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Only 4 New HIV Infections in 1013 HIV-Discordant Couples Using ART and PrEP - Integrated delivery of PrEP and ART results in sustained near elimination of HIV transmission in African HIV serodiscordant couples: final results from The Partners Demonstration Project
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21st International AIDS Conference (AIDS 2016), July 18-22, 2016, Durban, South Africa
IAC: Integrated delivery of PrEP and ART results in sustained near elimination of HIV transmission in African HIV serodiscordant couples: - (07/20/14)
Mark Mascolini
In 1013 Kenyan and Ugandan couples with one HIV-positive partner and one negative partner, only 4 initially negative partners picked up HIV during a 2-year program with high uptake of antiretroviral therapy (ART) by positive partners and temporary preexposure prophylaxis (PrEP) by negative partners [1]. Partners Demonstration Project researchers said the ART/PrEP strategy yielded "sustained near elimination" of HIV transmission in a high-risk cohort.
Results of randomized trials and cohort studies show that both ART and PrEP can be effective HIV prevention tools. The World Health Organization recommends both to prevent new HIV infections in HIV-discordant couples. Arguing that neither ART nor PrEP alone can completely thwart HIV transmission, Partners researchers conducted this demonstration project in Kenyan and Ugandan couples with one positive and one negative partner.
The Partners team recruited high-risk HIV-discordant heterosexual couples not using ART or PrEP. They offered ART to all positive partners regardless of CD4 count (in line with national guidelines), and they offered tenofovir/emtricitabine PrEP to negative partners until the positive partner started ART and for the first 6 months of ART. Quarterly follow-up visits for 24 months included HIV testing, risk reduction counseling, brief adherence support, and primary HIV care. The researchers compared HIV incidence (the new-infection rate) in initially negative partners with expected new infections modeled on data from the placebo group in the Partners PrEP trial [2].
The demonstration project involved 1013 couples in which women made up one third of the HIV-negative partners. Median age stood at 30, and 20% of participants were younger than 25. Two thirds of couples reported condom-free sex in the past month. Median CD4 count in positive partners stood at 436, and 41% of positive partners had a CD4 count above 500. Median pretreatment viral load measured 37,095 copies.
Almost all negative partners, 97%, started PrEP, and tenofovir could be detected in 82% of plasma samples. Among positive partners, 91% started ART within 24 months and more than 90% reached a viral load below 400 copies. Couples used PrEP alone during 20% of follow-up time; PrEP and ART overlapped during 33% of follow-up time; ART alone held sway during 39% of follow-up time; and couples used neither PrEP nor ART only 7% of the time.
Modeling indicated that this population could expect 83 new HIV infections during 2 years of follow-up for an incidence of 4.9 per 100 person-years (95% confidence interval [CI] 3.9 to 6.0). In the 1013 demonstration project couples, only 4 negative partners became infected in 2 years for an incidence of 0.2 per 100 person-years (95% CI 0.1 to 0.6). Compared with expected new infections, the observed rate represents a 95% reduction in incidence (95% CI 87% to 98%, P < 0.0001).
HIV protection rates were consistently high in subgroup analyses--97% in men, 93% in women, 95% in couples with a positive partner younger than 25, and 95% in couples with a positive partner who had a pretreatment viral load at or above 50,000 copies (P< 0.0001 for all). The four people who became infected during follow-up did not take PrEP and had other risk factors, including multiple partners, commercial sex work, and a positive partner not taking ART.
The researchers believe their strategy enabled "virtual elimination of incident HIV" in a high-risk population and that it offers "a model for integrated delivery of ART and PrEP for couples as a highly potent combination prevention intervention."
References
1. Baeten J, Heffron R, Kidoguchi L, et al. Integrated delivery of PrEP and ART results in sustained near elimination of HIV transmission in African HIV serodiscordant couples: final results from The Partners Demonstration Project. 21st International AIDS Conference (AIDS 2016). July 18-22, 2016. Durban, South Africa. Abstract WEAC0105.
2. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367:399-410.
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