In a community statement, many HIV/AIDS charities have backed the PROUD study, which is exploring the use of Pre-Exposure Prophylaxis (PrEP) – the taking of HIV medication to prevent HIV infection before exposure, in the same way Post-Exposure Prophylaxis (PEP) is used in the 72hr period after exposure to try and stop transmission of HIV.
Whilst the biggest names in charitable organisations in the HIV sector – THT, NAT and GMFA among others – have signed up to a community statement, all it says is what PrEP is and how it works, along with its use in the PROUD study.
No individual has come forward to discuss it openly, so we went in search and spoke directly to the experts who are dealing with the daunting task of reducing the rates of transmission.
The prevailing opinion that came back is that PrEP is a method of reducing transmission rates, as there will be a minority of people who will be able to take this medication as a method to reduce infection rates.
Cary James, Head of Health Improvement at Terrence Higgins Trust, in particular, said, “We need to employ every method at our disposal to drive down the onward transmission of HIV. In the future, PrEP may become one of the many strategies we use to prevent it, but it won’t be for everyone. Condoms remain the best way to protect yourself from HIV. And if you’ve been at risk, regular testing is the best thing you can do for your own health and can help stop the spread of HIV to others.”
Also going along the PrEP + condoms and regular testing line was Yusef Azad, Director of Policy and Campaigns at National AIDS Trust.
He said, “PrEP is as effective as condoms in preventing HIV. It is foolish and unethical to ignore other effective prevention options and insist only on condom promotion as the HIV prevention response. The PROUD study is researching how PrEP will impact on sexual behaviour – will it have any impact on condom use or the number of partners men have, for example, or the frequency with which men test? There is a lot of speculation in this area. It would be good to have some strong data to go on!”
Tom Hayes, UKPositiveLad and Editor-in-Chief of beyondpositive, also commented on the benefits of PrEP, saying, “HIV has always been an emotive issue and one that has the ability to divide people, this is never truer than when looking for romantic or sexual partners. So anything that can help reduce risk of transmission between partners can only make things easier in that area. PrEP trials have shown a four-fold reduction in infection in sero-discordant (where one partner is positive and one is negative) relationships. Great news.”
As with most drugs, PrEP can have side effects, and these will not be fully known until the trial is completed.
The predominating cause of death from HIV/AIDS at the moment is complication involving opportunistic infection, according to the World Health Organisation, which anti-retroviral medications may not defend against.
There are even instances of anti-retroviral medications causing their own problems – for example, there is an increased risk of getting fatty liver disease as a result of liver toxicity caused by the drugs.
The risks of Truvada include kidney problems, an excess of lactic acid in the blood and a higher risk of bone fractures. Worsening of hepatitis B may also occur.
Yusef Azad said, “PrEP does not involve the use of all the drugs used in PEP and in medication for people living with HIV and this makes a big difference in terms of risk of side-effects. One expert told me, ‘As well as demonstrating efficacy, these trials have confirmed the excellent safety profile of Truvada [the medication being used in the PROUD study as PrEP] in HIV-negative individuals, consistent with data in HIV positive individuals. In the large numbers exposed to the drug, the only safety concerns to date have been mild gastro-intestinal discomfort at an early stage of follow-up, and mild elevations of creatinine. Only 7 out of 4,500 participants had to stop Truvada because of toxicity‘.”
Meanwhile as part of his commentary, Rob Anderson, former Chair of Positive Life and HIV Activist, states, “The meds have serious side effects and if you have another serious long term chronic health condition sometimes PrEP cannot be offered.”
Iain Murtagh, Chair of the Crescent Support Centre, cautioned that people should remember that PrEP does not protect against other STIs.
“In the real world people will always take risks, and so anything that can minimise that is welcome,” Iain says. “In essence in certain settings PrEP is useful, in others it could possibly make things worse by allowing other STIs to be transmitted, and also encouraging risky behaviour in others who may not be on PrEP, but think there is no risk…”
Yusef warns against using “increases in risky behaviour” to cause moral panic.
“The arguments against PrEP have a very dangerous way of reinforcing a moral argument against ‘irresponsible’ sexual behaviour, ignoring the fact that a high proportion of gay men do not adopt 100% condom use, nor are condoms 100% effective,” he says.
“For some gay men, for perhaps a certain period of their lives, PrEP may help protect them from HIV transmission. Condoms should also be used since there remains the real risk of other STIs, some of them very serious, which PrEP cannot protect against.
“PrEP is about adding to our prevention options, not replacing any. What it may allow us to do – for gay men at high risk and with multiple partners – is to break the HIV transmission chain, where extensive sexual networks are currently spreading HIV very quickly and efficiently.”
There is also the small possibility that HIV-positive people who use the drug without knowing their status might develop resistance to Truvada.
Yusef, however, clarifies the risk of resistance in Truvada use: “Pre-Exposure Prophylaxis involves using only some of the drugs (the combination Truvada) which are used in the treatment of someone who actually has HIV. It is therefore very important that anyone using PrEP is HIV negative – should they have HIV but not know it, and then start on PrEP, there is a serious risk that they develop resistance to Truvada. That is one less drug they can then take to manage their HIV.
“Anyone starting on PrEP would need to have an HIV test to confirm they are HIV negative and there would need to be particular care that they had not had unsafe sex in the four weeks prior to the test (HIV tests do not pick up very recent infection). As important in PrEP is taking the medication daily, as prescribed. Irregular or intermittent dosing significantly reduces the efficacy of PrEP and can mean that you do acquire HIV if you put yourself at risk. Again, taking Truvada for PrEP when you have in fact become HIV positive risks developing drug resistance.”
The PROUD study
The PROUD study is a preliminary study taking two years, and there is a full study expected afterwards.
This is probably why, when asked to comment on PrEP, Susie Grady from the All Parties Parliamentary Group for HIV/AIDS, said, “I’ve spoken to our Chair [Pamela Nash MP, Labour, Airdrie and Shotts] about this and she said it is not really our place to comment on PrEP while the study is being carried out – we don’t know what the effects will be in a UK specific context. We would agree with the general community response that PrEP could potentially be an effective preventative measure but it is too early to pass judgment on this.”
With greater awareness and scrutiny of its potential impact, the use of PrEP will perhaps become clearer with time and offere real change when it comes to HIV prevention.