FDA Approves Oral Suspension Formulation of Prezista

On December 16, the Food and Drug Administration (FDA) approved an oral suspension formulation of Prezista (darunavir). Prezista is now available as a 100 mg/mL oral suspension for pediatric patients and for adult patients who have difficulty swallowing Prezista tablets.

Additionally, the product labeling was updated to provide dosing recommendations for pediatric patients ages 3 to less than 6 years of age and for adult and pediatric patients greater than 6 years of age who cannot swallow Prezista tablets.

Section 2: “Dosage and Administration” was updated to provide the dosing instructions for the oral suspension. Treatment-naïve adults and treatment-experienced adults with no Prezista resistance-associated substitutions can take Prezista 8 ml once daily with 1.25 ml of Norvir (ritonavir) once daily with food. The 8 mL dose should be taken as two 4 mL administrations with the included oral dosing syringe. For treatment-experienced adults with at least one Prezista resistance-associated substitution, the dose for oral suspension is 6 mL with 1.25 mL Norvir twice daily with food. For pediatric patients, dosing with oral suspension or tablets is based on weight. Please refer to full prescribing information for details. Do not use Prezista/ritonavir in pediatric patients under 3 years of age.  

Section 6 “Adverse Reactions” (ADRs) was update to reflect clinical trial experience in pediatric patients from Study TMC1140C228 as follows: ADRs to Prezista/Norvir (all grades, greater than or equal to 3%), excluding laboratory abnormalities, were diarrhea (19%), vomiting (14%) and rash (10%). There were no Grade 3 or 4 laboratory abnormalities considered as ADRs in this study.

Section 12.3 “Pharmacokinetics” was updated to provide population pharmacokinetic estimates of Prezista exposure in pediatric patients. Section 14: “Clinical Studies” was updated to reflect the results from the pediatric trial Study TMC114-C228.

Advertisements

AIDS United Condemns Reinstatement of Ban on Federal Funding for Syringe Exchange

Needle Exchange Program - FACT OR FICTION towaardsIn a press release on December 16, AIDS United expressed outrage and disappointment at Congress’ reinstatement of the ban on federal funding for syringe exchange programs, which was lifted in 2009. The ban is included in the Labor Health and Human Services appropriations bill included in the final FY 2012 appropriations package.  

“Congress’ shameful act of reinstating the ban on federal funding for syringe exchange programs is a step backward in our fight to end the HIV epidemic in this country,” said Mark Ishaug, AIDS United President and CEO. “How are we to create an AIDS-free generation if we can’t use one of the most important tools in our toolbox?”

Numerous scientific studies, including eight federally funded research studies, have shown that, when implemented as part of a comprehensive HIV/AIDS prevention strategy, syringe exchange programs are an effective public health tool in preventing HIV and do not increase illicit drug use.  In fact, the Journal of the American Medical Association credits syringe exchange programs with helping to lower HIV incidence by 80% among people who inject drugs, the press release noted.

Syringe exchange programs have proven to be one of the most effective HIV prevention interventions available. The cost to avert one infection through syringe exchange services is significantly less than treating a person living with HIV over a lifetime.

“What is most disturbing is that the reinstatement of the federal ban directly undermines and contradicts the National HIV/AIDS Strategy released by President Obama only last year,” said Ronald Johnson, AIDS United Vice President of Policy and Advocacy.  “Syringe exchange is specifically mentioned in the Strategy as a key evidence-based approach to expanding targeted efforts to prevent HIV infection.”

When it was learned in early December that the federal ban reinstatement was a part of the proposed appropriations bill, AIDS United worked with its national partners and grantees around the country to generate thousands of calls and emails to Members of Congress and the White House.

“Today is a dark day for science, public health and those at risk for HIV in our country,” said Ishaug.  “And though this loss is a frustrating setback in our fight, AIDS United, along with our national, regional, and community partners, will not give up.  We will continue to hold our lawmakers accountable for ending AIDS in America, and will work tirelessly to have this ban lifted once again.”

