Proposal to Add HIV Tests to Medicare's List of Covered Preventive Services
Once-Daily, Unboosted Integrase Inhibitor Evaluated in Phase 1-2a Study
FDA Approves Abbott Labs Blood Test
Proposal to Add HIV Tests to Medicare's List of Covered Preventive Services
On September 11, the Department of Health and Human Services (DHHS) announced a new proposal that would cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries of any age who voluntarily request the service.
"While younger age groups account for most cases of HIV infection in the United States, the Centers for Disease Control and Prevention (CDC) estimates that in 2006, approximately 19% of all U.S. residents with AIDS were age 50 years or older when the disease was diagnosed," Secretary of Health and Human Services Kathleen Sebelius stated.
The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) gave the Centers for Medicare and Medicaid Services (CMS) the ability to consider whether Medicare should cover "additional preventive services," if certain requirements are met.
"This proposal to cover HIV screening for our Medicare population has great potential in terms of saving lives and improving the quality of life for many seniors, as well as beneficiaries under age 65," said Acting CMS Administrator Charlene Frizzera.
The White House's top HIV/AIDS official saluted the move by HHS, calling it a critical step in helping HIV and AIDS patients to get the treatment they need.
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Once-Daily, Unboosted Integrase Inhibitor Evaluated in Phase 1-2a Study
Shionogi-GlaxoSmithKline Pharmaceuticals, LLC announced, on September 14, results from a Phase 1-2a study evaluating the pharmacokinetics (PK), safety, and antiviral activity of its investigational integrase inhibitor (INI) S/GSK1265744 in both healthy and HIV-positive subjects. The data showed a significant decline in viral load in HIV-positive participants, as well as favorable pharmacokinetic and short-term safety profiles in all study participants. The results of this study were presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held last week in San Francisco, California.
"Shionogi-GlaxoSmithKline Pharmaceuticals is committed to the integrase inhibitor class of antiretrovirals because new treatments are urgently needed to address issues of viral resistance and dosing complexity faced by many HIV patients," said Garrett Nichols, M.D., Project Leader, GlaxoSmithKline (GSK).
Integrase inhibitors are a new class of anti-HIV drugs that block HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV-1 replication cycle. Integrase inhibitors are of great interest because they have a different mechanism of action from other anti-HIV drugs, and there is a need for new medications that help address resistance issues and provide additional treatment options. Patients need multiple, active antiretroviral drugs that can be administered in combination to attain viral suppression, as well as new drugs that offer different resistance profiles and simplified dosing.
"The joint venture between Shionogi and GSK was formed for the purpose of driving the successful research and development of new treatments for HIV," said Tamio Fujiwara, Ph.D., HIV Integrase Inhibitor Project Leader, Pharmaceutical Development Division, Shionogi & Co., Ltd.
Though results from this study are encouraging, research on GSK’s integrase inhibitor S/GSK1265744 will continue.
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FDA Approves Abbott Labs Blood Test
Abbott Laboratories announced on September 21 that it received approval from the U.S. Food and Drug Administration (FDA) for its ABBOTT PRISM HIV O Plus test, the first fully automated blood screening test for HIV-1/HIV-2. This test can be used by laboratory professionals to screen individual donors of blood and plasma for antibodies to human immunodeficiency virus type 1 Groups M and O (anti-HIV-1) and type 2 (anti-HIV-2), and as an aid in the diagnosis of HIV-1/HIV-2 infection.
According to the press release, the American Association of Blood Banks (AABB) said that eight million volunteers donate about 15 million units of whole blood each year in the United States alone. Each donated unit of blood must be tested for infectious diseases including hepatitis, HIV and other retroviruses. Abbott’s hepatitis and retrovirus tests are used thousands of times every day around the globe for blood screening and diagnostic testing. This new test will increase speed and efficiency, allowing labs to test more than 1,200 blood samples in an eight-hour shift.
"Abbott has a strong heritage in HIV assay development, beginning in 1985 with the first blood-screening test for HIV approved in the United States" said Mike Warmuth, Senior Vice President, Diagnostics at Abbott. "The approval of ABBOTT PRISM HIV O Plus marks an important milestone as we continue our leadership in HIV and our work to ensure the safety of the world’s blood supply."
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