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U.S. debates recommending drug for AIDS prevention

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US health advisors are poised to decide Thursday on whether to recommend the drug, Truvada, as the first preventive pill against AIDS instead of just a treatment for infected people.

Landmark study results published in 2010 showed that the drug, made by California-based Gilead Sciences, helped ward off HIV in gay men who engage in risky sex behaviors by 44 to nearly 73 percent.

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But critics note that the pill is costly — up to $14,000 per year — and some warn that the clinical trial did not represent real-world circumstances and could lead to a spike in unprotected sex and a new surge in AIDS cases.

The Antiviral Drugs Advisory Committee is expected to issue a decision later Thursday. The Food and Drug Administration does not have to follow its advice, though it often does.

Truvada is currently available as a treatment for people with HIV in combination with other anti-retroviral drugs and was FDA approved in 2004.

Drug maker Gilead Sciences Inc. of California has filed a supplemental new drug application to market it for prevention purposes.

The data being mulled comes mainly from the iPrEx HIV Prevention Study, the research was carried out from July 2007 to December 2009 in six countries — Brazil, Ecuador, Peru, South Africa, Thailand and the United States.

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The study was conducted among 2,499 men, including 29 transgendered women, between the ages of 18 and 67 who were sexually active with other men but were not infected with the virus that causes AIDS.

Participants were selected at random to take a daily dose of Truvada — a combination of 200 milligrams of emtricitabine and 300 milligrams of tenofovir disoproxil fumarate — or a placebo.

Those in the study who took the drug regularly had almost 73 percent fewer infections. Across the entire study, including those who had not been as faithful in taking Truvada, there were 44 percent fewer infections than those who took a placebo.

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The method of taking a drug ahead of potential exposure to HIV is called pre-exposure prophylaxis (PrEP).

After the study’s publication in the New England Journal of Medicine, some experts hailed the results as game-changing and the first demonstration that an already-approved oral drug could decrease the likelihood of HIV infections.

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However, others have warned of the risks of depending on people — particularly those who may be already engaged in careless behaviors — to take a daily pill.

“There could be an increased risk to men as they may falsely believe they are 100 percent protected and stop using condoms. A reduction in condom use will mean increased risk of transmission and the spread of a drug-resistant virus,” said a statement from the AIDS Healthcare Foundation.

“The 44 percent who received a benefit from Truvada in the iPrex Study were intensively counseled monthly and tested frequently for sexual infections — this is not likely to occur in the real world.”

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Gay men account for more than half of the 56,000 new cases yearly of human immunodeficiency virus in the United States, according to the Centers for Disease Control and Prevention.

A cost-benefit analysis by experts at Stanford University last month suggested the pill would make financial sense among gay men with five or more sex partners per year, but could be prohibitively expensive if promoted for all gay men.

[Bottles of antiretroviral drug Truvada. AFP Photo/Justin Sullivan]


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Giuliani pummeled by ex-press secretary for ‘returning to the scene of the crime’ to create Ukraine chaos

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On CNN Saturday, Rudy Giuliani's former mayoral press secretary Ken Frydman harshly criticized his former boss for his ongoing efforts in the Ukraine scheme.

"As you've watched the former mayor over the last several years, have you identified a point at which things shifted for the man who I guess still is for some known at America's Mayor?" asked anchor Victor Blackwell."

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‘Unbelievable’: Ex-Trump official stunned president is still letting Giuliani run around unchecked in Ukraine

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In a Washington Post report on the continuing attempts by former New York City Mayor Rudy Giuliani to dig up dirt on political opponents -- at the same time that President Donald Trump is facing impeachment for pressuring Ukraine with the promise of aid for the same -- a former Trump administration official expressed shock that Giuliani hasn't been told to stop.

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‘Hell no’: Texans join forces to stop Trump from stealing their land

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President Donald Trump's pledge to build a wall at the southern border with Mexico has been a huge winner with his base. But there is one group of people who are not happy: the Texans who actually live in the region where the wall would be built.

According to the Washington Post, many people in the region have no intention of letting the federal government seize their land to construct the wall, like Afghanistan war veteran Salvador Castillo of Brownsville, who received a letter from officials demanding unlimited access to and use of his land, which gradually escalated into a lawsuit.

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