenze

2 Evolution of ARVs DARUNAVIR PI ETRAVIRINA NNRTI DOLUTEGRAVIR INI POTENZA E ALTA BARRIERA GENETICA POTENZA E ALTA BARRIERA GENETICA POTENZA E ALTA BARRIERA GENETICA EFFICACIA DAI PLURIFALLITI (POWER) AI NAIVE (ARTEMIS) EFFICACIA DAI PLURIFALLITI (DUET) AI NAIVE (SENSE) EFFICACIA DAI PLURIFALLITI (VIKING) AI NAIVE(SPRING- 2,SINGLE,FLAMINGO) LUNGA EMIVITA BUONA PENETRAZIONE NEI RESERVOIRS DOSAGGIO QD e BID LUNGA EMIVITA BUONA PENETRAZIONE NEI RESERVOIRS DOSAGGIO QD e BID LUNGA EMIVITA BUONA PENETRAZIONE NEI RESERVOIRS (?) DOSAGGIO QD e BID

3 ARV Potency & Resistance genetic barrier tolerance DRV/r poor better enetic barrier ATV/r ETR DTG EFV RAL Schematic rappresentation Potency

4 Darunavir, Five years of Efficacy Data M. Llibre, et al. AIDS 2013

5 Antivir Ther. 2013;18(3): Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G The aim of this analysis was to characterize viral resistance in the Phase III, randomized ODIN trial, which demonstrated non-inferiority of once-daily darunavir/ritonavir (DRV/r) 800/100 mg to DRV/r 600/100 mg twice daily, each combined with an optimized background regimen in treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening. Mean baseline HIV-1 RNA was 4.16 log10 copies/ml and 53.9% of patients were protease inhibitor (PI)-experienced at enrolment. VF rate was similar in both arms. Similar proportion of virologically failing patients in both arms developed PI RAMs (11.7% versus 9.5%, respectively) or nucleoside reverse transcriptase inhibitor RAMs (6.7% versus 7.1%). One patient with VF (once-daily arm) developed four primary PI mutations, three of which were also DRV RAMs. This patient was also the only VF to lose susceptibility to DRV. These analyses showed once-daily DRV/r 800/100 mg was associated with similar rates of VF and emergence of resistance as DRV/r 600/100 mg twice daily in treatment-experienced patients with no DRV RAMs.

6 GRACE (Gender, Race And Clinical Experience) GRACE a is the largest treatment trial to date in the US to focus on women with HIV, and the first treatment trial to focus on treatmentexperienced women with HIV in North America GRACE is a multi-center, open-label phase IIIb trial designed to assess sex and race differences in efficacy, safety, and tolerability of darunavir/ritonavir (DRV/r) over 48 weeks in treatment-experienced patients Final enrollment figures for GRACE (N=429): 287 (67%) women and 142 (33%) men 265 (62%) black, 96 (22%) Hispanic, 65 (15%) white, and 3 (1%) other 6 a TMC114HIV3004

7 GRACE Study Design

8 Confirmed virologic response in intent-to-treat and non-virologic failure censored populations

9 Dual Therapy

10 Most used mono PI or dual therapies in first line according to calendar period N (n=64) (n=145) (n=372) Italia Cohor n t Naive Antiretrovirals I. C O. N. A. 0

11 DUAL THERAPY: DARUNAVIR- LAMIVUDINA

12 Study Design Single-center, retrospective, observational study Primary Objective: To analyze the safety and efficacy of a dual therapy with 3TC plus a PI/r as simplification strategy for suppressed patients with prior intolerance to nucleoside analoga (NAs) in a Spanish cohort Screening Phase 44 HIV-infected patients Inclusion Criteria: On suppressive ART with 2 NAs + PI/r HBV negative Regimen switch to 3TC + PI/r due to NA intolerance or toxicity Treatment change between Jan and Dec Treatment Phase (48 weeks) 3TC + Boosted PI Data Collection (@ 4 weeks & every 12 weeks thereafter) Complete blood count Viral load (VL) CD4 cell count Tests of liver & kidney function Glucose & lipids measurements Casado, José L, Cristina de la Calle, María Del Palacio, María J Perez-Elías, Ana Moreno, and Santiago Moreno. Lamivudine Plus a Boosted-Protease Inhibitor as Simplification Strategy in HIV-Infected Patients: Proof of Concept. AIDS Research and Human Retroviruses (November 19, 2012). doi: /aid

13 DUAL THERAPY: DARUNAVIR (PIs)- ETRAVIRINA SETTING STUDY AUTHORS Simplification Simplification Simplification Dual therapy Switching to Dual Therapy switch strategy Burgos et al. J Antimicrob Chemother 2012 N Marshall et al. P24 BHIVA 2010 Martini et al. ICAR 2012 Experience-Naive INROADS Ruane et al. IAS 2013