Once again, Here we are at a point that we have the answers(PROOF) that HIV/AIDS can be prevented for IVDU’s with the needle exchange program.  This program was apart of my life in the mid 80’s. Being an outreach worker for the first HIV/AIDS Outreach Program that covered all five boro’s. We notice that the bleach kits were helping, but still seeing the sharing of a needle more due to not having the kits all the time or just not caring. We at ADAPT notice that our outreach needed the needle exchange to be apart of the condoms, bleach kits & hand out. Then came Former  Mayor Dinkins who stated when he was running for Mayor of New York that we would shut down all needle exchange programs, which he won & did stop the program, but two years later He went on TV to announce that he was wrong to close the program.  Since his office had receive an update of usage of drugs & it showed the increase of heroin usage & the rate of HIV infection was increasing.  This project is important, The usage of heroin is going up & meth user are shooting up more than ever.

The madness must stop.  Share your thoughts with us so we can advocate for those who are in need of help. 

Bristol-Myers Squibb and ADAP Crisis Task Force Announce Enhanced Support for AIDS Drug Assistance Programs

On December 19, Bristol-Myers Squibb (BMS) and the ADAP Crisis Task Force (ACTF) announced an enhanced agreement to support the AIDS Drug Assistance Programs (ADAPs), which provide antiretroviral medicines to people living with HIV and AIDS. Building on a long-standing agreement with the ACTF, this enhanced agreement directly supports ADAPs in meeting the challenges of increasing patient loads while government funding is strained.

“Today’s announcement of additional pricing considerations further exemplifies Bristol-Myers Squibb’s commitment to ADAP and the patients that ADAP serves,” said Dwayne Haught, spokesperson for ACTF and manager of the Texas ADAP. “ADAPs are a critical safety net to ensure people living with HIV can continue to receive the HIV treatments they need, and we commend Bristol-Myers Squibb for responding once again to the unprecedented need faced by state ADAPs by providing additional support to help provide people living with HIV access to life-saving HIV medicines.”

HIV medications made by BMS include Reyataz, Sustiva, Videx, Zerit, and, with Gilead Sciences, the popular Atripla.

“Bristol-Myers Squibb has a longstanding commitment to people living with HIV, and we have worked with the ACTF since its inception in 2002 to help ensure patient access to our HIV medications,” said Raymond Sacchetti, senior vice president, U.S. Virology, Bristol-Myers Squibb. “We are proud to continue our support of the ADAP Crisis Task Force, and we applaud its ongoing efforts in working with state and federal officials to secure the necessary funding to appropriately meet this critical public health challenge.”

In response to ACTF and advocacy community requests, Bristol-Myers Squibb has also agreed to further enhancements of its “Access Virology” Patient Assistance Program. By broadening financial eligibility criteria, Bristol-Myers Squibb was able to extend the availability of free medication to a wider range of qualifying patients beginning on January 1, 2012.

WOW!!!  CAN WE GET A KUDOS  HERE PLEASE!!!

Merck and the ADAP Crisis Task Force Announce New Agreement

Following the BMS/ACTF announcement, Merck and the ADAP Crisis Task Force (ACTF) announced on December 20 several new initiatives to help struggling state ADAPs. The ACTF has also previously reached enhanced agreements with Boehringer Ingelheim, Gilead Sciences, Janssen Therapeutics, and ViiV Healthcare. 

Merck has agreed to again lower the price of its HIV integrase inhibitor Isentress, effective January 1, 2012. The new price will be “frozen” and will be available to ADAPs as part of the existing Merck special pricing program through December 31, 2013. Merck was the first company, in 2003, to freeze the price of an antiretroviral therapy to ADAPs.

