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HIV infection reduced in 6-month-old infants receiving nevirapine

ATLANTA — HIV infection was significantly lower at age 6 months among infants randomly assigned at 6 weeks to receive daily nevirapine vs. placebo prophylaxis, according to data presented here at the 2013 Conference on Retroviruses and Opportunistic Infections.

Mary Glenn Fowler, MD, of Johns Hopkins University School of Medicine, and colleagues reported 18-month outcomes from the HPTN 046 trial that compared the efficacy and safety of extending daily nevirapine from 6 weeks to 6 months among 1,527 breast-feeding HIV-exposed infants to prevent postnatal infection.

 

Mary Glenn Fowler

During this trial — conducted in Zimbabwe, South Africa, Uganda and Tanzania — infant diagnostic testing was performed at 3, 6, 9, 12 and 18 months. The researchers used Kaplan-Meier analysis to evaluate cumulative HIV infection and HIV-free survival.

Fowler and colleagues observed that postnatal HIV infection after age 6 weeks was significantly lower at age 6 months when daily infant nevirapine prophylaxis was given for 6 months vs. 6 weeks (1.1% vs. 2.4%, P=.049)

However, after termination of prophylaxis, differences were no longer significant at 9, 12 and 18-month follow-up.

“We found that there was a definite benefit shown for giving the 6 months of [nevirapine] vs. 6 weeks in terms of postnatal transmission of HIV, but as we followed the data, there was loss or washout of that benefit by 18 months,” Fowler said during a press conference. “However, the transmission rates for both arms of the placebo and the nevirapine were extremely low (2.2% vs. 3.1%) between 6 weeks and 18 months. This speaks to the importance of the very early coverage in the first 6 weeks of the infant nevirapine.”

Women receiving antiretroviral therapy for their own health exhibited the lowest 18-month postnatal infection rates (0.5%; 95% CI, 0.0-1.1). However, HIV infection/death rates at 18 months were low and not significantly dissimilar for infants of mothers on continuous ART (3.7%; 95% CI, 1.9-5.5) and infants of mothers with CD4 counts ≥350 cells/mm3 not receiving ART (4.8%; 95% CI, 2.7-6.8).

“These findings are obviously in the context of a move by the WHO to truly harmonize pediatric and adult treatment guidelines, and very much to push the use of maternal ART,” Fowler said. “The data are also encouraging for situations in which women may either be lost to follow up for periods of time or refuse to take medication for themselves, that infant prophylaxis with nevirapine does provide very good protection through the long run out to 18 months.”

For more information:

Fowler MG. Abstract #84LB. Presented at: 2013 Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta.