Point-of-care early infant HIV diagnosis eliminates delays

During a trial conducted in six clinics in Lusaka, Zambia, infants randomly assigned to receive point-of-care early infant HIV diagnosis all received same-day test results and rapidly initiated ART, compared with an average wait time of 27 days for results among infants who received offsite diagnosing, findings presented during CROI showed.

But Carla J. Chibwesha, MD, MSc, assistant professor of obstetrics and gynecology at the University of North Carolina Institute for Global Health & Infectious Diseases, and colleagues also found that point-of-care early infant diagnosis (POC EID) did not translate to long-term treatment success.

Between March 2016 and November 2018, Chibwesha and colleagues randomly assigned 4,000 HIV-exposed infants (median age, 6 weeks) to receive either POC EID or offsite EID. They implemented a safety net through testing of archived samples if offsite EID results did not come back within 4 weeks. Most of the offsite results were provided by the safety net.

“In the point-of-care arm, EID results were available on the same day. HIV uninfected infants were exited, while HIV infected infants were referred immediately for ART and had a second sample drawn for confirmatory testing. Follow up study visits were scheduled at 3, 6 and 12 months,” Chibwesha said during a presentation.

Overall, 81 infants tested positive for HIV — 37 in the EID POC group, and 44 in the offsite group.

“Encouragingly, we observed low rates of mother-to-child HIV transmission. When we began our trial in 2016, 3% of infants were HIV infected. By the end of our enrollment period in late 2018, 2% of infants were infected,” Chibwesha said.

But 15 infants died, and adverse events were common in both arms, the researchers reported. After a year, only 20 of the 81 infants were alive, in care and virally suppressed, and the results did not differ between the two study arms: 13 (30%; 95% CI, 16% to 43%) infants in the POC arm vs. seven (19%; 95% CI, 7% to 32%) in the offsite arm (RR = 1.5; 95% CI, 0.7-3.4).

Chibwesha said that although many HIV-exposed infants were enrolled in the trial, the sample of 81 infected infants limited the power to detect nuanced differences between the study group.

“Despite this and despite the country's successful [prevention of mother-to-child transmission] program, adverse clinical outcomes such as virologic failure, attrition and death were common among HIV infected infants,” she said. “We therefore conclude that substantial investments are needed to strengthen pediatric HIV treatment programs in low-resource settings such as Zambia.” – by Ken Downey Jr.

Reference:

Chibwesha CJ, et al. Abstract 133. Presented at: Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston.

Disclosures: The authors report no relevant financial disclosures.