14 Patients with viral load <50 copies/ml at Week 96 (%) DUET Week 96: patients with VL<50 copies/ml (ITT-TLOVR) 100 ETR + BR Placebo + BR 70 60% 60 57% % 30 36% p<0.0001* 0 Baseline Time (weeks) *Logistic regression model controlling for baseline viral load, ENF use and study number ITT = intent-to-treat; TLOVR = time-to-loss of virologic response imputation algorithm

15 Patients with viral load <50 copies/ml at Week 48 (%) DUET: Virological response at Week 48 (TLOVR) with fully active ETR and fully active DRV p=0.0011* ETR + BR (n=227) p=0.0177* 83% 74% 71% 53% Placebo + BR (n=236) p=0.0283* 80% 64% 100% p=n/a 86% /108 57/107 62/75 55/78 33/41 28/44 3/3 6/ Number of active NRTIs in the BR (PSS) Total number of active agents used (including ETR + DRV) Fully active ETR = patients with ETR FC 3; DRV = patients with DRV FC 10; ETR and DRV were not included in the PSS calculation; Analysis excludes patients who discontinued for reasons other than VF; *Logistic regression; According to Antivirogram N.Clumeck, ET AL.

16

17 Ruane et al. EACS 2013

18 INROADS: Results Ruane et al. EACS 2013

19 Ruane et al. EACS 2013

20 Virological responses in HIV-1-infected patients treated with Etravirine combined with a boosted protease inhibitor other than Darunavir/r: an observational study using pooled European cohort data Vingerhoets et al. EACS 2013

21 DUAL THERAPY: DARUNAVIR (PIs)- MARAVIROC SETTING STUDY AUTHORS naive MIDAS PILOT STUDY singol arm Taiwo et al. Journal of Acquired Immune Deficiency Syndromes 2013 naive MODERN STUDY Randomized trial MVC 150mg vs. FTC/TDF (both + DRV/r) (n=804) Ongoing trial Simplification Simplification GUSTA Prospective Randomized Italian Multicenter Real Life- Retrospective Multicenter Cohort Ongoing (Univ. Cattolica, Roma) Macías et al. EACS 2013

22 Efficacy and Safety of Once Daily Maraviroc plus Darunavir/r in Pretreated HIV-infected Patients in a Real Life Setting Study design: Retrospective multicenter cohort. Patients and follow-up: All HIV-infected patients previously treated with antiretroviral therapy evaluated in the participating centers January 2009-June 2011 were included, if they received MVC 150 mg qd plus DRV/r 800/100 qd. for at least one week. Primary end-point: Frequency of plasma HIV ARN<50 copies/ml 48 weeks after starting MVC plus DRV/r [intent-to treat, ITT(M=F)]. Sixty patients were recruited to the study, of whom 48 (80%) had HIV RNA < 50 copies/ml at baseline. Reasons for starting MVC plus DRV/r were: adverse effects in 38 individuals (63%), simplification in 15 (25%) and virological failure in seven (12%). Macías et al. EACS 2013

23 Objectives: To assess the efficacy and safety of dual-antiretroviral therapy containing a ritonavir-boosted protease inhibitor (PI/r) in treatment-experienced patients failing a current antiretroviral regimen. Methods: Retrospective analysis of 60 consecutive HIV-1-infected patients who started a dual-antiretroviral rescue regimen containing a PI/r, in three hospitals in Spain A darunavir-based regimen was started in 49 (81.7%) patients, combined with etravirine (26.7%), tenofovir (26.7%) raltegravir (25%). Journal of Antimicrobial Chemotherapy February 29, 2012

24 Characteristics of patients were: 13 years on antiretroviral therapy (four prior highly active antiretroviral therapy regimens and eight different drugs)

25 to examine the impact of maintaining patients on failing second line ART on the accumulation of protease (PR) mutations Genotypic resistance testing was performed on a subset of patients experiencing 2 L failure, defined as 2 consecutive viral loads (VL).1000 copies/ml after >6 months on 2 L. Of 6714 patients who received protease inhibitor (PI)-based ART, 673 (10.0%) met virologic failure criteria. Genotypes were performed on 61 samples September 2013 Volume 8 Issue 9

26

27 Conclusioni Darunavir rappresenta la colonna portante nella costruzione di un regime terapeutico efficace in pazienti in fallimento virologico Una strategia Dual Therapy è possibile in corso di fallimento virologico in base alle caratteristiche del test di resistenza

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