Tag Archives: Aids Healthcare Foundation

US Regulators Vote For Approval of PrEP by Large Majority

The US Food and Drug Administration (FDA) took a decisive step yesterday towards approving the use of combination pill Truvada(tenofovir/FTC) as a prevention method for HIV-negative people.

The FDA’s Antiviral Drugs Advisory Committee (ADAC) voted by a majority of 19 to 3 in favour of recommending Truvada as PrEP (pre-exposure prophylaxis) for men who have sex with men, and by 19 to 2 with one abstention for an approval for use by the HIV-negative partner in serodiscordant couples.

There was a close vote, however, when it came to recommending its use generally in individuals for people at risk of HIV infection: 12 to 8, with two abstentions, voted for a general recommendation for any person at risk of HIV.

The ADAC decision was taken after an all-day meeting on 10 May. This meeting discussed the findings of a written report and also heard submissions from a large number of community prevention and treatment advocates. Interest was such that the FDA extended the time for submissions from advocates and community members from one hour to two and had to organise a ballot for access to the hearings.

The written report had concluded that concerns about safety and HIV drug resistance were not sufficient to delay the introduction of PrEP. It also decided that concerns about poor adherence levels seen in some randomised controlled trials, and about whether PrEP would negatively influence behaviour to such a degree that people ended up at greater risk of HIV, were beyond the remit of the FDA.

“I don’t think it’s our charge to judge whether people will take the medicine,” panellist Dr Tom Giordano told the Los Angeles Times. “Our charge is to judge whether it works when taken.”

Considerations of cost are also explicitly ruled out of the FDA’s remit when it comes to approving a new drug or indication.

The FDA is not bound to follow the recommendations of its advisory committees and will make a final decision by 15 June. However it is very rare for it not to do so and the large majority in favour of its approval for gay men and in serodiscordant couples makes this unlikely.

PrEP has always excited controversy amongst HIV prevention advocates and people affected by HIV. Some organisations have opposed its introduction and the AIDS Healthcare Foundation, in particular, has mounted a provocative campaign against its approval. “If you love Vioxx you’ll love PrEP,” read one poster displayed on bus shelters near the White House, referring to the painkilling drug that was withdrawn in 2004 when it was linked to heart attacks.

The majority of HIV prevention advocates, however, has supported PrEP. Mitchell Warren of the AIDS Vaccine Advocacy Coalition (AVAC) commented: “Some funders and policy makers have been awaiting a signal from the FDA before launching demonstration projects or developing implementation plans.

“The time for waiting is over. We need to get on with the work of setting priorities and rolling out PrEP to people who can benefit the most.”
The controversy was if anything reinforced when the randomised controlled trials (RCTs) of PrEP that have reported in the last 18 months –iPrEX, Fem-PrEP, Partners PrEP and TDF2 – produced strikingly different results, with headline efficacy levels ranging from zero (in Fem-PrEP) to 83% (for men in Partners PrEP). Studies of drug levels found that these results could be explained by different levels of adherence in trial participants. PrEP was 92% efficacious in participants in iPrEx who had detectable levels of drug in their blood, and it is clear that adherence levels will crucially determine whether it protects the people who take it.

At present randomised controlled trials have only tested daily doses of PrEP, though a study in France, IPERGAY, is currently testing its efficacy in gay men when taken on a before-and-after-sex basis.
In contrast concerns about negative behaviour change and participants putting themselves at greater risk of HIV have not been supported by RCT findings, but it is recognised that these will only be answered by an open-label study in which people know for sure that they are taking the drug and not a placebo.

Such a study, called PROUD, has been suggested for the UK and is awaiting a decision on approval. In this study gay men attending genitoruinary medicine clinics in the UK who are at significant risk of HIV will be offered TruvadaPrEP plus a package of behavioural support and counselling, but will be randomised to receive the PrEP component either immediately or a year later.

Principal Investigator of the proposed study, Dr Sheena McCormack of the UK Medical Research Council (MRC), told Aidsmap: “It is unusual for the MRC to talk publicly about a trial before it receives approval, but in the case of PrEP it is so important that the trial involves and is supported by its target community.”

Original article by Gus Cairns at Nam

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New Law in Los Angeles – Adult Movie Actor’s Required To Wear Condoms


Actors making pornographic movies in Los Angeles will be required to use condoms while filming, under a new law signed by the city mayor.

The new regulation has been welcomed by health officials but pornography industry leaders say it could force them to abandon the city.

LA’s San Fernando Valley is considered the capital of the multibillion-dollar US adult film industry.

Correspondents say it is not yet clear how the new law will be enforced.

The LA-based Aids Healthcare Foundation welcomed the move saying it was crucial in protecting adult film actors from HIV and other sexually transmitted diseases.

The foundation, which has campaigned for the measure for six years, said it would now seek similar condom requirement elsewhere in the US.

“The city of Los Angeles has done the right thing. They’ve done the right thing for the performers,” said foundation president Michael Weinstein.

He said his group would also be vigilant in keeping track of where porn producers might move to.

Several of the industry’s biggest adult filmmakers have said they might consider moving just outside city boundaries.

They insist that adult films featuring condoms are not as popular and that some actors prefer not to use them.

The new law was signed by Los Angeles Mayor Antonio Villaraigosa on Monday.

The city council has now asked the police, city attorney’s office and workplace safety officials to figure out how they enforce the rule, the Los Angeles Times reports.

Industry experts estimate as many as 90% of all pornographic films produced in the US are made in Los Angeles.

Last year, pornographic film productions across the US were temporarily shut down after an adult film performer tested positive for HIV – the virus that causes Aids.

Above article via BBC News

Our message is clear!

Condoms provide the best protection from HIV and other sexually transmitted infections.  HIV stands for human immunodeficiency virus. It was identified in the early 1980s and it belongs to a group of viruses called retroviruses.

Normally, the body’s immune system would fight off an infection, but HIV prevents the body’s immune system from working properly. HIV infects key cells in the body’s natural defences called CD4 cells, which co-ordinate the body’s response to infection. Many CD4 cells are destroyed by being infected, and some stop working as they should.

Although HIV can’t be cured, it can be treated. Modern HIV treatment means that many people with HIV are living long, healthy lives and can look forward to a near-normal lifespan.

AIDS
If HIV isn’t treated, the gradual weakening of the immune system leaves the body vulnerable to serious infections and cancers which it would normally be able to fight off. These are called ‘opportunistic infections’ because they take the opportunity of the body’s weakened immunity to take hold.

If someone with HIV develops certain opportunistic infections, they are diagnosed as having AIDS. The term ‘AIDS’ stands for acquired immune deficiency syndrome. People diagnosed as having AIDS can become unwell with a range of different illnesses, depending on the specific opportunistic infections they develop. This is why AIDS is not considered a disease, but a syndrome – a collection of different symptoms and illnesses, all caused by the same virus, HIV.

Most people who have HIV have not had an AIDS diagnosis. Also, if someone develops an AIDS-defining illness this doesn’t mean that they are on a one-way path to illness and death. Thanks to HIV treatment, many people who were once diagnosed as having AIDS are now living long and healthy lives.

Have you ever had a HIV test?

If you’re interested in having a HIV test, we offer a completely free and confidential rapid HIV test and you’ll get the results within 60 seconds from a simple finger prick test. We use the Insti HIV test produced by BioLytical laboratories. The test is 99.96% accurate from 90 days post contact for detecting HIV 1 and 2 antibodies. We also have a mobile testing van which is often out in communities providing mobile rapid HIV tests. Appointments are not always necessary, if you would like a test, please contact us on 0116 2559995

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