INSUBCONTINENT EXCLUSIVE:
Hopes have been dashed an experimental vaccine could protect people against HIV, the virus that causes Aids.The National Institutes
of Health has stopped its HVTN 702 trial, of more than 5,000 people in South Africa, as it found the jab did not prevent HIV.Experts
expressed "deep disappointment" but added the search for a preventive HIV vaccine must continue.Such vaccines do not contain HIV and
therefore do not pose any danger of giving HIV to an individual.The jab was a new version of the first HIV-vaccine candidate shown to
provide some protection against the virus - in the RV144 clinical trial, in Thailand.There are many different strains of HIV and the vaccine
had been adapted to the subtype most common in South Africa, which has one of the highest HIV rates in the world.There were great hopes that
the vaccine would work and it could then be adapted to cover other strains of HIV circulating in other parts of the world.What happened in
the trial?Volunteers were randomly assigned to receive either the vaccine or placebo injections.And preliminary data showed:129 HIV
infections among the vaccine recipients123 HIV infections among those given the dummy jabDr Anthony Fauci, from the NIH, said: "An HIV
vaccine is essential to end the global pandemic and we hoped this vaccine candidate would work
Regrettably, it does not."
"Research continues on other approaches to a safe and effective HIV vaccine, which I still believe can be
achieved."
Linda-Gail Bekker from the International Aids Society said: "Whilst this is a significant setback for the field, we need to
continue the quest for a preventive vaccine."
There is still hope other HIV vaccines in development may work.
How can HIV be stopped?A
drug treatment called pre-exposure prophylaxis (Prep) is effective at preventing HIV infection but, unlike a vaccine, it needs to be taken
regularly, even daily.
In countries where such treatments may not be available, the only effective prevention remains using condoms during
sexual intercourse - or abstinence.
Recent breakthroughs in anti-retroviral treatments have improved the lifespan of people with
HIV.
Debbie Laycock, Head of Policy at Terrence Higgins Trust said: "Through regular testing, condoms, Prep and effective treatment which
means people living with HIV can't pass on the virus - we now have a once-in-a-generation opportunity to end the HIV epidemic
It's vital we seize this."
The HIV-positive man who stopped thousands getting the virusBy Tom de CastellaBBC Stories28 June 2018Share this
with Facebook Share this with Messenger Share this with Twitter Share this with Email ShareRelated TopicsNHS at 70Greg Owen wanted a new
drug, not available through the NHS, that would stop him becoming HIV-positive
But it was too late - he already had the virus
Despite this, he and a friend worked on an ambitious plan to help thousands of others get the new treatment.
"You know when you do one
thing… when your whole life changes? Pressing that send on Facebook was actually the moment my whole life changed."
Greg Owen grew up in
Belfast, the eldest of six children
It was the 1980s, the height of the Troubles, and he was, as he puts it, "very gay".
Fast-forward to London in 2015
Greg is working in bars and clubs, sleeping on friends' sofas.
There is no sign of what is to come - that Greg is going to help save
thousands of lives and change the way the NHS thinks about gay men having sex.
Then, Greg met Alex Craddock.
"He was cute, a little bit
And I fancied him a little bit," says Greg.
Alex had just come back from New York
He had something Greg wanted very much
He was on Prep, a relatively new drug seen as a game-changer in the fight against HIV infection.
If you are on Prep and have sex with
someone with HIV, the drug - if taken as directed - is almost 100% effective in preventing you becoming HIV positive even if you are not
wearing a condom.
The British HIV Association (BHIVA) says the efficacy of Prep is "highly dependent on adherence" by those taking
"I was trying to get Prep
And Alex was already on it
He'd got in the States." Alex told him it was easy to get in New York
But Alex's supply was about to run out
Here in the UK, it wasn't available.
"I'd been given this amazing new thing and then it had been taken away from me," Alex says
"That's when I first met Greg."
At the time, HIV diagnoses for high risk groups in the UK were going up
One in eight gay men in London had HIV.
Short for pre-exposure prophylaxis, Prep is a pill you take before penetrative sex.
Some users
take it daily - while others take it "on demand", in the days before and after intercourse.
If a condom is not worn, and you come into
contact with HIV, the drug stops the virus from getting into the bloodstream permanently
Prep is prevention not cure.
But before you can take Prep, you have to make sure you don't already have HIV.
Greg had managed to get hold
of a small amount of the drug - and so he went for a test.
He wasn't too worried as he'd gone for sexually transmitted infection (STI)
He was watching the doctor
The testing kit would show one dot for negative, and two for positive
Suddenly, in a heartbeat, everything changed.
"Literally, 'Boom,' like two dots so [the doctor] didn't even have to say anything, I saw it
because it was sitting in-between us."
Greg felt numb, trapped and alone
"I was seeing people go past me and I felt like I was in like a bubble - like there was a something separating me from the rest of the
world."
And that's when he made the decision that changed his life and maybe that of thousands of other gay men.
