SEATTLE – Antiretroviral therapy (ART) in the earliest weeks of life is associated with reduced time to suppression, according to a new study. Each week that treatment was delayed, patients had a 35% reduction in odds of achieving earlier viral load (VL) suppression.
Previous research had already shown that patients treated in the first year of life have better outcomes, including shortened time to viral suppression, and a lower reservoir size. Those studies looked at median age of ART start by month, and a review of the literature revealed that no research had been done on the first month.
The research was presented at the Conference on Retroviruses & Opportunistic Infections by Sara Domínguez Rodríguez, biostatistician and data manager in the pediatric infectious disease service at Hospital 12 Octubre, Madrid.
The researchers retrospectively analyzed 44 patients who were treated in the first 28 days of life, who had uninterrupted ART for at least 2 years, and who had VL measured at least twice during follow-up. Among these, 25 patients received ART in the first week, 19 in weeks 2-4. Patients treated prophylactically with AZT + 3TC (lamivudine) + NVP (nevirapine) any time in the first 15 days of life were considered treated at day 1.
Five of the patients were from the United Kingdom, 23 from Spain, 3 from Italy, and 13 from Thailand. Fifty-seven percent were girls; 35% were preterm. Patients treated in the first week had a higher log10 HIV viral load at ART initiation (P = .02). There was no significant difference between the two groups with respect to CD4 count at ART initiation.
The time to suppression was not significantly different between the two groups, nor was the percentage of patients suppressed at various time points. Patients treated in the first week had reached suppression more often at 3 months and 6 months, but neither result reached statistical significance.
The small sample size of the study produced a challenge, and that led the team to consider suppression time and age as continuous variables. That revealed a curve that favored treatment in the first week of life: Each week of delay reduced the probability of achieving early viral suppression by 35% (hazard ratio, 0.65; 95% confidence interval, 0.46-0.92). “This means that if you delay the age at ART in terms of weeks, the probability of achieving suppression (over) time decreases, and this effect is particularly seen in the first year of follow-up,” Dr. Domínguez Rodríguez said in an interview.
Some might have concerns that treating children too early could have adverse effects. This study, though small, showed promising results. “You might think if you treat very early, maybe the child will not tolerate the medicine or keep on with the treatment, and we saw no difference. So that supports treating early,” senior author Pablo Rojo Conejo, PhD, an infectious disease specialist at Hospital 12 de Octubre, said in an interview.
Others in attendance found the results encouraging. “It’s very good news to see that early starting impacts the life of these children,” Filipe de Barros Perini, MD, head of care and treatment of the HIV program at the Brazilian Ministry of Health, said in an interview.
SOURCE: Domínguez Rodríguez S et al. CROI 2019, .