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:
- Section 2: DOSAGE and ADMINISTRATION with information about use of the oral solution with a feeding tube
Continue reading FDA Approved Changes to the Kaletra Label
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.
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.
Continue reading Generic Version of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (Truvada) Approved
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:
Continue reading FDA Updates STRIBILD and TYBOST Labels
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
In December 2014, CDC’s Division of STD Prevention released the latest national data on reported cases of chlamydia, gonorrhea, and syphilis in the 2013 STD Surveillance Report. The report finds that STDs continue to threaten the health and well-being of millions of Americans, particularly young people as well as gay, bisexual, and other men who have sex with men (MSM).
Trend data show that primary and secondary syphilis (P&S) cases – the most infectious stages of the disease — are increasing among MSM, who now account for 75 percent of all infections. Syphilis infection can place a person at increased risk for HIV infection. Surveillance data from several major cities throughout the country indicate that 52% of MSM who have P&S syphilis are also infected with HIV.
Data from the report also show that cases and rates of chlamydia and gonorrhea infection are highest in Americans between the ages of 15 and 24. Both young men and young women are heavily affected by STDs – but young women face some of the most serious long-term health consequences. It is estimated that undiagnosed STDs cause infertility in 24,000 women each year.
Stay current with the Division of STD Prevention by following them on Twitter @CDCSTD and on Facebook.
Source: Clinician Consultation Center
The CCC Pre-Exposure Prophylaxis Service
11 a.m. – 6 p.m. EST
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.
The Clinician Scholars were chosen from a pool of applicants for our 2014-2015 fiscal year. Over the next 12 months, MATEC will be supporting these Scholars through a series of clinical training opportunities tailored to their personal goals as HIV care providers. Congratulations, Amy, Elizabeth, and Julie! We look forward to working with you!