He decided to reveal this
So, he posted on Facebook that he was HIV positive
And he talked about Prep - this drug few knew much about, which could have stopped him getting HIV.
His phone "just lit up", he
says.
"First of all, people couldn't believe I'd done that
And then there was, 'What is all this Prep stuff?' Why would Prep have kept you HIV negative?' So, I could tell people what Prep was and I
could tell people how it worked
And then obviously the next question was, 'How do I get Prep?'"
Watch Greg and Alex's storyThe People vs The NHS: Who Gets the Drugs? was
first broadcast on BBC Two.
It is now on the BBC iPlayer along with more programmes about the NHS at 70.
And that was Greg and Alex's next
move.
"We don't even need the government right now," Alex recalls them saying
We'll tell everyone to order pharmaceutical drugs on the internet and start taking them."
From Alex's bedroom, they started building a
website.
First, came all the medical information people needed to know
And then, the bit everyone wanted - the opportunity to "click to buy"
"We didn't want to make any money ourselves
We were just linking up buyers to sellers," Greg says.
It was a simple, radical idea.
"I'm not going to wait for the NHS to come and save
"I want Prep now and this is how I'm going to get it."
So, they called the website I Want Prep Now
It launched in October 2015.
They got 400 hits in the first 24 hours and it mushroomed from there.
Then, the medical profession took an
interest.
Mags Portman, an NHS consultant on HIV and sexual health, emailed Greg asking if she could meet.
Will Nutland, an activist at
Prepster, a website giving information about Prep, also became involved.
Will even became a guinea pig.
He took Prep pills from new
suppliers and then had his blood tested at Portman's sexual health clinic
It tested more than 300 batches and found no fakes.
At the same time, the UK Medical Research Council was running the Proud study,
comparing gay men on Prep against non-users.
The result was so clear-cut - an 86% fall in new HIV infections among in Prep users - that the
study was ended early and those on the study not taking Prep were immediately offered it.
So where was NHS England?
At the end of 2014, it
had begun a process to decide whether Prep should be made available
Time passed, nothing happened.
"It was very, very difficult and frustrating as a clinician to know that this HIV prevention tool was out
there," says Mags.
"We couldn't access it and we couldn't prescribe it and we were seeing people that we knew were at risk and then coming
back with HIV."
By 2016, the NHS was still debating the matter
And then it said no.
"I was gobsmacked," says Sheena McCormack, professor of clinical epidemiology, who ran the Proud trial.
"Oh, my
goodness, it was absolutely horrifying," says Mags.
But what began in a bedroom ended up going to the High Court.
The National Aids Trust,
a charity, took NHS England to court
They wanted Prep to be looked at according to the same rules as any other new medication would be.
The stakes were high
The Terrence Higgins Trust - another leading HIV/Aids charity - sent a letter to the Times, saying that every day Prep was delayed at least
17 people were becoming infected with HIV.
The legal case was complex
The NHS said it wasn't legally required to fund prevention
That was the job of local government, it said.
The NHS was facing one of the biggest funding crises in its seven-decade history
It was not a good time to be taking on new funding responsibilities
Today, despite record levels of investment, there are still funding gaps.
The case also revealed something else - society's view of what
gay men were entitled to.
The journalist and broadcaster Andrew Pierce, who is gay himself, is against Prep being funded by the state.
"I
don't think the NHS can afford £450 per month to a homosexual," he says.
"Because this is what it is about - indulging gay men who don't
Well, that is outrageous - why should the taxpayer subsidise a reckless sex life?"
The official list price for Prep has now come down to
£355 per month - but the different regions of the NHS will negotiate significantly lower prices for the drug
This price is not in the public domain because of its commercial sensitivity.
For Greg, "gay guys have the right to fear-free, guilt-free,
For too long, he says, there has been too much self-loathing.
"We are ultimately conditioned to believe that love, particularly sex between
two men, always has to come at a price
And it doesn't."
Buying generic Prep - rather than branded Prep, known as Truvada - doesn't necessarily cost patients hundreds of pounds a
month.
Currently, a 30-day supply can be bought privately for between £20 and £55.
In court, the NHS's argument unravelled
It turned out it did fund prevention - statins, for example, which help to lower harmful cholesterol
The judge found unequivocally in favour of the National Aids Trust.
But NHS England said it would appeal and sent out a press release that
Ian Green, chief executive of the Terrence Higgins Trust, remembers all too well
"They said the decision had been taken for high risk men who have condomless sex, with multiple sexual partners - it was condemnatory."
For
"It just felt, that felt really vicious actually
It felt like sour grapes."
Suddenly the NHS's decision-making was under the microscope at almost a philosophical level.
"It's interesting,
this question of personal responsibility and on what role it plays in the NHS's decisions - officially it doesn't play any role at all,"
says Sean Sinclair, a medical ethicist at the University of Leeds
"Unofficially, you can see it playing a role."
The matter was settled in November 2016
The NHS lost its legal appeal and would have to take responsibility for Prep.
