The injectables: a new silver bullet?
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- Clare Walker
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1 The injectables: a new silver bullet? Geneva October 6 Francois Venter Wits Reproductive Health and HIV Institute Thanks Clinical Care Options, Helen Rees, Joe Eron, Wits RHI sex worker team
2 Disclosures Part of optimisation collaborations grants to improve testing, new drug regimens, linkage to care Pharma (including drug donations for studies) and managed care
3 The silver bullet For ART treatment and PrEP Note: benefits in most of medicine is incremental
4
5 LATTE-: Cabotegravir IM + Rilpivirine IM for Long-Acting Maintenance ART Multicenter, open-label phase IIb study Cabotegravir: integrase inhibitor Induction Phase* Maintenance Phase Wk primary analysis Wk 6: RPV Wk PO added Wk ART-naive HIVinfected pts with CD4+ cell count > cells/mm (N = 9) Wk 96 CAB 4 mg IM + RPV 6 mg IM Q4W (n = 5) CAB mg PO QD + ABC/TC CAB 6 mg IM + RPV 9 mg IM Q8W (n = 5) CAB mg PO + ABC/TC PO QD (n = 56) 6 pts discontinued for AEs or death in induction analysis. *Pts with HIV- RNA < 5 c/ml from Wk 6 to Wk continued to maintenance phase. Loading dose: Day, CAB 8 mg + RPV 6 mg. Loading dose: Day, CAB 8 mg + RPV 9 mg; Wk 4, CAB 6 mg. Margolis DA, et al. CROI 6. Abstract LB. Slide credit: clinicaloptions.com
6 LATTE-: Wk Efficacy and Safety HIV- RNA <5 c/ml (%) Treatment Differences (95% CI): Q4W IM vs Oral:.8 (-5.8 to.5) Q8W IM vs Oral:.7 (-4.8 to.) Most frequent ISRs were pain (67%), swelling (7%), and nodules (6%) IM CAB + RPV Q4W (n = 5) IM CAB + RPV Q8W (n = 5) Oral CAB + ABC/TC (n = 56) 8 6 ISR events/injection:.5 99% of ISRs grade /; none grade 4 % of pts withdrew for ISRs 4 Oral Arm (n = 56) Drug-related grade /4 AEs (excluding ISRs) Serious AEs 6 5 AEs leading to withdrawal AEs, % Pooled IM Arms (n = ) < 4 Virologic Success 4 Virologic Nonresponse 5 < 5 No Virologic Data No INSTI, NNRTI, or NRTI resistance mutations detected Margolis DA, et al. CROI 6. Abstract LB. Slide credit: clinicaloptions.com
7 LATTE-: Wk Pt Satisfaction With Maintenance Therapy vs Oral Induction How satisfied are you with your current treatment? (vs oral induction treatment) More Neutral Pts (%) Less Neutral Less More 8 How satisfied would you be to continue with your present form of treatment? (vs oral induction treatment) Q8W (n = 6) Q4W (n = ) Oral CAB (n = 49) Margolis DA, et al. CROI 6. Abstract LB Q8W (n = 6) Q4W (n = ) Oral CAB (n = 49) Slide credit: clinicaloptions.com
8 Other Potential Long-Acting ARVs Agent MoA Study results MK-859 (EFdA) NRTI[] Phase I study: treatment-naive pts, single -mg dose (N = 6) Mean t/: 8 hrs Mean VL reduction at days postdose:.78 log BNC7, VRC Broadly neutralizing antibodies (bnabs) BNC7: single infusion reduced VL up to.5 log (n = 7); mean t/: 9 days[] VRC: single infusion reduced VL up to.8 log in treatment-naive pts (n = 8); minimal responders exhibited resistant virus at BL[]. Friedman EJ, et al. CROI 6. Abstract 47LB.. Caskey M, et al. Nature. 5;5: Lynch RM, et al. Sci Transl Med. 5;7:9ra6. Slide credit: clinicaloptions.com
9 And nanoparticles.
10 Concerns?breakthrough on PrEP may lead to prolonged exposure to drug, accumulating resistance Serious side effects means lead-in dose
11 But. What problem are we trying to fix?
12 Adherence issues generally? But PrEP adherence ins some groups >9% And treatment improving Thanks Joe Eron
13 Improved outcomes may be more dependent on social support than new drugs Thanks: Simon Collins
14 And special populations? TAPS project adherence superb to ART and PrEP IDUs? Similarly if support them, they take their treatment and PrEP Psychiatric, adolescent, chaotic patients
15 Clinics in central Johannesburg Thanks to Sam Lalla-Edwards and team, M&E Dept, RHI First and Second line regimens at ART initiation for Jan to Dec 5 Facility name JAN HCHC Yeoville 8 Albert Jeppe Clinic Joubert Park Rosettenville Malvern Jeppe Street Bellavista Crown Gardens Mayfair Bezvalley Glenanda SRH South Hills Kibler Park CMJAH FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC TOTAL INITIATIONS st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line st Line nd Line 6
16 First and Second line regimens at ART initiation for Jan to Dec 5 FEB M A R APR MAY JUN JUL AUG SEP OCT NOV DEC TOTAL INITIATIONS
17 Thanks: Andrew Hill In press, SAMJ
18 ART is starting to look increasingly like contraception Oral, injectables, implantables, rings. Interesting to examine the history slow and steady move towards more long acting agents But: breakthrough pregnancies ESPECIALLY if no reminders/ support
19 Injectables are exciting But we must be careful about what problem we are fixing Complex if a lead-in oral dose Will not cure bad health systems Need lots of real world and adherence research Lessons from the contraceptive world
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