Although HIV drugs can help expectant mothers from passing HIV—the virus that causes AIDs—to their unborn babies, HIV drugs may increase risks for some birth defects, according to emerging research. The drugs studied included Epivir (lamivudine); Sustiva (efavirenz); Viracept (nelfinavir); and Trizivir, (abacavir sulfate, lamivudine, and zidovudine).
Known as antiretrovirals, the drugs may increase birth defects such as cleft lip and cleft palate, a new study has found, wrote Everyday Health. At the same time, these drugs do reduce risks for mother-fetus transmission of HIV from 15-25 percent to under 1 percent. Regardless, the drugs remain unsafe during pregnancy, said the study authors, and remain under investigation.
Vassiliki Cartsos, associate professor and director of graduate orthodontics at Tufts University School of Dental Medicine in Boston, and colleagues, reviewed five years of adverse events compiled by the U.S. Food and Drug Administration (FDA), Everyday Health explained. The study findings appear in this month’s issue of the journal Cleft Palate—Craniofacial Journal.
The team discovered that seven antiretrovirals were linked to 26 incidents of cleft lip and cleft palate, but note that this association is not necessarily proof of a cause-and-effect relationship, said Everyday Health. According to the researchers, the findings are a red flag but do not confirm that the drugs cause birth defects and conclude that more research is needed to determine if links exists between the drugs and the congenital malformation long linked to genetic and environmental factors.
As we’ve previously written, a safety review of HIV-1 drug treatments, namely, abacavir, which is sold under the brands Ziagen, Trizivir, and Epzicom, is not definitively connected to an increased risk of heart attacks, as first believed.
The FDA had received what it described as “conflicting information” about potential links between abacavir and heart attacks. While several observational studies and a randomized control trial did reveal an increased risk of heart attack in patients taking abacavir, the risk was not seen in GlaxoSmithKline’s database and in other randomized trials. GlaxoSmithKline manufactures Ziagen (abacavir).
The FDA’s meta-analysis reviewed 26 randomized clinical trials, which involved more than 9,000 people on abacavir or a nonabacavir treatment regimen and 16 trials from the GlaxoSmithKline’s database—5 from the AIDS Clinical Trials Group (ACTG) and 5 from academic centers. A total of 46 myocardial infarction (MIs, also known as heart attack) events were noted in the research; however, the FDA said that 24 events occurred in the abacavir group, and 22 in the nonabacavir group, making the difference between the two groups not statistically significant, according to the agency.
While the FDA said healthcare professionals should continue to prescribe abacavir in accordance with the drug’s label—and patients should not cease treatment without speaking to their physicians—they should be aware that conflicting data exist on whether abacavir treatment increases heart attack risks.