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VIROLOGIC OUTCOMES IN EARLY ANTIRETROVIRAL TREATMENT: HPTN 052
HPTN 052
Early ART
Viral suppression
Virologic failure
Virologic outcomes
HIV prevention
Author
Eshleman, Susan H.
Wilson, Ethan A.
Zhang, Xinyi C.
Ou, San-San
Piwowar-Manning, Estelle
Eron, Joseph J.
McCauley, Marybeth
Gamble, Theresa
Gallant, Joel E.
Hosseinipour, Mina C.
Kumarasamy, Nagalingeswaran
Hakim, James G.
Kalonga, Ben
Pilotto, Jose H.
Grinsztejn, Beatriz
Godbole, Sheela V.
Chotirosniramit, Nuntisa
Santos, Breno Riegel
Shava, Emily
Mills, Lisa A.
Panchia, Ravindre
Mwelase, Noluthando
Mayer, Kenneth H.
Chen, Ying Q.
Cohen, Myron S.
Fogel, Jessica M.
Wilson, Ethan A.
Zhang, Xinyi C.
Ou, San-San
Piwowar-Manning, Estelle
Eron, Joseph J.
McCauley, Marybeth
Gamble, Theresa
Gallant, Joel E.
Hosseinipour, Mina C.
Kumarasamy, Nagalingeswaran
Hakim, James G.
Kalonga, Ben
Pilotto, Jose H.
Grinsztejn, Beatriz
Godbole, Sheela V.
Chotirosniramit, Nuntisa
Santos, Breno Riegel
Shava, Emily
Mills, Lisa A.
Panchia, Ravindre
Mwelase, Noluthando
Mayer, Kenneth H.
Chen, Ying Q.
Cohen, Myron S.
Fogel, Jessica M.
Affilliation
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, MD, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, MD, USA.
University of North Carolina at Chapel Hill. Department of Medicine. Chapel Hill, NC, USA.
Science Facilitation Department. FHI 360. Washington, DC, USA.
Science Facilitation Department. FHI 360. Durham, NC, USA.
Southwest CARE Center. Santa Fe, NM, USA.
University of North Carolina at Chapel Hill. Institute for Global Health and Infectious Diseases. Chapel Hill, NC, USA / UNC Project-Malawi. Institute for Global Health and Infectious Diseases. Lilongwe, Malawi.
YRGCARE Medical Centre. VHS. Chennai, India.
University of Zimbabwe. Department of Medicine. Harare, Zimbabwe.
College of Medicine-Johns Hopkins Project. Blantyre, Malawi.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Hospital Geral de Nova Iguaçu. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
National AIDS Research Institute (ICMR). Pune, India.
Chiang Mai University. Research Institute for Health Sciences. Chiang Mai, Thailand.
Hospital Nossa Senhora da Conceição. Porto Alegre, RS, Brasil.
Botswana Harvard AIDS Institute. Gaborone, Botswana.
Centers for Disease Control and Prevention. Division of HIV/AIDS Prevention and Kenya Medical Research Institute (KEMRI)/CDC Clinical Research Site. Kisumu, Kenya.
University of the Witwatersrand. Perinatal HIV Research Unit. Soweto HPTN CRS. Soweto, South Africa.
University of the Witwatersrand. Department of Medicine. Clinical HIV Research Unit. Johannesburg, South Africa.
The Fenway Institute. Fenway Health/Infectious Disease Division. Beth Israel Deaconess Medical Center. Department of Medicine. Harvard Medical School. Boston, MA, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
University of North Carolina at Chapel Hill. Department of Medicine. Chapel Hill, NC, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, MD, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, MD, USA.
University of North Carolina at Chapel Hill. Department of Medicine. Chapel Hill, NC, USA.
Science Facilitation Department. FHI 360. Washington, DC, USA.
Science Facilitation Department. FHI 360. Durham, NC, USA.
Southwest CARE Center. Santa Fe, NM, USA.
University of North Carolina at Chapel Hill. Institute for Global Health and Infectious Diseases. Chapel Hill, NC, USA / UNC Project-Malawi. Institute for Global Health and Infectious Diseases. Lilongwe, Malawi.
YRGCARE Medical Centre. VHS. Chennai, India.
University of Zimbabwe. Department of Medicine. Harare, Zimbabwe.
College of Medicine-Johns Hopkins Project. Blantyre, Malawi.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Hospital Geral de Nova Iguaçu. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
National AIDS Research Institute (ICMR). Pune, India.
Chiang Mai University. Research Institute for Health Sciences. Chiang Mai, Thailand.
Hospital Nossa Senhora da Conceição. Porto Alegre, RS, Brasil.
Botswana Harvard AIDS Institute. Gaborone, Botswana.
Centers for Disease Control and Prevention. Division of HIV/AIDS Prevention and Kenya Medical Research Institute (KEMRI)/CDC Clinical Research Site. Kisumu, Kenya.
University of the Witwatersrand. Perinatal HIV Research Unit. Soweto HPTN CRS. Soweto, South Africa.
University of the Witwatersrand. Department of Medicine. Clinical HIV Research Unit. Johannesburg, South Africa.
The Fenway Institute. Fenway Health/Infectious Disease Division. Beth Israel Deaconess Medical Center. Department of Medicine. Harvard Medical School. Boston, MA, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA.
University of North Carolina at Chapel Hill. Department of Medicine. Chapel Hill, NC, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, MD, USA.
Abstract
Introduction: The HIV Prevention Trials Network (HPTN) 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure. Objective: To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052. Methods: 1566 participants who had a viral load (VL) > 400 copies/mL at enrollment were included in the analyses. This included 832 in the early ART arm (CD4 350-550 cells/mm3 at ART initiation) and 734 in the delayed ART arm (204 with a CD4 < 250 cells/mm3 at ART initiation; 530 with any CD4 at ART initiation). Viral suppression was defined as two consecutive VLs ≤ 400 copies/mL after ART initiation; virologic failure was defined as two consecutive VLs > 1000 copies/mL > 24 weeks after ART initiation. Results: Overall, 93% of participants achieved viral suppression by 12 months. The annual incidence of virologic failure was 3.6%. Virologic outcomes were similar in the two study arms. Longer time to viral suppression was associated with younger age, higher VL at ART initiation, and region (Africa vs. Asia). Virologic failure was strongly associated with younger age, lower educational level, and lack of suppression by three months; lower VL and higher CD4 at ART initiation were also associated with virologic failure. Conclusions: Several clinical and demographic factors were identified that were associated with longer time to viral suppression and virologic failure. Recognition of these factors may help optimize ART for HIV treatment and prevention.
Keywords
HIVHPTN 052
Early ART
Viral suppression
Virologic failure
Virologic outcomes
HIV prevention
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