Drug Safety and Efficacy
Antiretroviral Drugs and Birth Complications.  The standard of care for a pregnant woman with HIV, the virus that causes AIDS, includes ongoing treatment with antiretroviral (anti-HIV) drugs.  This approach avoids interrupting treatment of the woman while also helping to prevent transmission of the virus to the infant.  But doubts about this approach arose when several studies, involving relatively small numbers of women, suggested that treatment during pregnancy with combination antiretroviral therapy increased the risk of premature delivery. Recently scientists reviewed multiple clinical trials and concluded that women who continued antiretroviral therapy (standard combination drug therapies and single-drug therapy) during pregnancy were no more likely to give birth prematurely than those who either stopped combination therapy or took only one antiretroviral drug.  These scientists also found that antiretroviral drugs did not generally increase the risk of other complications, including low birth weight, still birth, or impaired condition of a newborn, as indicated by a standard test (Apgar test) at birth.  A subgroup of women did appear to have a slightly higher risk of having very low birth weight infants; however, factors other than drugs, such as alcohol or tobacco use, could be responsible.  The new findings permit more informed treatment choices by pregnant, HIV-positive women and their physicians. 

Pediatric HIV and Drug Treatment.  There are limited data on the safety and efficacy of antiretroviral drugs in children and adolescents with HIV, who are treated with drugs that have been more fully studied in adults.  Recently, scientists reported that antiretroviral drugs, in various combinations, markedly reduced deaths in infected children and adolescents who were followed over a three-year period.  In these children, the drugs reduced the risk of HIV-related death by 67 percent.  An important aspect of the study was that scientists were able to assess the effects and safety of the drugs as young patients were treated under ordinary clinical conditions.  Scientists also determined that the drugs had similar effects in lowering death rates, regardless of a child’s race, ethnic group, age or sex, educational level of parents or guardians, or stage of HIV infection when the child entered the study.