The Food and Drug Administration (FDA) has recently shared several HIV-related updates. In case you missed them, we are re-capping them below:
FDA Invites Comments on Draft Guidance for Industry on Drug Development for Pediatric HIV Infection
On May 14, 2018, the FDA announced the availability of a draft guidance entitled “Pediatric HIV Infection: Drug Development for Treatment” and invited public comment on the draft. This draft guidance provides general recommendations on the development of products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients (birth to younger than 17 years of age), including recommendations on when sponsors should initiate pediatric formulation development and begin pediatric studies to evaluate antiretroviral drug products for the treatment of HIV infection. You can find the entire document [PDF, 64KB]. Before it prepares the final version of the guidance, FDA welcomes either electronic or written comments on the draft guidance by July 13, 2018. Details on how to submit comments are available.
FDA Approves Use of Truvada as PrEP for Adolescents
On May 15, 2018, the FDA approved revisions to the Truvada (emtricitabine and tenofovir disoproxil fumarate) labeling to expand the Pre-Exposure Prophylaxis (PrEP) indication to include adolescents weighing at least 35 kg who are at risk of HIV-1 acquisition. The major labeling changes with respect to this expanded indication are summarized.
FDA to Evaluate Potential Risk of Neural Tube Birth Defects with HIV Medicine Dolutegravir
On May 18, 2018, FDA alerted the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects. Dolutegravir is an component of HIV medicinces Juluca, Tivicay, and Triumeq. Patients should not stop taking dolutegravir without first talking to your health care professional because stopping your medicine can cause the HIV infection to worsen. Read FDA’s complete Drug Safety Communication on this topic.