Extension of iPrEX HIV PrEP Study Begins at 11 Sites in 6 Countries

Via iPrEX News.

The iPrEx Open-Label Extension Study (iPrEx OLE), the next phase of the first human study to report efficacy results on pre-exposure prophylaxis (PrEP) to prevent HIV infection, has begun at clinical trial sites around the world. Approximately 2,000 men and transgender women who have sex with men are expected to participate in the 72-week iPrEx OLE study. Study sites in the United States and South Africa are enrolling participants now, as other study sites finalize the regulatory approval process.

In PrEP, antiretroviral medications that are usually used to treat HIV are taken by uninfected people to reduce their risk of infection. The iPrEx study found that men and transgender women who have sex with men (MSM) who took a single daily tablet containing the HIV medications emtricitabine and tenofovir (FTC/TDF), known commercially as Truvada®, experienced an average of 44% fewer HIV infections than those who received a placebo (blank pill). HIV infection rates in the iPrEx study dropped by 90% among those who used PrEP consistently enough to have detectable drug in the body. The HIV risk reduction benefits of PrEP were in addition to those provided by safer sex counseling, condoms, HIV testing and the detection and treatment of sexually transmitted infections. iPrEx study results were published in the New England Journal of Medicine in November, 2010.

The news of the start of iPrEx OLE follows the announcements by two other major PrEP studies, Partners PrEP and the CDC study in Botswana, known as TDF2, which demonstrated the safety and efficacy of PrEP in heterosexual women and men.

AdvertisementiPrEx OLE is a continuation of the iPrEx study that will collect additional data on PrEP efficacy, safety and adherence. All HIV-negative participants who took part in the original iPrEx study and who wish to participate will receive FTC/TDF for HIV prevention for 72 weeks through iPrEx OLE. No placebo will be used in the Open Label Extension.

"We are in a critical moment in HIV prevention research," said iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institutes and the University of California at San Francisco. "iPrEx provided the first proof of an important new method of HIV prevention that can help slow the global toll of 2.6 million new HIV infections each year. Partners PrEP and the TDF2 study have now expanded that finding by demonstrating the effectiveness of PrEP in heterosexual women and men. Developing and deploying proven HIV prevention methods -- including PrEP, microbicides, vaginal gels, clean needles, medical male circumcision, early treatment, counseling, testing, condoms and suppressive therapy for pregnant women will all be key to slowing the global epidemic."

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Two large studies show that ARVs can prevent HIV

Today, all of us in the HIV prevention field have woken up to heartening news: two large PrEP studies have shown that taking antiretrovirals (ARVs) can reduce the risk of HIV infection through sexual intercourse by 62-73% among heterosexual couples. This news comes close on the heels of the encouraging results from the IPrEX trial, which showed that ARVs could provide protection against HIV among gay men.

The Partners study, funded by the Bill & Melinda Gates Foundation, took place in Kenya and Uganda. It was stopped a year and a half early because of the highly significant results. Unlike the earlier FEM-PrEP trial, adherence in this case was extremely high: more than 97% of doses dispensed were taken, and 95% of participants stayed in the study. The TDF2 study, conducted in Botswana, concluded as planned.

The results of both these PrEP studies are being called “fundamentally important for HIV prevention” and provide added impetus to the ongoing discussion about ensuring the widespread availability of affordable ARV drugs in developing countries.

To know more, check out Reuters’ coverage of the studies here or The Washington Post’s story here. For more details, read the article on The University of Washington website as well as the CDC website.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

New Studies Show PrEP Works for Heterosexuals Too

via Aidsmap, by Keith Alcorn

Two large studies of pre-exposure prophylaxis – use of antiretroviral drugs by uninfected people to prevent HIV infection – have shown that taking tenofovir or tenofovir plus emtricitabine (Truvada) can cut the risk of HIV infection through sexual transmission by between 62% and 73% in male-female couples. Results from both the Partner study and the TDF2 study were released today.

“This study demonstrates that antiretrovirals are a highly potent and fundamental cornerstone for HIV prevention and should become an integral part of global efforts for HIV prevention,” said Dr Connie Celum, Professor of Global Health and Medicine at the University of Washington, Seattle.

The results, released this morning ahead of the International AIDS Society conference in Rome next week, follow positive results from the IPrEX study of Truvada PrEP in men who have sex with men released in November 2010.

Fuller results from the studies will be presented next week.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Gilead Deal: More AIDS Patients May Get Cheaper Drugs

Ranbaxy Laboratories recently entered into a deal with Gilead Sciences that will allow the Indian pharmaceuticals company to manufacture generic versions of three new HIV medications.

Via Associated Press:

Gilead Sciences Inc. will allow some of its AIDS drugs to be made by generic manufacturers, potentially increasing their availability in poor countries, particularly in Africa, officials said Tuesday.

In the first deal of its kind, the pharmaceutical company has agreed to allow four of its AIDS drugs to be made by generic drug companies at a cheaper cost in return for a small proportion of royalties, United Nations health officials said.

Most of the 33 million people worldwide who have HIV, the virus that causes AIDS, live in Africa. One of the drugs will also be used to treat people with hepatitis.

The deal was negotiated by the Medicines Patent Pool, part of a U.N.-led partnership that raises money for AIDS, tuberculosis and malaria by things like taxing airplane tickets. Among the partnership's 29 member countries, only Chile, France, Korea, Mali and Niger are actually implementing the airline tax.

"We will continue to work with Gilead and others to expand access to all people living with HIV in developing countries," said Ellen 't Hoen, executive director of the Medicines Patent Pool.

Gilead will receive from three to five percent royalties on its four drugs, which will be supplied to about 100 countries.

Until now, its drugs have been mainly sold in rich countries, and profits from the new deal are expected to be a tiny fraction of those Gilead gets from the West.

Typically, patients in poor countries have to wait for years until the patents expire on new drugs before they can be made more cheaply by generic companies.

Read the rest here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

India says EU deal won't hit AIDS drugs supply

Via Reuters, by Nita Bhalla.

India has promised not to link a proposed trade deal with the European Union with limiting its production of generic HIV/AIDS drugs, the United Nations said on Thursday, giving hope to millions of infected patients but underlining the hurdles for the controversial pact.

The EU and India began negotiations in 2007 on a free-trade agreement which could generate two-way trade annually worth about $134 billion. But campaigners, including the U.N., have voiced concerns over how it could block India's ability to produce anti-retroviral (ARV) drugs and prevent the world's poor from accessing cheaper treatment.

"The Government of India reaffirms its full commitment to ensure that quality generic medicines, including anti-retroviral drugs, are seamlessly available, and to make them available to all countries," India's Commerce Minister Anand Sharma was quoted as saying in a statement issued by the Joint United Nations Programme on HIV/AIDS (UNAIDS).

"India will also use the flexibilities allowed under (the copyright pact) TRIPS, including the use of compulsory licensing, to ensure that people living with HIV have access to all life-saving medicines."

Sharma made the comments in a meeting with UNAIDS Executive Director Michel Sidibe, who on Tuesday told Reuters in an interview that millions of people around the world would die if the deal blocked India from producing generic medicines.

An estimated 15 million people are eligible for ARVs in low-and middle-income countries, yet currently only about 6.6 million people have access to treatment. India's pharmaceutical industry produces about 86 percent of the first-line cheap generic drugs, most of whom live in Africa.

Generic ARVs cost about $137 per person per year, a fraction of the price of patented ARVs used to treat the human immunodeficiency virus (HIV) that causes AIDS, and are sold by western pharmaceutical firms, say experts

Read more here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]