FDA Approved changes to the Sustiva label, Genvoya, Norvir, Descovy and more.
On October 12, 2017 the FDA approved changed to the Sustiva (efavienz) package insert to:
Update information on hepatotoxicity in DOSAGE and ADMINISTRATION, WARNINGS AND PRECAUTIONS, ADVERSEREACTIONS and Patient Information sections.
Update CONTRAINDICATIONS and Patient Information sections with drug-drug interaction information on elbasvir and grazoprevir.
Update DRUG INTERACTIONS, Table 5 with more information about hepatitis C antiviral agents.
Statement from the Perinatal Guidelines Panel
October 5, 2017: The Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission (the Panel) released the following statement:
A recent BMJ clinical practice guideline recommended that pregnant women living with HIV should not be treated with the combination of tenofovir/emtricitabine (TDF/FTC). After fully considering the results of the PROMISE study, both the Panel and the British HIV Association do not support these recommendations. The Panel found that there were important study design and statistical considerations that limit the generalizability of the PROMISE findings, and in consideration of all available evidence, the Panel concluded that the assessment of expected benefits and harms favored TDF/FTC over ZDV/3TC, leading the Panel to keep TDF/FTC as a preferred recommendation and ZDV/3TC as an alternative recommendation for antiretroviral-naive pregnant women living with HIV in the United States.
FDA Approves NORVIR Oral Solution Label
October 3, 2017: The NORVIR (ritonavir) Oral Solution package insert was recently updated with the types of feeding tubes that are compatible for use.
The DOSAGE AND ADMINISTRATION section was updated as follows:
Administering Oral Solution by Feeding Tube
Because NORVIR oral solution contains ethanol and propylene glycol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility. Feeding tubes that are compatible with ethanol and propylene glycol, such as silicone and polyvinyl chloride (PVC) feeding tubes, can be used for administration of NORVIR oral solution. Follow instructions for use of the feeding tube to administer the medicine.
FDA Approves changes to the DESCOVY Label
October 3, 2017: The DESCOVY (emtricitabine/tenofovir alafenamide) package insert was recently updated to include the Week 24 safety and efficacy data from Study GS-US-292-0106 (cohort 2) in HIV-1 positive, virologically suppressed children 6 to less than 12 years of age weighing at least 25 kg. The following revisions were made to the package insert
Section 1: INDICATIONS AND USAGE was updated as follows:
DESCOVY is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg.
DESCOVY is also indicated, in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg and less than 35 kg.
Section 2: DOSAGE AND ADMINISTRATION was updated
FDA approved changes to the GENVOYA package insert
September 27, 2017: FDA approved changes to the GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir, alafenamide) to update the package insert with Week 24 safety and efficacy data fromstudy GS-US-292-0106 (Cohort 2) in HIV-1 positive, virologically suppressed children 6 to < 12 years of age weighing at least 25 kg. The specific changes are summarized below.
Section 1: INDICATIONS AND USAGE
Section 2: DOSAGE AND ADMINISTRATION
Section 6: ADVERSE REACTIONS
Section 8.4: Pediatric Use
Section 14.5: Clinical Trial Results in HIV-1 Infected Pediatric Subjects Between the Ages of 6 to Less than 18
HIV, HCV Clinical Training and Resources
The list of resources you normally see on the bottom of the HIV alerts has moved to a new, easier to view format. Check it out!
We've gathered a list of really useful - and free - training and clinical resources available to you and your colleagues. You'll find links to resources on HIV/HCV Clinical Training, Guidlines & Clinical Information, Warmlines and Hotlines, Drug Assistance Programs, Drug & Biomedical Info, HIV/AIDS Policy & Surveillance, and info for Consumers and Patients.
Ocober 15 is National Latinx AIDS Awareness Day #NLAAD
The 2017 NLAAD theme is "To Defeat HIV You're a Superhero. Use your Superpowers."
For more info, go to the National Latinx AIDS Awareness Day to learn about their newest campaign.