Clinical support for reduced drug regimens. David A Cooper The University of New South Wales Sydney, Australia

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1 Clinical support for reduced drug regimens David A Cooper The University of New South Wales Sydney, Australia

2 Clinical support for reduced drug regimens First line optimisation Virological failure New approaches Future of second line

3 Clinical support for reduced drug regimens First line optimisation Treatment optimisation: reduced dose ART drugs GFATM/PEPFAR and WHO/UNAIDS plans to expand treatment will come at significant cost although reduced, the cost of ARV remains substantial dose reduction may be a means to reduce drug costs phase II trial and observational cohort data suggest comparable performance at lower daily doses of EFV

4 Clinical support for reduced drug regimens First line optimisation Encore1: study design randomisation 1:1 (400mg:600mg), stratified by clinical site and screening pvl TDF/FTC + 400mg EFV qd 2 x 200mg EFV + 1 x 200mg matched placebo TDF/FTC + 600mg EFV qd 3 x 200mg EFV

5 Clinical support for reduced drug regimens First line optimisation Encore1: primary endpoint at 96 weeks EFV 400 EFV 600 difference %HIV RNA < 200copies/mL 95% CI EFV 400 EFV 600 Difference 95%CI HIV RNA <200 copies/ml TT , 4.0 ITT ,4.0 NC=F ,8.6 C=F , 8.6 PP ,-1.5 P , 1.5 %HIV RNA < 50copies/mL HIV RNA <50 copies/ml TT , 4.9 ITT ,4.9 NC=F ,8.8 C=F , 8.8 PP ,2.8 P , 2.8 favours 600mg favours 400mg difference in % suppressed (400mg-600mg) favours 600mg favours 400mg

6 Clinical support for reduced drug regimens First line optimisation Encore1: adverse events at 96 weeks adverse events EFV 400 mg n (%) EFV 600 mg n (%) total n (%) difference (95% CI) P pts with AEs 287 (89.4) 276 (89.3) 0.1 (-4.7, 4.9) 0.97 AE s 1283 (49.4) 1313 (50.6) 2596 (100) - - grade 1 / (49.7) 1242 (50.3) 2467 (95.0) - - grade 3 / 4 58 (2.3) 71 (2.7) 129 (5.0) - - pts with EFV-related AE* pts ceasing EFV due to EFV-related AE* 121 (37.7) 148 (47.9) (-17.9, -2.5) (8.3) 23 (15.5) -7.3 (-14.9, 0.4) 0.07 *definitely or probably

7 Clinical support for reduced drug regimens First line optimisation EFV 400mg: implementation EFV 400mg is non-inferior to EFV 600mg with fewer EFVrelated adverse events CNS toxicity is by-and-large manageable, alternatives are available for those who are intolerant efficacy of 400mg in last trimester of pregnancy and its use with rifampicin in HIV-TB coinfection has been addressed these outcomes have resulted in rapid transition through normative WHO treatment guidelines to recommend routine use of reduced dose EFV

8 Patients With HIV-1 RNA < 50 c/ml, % Clinical support for reduced drug regimens First line optimisation SINGLE: DTG + ABC/3TC vs EFV/TDF/FTC in treatment-naives % DTG + ABC/3TC qd (n = 414) 80% 71% % 72% EFV/TDF/FTC qd (n = 419) 63% CD4 from BL treatment adjusted treatment difference between groups at wk 144: 8.3% (95% CI: ; p = 0.01) 0 BL Wk CD4 wk144 from BL adjusted mean SE difference in response (95% CI) DTG + ABC/3TC (n = 414) (16-78) EFV/TDF/FTC (n = 419) P =.003 Pappa et al, ICAAC 2014

9 Clinical support for reduced drug regimens First line optimisation Gilead 104 and 111: TAF versus TDF, virologic results virologic outcome treatment difference (95% CI) E/C/F/TAF (n=866) E/C/F/TDF (n=867) favours E/C/F/TDF favours E/C/F/TAF HIV-1 RNA <50 c/ml, 60 % % 2.0% 4.7% success failure no data 12% 0 +12% E/C/F/TAF was non-inferior to E/C/F/TDF at week 48 in each study 93% E/C/F/TAF vs 92% E/C/F/TDF (study 104) 92% E/C/F/TAF vs 89% E/C/F/TDF (study 111) high and similar response rates, irrespective of age, sex, race, HIV-1 RNA, and CD4 cell count Wohl et al, CROI 22; 2015.

