Both the House of Representatives and Senate have now given their assent to a bill that would allow patients infected with the Human Immunodeficiency Virus (HIV) to donate organs to other HIV-positive individuals, a major reversal of longstanding policy that now awaits President Barack Obama's signature. Background Current tissue, cellular and organ donations policies in the US are geared toward the absolute minimization of risk with respect to the transmission of commu...

US regulators have released a new guidance document aimed at providing clarity to the process of developing drug products to treat-not prevent the transmission of-Human Immunodeficiency Virus-1 (HIV-1), bringing up to date a development paradigm last updated more than a decade ago. The guidance revises Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations for Accelerated and Traditional Approval , a guidance released to the public in 2002. FDA...

A new untitled letter sent by US regulators to an Internet domain hosting company alleges that the company marketed an unapproved diagnostic test capable of testing for HIV, thereby violating federal law. Background HIV diagnostic kits were only recently approved for over-the-counter (OTC) sales. In July 2012, the US Food and Drug Administration (FDA) approved OraSure's In-Home OraQuick HIV test after its Blood Products Advisory Committee overwhelmingly supported its ...

A new draft guidance published by the US Food and Drug Administration (FDA) is seeking to assist in the development of a specific class of product-vaginal microbicides-intended to prevent human immunodeficiency virus (HIV) infections. Vaginal microbicides are chemicals used to treat or prevent infections, and are most commonly physically expressed as topical gels or creams. Researchers have long hoped that vaginal microbicides could be used to prevent the spread of HIV i...

The U.S. Food and Drug Administration (FDA) approved a new combination pill to treat HIV-1 infection in adults, according to an agency press release. The new pill, called Stribild, contains two new drugs combined with two previously approved drugs. The statement said these drugs together provide a complete treatment plan for HIV infection. "Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to si...

There's a new top threat to the safety of the nation's blood supply.  The Wall Street Journal reports donated blood products containing bacterially contaminated blood platelets have usurped HIV for the status of the most potent threat to patients. Contaminated variants of platelets, which are used to clot blood, have been blamed in nearly two dozen deaths and hundreds of injuries in recent years. While testing is available to screen donated blood for contaminated...

The US Food and Drug Administration (FDA) this week published a citizen petition denial to a group seeking to pre-emptively block the approval of a supplemental New Drug Application (sNDA) for Gilead Sciences' Truvada for preventing the transmission of HIV-1. The group, the AIDS Healthcare Foundation (AHF), had filed the petition on 7 March 2012-part of a subsequent campaign by the group to call attention to the drug. In a series of advertisements, AHF asked, "What rotte...

New guidance issued by the World Health Organization (WHO) is intended to aid countries in assessing pre-exposure prophylaxis (PrEP) drugs for use in preventing the transmission of HIV in high-risk individuals. In a statement, WHO said the guidance is based on clinical research indicating the drugs are "both safe for people to use and effective in preventing HIV." Though the drug class is far from a silver bullet, it can still reduce rates of infection by between 40% a...

The US Food and Drug Administration's (FDA) drug regulatory division announced the approval of a new indication for Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate), making it the first drug with an approved indication to prevent the transmission of the Human Immunodeficiency Virus (HIV). The drug was first approved in August 2004 under priority review for the treatment of existing HIV. FDA said under the new indication, approved 16 July 2012 via a supple...

In a statement on 5 June 2012, the German health technology assessment body Institute for Quality and Efficiency in Health Care (IQWiG) said it would reverse its  April 2012 decision not to recommend Eviplera (rilpivirine) for HIV in fixed combination.  The agency said in a statement its change in determination was due to the manufacturer having submitted additional information supporting this dosage form. The company used an alternative so-called vi...

Regulators at the US Food and Drug Administration (FDA) announced Tuesday, 3 July the approval of an over-the-counter (OTC) home testing kit for the detection of the Human Immunodeficiency Virus (HIV)-the first of its kind to be approved. The test, called the OraQuick In-Home HIV Test, is manufactured by Pennsylvania-based OraSure Technologies, Inc. OraQuick received overwhelming approval from FDA's Blood product Advisory Committee in May 2012, voting 17-0 to recomme...

The US Food and Drug Administration (FDA) will take an additional three months to review Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/emtricitabine) to assess newly-submitted plans to reduce the possible misuse of the drug, reports The Associated Press . Truvada, currently seeking marketing clearance from FDA to reduce the risk of contracting HIV when used in conjunction with other risk reduction methods, was cleared by an FDA Advisory Com...