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On Demand PrEP
with Oral TDF/FTC in MSM
Results of the ANRS IPERGAY Trial Economic
Evaluation
Isabelle DURAND-ZALESKI, Pierre MUTUON, Isabelle CHARREAU, Cecile
TREMBLAY, Daniela ROJAS, Gilles PIALOUX, Christian CHIDIAC, Catherine
CAPITANT, Bruno SPIRE, Laurent COTTE, Julie CHAS, Laurence MEYER, and
Jean Michel MOLINA for the ANRS IPERGAY Study Group*.
Henri Mondor & Hotel Dieu hospital, university Paris 12, UMR 1123, Hospital
Saint-Louis and University of Paris 7, Inserm SC10-US019 Villejuif, Hospital
Tenon, Paris, Hospital Croix-Rousse, Lyon, UMR912 SEAS Marseille, France,
CHUM, Montreal, Canada
and ANRS, Paris, France
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Disclosures
 Advisory Boards: BMS, Pfizer, GSK, Janssen, Abbvie,
MSD
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Background
 High number of new HIV infections among MSM in
France and Canada
 Ipergay used a more convenient (and potentially
cheaper) dosing regimen: « On Demand »
 High costs of TDF/FTC: the sustainability of
debated
Keller SB, Smith DM. The price of tenofovir-emtricitabine undermines the cost-effectiveness and
advancement of pre-exposure prophylaxis. AIDS. 2011 Nov 28;25(18):2308-10
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PrEP is
Ipergay event driven iPrep
 2 tablets (TDF/FTC or placebo) 2-24 hours before sex
 1 tablet (TDF/FTC or placebo) 24 hours later
 1 tablet (TDF/FTC or placebo) 48 hours after first intake
Friday
Saturday
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Monday
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Tuesday
Wednesday
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Economic evaluation
• Viewpoint of the healthcare system
• 1 year time horizon
• Medical direct costs including counseling, PrEP
(€501 per 30 tablets), treatments of STIs
• Initial costs of the program documented
• Costs of the placebo arm set to zero
• Average cost per participant and cost per infection
averted (cost x NNT)
• Scenario and sensitivity analyses
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Ipergay clinical trial results
400 participants
Mean follow-up of 13 months
16 subjects infected
14 in placebo arm (incidence: 6.6 per 100 PY),
2 in TDF/FTC arm (incidence: 0.91 per 100 PY)
86% relative reduction in the incidence of HIV-1
(95% CI: 40-98, p=0.002)
NNT for one year to prevent one infection : 18
133 STIs diagnosed in the TDF/FTC arm
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Ipergay economic results
total one-year costs of PrEP were €4,812/participant
N= 199 participants on TDF/FTC
Average utilization
Cost per participant (€)
Mean (sd)
Counseling & pre PrEP workup
On demand TDF-FTC (tablets per month)
1
748
15.62 (7.2)
3,129 (1,449)
8.6 (5.1)
126 (74)
0.3 (0.6)
16 (36)
8.2 (5.12)
205 (128)
16 (10.0)
31 (19)
HIV ELISA tests
HIV Plasma viral loads
Consultations (protocol-driven)
Serum creatinin & ALAT (protocol driven)
Total cost of STIs (mostly chlamydia)
793 (479)
Total per participant
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4,812 (2,758)
Cost effectiveness ratios
€84,691 per HIV infection averted at current drug prices
Red : ICER at current drug price
(€500.88 per 30 tablets);
Blue: ICER at French
discounted drug price
(€200.35 per 30 tablets in 2017);
Green : ICER at cost neutral
drug price (€60 per 30 tablets);
NNT= number needed to treat=
18 participants to avoid 1 HIV
infection
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Acceptability curves
Red : ICER at current drug
price (€500.88 per 30
tablets);
Blue: ICER at French
discounted drug price
(€200.35 per 30 tablets in
2017);
Green : ICER at cost
neutral drug price (€60
per 30 tablets)
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Discussion
At current drugs prices, the yearly cost of avoiding 1 infection is about 3-4
times the yearly cost of treatment
Other benefits must be considered:
• Secondary infections: an estimated 1.6 to 2.3 secondary infections
averted for each non-infected person
• Treatment of STIs
• Improved access to healthcare for vulnerable populations
• Improved quality of life
• PrEP may not be lifetime
Lower drug prices will proportionally improve the cost effectiveness of PrEP
PrEP in a population with higher incidence of HIV infection (and lower NNT)
will be more efficient
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Conclusions
 Strategies based on detection and treatment of HIV
infection are insufficient to eradicate HIV
 Despite its high price, PrEP is a useful complement
 on-demand PrEP has received conditional approval in France
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Acknowledgments
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The Participants
The Study Staff and Peer-Counselors
The Trial Scientific Committee
The DSMB
The Community Advisory Board
The ANRS Staff
INSERM SC10-US19
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Acknowledgments
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The Study Staff and Peer-Counselors
- Paris St-Louis: C. Pintado, B. Loze, C. Delaugerre, P. Charbonneau, C. Gatey, D. Ponscarme, P. Penot, L. Niedbalski, R. Veron,
J. Delgado, E. Dalle, S. Parlier, I. Madelaine, J. Fonsart, M. Danet, N. Mahjoub, N. Mezreb, K. Moudachirou, S. Morel, G. Conort, F. Lorho, M.