10 Clinical support for reduced drug regimens First line optimisation What is the next universal first-line regimen? established scheme of 2N(t)RTI backbone and anchor drug unlikely to change for the foreseeable future TAF will replace TDF as a prodrug of TFV due to better safety profile, smaller dose to coformulate while retaining hepatitis B activity integrase inhibitors will replace EFV as anchor drug globally both for initiation and stable switch this will require extensive programmatic changes for the public health approach TLD approved 2017 at low cost Long-acting injectables using an integrase anchor will be developed

11 Clinical support for reduced drug regimens First line optimisation Virological failure New approaches Future of second line

12 Clinical support for reduced dose regimens Virological failure EACS: guidelines for virological failure VF: confirmed HIV-VL > 50c/mL 6 months after starting therapy General measures Review expected potency of the regimen Evaluate adherence, compliance, tolerability, drug-drug interactions, drug-food interactions, psychosocial issues Perform resistance testing on failing therapy and obtain historical resistance testing for archived mutations Tropism testing Consider TDM Review antiretroviral history Identify treatment options, active and potentially active drugs/combinations EACS Guidelines

13 EACS Guidelines Clinical support for reduced dose regimens Virological failure EACS: management of virological failure If HIV-VL > 50 and < c/ml Check for adherence Check HIV-VL 1 to 2 months later If genotype not possible, consider changing regimen based on past treatment and resistance history If HIV-VL confirmed >500 c/ml Change regimen as soon as possible. What to change will depend on the resistance testing results: If no resistance mutations found: recheck for adherence, perform TDM If resistance mutations found: switch to a suppressive regimen based on drug history; multidisciplinary expert discussion advised goal of new regimen: HIV-VL <50 c/ml within 6 months

14 Bartlett and Shao, Lancet 2009 Clinical support for reduced dose regimens Virological failure Treatment failure in the presence of ongoing viral replication Virological failure Immunological failure Clinical failure CD4 cell count Viral load Resistance on NNRTI Resistance on BPI limit of detection

15 WHO Consolidated ART guidelines 2016 Clinical support for reduced dose regimens Virological failure WHO: decision to switch ART regimens in adults Failure Definition Comments Clinical failure Immunological failure Virological failure New or recurrent clinical event indicating severe immunodeficiency (WHO stage 4 condition) after 6 mo of effective treatment CD4 count below 250 cells/µl following clinical failure OR persistent CD4 levels below 100 cells/µl VL >1000 copies/ml based on two consecutive VL measurements in 3 mo, with adherence support Condition must be differentiated from IRIS Certain WHO clinical stage 3 conditions (pulmonary TB, severe bacterial infections), may also indicate treatment failure without concomitant or recent infection to cause a transient decline in the CD4 cell count An individual must be taking ART for at least 6 mo before it can be determined that regimen has failed

16 Clinical support for reduced dose regimens Virological failure APIN PEPFAR Nigeria: immunologic criteria are poor predictors of virologic outcome probability of no regimen failure % n=9690 VL monitoring CD4 monitoring 0.25 CD4 criteria to detect VF sensitivity 58%, specificity 75%, PPV 39% months since ART initiation Rawizza et al, CID 2011

17 Mermin et al, BMJ 2011 Clinical support for reduced dose regimens Virological failure TASO: severe morbidity or mortality, ITT analysis proportion without severe morbidity/ mortality years to first event of severe morbidity or mortality

18 Clinical support for reduced dose regimens Virological failure WHO: diagnosis of treatment failure Viral load is recommended as the preferred monitoring approach to diagnose and confirm ARV treatment failure (strong recommendation, low-quality evidence) If viral load is not routinely available, CD4 count and clinical monitoring should be used to diagnose treatment failure (strong recommendation, moderate-quality evidence) Viral failure is defined by a persistently detectable viral load exceeding 1000c/mL after at least 6 months of starting a new ART regimen Dried blood spot specimens can be used to determine HIV viral load WHO consolidated guidelines 2016

19 Clinical support for reduced drug regimens First line optimisation Virological failure New approaches Future of second line

20 Clinical support for reduced drug regimens New approaches Second-line: LPV/r with 2-3 N(t)RTI or RAL in subjects failing first-line NNRTI/2N(t)RTI inclusion criteria received first-line ART comprising an NNRTI + 2 N(t)RTIs for 24 weeks with no change within 12 weeks prior to screening VF as defined by two consecutive ( 7 days apart) plasma HIV RNA results > 500 copies/ml no previous use of HIV integrase and protease inhibitors nucleoside/nucleotide choices TDF + FTC/3TC 46% AZT + FTC/3TC 18% of 492 participants with baseline GRT 89% had 1 N(t)RTI resistance mutation 60% had M184V plus one or more additional N(t)RTI mutations genotypic antiretroviral testing (GART) prior to randomisation was optional Boyd et al, Lancet 2013.

