• The Republicans in the US House of Representatives are pushing forward with an effort to repeal The Affordable Care Act (ACA).Repealing ACA will deny coverage to more than 32 million people who would have otherwise benefited from health care reform, as well as jeopardize the nearly 40,000 lives a year that would have been saved by the law. People living with HIV and AIDS would be negatively and disproportionately affected a repeal. Repealing the ACA would allow these critical consumer protections to be lost:

    • 16 million people with incomes below 133% of the federal poverty level and disabilities would lose eligibility to be covered by Medicaid expansion in 2014. This means that thousands of individuals living with HIV will continue to wait for an AIDS diagnosis before becoming eligible for Medicaid.
    • The ACA will eliminate the Medicare Part D drug benefit coverage gap (known as “the donut hole”).   Repealing the ACA will force millions of people to continue to pay absurd out of pocket costs.  Until the gap is eliminated, the ACA allows State AIDS Drug Assistance Plans (ADAPs) to cover out-of-pocket costs which is an important benefit for people living with HIV/AIDS and saves money for the ADAPs.
    • Loss of the Prevention and Public Health Awareness Fund. This  funding makes $15 billion available over ten years to expand and sustain the necessary infrastructure to prevent disease, detect it early, and manage conditions before they become severe.  These funds will likely be used for HIV/AIDS and/or related conditions.
    • Over 1.2 million young adults including people living with HIV would lose their insurance coverage through their parents’ health plans.
    • Over 165 million residents of the United States with private insurance coverage would suddenly find themselves vulnerable again to having lifetime limits placed on how much insurance companies will spend on their health care.  This is a particular problem for people living with HIV
    • 15.9 million people in the United States would be at risk of losing their insurance as insurance companies would once again be allowed cut off someone’s coverage unexpectedly when they are in an accident or become sick because of a simple mistake on an application.

    It is critical that we step up our game and contact our members of Congress, both Senators and members of the House of Representatives and urge them to maintain the Health Care reform bill passed last year

    In Health

    Michelle (MichRx)

  • On January 3, 2011, the U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

    The recommended oral dose of INTELENCE tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. The new 200 mg product formulation is expected to launch in the U.S. later this month, and the 100 mg tablet will remain available. Patients who are unable to swallow INTELENCE tablets whole may disperse the tablets in a glass of water.

    The FDA granted accelerated approval to INTELENCE in January 2008, and it has since been approved in more than 65 countries. INTELENCE received traditional FDA approval in November 2009, based on 48-week data from the DUET-1 and DUET-2 studies, and is currently marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P.

    INTELENCE Indication
    INTELENCE, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in ARV treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other ARV agents. This indication is based on Week 48 analyses from two randomized, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, three-class ARV (NNRTI, N[t]RTI, PI) treatment-experienced adults.

    The following points should be considered when initiating therapy with INTELENCE:
    Treatment history and, when available, resistance testing, should guide the use of INTELENCE.
    The use of other active ARV agents with INTELENCE is associated with an increased likelihood of treatment response.
    In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs.

    The risks and benefits of INTELENCE have not been established in pediatric patients or in treatment-naïve adult patients.

    This new 200mg formulation of INTELENCE will make dosing easier for patients taking it and will help improve adherence. Instead of taking 4 INTELENCE Tablets each day patients will take 2 of the 200mg tablets each day- 1 every 12 hours. The company is expected to launch the new 200g formulation later this month and will then be available pharmacies

  • Featured 02.01.2011 No Comments

    “I will be writing my thoughts and ideas and opinions on HIV/AIDS, Health Care, Pharmacy related issues and anything else I may feel is relevant. The opinions given in the blog are the personal opinions of Michelle J. Sherman, RPh FASCP AAHIVE and should not be used to substitute for personal medical care or pharmacist care. All medical and pharmacy concerns should be addressed directly with one’s personal doctor, pharmacist or health care professional.”