News from Gilead on TMC278 and GS9450
Women’s SitRelief Shorts Now Available
ADAP Crisis Deepens; 1,001 Individuals Now on Waiting Lists
Illinois First to Pass State Health Care Reform Legislation
News from Gilead on TMC278 and GS9450
On April 20, Gilead Sciences announced that the Phase 2 clinical trial of GS 9450, an investigational capsase inhibitor, in patients with chronic hepatitis C, was halted. This decision follows reports of significant laboratory abnormalities and adverse events in a number of clinical study participants.
According to a press release issued by Gilead, “Patient safety is Gilead’s top priority, and the company has therefore made the decision to halt this study immediately. Gilead will be conducting a thorough review of all available data to assess future clinical development of the compound.”
Better news was reported in an April 27th press release regarding progress on the fixed dose combination of Gilead’s Truvada with Tibotec Pharmaceutical’s TMC278. According to the release, data supports “bioequivalence of a formulation of the fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).”
A bioequivalence study is required to demonstrate that a co-formulated product results in the same levels of medication in the blood as achieved when the individual products are dosed simultaneously as separate pills.
Gilead anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the fixed dose combination following validation of the TMC278 NDA.
Johnson & Johnson, which owns Tibotec Pharmaceuticals, announced last week that the two pivotal Phase 3 studies evaluating TMC278 as a treatment for HIV in treatment-naïve patients met the primary efficacy objective. In addition, the company announced plans to present the data in full at an upcoming HIV conference, and that submission of TMC278 for regulatory review is on track for the third quarter of this year.
The fixed-dose single-tablet combination of Truvada and TMC278 is an investigational product and the safety and efficacy have not yet been established.
Discuss this news in our discussion forum
Women’s SitRelief Shorts Now Available
LipoWear, a company founded by a man with AIDS to create padded undergarments for people suffering from lipodystrophy, now has a product specifically designed for women. According to a press release, “The clinically tested padded shorts (patent pending) are highly effective and alleviate sitting pain, a debilitating problem common to several patient populations. Sitting pain is caused by fat and muscle wasting in the buttocks resulting in crushed nerves when sitting and causes the withdrawal from many daily activities which contribute to the quality of life.” For more information on SitRelief Shorts, see News Briefs in the January/February Positively Aware, or visit www.lipowear.com. LipoWear develops therapeutic clothing products for select patient populations, including seniors and people with cancer or HIV, addressing specific debilitating problems common to these groups. The small company donates 10% of corporate profits to AIDS service organizations.
Discuss this news in our discussion forum
ADAP Crisis Deepens; 1,001 Individuals Now on Waiting Lists
The National Minority AIDS Council (NMAC) reported in their weekly newsletter that the condition of state ADAP programs has become even grimmer. NMAC, along with the National Alliance of State and Territorial AIDS Directors (NASTAD), “urges the Obama Administration and Congress, state legislatures and pharmaceutical companies to take immediate action to provide relief to the nation’s struggling ADAPs.”
According to the report, “The program is in need of an additional $126 million in FY2010 emergency funding in order to ensure access to lifesaving medications. As of April 30, 1,001 individuals in ten states are on waiting lists. ADAP waiting lists have increased ten-fold in the last year (99 individuals were on ADAP waiting
lists in May 2009). In addition to waiting lists, 16 states have implemented other access restrictions such as lowering financial eligibility criteria, removing drugs from their formulary and capping expenditures.”
To see a list of states with access restrictions please visit NASTAD’s website at www.NASTAD.org.
“ADAPs are struggling to provide their clients with access to the medications they need to stay healthy and productive,” stated Julie Scofield, NASTAD’s Executive Director. “Without additional resources and assistance we fear we will continue to see more states reducing access to these critical, life-saving programs.”
The current economic crisis has impacted ADAPs heavily. Individuals losing jobs and their insurance, as well as increased HIV testing efforts, have created a greater demand for ADAP services. During FY2009, clients utilizing ADAP services increased by an average of 1,271 individuals per month, an increase of 80% from FY2008 when ADAPs experienced an average monthly growth of 706 clients.
NASTAD believes we have reached the point where federal and state governments as well as our pharmaceutical partners must step up and ensure that eligible ADAP clients have access to their medications,” remarked Scofield. “We call upon President Obama to provide sufficient funding to ease access restrictions in ADAPs nationwide.”
The ADAP Crisis Task Force (Task Force), convened by NASTAD, is negotiating with the major antiretroviral manufacturers at meetings this week in Washington, D.C. in an effort to provide additional rebates and discounts as well as multiple-year cost protections for ADAPs, which will allow increased state and federal revenues to go toward eliminating waiting lists, providing medications to new clients, and maintaining formularies.
ADAPs are the safety net under other public programs, such as Medicare and Medicaid. Over seventy-five percent of ADAP clients earn less than 200 percent of the federal poverty level, which is $22,000 for an individual.
It is estimated that the additional $126 million needed in FY2010 emergency federal funding will only allow states to continue their programs with the same composition, not expand their programs in any way. Emergency funding to curtail ADAP waiting lists has not been available since 2004 when President Bush provided additional funds to the program.
Discuss this news in our discussion forum
Illinois First to Pass State Health Care Reform Legislation
In an e-mail from the Campaign for Better Health Care (CBHC) on May 3, it was announced that the Illinois House of Representatives joined with the State Senate and passed the Health Care Justice Implementation Act (SB3047) by a vote of 76-41.
"Passage of SB 3047 confirms Illinois's commitment to President Obama's recently passed federal health care reform," said Jim Duffett, Executive Director of the CBHC. "Illinois has now become the first state in the nation to pass legislation since the passage of federal health care that embraces the implementation of these reforms."
Duffett praised State Senator Dave Koehler, vice-chair of the Health Care Justice Task Force, and State Representative Mary Flowers for their leadership and hard work in getting the bill passed with bipartisan support.
The main goals of the Health Care Justice Implementation Act are to monitor the implementation of the federal health care reforms and make recommendations per state implementation; assess current state programs and how they interface with the federal reform and recommend any changes if needed; and develop a plan regarding additional reforms needed to ensure affordable health care. A bipartisan Health Care Justice Implementation Task Force will be established to achieve those aims.
Discuss this news in our discussion forum
