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. 2021 Aug 1;87(Suppl 1):S73-S80.
doi: 10.1097/QAI.0000000000002707.

HIV-1 Recent Infection Testing Algorithm With Antiretroviral Drug Detection to Improve Accuracy of Incidence Estimates

Andrew C Voetsch  1 , Yen T Duong  2 , Paul Stupp  1 , Suzue Saito  2 , Stephen McCracken  1 , Trudy Dobbs  1 , Frieda S Winterhalter  2 , Daniel B Williams  1 , Assegid Mengistu  3 , Owen Mugurungi  4 , Prisca Chikwanda  1 , Godfrey Musuka  2 , Clement B Ndongmo  1 , Sindisiwe Dlamini  5 , Harriet Nuwagaba-Biribonwoha  2 , Munyaradzi Pasipamire  1 , Belete Tegbaru  2 , Frehywot Eshetu  1 , Samuel Biraro  2 , Jennifer Ward  1 , Dorothy Aibo  2 , Andrew Kabala  2 , George S Mgomella  1 , Optatus Malewo  1 , Jeremiah Mushi  6 , Danielle Payne  1 , Yohannes Mengistu  1 , Fred Asiimwe  1 , Judith D Shang  1 , Emily K Dokubo  1 , Laura T Eno  1 , Anne-Cécile Zoung-Kanyi Bissek  7   8 , Leonard Kingwara  9 , Muthoni Junghae  1 , John N Kiiru  10 , Richard C N Mwesigwa  1 , Shirish Balachandra  1 , Roger Lobognon  1 , Elizabeth Kampira  1 , Mervi Detorio  1 , Ernest L Yufenyuy  1 , Kristin Brown  1 , Hetal K Patel  1 , Bharat S Parekh  1
Affiliations

HIV-1 Recent Infection Testing Algorithm With Antiretroviral Drug Detection to Improve Accuracy of Incidence Estimates

Andrew C Voetsch et al. J Acquir Immune Defic Syndr. .

Abstract

Background: HIV-1 incidence calculation currently includes recency classification by HIV-1 incidence assay and unsuppressed viral load (VL ≥ 1000 copies/mL) in a recent infection testing algorithm (RITA). However, persons with recent classification not virally suppressed and taking antiretroviral (ARV) medication may be misclassified.

Setting: We used data from 13 African household surveys to describe the impact of an ARV-adjusted RITA on HIV-1 incidence estimates.

Methods: HIV-seropositive samples were tested for recency using the HIV-1 Limiting Antigen (LAg)-Avidity enzyme immunoassay, HIV-1 viral load, ARVs used in each country, and ARV drug resistance. LAg-recent result was defined as normalized optical density values ≤1.5. We compared HIV-1 incidence estimates using 2 RITA: RITA1: LAg-recent + VL ≥ 1000 copies/mL and RITA2: RITA1 + undetectable ARV. We explored RITA2 with self-reported ARV use and with clinical history.

Results: Overall, 357 adult HIV-positive participants were classified as having recent infection with RITA1. RITA2 reclassified 55 (15.4%) persons with detectable ARV as having long-term infection. Those with detectable ARV were significantly more likely to be aware of their HIV-positive status (84% vs. 10%) and had higher levels of drug resistance (74% vs. 26%) than those without detectable ARV. RITA2 incidence was lower than RITA1 incidence (range, 0%-30% decrease), resulting in decreased estimated new infections from 390,000 to 341,000 across the 13 countries. Incidence estimates were similar using detectable or self-reported ARV (R2 > 0.995).

Conclusions: Including ARV in RITA2 improved the accuracy of HIV-1 incidence estimates by removing participants with likely long-term HIV infection.

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Conflict of interest statement

As an inventor of LAg-Avidity EIA, B.S.P. receives royalties from the sale of test kits sold by the manufacturer per US government policy. The other authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
HIV-1 recent infection testing algorithm test outcomes for HIV-1 Limiting Antigen (LAg) Avidity test, HIV viral load test, and antiretroviral test results, Population-based HIV Impact Assessment, 2015–2019
Figure 2.
Figure 2.
Correlation of HIV-1 incidence estimates by RITA adjusting for exposure to ARV. A) Comparison of incidence estimates by RITA1 (LAg ODn ≤1.5 + VL ≥1000 RNA copies/mL) and RITA2 (LAg ODn ≤1.5 + VL ≥1000 RNA copies/mL + no ARV detected) B) Comparison of incidence estimates by RITA2 using ARV detection and RITA2 using self-reported ARV. Solid lines represent linear correlation trendlines with equation parameters and R2 shown for both plots. Dotted lines represent ideal fit with R2=1.0 and slope of 1.0 for comparison purposes. Abbreviations: LAg, HIV-1 Limiting Antigen Avidity test; VL, HIV viral load test; RITA, recent infection testing algorithm; proportion false recent, PFR; normalized optical density values, ODn; ribonucleic acid, RNA; ARV, antiretroviral medication
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