Meunier, W. Rozenbaum, JM Molina
- Paris Tenon: J. Chas, C. Monfort, J. Foucoin, B. Boissavy, S. Cousseau, S. Huon, M. Danet, A. Djessima, A. Adda,
S. le Nagat, L. Zarka, J. Berdougo, G. Pialoux
-Lyon: C. Chidiac, N. Mzoughi, F. Clement, A. Decouty, C. Chapolard, M. Godinot, C. Adouard-groslafeige, J. Koffi, A. Pansu, A. Becker, S.
Pailhes, F. Bonnet, F. Jeanblanc, C. Brochier, X. Teruin, S. Rouby, L. Gilly; L. Cotte
- Montréal: C. Beauvais, P. Arlotto, C. Fortin, A. Talbot, A. McKenzie, M. Blanchette, R; Rousseau, K. Montheuth, D. Thompson, M. Morin, M.
Wainberg, C. Tremblay
- Nice: C. Etienne, F. Tolonin, S. Breaud, V. Péchenot, S. Bagge, T. Cepitelli, E. Cua
- Lille: A. Cheret, P. Cornavin, S. Vandamme, J. Lambec, N. Dumon, O. Leclanche, T. Huleux, R. Biekre, O. Robineau, H. Melliez,
H. Bazus, A. Pasquet
- Nantes: C. Bernaud, M. Besnier, B. Bonnet, N. Hall, M. Cavellec, H. Hue, L. Larmet, M. Colas, R. Choquet, F. Raffi
The Trial Scientific Committee: JM Molina, M. Wainberg, C. Tremblay, G. Pialoux, L. Cotte, Ar. Pasquet, E. Cua, M. Besnier, W. Rozenbaum, C.
Chidiac, C. Delaugerre, N. Bajos, J. Timsit, G. Peytavin, J. Fonsart, I. Durand-Zaleski, L. Meyer, B. Spire, M. Suzan-Monti, G. Girard, D. Rojas Castro,
M. Préau, D. Thompson, C. Capitant, A. Menecier, V. Doré, MC. Simon, I. Charreau, J. Otis, F. Lert, A. Diallo
The DSMB: AM Taburet, VK Nguyen, Y. Yazdanpanah, C. Taeron, D. Costagliola
The Community Advisory Board: S. Karon, D. Villard (Action Santé Alternative), JM Astor (Boucle Rouge), D. Ganaye (Federation LGBT), T. Craig
(Act-Up), B. Brive (J’y suis j’y reste), R. Orioli (les flamands roses), M. Vanhedde (Solidarite SIDA), H. Baudoin (Sida info service), H. Fisher (TRT-5)
INSERM SC10-US19 : L. Meyer, C. Capitant, I. Charreau, E. Netzer, N. Leturque, J. Binesse, V. Foubert, M. Saouzanet, F. Euphrasie,
B. Guillon, Y. Saïdi, JP Aboulker
INSERM UMR 912: B. Spire, M. Suzan, G. Cattin, B. Demoulin, L. Sagaon-Teyssier, N. Lorente
ANRS: V. Doré, I. Porteret, L. Marchand, S. Lemestre, A. Menecier, N. Etien, MC Simon, JF Delfraissy
AIDES: JM. Le Gall, S. Morel, V. Pechenot , S. Bagge , A. Djessima Taba, M Danet, K. Moudachirou , B. Dos Santos , J. Lambec , S. Rouby , X. Teruin ,
N. Dumon , V. Coquelin , P. Brunet, L. Gilly, T. Cepitelli, R. Porion, D. Rojas Castro, B. Spire
Rezo Canada: D. Thompson
Canadian Trial Network: J. Sas, J. Pankovitch, M. Klein, A. Anis
Gates Foundation: S. Becker, S. Sow, J. Presley, M. Aikenhead
Fondation Pierre Bergé/SIDACTION
Gilead: J. Rooney, A. Cheng, P. Petour, C. Rabian , V. Berrebi
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