21 Clinical support for reduced drug regimens New approaches EARNEST: trial design HIV positive adolescents/adults (n=1200) 1 st line NNRTI-based regimen >12mo; > 90% adherence last 1mo failure by WHO (2010) clinical, CD4 (VL-confirmed) or VL criteria randomise PI NRTIs (NRTIs according to local standard of care) PI + RAL PI + RAL (12 wk induction) PI (monotherapy) follow-up for 144 weeks primary outcome at week 96: good HIV disease control defined as all of alive and no new WHO4 events from 0-96 weeks and CD4 cell count > 250 cells/µl at 96 weeks and VL<10,000 c/ml or >10,000 c/ml without PI res. mutations at 96 weeks

22 Clinical support for reduced drug regimens New approaches Second-line trials: baseline SECOND-LINE EARNEST SELECT n= regimen NRTI RAL NRTI RAL PI mono NRTI RAL age (yrs) female (%) HIV-RNA log c/ml ,000 c/ml (%) CD4 cells/µl time on treatment 5.8* 6.1* * time since diagnosis

23 Clinical support for reduced drug regimens New approaches Second-line trials: virological failure Trial SECOND-LINE EARNEST SELECT VF regimen NRTI RAL NRTI RAL PI mono NRTI RAL wk wk *

24 Clinical support for reduced drug regimens New approaches Second-line: antiviral efficacy percent 60 patients HIV RNA <200 copies/ml (ITT) LPV/r + RAL LPV/r + 2-3N(t)RTI 82.6% ( ) 80.8% ( ) P-value= week Boyd et al CROI20 Atlanta 2013

25 Clinical support for reduced drug regimens New approaches Second-line: VF by ggss at baseline and treatment arm 100% 80% HIV-1 RNA <200 c/ml HIV-1 RNA >200 c/ml % 40% 20% 0% n = 117 n = 134 n = 77 n = 86 n = 21 n = 16 NtRTI-arm RAL-arm NtRTI-arm RAL-arm NtRTI-arm RAL-arm ggss: ggss: ggss: ggss = number of available N(t)RTIs with full sensitivity (max=6) n = 451

26 Clinical support for reduced drug regimens New approaches EARNEST: resistance at 96 wks predicted in whole population % of randomised patients with intermediate/ high level resistance PI/NRTI PI/RAL PI mono X 0 1 * 0 X NRTI RAL LPV NRTI RAL LPV NRTI RAL LPV

27 Clinical support for reduced drug regimens New approaches SECOND-LINE, EARNEST and SELECT: conclusions a novel antiretroviral therapy regimen of RAL combined with LPV/r is non-inferior to a WHO-recommended second-line regimen (ritonavir-boosted lopinavir combined with two or three nucleoside or nucleotide reverse transcriptase inhibitors) support the current WHO-recommended approach for management of first-line treatment failure the simpler combination of an HIV integrase inhibitor combined with boosted lopinavir may extend the successful public health approach to the provision of second-line ART PI monotherapy is inferior to PI/NRTI: lower VL suppression, more resistance. PI monotherapy is unsuitable for public health approach new/recycled NRTIs retain substantial virological activity in second line with little added toxicity

28 Clinical support for reduced drug regimens First line optimisation Virological failure New approaches Future of second line

29 Clinical support for reduced dose regimens Future of second line WHO: preferred second-line ART regimens for adults Population failing first-line regimen preferred second-line regimen alternative second-line regimen Adults 2 NRTIs + EFV (or NVP) 2 NRTIs + DTG 2 NRTIs + ATV/r or LPV/r 2 NRTIs + DRV/r WHO consolidated guidelines 2016

30 Clinical support for reduced dose regimens Future of second line The case for improved second-line cart cart provided in low and middle income countries (LMIC) through donor agency programs Programs delivered care to 18 million people by 2017; projected to increase to 30 million by 2020 Standardised treatment regimens using coformulated drugs First line therapy failure rate 15% per annum Failure results in switching to a more expensive second-line ARV regimen (US$465 py versus US$146 py) Simple and sustainable approach needed for second-line therapy

31 Clinical support for reduced dose regimens Future of second line Ideal second-line cart Criteria for ideal second-line cart regimen in resource limited settings: 1 o criteria include agents with high potency high genetic barriers to resistance established safety profiles good tolerance 2 o criteria able to be administered once-daily no impact on the activities of daily living able to be co-formulated. SECOND-LINE study satisfied 1 o criteria only

32 Clinical support for reduced dose regimens Future of second line D 2 EFT trial Innovative cart regimen of dolutegravir (DTG) and ritonavir boosted darunavir (DRV/r) Designed to confirm safety and efficacy of innovative regimen test non-inferiority to the current WHO standard of care (SOC) second line regimen be applicable to LMIC settings satisfy secondary criteria of ideal second line cart regimen

