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9 Dezember 2016, 15:40
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Charlie Sheen reveals he achieves HIV suppression by experimental medication

Charlie Sheen reveals he achieves HIV suppression by experimental medication - Bild 1

Charlie Sheen has spoken exclusively to Daily Mail Online to reveal his HIV has been fully suppressed by an experimental injection in a clinical trial.

The actor, who has been involved in a clinical trial for a drug called PRO-140 since early 2016, opened up about the news on the eve of World AIDS Day as health officials around the world celebrate immense progress in HIV research. 

As opposed to traditional antiretroviral therapy (ART), which involves taking daily medication, Sheen receives a weekly injection that has no side effects.

On Tuesday, Sheen received the news from the head of his clinical trial that he has achieved complete suppression of the virus using this method alone. 

In other words: his virus is no longer detectable, making PRO-140 a promising prospect for people with HIV/AIDS. 

It came just over a year since the 51-year-old publicly revealed his diagnosis, and coincided with the global day of recognition as public health officials unite to raise awareness for the cause on World AIDS Day.

Speaking to Daily Mail Online, Sheen said he has never felt so strong and confident about his condition, and hopes the research will both bolster approval for this treatment and de-stigmatize people living with HIV.

'It's impossibly amazing,' Sheen tells Daily Mail Online. 

'Personally, I think about how I felt on the day and how I feel today. Wow. Talk about a transformation.

'One minute you're on the road to perdition, the next you're on the road to providence. It's amazing. 

'I thought for sure I'd be stuck on that cocktail forever, but look at me now.

'I'm so grateful for the geniuses at CytoDyn for developing this and finding me.'

PRO-140 is an 'entry and fusion inhibitor' that is injected weekly.

It is made from an antibody, rather than synthetic chemicals.

Entry and fusion inhibitors protect cells in the immune system from HIV infection.

To do so, the drug attaches to a protein receptor on the surface of the immune cell.

Normally, HIV would use that protein as a gateway to enter and infect a cell.

Studies show that when this gateway is blocked, HIV has no other way of entering that cell.

If possible, this process would block the virus from multiplying. It could also reduce that amount of HIV in the body.

The injection does not work for all strains of HIV, just R5. However, given that data show approximately 70 percent of people with HIV have R5, and 90 percent of new infections are R5, it has gained the excitement of scientists and regulators.

To date, this has only ever been achieved with daily doses of antiretroviral therapy drugs. 

But a number of clinical trials - including of PRO-140 by CytoDyn - hope to be developing less emotionally and physically taxing treatments. 

Taken daily, ART suppresses the virus. 

But keeping up a daily medication regimen may be difficult for some especially those who face social and structural barriers such as HIV stigma, unstable housing, food insecurity and mental health issues. 

Some find the drugs are expensive, or may not be able to tolerate the side effects such as nausea, fatigue and nerve problems in the short-term, and insulin resistance and other problems over time.

Only about a third of US patients take ART consistently enough to push the virus down to undetectable levels.

'We're going to need other approaches,' said Dr. Nelson Michael, director of the U.S. Military HIV Research Program at the Walter Reed Army Institute.  

 

Eight months into the trial, Charlie Sheen said he hasn't felt any side effects.

'You'd think that I have this disease and I'm doing a trial so I'm probably covered in blackheads and all that. Not at all. I haven't felt anything - nothing. 

'The only thing that I've noticed was that on the day of the injection I felt a little bit of fatigue. Just a little bit. But you know... 'hash tag so what?!' I could barely notice it, and now I feel great.

'It's beyond the pale of amazing.' 

On Tuesday November 29, he received a text from Dr Nader Pourhassan, CEO of the Washington pharmaceutical company CytoDyn Inc, the firm behind the drug, saying he had just received Sheen's recent two viral load results. Both are TND (target not detectable) - i.e.: complete suppression.

Since it is a Phase III trial, Sheen is in the last batch of human volunteers to try it before it can be released.

There are a couple of months left before the results will be studied by the FDA to see if it can be publicly released.

CytoDyn Inc is eyeing up a mid-2017 or early 2018 release.

UNDETECTABLE = UNTRANSMITTABLE

Sheen first mentioned the idea that a person with an 'undetectable load' of the virus carries 'negligible risk' in November 2015 when he revealed his diagnosis. 

A person with HIV becomes 'undetectable' when ART suppresses the virus to a level so low in their blood that it cannot be detected by measurements.

Despite the growing swell of scientific studies supporting this view, Sheen had his critics. 

