" Susceptibility to transmitting HIV in ART- treated individuals: Longitudinal analysis from Stratall ANRS 12110/ESTHER trial." Julien COHEN 1,2,3, Sylvie.

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" Susceptibility to transmitting HIV in ART- treated individuals: Longitudinal analysis from Stratall ANRS 12110/ESTHER trial." Julien COHEN 1,2,3, Sylvie BOYER 1,2,3, Charles KOUANFACK 4, Maria Patrizia CARRIERI 1,2,3, Gilbert NDZIESSI 1,2,3, Camélia PROTOPOPESCU 1,2,3, Jean-Paul MOATTI 1,2,3, Eric DELAPORTE 5,6, Christian LAURENT 5,6, Bruno SPIRE 1,2,3 and the Stratall ANRS 12110/ESTHER Study Group 1 INSERM, U912 (SE4S), Marseille, France 2 Université Aix Marseille, IRD, UMR-S912, Marseille, France 3 ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d’Azur, Marseille, France 4 Central Hospital, Yaoundé, Cameroon 5 Institut de Recherche pour le Développement (IRD), University Montpellier 1, UMR 145, Montpellier, France 6 Department of Infectious and Tropical Diseases, University Hospital, Montpellier, France

Background (1) ART preventive intervention for reducing sexual HIV transmission: High efficacy of antiretroviral therapy for vertical transmission A 92% reduction in transmission among 3381 ART- treated heterosexual African couples Donnel, 2010 HPTN 052 trial: Immediate ART initiation reduced HIV-infection in sexual partners by 96% compared with ART initiation following WHO guidelines.

Background (2) Reduction of HIV transmission by ART Behavioral disinhibition concerning condom use? Longitudinal data from the ANRS STRATALL study were used to explore : the course of sexual risk of HIV-transmission during the first 24 months of treatment in ART naïve HIV- infected adults the characteristics of viremic ART-treated PLWHA who do not consistently use condoms

Methods (1) Stratall ANRS 12110/ESTHER : 24-month, randomized, open-label trial Enrolled 459 HIV-infected adults followed-up in rural district hospitals in Cameroon Primary objective : to compare the increase in CD4 cell counts in two groups using:  Either the recommended WHO “public health” approach for low-income countries  Or the standard approach used in developed countries

Methods (2) Plasma viral load measured during clinical visits at M0, M6, M12, M18 and M24. Psychosocial data (including sexual behaviors and healthcare staff’s readiness to listen) collected using face-to-face questionnaires administered at M0, M6, M12 and M24

Methods (3) 361 patients sexually active at least once between M0 and M patients sexually active with complete data on condom use Study population

Methods (4) Stable virological success (SVS) : having an undetectable viral load (<40 copies/ml) for more than 6 months. Inconsistent condom use (ICU): Not using condoms with HIV-negative partners or those with unknown serostatus at least once in the three months prior to the visit Susceptibility to transmitting HIV was defined as: lack of SVS + ICU

Methods (5) McNemar tests were performed to assess changes in ICU and susceptibility to transmitting HIV during follow-up A mixed logistic regression model was used to identify correlates of susceptibility to transmitting HIV

Results (1) Proportion of patients with detectable viral load among patients sexually active during follow-up (n=290)

Results (2) Proportion of ICU among patients sexually active during follow-up (n=290)

Results (3) Proportion of patients susceptible to transmitting HIV among those sexually active during follow-up (n=290)

Results (4) Factors associated with susceptibility to transmitting HIV (Mixed logistic regression, N=290 patients, 593 visits) AOR [95% CI]P-value Time since ART initiation - M0 (ref) - M6 - M12 - M [ ] 0.16 [ ] 0.11 [ ] <10 -3 More than one sexual relationship per week 2.01 [ ] 0.05 More than one sexual partner 2.44 [ ] 0.03 Limited readiness by health staff to listen 1.81 [ ]0.05

Conclusion Despite an increase in ICU, the proportion of individuals susceptible to transmitting HIV decreased and remained low. Fear of behavioral disinhibition should not be a barrier to universal access to treatment. Reinforcing healthcare staff’s counseling skills may be crucial for positive prevention.

