Policy brief: update on antiretroviral regimens for treating and preventing HIV infection and update on early infant diagnosis of HIV: interim guidance
Since WHO published the 2016 ARV guidelines, several studies have evaluated the safety and efficacy of dolutegravir (DTG) during pregnancy and the periconception period, among children and among people with HIV-associated TB infection. Ample evidence supports using DTG as a preferred first-line ARV drug for everyone living with HIV older than six years and weighing more than 15 kg, including women and adolescent girls of childbearing potential who are using consistent and reliable contraception. DTG has been found to be effective for pregnant women and is found in breast milk, resulting in significant plasma concentration in infants and thus a potential important tool to reduce the mother-to-child transmission of HIV infection. However, an ongoing observational study in Botswana recently identified a signal of potential safety risk for developing neural tube defects among infants born to women who were taking DTG at conception. WHO is taking this potential safety issue seriously and is working closely with all relevant stakeholders, including health ministries, the study investigators, the manufacturer and partner organizations, to further investigate these preliminary findings. Regulatory authorities are also reviewing this matter. WHO will update these data and provide additional information as it becomes available.
In 2016, WHO also recommended that HIV virological testing be used to diagnose HIV infection among infants and children younger than 18 months and that ART be started without delay while a second specimen is collected to confirm the initial positive virological test result. Confirmatory testing of initial positive early infant test results is critical due to the risk of low level viremia, potential contamination with maternal blood, specimen mislabeling, and laboratory contamination. However, the complexity of early infant diagnosis testing is now growing because of the significant scaling up of the “treat all” policy, implementation of enhanced prophylaxis, reduced mother-to-child transmission rates and the increased relative contribution of postnatal transmission. Early infant diagnosis can no longer be a one-test process but now requires additional testing over the duration of exposure. Several additional key considerations are therefore required to strengthen the early infant diagnosis testing cascade. These include repeat testing of indeterminate results in the laboratory, confirmatory testing of all positive test results and testing throughout the exposure period.