However, in August an international coalition of doctors and health policymakers signed the first consensus statement to say that studies show antiretroviral (ART) drugs make the risk of transmission 'negligible' - so low as to not be worth considering; insignificant.

It was the first time a US public health official had publicly supported the idea - in this case New York City's Assistant Health Commissioner.

 

Swathes of surveys published today, to coincide with World AIDS Day, show there remains widespread misunderstanding about HIV, AIDS, the differences between the two, and what it means to be HIV positive in 2016. 

A YouGov poll has found 20 percent of people still believe HIV can be transmitted by kissing - something that was proven wrong by scientific research decades ago.

Almost a third of people in the 2,000-person survey believed sharing a toothbrush can spread HIV, which is also impossible since HIV - an incredibly weak pathogen - cannot survive outside the body.

Crucially, 61 percent of people did not know that the virus can be suppressed to such a low level that transmission is virtually impossible.

The real risk is among untested people who may have and spread the virus without knowing they have it.

People who have been tested, diagnosed as HIV positive, and administered viral-suppressing treatment can reach a point where they cannot transmit the virus.

Viral suppression can also protect people with HIV from passing the virus on to their children - which was news to 29 percent of those surveyed by YouGov.

According to Dr. Carl Dieffenbach, Director of the Division of AIDS at the National Institutes of Health, this misunderstanding about viral suppression is the biggest obstacle to public awareness surrounding HIV and AIDS today.  

'If you are durably virologicially suppressed you will not transmit to your partner,' he said. 

'I'll say this again, for somebody who is in a discordant couple, if the person [with HIV] is virologically suppressed, 'durably' - means there is no virus in your system, hasn't been for several months - your chance of acquiring HIV from that person is ZERO.

'Let's be clear about that: ZERO. 

'If that person the next day stops therapy for two weeks and rebounds, your chance goes up. 

'That's why we talk about durable viral suppression. 

'You're as virologically suppressed as good as your adherence. That's the message.'  

PROGRESS IN 2016 - AND WHAT'S NEXT 

Decades on from the 80s, the focus is now on raising awareness about viral suppression and supporting research. 

'Advances in medicine and science are changing lives in ways that we never thought possible,' Bruce Richman, executive director of the Prevention Access Campaign, told Daily Mail Online. 

'Twenty years ago we learned that effective HIV treatment would save lives. Now we know it also prevents HIV transmission to others.

'People living with HIV can now have confidence that if they are virally suppressed and take their medications regularly they will live healthier lives and will not transmit HIV to others. That lifts a tremendous burden from people with HIV and their partners.

'If we focus on the facts instead of fear, we have unprecedented opportunities to end HIV stigma and end the epidemic.'

Indeed, in a powerful op-ed for TIME, Dr Oxiris Barbot, NYC First Deputy Health Commissioner, declared it is possible to end AIDS in our lifetime. 

This year, for the first time since the epidemic outbreak, no babies were born with HIV in New York City, he wrote referring the city's report released this week.  

'With coordinated strategies to keep parents HIV-free or virally suppressed, we can end mother-to-child HIV transmission not only in New York City but across the nation,' Dr Barbot wrote.

'While there's more work to be done, achieving zero mother-to-baby HIV transmissions helps honor the sacrifices of the thousands of family members that lost 1,255 of our littlest New Yorkers to an entirely preventable disease, according to an NYC Health Department analysis.'

Dr Demetre Daskalakis, assistant commissioner of the city's HIV/AIDS Bureau, said the aim is to combat AIDS by 2020 - and he believes that is a realistic estimate. 

'The lessons that got us to the end of this important part of our epidemic are the lessons that will power us to our goal of extinguishing AIDS by 2020,' he said this week. 

'Biomedical technology and community engagement merge into a single strategy to drive down this epidemic with love and respect for the communities overburdened by this infection. 

'Together we will end the HIV divide caused by stigma and will see even faster progress to our goal of an AIDS-free generation.' 

Reflecting on World AIDS Day, Charlie Sheen said the progress is bitter-sweet - for him and for everyone else.

'When you think of the poor souls - countless - that perished, that just were wrought with dismay and strife and confusion back in the eighties... 

'I feel like I stand for those individuals as well.

'It's bitter-sweet. But I'm so grateful to be a part of it, supporting research with this clinical trial.' 

http://www.dailymail.co.uk/health/article-3988106/Charlie-Sheen-reveals-HIV-fully-suppressed-drug-clinical-trial.html

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