In addition, Merck and ACTF have agreed to the following initiatives:

  • Increasing support for the Welvista ADAP Program. After its initial year in 2010 and evaluation of current needs, Merck is increasing it operations funding and medication donations for the Welvista ADAP Program. The program helps address the medication needs of ADAP clients who are currently on state ADAP waiting lists by expediting access to HIV medicines through a simplified application process.
  • Working to optimize the use of comprehensive health insurance options available to persons with HIV. The National Alliance of State and Territorial AIDS Directors (NASTAD) reported about 40 ADAPs used ADAP funds to purchase health insurance or pay insurance premiums, co-payments and/or deductibles for individuals eligible for ADAP (provided the insurance has comparable formulary benefits to that of the ADAP). Merck and NASTAD will seek solutions that overcome barriers to more widespread use of such approaches, such as expanding enrollments in Medicare Part D, private insurance, and pre-existing condition insurance plans (PCIPs).

Merck and the ACTF maintain a mutual commitment to partner together to assess the situation and to find solutions that will help to sustain ADAPs. It has become clear within the last year that previous agreements coupled with current federal and state funding were not enough to sustain ADAPs until 2014. Merck’s latest response was a result of discussions between Merck and the ACTF over the last few months, and reflects the continuing fiscal circumstances in the states and the unmet needs of people with HIV.

At the time of this latest response, both Merck and ACTF expect that the actions taken will be sufficient until 2014, when it is believed that the expanded Medicaid and subsidized private health insurance programs mandated by the Patient Protection & Affordable Care Act will provide sufficient, sustainable care to the majority of people served by ADAPs.

“With our company’s legacy in HIV over the last 25 years, we consider it our obligation to continue to work with the ADAPs on solutions that provide crucial support for uninsured and underserved people living with HIV,” said Chirfi Guindo, vice president and general manager, Merck HIV Franchise. “It is imperative to act now, given the ongoing ADAP funding crisis. We applaud President Obama’s recent announcements of enhanced federal support for ADAPs and state HIV programs, and look forward to working together on sustainable solutions through improvements in the health care delivery system.”

“These actions come at a time when federal funding for ADAPs remains relatively flat

compared to enrollment growth, and state funding continues to fluctuate, making it difficult for the ADAP programs to provide access and care to all the clients they need to serve,” said Lynda Dee, spokesperson for the Fair Pricing Coalition. “The Fair Pricing Coalition commends Merck for its long-standing commitment to providing access to treatment and welcomes Merck’s new initiatives to help with the current ADAP funding crises.”

Ron Paul for President? NOT!!!!!!

Donnie Johnson 12:05am Jan 9
This is the face of AIDS!! The Ron Paul Libertarian ideas on health-care are cold and heartless! This baby did nothing permescuis to get AIDS! AIDS isnt just spread by sex Ron Paul! RON PAUL DIDN’T EVEN SHOW UP TO VOTE ON HR-353 BANNING PARTIAL BIRTH ABORTION COVERAGE! HE VOTED NO ON HR-1298 AIDS FUNDING NO ON HR-633 NO ON HR-3470 INFANT MORTALITY NO ON HR03963 CHILDRENS CARE NO ON HR-5501 AIDS FUNDING THE LIST IS ENDLESS YOU CAN HIDE BEHIND OUR CONSTITUTION IN MURDER@!!!!! RON PAUL YOUR VOTES AGAINST AIDS IS FLAT OUT BIGOTRY AND DISCRIMINATION ITS STIGMA! AS A DOCTOR YOU KNOW BETTER!!! YOUR ONLY EXCUSE IS BIGOTRY AND DISCRIMINATION IN YOUR BOOK AND FOX NEWS INTERVIEW! aids isn’t a moral disease its a human disease!!

This was apart of our facebook family that past this informtion to us.  I believe that we need to remember that we have the power to place the best person to run our country.  Not Ron Paul.

Ron you need to get educated you need to sit with someone who is positve, so you can learn How we live our lives.