Connie Celum1,2,3, Ting Hong1, Anne Cent4, Deborah Donnell1,5, Rhoda Morrow4,5, Jared M Baeten1,2,3, Cynthia Firnhaber6, Beatriz Grinsztejn7, Mina C Hosseinipour8, Umesh Lalloo9, Mulinda Nyirenda10, Cynthia Riviere11, Jorge Sanchez12, Breno Santos13, Khuanchai Supparatpinyo14, James Hakim15, N Kumarasamy16, Thomas B Campbell17. 1. Department of Global Health, University of Washington , Seattle, Washington, USA. 2. Department of Medicine, University of Washington , Seattle, Washington, USA. 3. Department of Epidemiology, University of Washington, Seattle, Washington, USA. 4. Laboratory Medicine, University of Washington, USA. 5. Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. 6. Clinical HIV Research Unit, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. 7. Evandro Chagas Clinical Research Institute, FIOCRUZ, Rio de Janeiro, Brazil. 8. Kamuzu Central Hospital, Lilongwe, Malawi. 9. Nelson R. Mandela School of Medicine, Durban, South Africa. 10. Department of Medicine, College of Medicine, Blantyre, Malawi. 11. Institut Nacional de laboratoire et de Recherches, Port-au-Prince, Haiti. 12. Asociación Civil Impacta Salud y Educación, Lima, Peru. 13. Servico de Infectology, Hospital Nossa Senhora da Conceicao -GHC, Porto Alegre, Brazil. 14. Department of Medicine, Research Institute for Health Sciences, Chiang Mai University, Thailand. 15. University of Zimbabwe College of Health Sciences, Harare, Zimbabwe. 16. YRG Centre for AIDS Research and Education, Chennai, India. 17. Department of Medicine, University of Colorado School of Medicine, Aurora, USA.
Abstract
Objective: Tenofovir disoproxyl fumarate (TDF) disoproxyl fumarate (TDF) has in vitro activity against herpes simplex virus type 2 (HSV-2) and reduced HSV-2 acquisition as preexposure prophylaxis. Whether TDF-containing antiretroviral therapy (ART) reduces HSV-2 acquisition is unknown. Design: Secondary analysis of AIDS Clinical Trials Group A5175, a randomized, open-label study of 3 ART regimens among 1571 participants. Methods:HSV-2 serostatus was assessed at baseline, at study exit, and before a change in ART regimen. Results: Of 365 HSV-2-seronegative persons, 68 acquired HSV-2, with 24 receivingTDF-containing ART and 44 receiving ART without TDF (HSV-2 seroconversion incidence, 6.42 and 6.63 cases/100 person-years, respectively; hazard ratio, 0.89; 95% confidence interval, .55-1.44). Conclusions: HSV-2 acquisition was not reduced in HIV-infected, HSV-2-uninfected persons during TDF-containing ART.
RCT Entities:
Objective: Tenofovir disoproxyl fumarate (TDF) disoproxyl fumarate (TDF) has in vitro activity against herpes simplex virus type 2 (HSV-2) and reduced HSV-2 acquisition as preexposure prophylaxis. Whether TDF-containing antiretroviral therapy (ART) reduces HSV-2 acquisition is unknown. Design: Secondary analysis of AIDS Clinical Trials Group A5175, a randomized, open-label study of 3 ART regimens among 1571 participants. Methods:HSV-2 serostatus was assessed at baseline, at study exit, and before a change in ART regimen. Results: Of 365 HSV-2-seronegative persons, 68 acquired HSV-2, with 24 receiving TDF-containing ART and 44 receiving ART without TDF (HSV-2 seroconversion incidence, 6.42 and 6.63 cases/100 person-years, respectively; hazard ratio, 0.89; 95% confidence interval, .55-1.44). Conclusions: HSV-2 acquisition was not reduced in HIV-infected, HSV-2-uninfected persons during TDF-containing ART.
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