Greg, by now back in Northern Ireland, was working in a pub
Serving pints of beer to this poor Belfast boy who probably thought I was absolutely off my rocker."
So what's happened since then?
By
summer last year, eight clinics in London, and several outside the capital, had taken part in a trial to provide Prep
And many more men buy the drug privately due to better awareness
In August 2017, the NHS in England announced it would give Prep to 10,000 people in a £10m trial lasting three years.
In Wales, the drug
is available from selected NHS sexual health clinics as part of a similar trial
Prep is not currently available from the NHS in Northern Ireland
Scotland is the only part of the UK to offer full Prep provision through the NHS.
For the first time in recent years, the HIV diagnosis
From 2015 to 2016, it was down by about 20% nationwide
But in certain clinics in London it fell by 40%.
"That was the first moment when we were able to take a step back and actually be quite
shocked at how effective all of this was," says Alex.
Opponents say Prep may undermine safe-sex messages
They point to a four-year Australian study in the Lancet, suggesting that as Prep use grows, condom use falls
And men not on the drug, therefore not benefiting from it, were also having more condomless sex, the researchers say.
But for Sheena
McCormack, who ran the Proud trial, Prep is still a game-changer.
"We probably had done as much as we possibly could in the way of frequent
testing, early diagnosis and early treatment.
"The piece that was missing was the HIV-negative individuals who were catching HIV in-between
That's where Prep fills the gap."
Prep may also save the NHS money.
Scientists at University College London who studied its
cost-effectiveness said it would cost money for the first few decades but after 40 years it would begin to save the NHS cash.
And after 80
years it would save the UK about £1bn, they predicted.
Greg often tears up when he thinks about where they've got to.
He remembers one
phone call in particular that made him cry
Sheena McCormack was on the line
It was Christmas 2016, a few weeks after the Appeal Court victory.
She told him that without his website, the one set up by him and Alex,
there would have been only tiny numbers of people on Prep.
"Sheena was like, 'I want you to strip it back, think about the people, of the
thousands of people walking around now HIV negative because of something that you did.'"
Looking back, Greg says there was no grand plan
"I had a humble objective
I just wanted one person to remain HIV negative on the back of my diagnosis
If we prevent a second person, then I have won - my HIV status didn't cost anything."
It's fair to say, he won big.
New antibody attacks
99% of HIV strainsBy James GallagherHealth and science reporter, BBC News website22 September 2017Share this with Facebook Share this with
Messenger Share this with Twitter Share this with Email ShareImage copyrightSPLScientists have engineered an antibody that attacks 99% of
HIV strains and can prevent infection in primates.
It is built to attack three critical parts of the virus - making it harder for HIV to
resist its effects.
The work is a collaboration between the US National Institutes of Health and the pharmaceutical company Sanofi.
The
International Aids Society said it was an "exciting breakthrough"
Human trials will start in 2018 to see if it can prevent or treat infection.
Our bodies struggle to fight HIV because of the virus'
incredible ability to mutate and change its appearance.
These varieties of HIV - or strains - in a single patient are comparable to those
of influenza during a worldwide flu season.
So the immune system finds itself in a fight against an insurmountable number of strains of
HIV.
Super-antibodiesBut after years of infection, a small number of patients develop powerful weapons called "broadly neutralising
antibodies" that attack something fundamental to HIV and can kill large swathes of HIV strains.
Researchers have been trying to use broadly
neutralising antibodies as a way to treat HIV, or prevent infection in the first place.
'Mind-blowing' cows hold clue to beating
HIVAntibody helps keep man's HIV at bay for 10 monthsThe study, published in the journal Science, combines three such antibodies into an
even more powerful "tri-specific antibody".
Dr Gary Nabel, the chief scientific officer at Sanofi and one of the report authors, told the
BBC News website: "They are more potent and have greater breadth than any single naturally occurring antibody that's been discovered."
The
best naturally occurring antibodies will target 90% of HIV strains.
"We're getting 99% coverage, and getting coverage at very low
concentrations of the antibody," said Dr Nabel.
Experiments on 24 monkeys showed none of those given the tri-specific antibody developed an
infection when they were later injected with the virus.
Dr Nabel said: "It was quite an impressive degree of protection."
The work
included scientists at Harvard Medical School, The Scripps Research Institute, and the Massachusetts Institute of
Technology.
'Exciting'Clinical trials to test the antibody in people will start next year.
Prof Linda-Gail Bekker, the president of the
International Aids Society, told the BBC: "This paper reports an exciting breakthrough.
"These super-engineered antibodies seem to go
beyond the natural and could have more applications than we have imagined to date.
"It's early days yet, and as a scientist I look forward
to seeing the first trials get off the ground in 2018.
"As a doctor in Africa, I feel the urgency to confirm these findings in humans as
soon as possible."
Dr Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases, said it was an
intriguing approach.
He added: "Combinations of antibodies that each bind to a distinct site on HIV may best overcome the defences of the
virus in the effort to achieve effective antibody-based treatment and prevention."
