Source: matec.info
Published June 19, 2017
FDA approved changes to the Kaletra (lopinavir/ritonavir) tablet and oral solution labels. These changes include updates to the following sections:
Source: matec.info
Published June 8, 2017
On June 7, 2017, the Food and Drug Administration approved a new Norvir (ritonavir) oral powder formulation, 100 mg packet. This approval provides for the use of Norvir (ritonavir) oral powder (only for >100 mg dose increments) in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection. Norvir oral powder dosage form is free of alcohol and propylene glycol, both of which are present in the currently marketed Norvir oral solution, making it safer for use in the pediatric population.
Additionally, labeling was revised for the Norvir tablet for oral use and oral solution to reflect the new powder formulation.
The complete revised labeling will be available soon at Drugs@FDA and at DailyMed.
Norvir is manufactured by AbbVie Inc.
Source: matec.info
Published: June 9, 2017
On June 8, 2017, the Food and Drug Administration approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, determined to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada Tablets, 200 mg/300 mg.
Source: Midwest AIDS Training + Education Center
Published May 4, 2017
The STRIBILD and TYBOST labels were updated to include revised text regarding corticosteroids as follows:
Source: AETC National Coordinating Resource Center
Published April 17, 2017
Four new HIV Meds Updates have been added to the AETC Program Blog ShareSpot. This series provides a summary about new information on antiretroviral drug treatment presented at CROI 2017. The series includes the following articles:
CROI 2017: Doravirine Noninferior to Darunavir + Ritonavir in Initial Treatment
CROI 2017: Bictegravir and Dolutegravir, Head-to-Head Comparison
CROI 2017: Dolutegravir in 2-Drug Simplification Studies
CROI 2017: Failure of Dolutegravir Monotherapy
Click here to read the latest posts, and to catch up on past ShareSpot stories.
Published: U.S. Food & Drug Administration (FDA), April 5, 2016.
On April 4, 2016 FDA approved DESCOVY, a two-drug fixed dose combination tablet containing 2 HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), emtricitabine (FTC) and tenofovir alafenamide (TAF). Each DESCOVY tablet contains 200 mg of FTC and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate).
DESCOVY is not a complete regimen for the treatment of HIV-1 infection and must be combined with other antiretroviral agents to form a complete regimen.
The approval is based on a relative bioavailability trial demonstrating FTC and TAF exposures were similar between DESCOVY and GENVOYA (elvitegravir/cobicistat/FTC/TAF). A clinical trial to evaluate the efficacy and safety of DESCOVY was not required because the safety and efficacy of FTC and TAF was established previously in clinical trials with GENVOYA.
TAF 25 mg provides for TAF exposures that match or exceed those observed in patients receiving GENVOYA, ensuring adequate antiviral effect. With respect to safety, TAF exposures for FTC/TAF 200 mg/25 mg when used with some boosted protease inhibitors will be higher than that of GENVOYA. However, exposures of the metabolite, tenofovir, will remain substantially lower than that observed with previously approved tenofovir disoproxil fumarate (TDF) formulations such as, Viread (TDF), Truvada (FTC/TDF) and Stribild (Elvitegravir, COBI, FTC, TDF). Thus, the safety of DESCOVY is supported by formulations with substantially higher tenofovir exposures.
Source: Gail Bolan M.D.
Director, Division of STD Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention
Stay current with the Division of STD Prevention by following them on Twitter @CDCSTD and on Facebook.
Elvitegravir is an HIV integrase inhibitor that requires pharmacokinetic enhancement with cobicistat or ritonavir. Since 2012 it has been available in a coformulation with cobicistat, tenofovir, and emtricitabine (Stribild) for treatment-naïve adults. This month the FDA approved elvitegravir as an independent medication, for use in in combination with a ritonavir-boosted protease inhibitor (and other ARVs) in treatment-experienced adults. Its brand name is Vitekta.
It is dosed once daily, with the specific dosage determined by the coadministered ritonavir-boosted PI:
Elvitegravir should not be used with cobicistat, except in the coformulation with cobicistat/tenofovir/emtricitabine (Stribild); thus it is not recommended with cobicistat-boosted PIs. It also is not recommended with PIs other than those indicated above
It should be taken with food.
Further information is available in the prescribing information at Drugs @FDA.
To view original source Click here.
To see other article by Susa Coffey, MD follow this link — AETC Share Spot with Susan Coffey, MD
Source: Clinician Consultation Center
The Clinician Consultation Center announces its brand new service, the CCC Pre-Exposure Prophylaxis consultation telephone service, or PrEPline. This service will provide free, expert advice to clinicians across the country on PrEP, an important new HIV prevention tool. PrEP involves providing antiretroviral drug treatment to HIV uninfected persons to prevent HIV infection. PrEP is a single pill, two-drug combination of the antiretroviral drugs tenofovir and emtricitabine, taken daily to prevent HIV infection in adults at high risk of acquiring HIV.
The PrEPline is staffed with an expert team of HIV clinicians who advise healthcare professionals on the indications for and proper implementation of pre-exposure prophylaxis (PrEP). The PrEPline rounds out the spectrum of HIV treatment and prevention consultation services for clinicians at the CCC, joining the Warmline for consultation advice on HIV/AIDS management, the PEPline for bloodborne pathogen exposure advise, and the Perinatal HIV Hotline for advice on HIV in pregnancy and infancy. The CCC has continually evolved to address the clinical needs arising from the HIV epidemic, whose next phase includes the quest for an HIV-free generation. The addition of the PrEPline serves the National HIV/AIDS strategy’s first goal of reducing new HIV infections by making state-of-the-art information and consultation on prevention available to providers across the country.
The Clinician Consultation Center is part of the US Health Resources and Services Administration (HRSA) AIDS Education and Training Centers (AETCs) Program. The new PrEPline was made possible through supplemental funding from the Centers for Disease Control and Prevention (CDC) to this HRSA program that provides education and training to clinicians nationally. Consultation services are provided by UCSF physicians, nurses, and clinical pharmacists. The CCC has provided nearly 400,000 consultations to clinicians on preventing and managing HIV/AIDS since its inception in 1993.
Follow the link below to read the full press release and learn more about this service.
Join us in welcoming our new Clinician Scholars!
Amy Walker, MSN, ACNP-BC, AAHIVS
Amy comes to the Scholars program from Matthew25 Clinic in Evansville, IN where she has been employed since December of 2011. Coming from a more rural area she is looking forward to connecting with providers in other areas and expanding her knowledge of HIV care.
Elizabeth Shuck, NP-BC
Elizabeth has extensive experience as a nurse practitioner and is a new member of the LifeCare family. She has fully embraced the change to HIV care and comes to the Clinician Scholars program to reach her goal of learning more about HIV care.
Julie Borum, NP
Returning to HIV care after a small break to raise her family, Julie joins forces at LifeCare and returns to the HIV care arena. She hopes to update her clinical knowledge of HIV care through the Clinician Scholars Program.