Acknowledgments Participating patients & hospital teams Sponsorship: - French National Agency for Research on AIDS and viral hepatitis (ANRS) -French Public Interest Group ESTHER -SIDACTION The Stratall ANRS 12110/ESTHER trial Study Group C. Kouanfack, S. Koulla-Shiro (Central hospital, Yaoundé, Cameroon); A. Bourgeois, E. Delaporte, C. Laurent (IRD, University Montpellier 1, UMR 145, Montpellier, France); G. Laborde-Balen (French Ministry of Foreign Affairs, Yaoundé, Cameroon); T. Atemkeng Fotsop, M. Dontsop, S. Kazé, J-M. Mben, M-A. Ngo Hamga, Z. Tsomo (IRD, Yaoundé, Cameroon); A. Aghokeng, M.G. Edoul, E. Mpoudi-Ngolé, M. Tongo (Virology Laboratory, IMPM/CREMER/IRD-UMR 145, Yaoundé, Cameroon); J. Blanche, S. Boyer, M.P. Carrieri, J. Cohen, S. Loubière, M. Meresse, F. Marcellin, J-P. Moatti, B. Spire (INSERM, IRD, University Aix Marseille, UMR 912, Marseille, France); C. Abé, S-C. Abega, C-R. Bonono, H. Mimcheu, S. Ngo Yebga, C. Paul Bile (IRSA, Catholic University of Central Africa, Yaoundé, Cameroon); S. Abada, T. Abanda, J. Baga, P. Bilobi Fouda, P. Etong Mve, G. Fetse Tama, H. Kemo, A. Ongodo, V. Tadewa, HD. Voundi (District Hospital, Ayos, Cameroon); A. Ambani, M. Atangana, J-C. Biaback, M. Kennedy, H. Kibedou, F. Kounga, M. Maguip Abanda, E. Mamang, A. Mikone, S. Tang, E. Tchuangue, S. Tchuenko, D. Yakan (District Hospital, Bafia, Cameroon); J. Assandje, S. Ebana, D. Ebo’o, D. Etoundi, G. Ngama, P. Mbarga Ango, J. Mbezele, G. Mbong, C. Moung, N. Ekotto, G. Nguemba Balla, G. Ottou, M. Tigougmo (District Hospital, Mbalmayo, Cameroon); R. Beyala, B. Ebene, C. Effemba, F. Eyebe, M-M. Hadjaratou, T. Mbarga, M. Metou, M. Ndam, B. Ngoa, EB. Ngock, N. Obam (District hospital, Mfou, Cameroon); A. M. Abomo, G. Angoula, E. Ekassi, Essama, J.J. Lentchou, I. Mvilongo, J. Ngapou, F. Ntokombo, V. Ondoua, R. Palawo, S. Sebe, E. Sinou, D. Wankam, I. Zobo (District hospital, Monatélé, Cameroon); B. Akono, A. L. Ambani, L. Bilock, R. Bilo’o, J. Boombhi, F.X. Fouda, M. Guitonga, R. Mad’aa, D.R. Metou’ou, S. Mgbih, A. Noah, M. Tadena, Ntcham (District hospital, Nanga Eboko, Cameroon); G. Ambassa Elime, A.A. Bonongnaba, E. Foaleng, R.M. Heles, R. Messina, O. Nana Ndankou, S.A. Ngono, D. Ngono Menounga, S.S. Sil, L. Tchouamou, B. Zambou (District hospital, Ndikinimeki, Cameroon); R. Abomo, J. Ambomo, C. Beyomo, P. Eloundou, C. Ewole, J. Fokom, M. Mvoto, M. Ngadena, R. Nyolo, C. Onana, A. Oyie (District hospital, Obala, Cameroon); P. Antyimi, S. Bella Mbatonga, M. Bikomo, Y. Molo Bodo, S. Ndi Ntang, P. Ndoudoumou, L. Ndzomo, S.O. Ngolo, M. Nkengue, Nkoa, Y. Tchinda (District hospital, Sa’a, Cameroon ).

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