33 Clinical support for reduced dose regimens Future of second line D 2 EFT: potential public health benefits Non-inferiority of a DTG and DRV/r regimen could lead to single regimen of one pill, once-daily ARV for both first- and second-line therapy clinical care in a task-shifted environment simplified beyond first-line therapy drug resistance testing not required for secondline treatment reduce costs and complexity uncomplicated regimen simplified supply-chain and distribution, reducing costs and improving the durability of supply overcome the current commercial limitations for these drugs in resource-limited settings

34 Clinical support for reduced dose regimens Future of second line 3 D 2 EFT: study design Randomisation 1:1 n=610 SOC regimen (DRV/r + 2N(t)RTIs) DTG regimen (DTG + DRV/r) 1 45 day screening week 0 week 48 week 96 Failed first-line NNRTI + 2N(t)RTI combination therapy (HIV RNA >500 copies/ml after 24 weeks continuous firstline therapy) No prior exposure to PIs or INSTIs 2 All eligibility criteria met 4 Primary endpoint (week 48) proportion with pvl <50 copies/ml safety endpoints

35 Clinical support for reduced dose regimens Future of second line DAWNING: study design Open-label randomised noninferiority phase IIIb study Open label, randomised 1:1 DTG + 2 NRTIs LPV/RTV + 2 NRTIs DTG + 2 NRTIs Continuation phase Randomisation week 24 interim analysis week 48 primary analysis week 52 Key eligibility criteria: on first-line 2 NRTIs + NNRTI regimen for 6 months, failing virologically (HIV-1 RNA 400 c/ml on 2 occasions); no primary viral resistance to PIs or INSTIs; at least one active NRTI in backbone Stratification: by HIV-1 RNA ( or >100,000 copies/ml), number of fully active NRTIs in the investigator-selected study background regimen (2 or <2) Primary endpoint: proportion with HIV-1 RNA <50 c/ml at Week 48 using the FDA snapshot algorithm (12% noninferiority margin) Aboud et al. IAS 2017

36 HIV-1 RNA <50 c/ml, % Clinical support for reduced dose regimens Future of second line DAWNING: snapshot outcomes at week 24 DTG + 2 NRTIs is superior to LPV/RTV + 2 NRTIs with respect to snapshot in the ITT-E (<50 c/ml) at week 24, P< Virologic outcomes DTG + 2 NRTIs (ITT-E, n=312) LPV/RTV + 2 NRTIs (ITT-E, n=312) DTG + 2 NRTIs (PP, n=282) Treatment differences (95% CI) LPV/RTV DTG ITT-E 20 0 Virologic success CI, confidence interval; ITT-E, intentto-treat exposed; PP, per protocol. LPV/RTV + 2 NRTIs (PP, n=275) PP Aboud et al, IAS 2017 Paris

37 Clinical support for reduced dose regimens Future of second line DAWNING: snapshot outcomes by key baseline subgroups at week ITT-E, intent-to-treat exposed DTG + 2 NRTIs LPV/RTV + 2 NRTIs HIV-1 RNA <50 c/ml % / 215/ / 181/ / 70 34/ 63 45/ 61 35/ / 180/ / 100/ / / Overall 100,000 >100,000 2 <2 < HIV-1 RNA c/ml Fully active NRTIs CD4+ count cells/mm 3 Aboud et al, IAS 2017

38 Clinical support for reduced dose regimens Future of second line First-line ART regimens for adults After failure Preferred regimen Alternative regimens Special circumstances TDF + 3TC (or FTC) + EFV AZT + 3TC + EFV (or NVP) TDF + 3TC (or FTC) + DTG TDF + 3TC (or FTC) + EFV 400 TDF + 3TC (or FTC) + NVP Regimens containing ABC and boosted PIs WHO second-line WHO second-line No evidence base WHO second-line WHO second-line WHO consolidated guidelines 2016

39 Clinical support for reduced dose regimens Future of second line First-line DTG failures Retain DTG and switch NRTIs within class Retain DTG and switch NRTIs to boosted PI Retain DTG and switch NRTIs to NNRTI (eg RPV) Switch to new NRTIs and boosted PI Switch to new NRTIs and NNRTI Switch to NNRTI and boosted PI

40 Clinical support for reduced dose regimens Future of second line Conclusion Unmet need for a simple regimen of second-line cart for use in LMIC Such a regimen should offer a realistic opportunity for coformulation into a one pill, once daily tablet and inform if prescription could be made without the need for HIV drug resistance testing These characteristics would permit a public health approach (red-pill first-line, blue-pill second-line) to the management of HIV disease in LMIC At a time of flat line funding to donor agencies, this is a critical initiative that will allow ambitious treatment objectives to be realised If non-inferiority established, it will influence guideline change, resulting in rapid translation of findings into the treatment of millions of people in LMIC

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