News / Africa

A Step Closer to Major HIV Prevention Method

Gilead Science's Truvada combination antiretroviral pill that's taken once daily.Gilead Science's Truvada combination antiretroviral pill that's taken once daily.
x
Gilead Science's Truvada combination antiretroviral pill that's taken once daily.
Gilead Science's Truvada combination antiretroviral pill that's taken once daily.

Multimedia

Audio
Joe DeCapua
A U.S. government panel has recommended the use of a once daily pill to help prevent HIV infection. The pill has been shown to be very effective in studies. The Food and Drug Administration, the FDA, now has until June 15 to decide whether to approve the panel’s recommendation.

The Food and Drug Administration’s Antiviral Drugs Advisory Committee has endorsed the use of Truvada as a prevention method.

Mitchell Warren, head of the AIDS advocacy group AVAC, says it’s a combination pill.

“It’s made up of two different antiretrovirals – tenofovir and emtricitabine. And those two drugs had already been approved by the FDA a number of years ago individually; and then about 8 years ago they were approved as the combination drug. But all of those approvals related to the use of the drug for treating people who are already infected with HIV,” he said.

But since it now would be used as a prevention method it needs new FDA approval.

Warren said, “It’s the first time that the FDA is considering a pill for prevention of HIV. The data presented came from a number of trials looking at the potential benefit of providing this drug to HIV uninfected people, who are at high risk of HIV in hopes of preventing transmission.”

The evidence is based on trials where participants included men who have sex with men and discordant couples. That’s where one partner is infected and the other is not. The prevention method is called preexposure prophylaxis.

“If you are at risk of HIV, if you perceive yourself to be at risk, if you’re able to take this pill everyday as part of a combination of activities, including getting frequent HIV testing, you can reduce your risk of infection quite substantially. And that’s a huge step forward in adding a new option for men and women to prevent HIV,” he said.

The FDA often follows the recommendations of its advisory committees, but approval is not guaranteed. The agency must consider a number of things before deciding. One is what would the drug label say? Would it list only specific high risk groups like men who have sex with men or recommend it for both men and women?

It also must require the manufacturer – Gilead – to produce a risk evaluation and mitigation strategy. This would help ensure safe and effective use of Truvada, including extensive training for health providers and testing to ensure people are indeed HIV negative before taking the pill.

Warren says another big issue affecting Truvada is cost.

“One often hears in the United States where this is described as a $14,000 a year pill. Rarely does anyone pay that. And one of the really exciting things – when Gilead presented all of the data they actually said publically that they plan to create a patients assistance program. So if you are HIV infected and don’t have insurance, there are programs that Gilead supports to make the drug available at very low cost or in some cases even free,” he said.

The drug would be much cheaper in developing countries, possibly several hundred dollars a year. But that’s still high by developing country standards. Warren says that price could be negotiated and reduced if PEPFAR, the President’s Emergency Plan for AIDS Relief, and the Global Fund to Fight AIDS, Tuberculosis and Malaria, plan to use Truvada.

You May Like

Video VOA Reporter Tours Devastated Peshawar School

Islamist militants wearing military uniforms and strapped with explosives attacked a military run school Tuesday in the northwestern Pakistani city of Peshawar. At least 141 people were killed in the horrific attack, most of them young students. More

Video Sudan School Becomes Target of Aerial Attacks

Dropout rate at an all-time high in South Kordofan state because many schools have been destroyed during 3-year civil war More

Tennessee Songbirds Fly Coop Long Before Tornadoes Arrive

Researchers say birds apparently alerted to danger by sounds at frequencies below range of human hearing More

Featured Videos

Your JavaScript is turned off or you have an old version of Adobe's Flash Player. Get the latest Flash player.
US: Response to Sony Hack Will Be Proportionali
X
Aru Pande
December 19, 2014 1:45 AM
The White House says President Barack Obama considers the cyberattack on Sony Corp. a serious national security matter and that the U.S. will counter with an "appropriate response." VOA correspondent Aru Pande reports.
Video

Video US: Response to Sony Hack Will Be Proportional

The White House says President Barack Obama considers the cyberattack on Sony Corp. a serious national security matter and that the U.S. will counter with an "appropriate response." VOA correspondent Aru Pande reports.
Video

Video Sudan School Becomes Target of Aerial Attacks

The school dropout rate is at an all-time high in Sudan's South Kordofan state because many schools have been destroyed during the three-year civil war between the government and SPLA-N rebel forces. Adam Bailes visited Sudan's Nuba Mountains' region and reports many children are simply too scared to go to school
Video

Video Nigerians Fleeing Boko Haram Languish in Camp Near Capital

In its five-year effort to impose Islamic law in northeastern Nigeria, the Boko Haram extremist group has killed thousands of people and forced hundreds of thousands to flee. Some of those who ran for their lives now live in squalor on the edges of the capital, Abuja. Chris Stein reports for VOA.
Video

Video Putin Says Russian Economy Will Emerge Stronger

Russian President Vladimir Putin has said his country's sinking economy will not only recover but also become stronger, despite falling oil prices and Western sanctions over Ukraine. VOA's Daniel Schearf reports.
Video

Video Detained Turkish Journalists Follow Teachings of US-Based Preacher

The Turkish government’s jailing of critical journalists has sparked international condemnation and is being seen as an effort to undermine the followers of an ailing Turkish preacher based in the United States. VOA religion reporter Jerome Socolovsky has more.
Video

Video ‘Anti-Islamization’ Marches Increase Tensions In Germany

Anti-immigrant rallies in Germany have been building in recent weeks, peaking Monday night in the city of Dresden where tens of thousands of people turned out to demonstrate against what they call the ‘Islamization’ of the West. Germany has offered asylum to more Syrian refugees than any other country, and this appears to have set off the protests. Henry Ridgwell reports from London.
Video

Video Aceh Rebuilt Decade After Tsunami, But Scars Remain

On December 26, 2004 there was an earthquake in the Indian Ocean so powerful it caused the Earth’s axis to wobble a few centimeters. Onshore on the island of Sumatra, the resulting tsunami was devastating. A decade later, VOA Correspondent Steve Herman reports from Banda Aceh, Indonesia, where although there is little remaining evidence of the physical devastation, the psychological scars among survivors remain.
Video

Video Refugees Living in Kenya Long for Peace in the Home Countries

Kenya is host to numerous refugees seeking safe haven from conflict. Immigrants from Somalia face challenges in their new lives in Kenya. Ahead of International Migrants Day (December 18) Lenny Ruvaga has more for VOA News from the Kenyan capital.

All About America

AppleAndroid