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Randomized Controlled Trial
. 2017 May;18(3):100-109.
doi: 10.1080/15284336.2017.1311056. Epub 2017 Apr 7.

Virologic outcomes in early antiretroviral treatment: HPTN 052

Susan H Eshleman  1 , Ethan A Wilson  2 , Xinyi C Zhang  2 , San-San Ou  2 , Estelle Piwowar-Manning  1 , Joseph J Eron  3 , Marybeth McCauley  4 , Theresa Gamble  5 , Joel E Gallant  6 , Mina C Hosseinipour  7   8 , Nagalingeswaran Kumarasamy  9 , James G Hakim  10 , Ben Kalonga  11 , Jose H Pilotto  12 , Beatriz Grinsztejn  13 , Sheela V Godbole  14 , Nuntisa Chotirosniramit  15 , Breno Riegel Santos  16 , Emily Shava  17 , Lisa A Mills  18 , Ravindre Panchia  19 , Noluthando Mwelase  20 , Kenneth H Mayer  21 , Ying Q Chen  2 , Myron S Cohen  3 , Jessica M Fogel  1
Affiliations
Randomized Controlled Trial

Virologic outcomes in early antiretroviral treatment: HPTN 052

Susan H Eshleman et al. HIV Clin Trials. 2017 May.

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: Early ART; HIV; HIV prevention; HPTN 052; Viral suppression; Virologic failure; Virologic outcomes.

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Conflict of interest statement

Declaration of Interests

None of the authors has a financial or personal relationship with other people or organizations that could inappropriately influence (bias) their work, with the following exceptions:

Figures

Figure 1
Figure 1
Study cohort for virologic outcomes analysis. The figure shows the number of participants in the early ART arm and delayed ART arm (stratified by whether or not ART was initiated before or after May, 2011) included in the analyses of viral suppression and virologic failure. Abbreviations: ART: antiretroviral therapy, VL: viral load; c/mL: copies/milliliter. a The 1,566 participants included in the viral suppression analysis were followed for 4722.4 person-years in the early ART arm and 2674.8 person-years in the delayed ART arm (977.4 person-years in the delayed ART arm before May, 2011 and 1697.4 person-years in the delayed ART arm after May, 2011). b The 1,528 participants included in the virologic failure analysis were followed for 4216.1 person-years in the early ART arm and 2445.8 person-years in the delayed ART arm (893.1 person-years in the delayed ART arm before May, 2011 and 1552.7 person-years in the delayed ART arm after May, 2011).
Figure 2
Figure 2
Kaplan-Meier estimates for virologic outcomes after ART initiation by study group. Kaplan-Meier plots show the relationship of study group (early ART arm, delayed ART arm with ART initiation before May 2011, and delayed ART arm with ART initiation after May 2011) with time to viral suppression (Panel A) and virologic failure (Panel B) after ART initiation. The numbers below each graph show the number of participants who were at risk of viral suppression or virologic failure at each time point. Abbreviations: ART: antiretroviral therapy; c/mL: copies/milliliter.
See this image and copyright information in PMC

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