Protease inhibitors safe and effective in HIV-positive pregnant women

Protease inhibitors appear to be safe and effective for the prevention of foetal HIV-1 transmission in pregnant HIV-positive women, according to a report published in the December 1st issue of the Journal of Acquired Immune Deficiency Syndromes. Dr. Anne B. Morris, from the Community Research Initiative, in Springfield, Massachusetts, and colleagues retrospectively assessed the safety and efficacy of protease inhibitor therapy in 89 HIV-positive women.

The multi-centre study included women seen at six centres in the US and Puerto Rico between January 1997 and October 1998. The majority of women received one protease inhibitor, although some received sequential or dual PI therapy. Eighteen women were already on PI therapy at the time of conception, while the remaining women began PI treatment during pregnancy (most in the second trimester.) All participants also received concurrent treatment with nucleoside reverse transcriptase inhibitors.

From the group, 91 live infants were born, including three sets of twins. One neonate died shortly after birth. The authors detected no cases of perinatal HIV transmission. The prematurity rate of 19.1% was equivalent to that reported in other studies of HIV infection in pregnancy. Only cocaine and premature rupture of membranes were significantly associated with prematurity. Adverse outcomes related to protease inhibitor therapy were uncommon, the researchers note. “The lower the level of maternal HIV-1 RNA, the lower the risk of transmission,” the authors state. “Highly active combination therapy including PIs has been shown to lower viral loads in many prior studies and would be expected to have a beneficial effect in pregnancy as well,” they postulate.

While earlier smaller series have suggested that PI therapy during pregnancy may increase the risk of adverse events and prematurity, the current data agree with two recent reports that do not support this finding, the investigators note. Dr. Morris’s team observed that “the rate of adverse events in mothers and infants was similar to that reported in the literature for the general population.”

Although “protease inhibitors appeared generally safe in mothers and infants in this series,” and “no perinatal HIV-1 transmission occurred,” Dr. Morris’ group emphasizes that “further prospective, controlled studies are needed to define the optimal management of HIV-1 in pregnancy.”