The first drug designed to help prevent HIV transmission in people at high risk of infection has been approved for use in the European Union today.
The European Medicines Agency (EMA) approved the use of the drug Truvada for pre-exposure prophylaxis, or PrEP, in combination with safer sex practices.
The London-based agency said that PrEP was recommended by the World Health Organisation (WHO).
“The drug will help people who do not have HIV but who are at high risk of infection with HIV to lower their chances of becoming infected when they are exposed to the virus.
“The oral drug should be used in combination with condoms as part of an HIV prevention strategy.
Tenofovir disoproxil/emtricitabine (trade name Truvada) is a fixed-dose combination of two antiretroviral drugs used for the treatment of HIV/AIDS . It was developed by Gilead Sciences and consists of 300 milligrams of tenofovir disoproxil fumarate (of which 245 mg is tenofovir disoproxil, equalling 136 mg tenofovir) and 200 milligrams of emtricitabine .
The drug has been approved in the USA for pre-exposure prophylaxis against HIV infection. The Food and Drug Administration approved it for prophylactic use on July 16, 2012. In studies, tenofovir reduced the incidence of HIV infection, especially in high-risk individuals (by 42% in MSM in the iPrEx study), but produced conflicting results in other studies (notably the FEM-PrEP study in heterosexual African women).
One study estimated through mathematical modeling that daily intake of Truvada could potentially achieve a 99% of risk reduction of contracting HIV in high risk individuals. Another study, iPrEX OLE , showed overall PrEP effectiveness of 50% rising to 100% when participants took the drug four or more times per week. A Cochrane review found that both tenofovir alone, as well as the tenofovir/emtricitabine combination, decreased the risk of contracting HIV by 51% (RR 0.51; 95% CI 0.30 to 0.86; 8918 participants). 
In certain studies, the drug has demonstrated rare side effects including: transient nausea ,dizziness , loss of appetite, and loose stools .
“Truvada was previously approved for use in the EU as part of drug cocktails designed to treat people infected with HIV,’’ the WHO said.
Despite major advances in the fight against HIV/Aids in recent decades, the infection rate among men who have sex with men remains stubbornly high in the UK, and the results of the trial have led to calls for PrEP to be offered free by the NHS.
The study was funded by government agencies, the Medical Research Council and Public Health England, and a senior panel of NHS experts is already considering how PrEP could be introduced.
With evidence of its effectiveness now established, it will have to consider whether the pills, which will cost £423 per month for each patient, will be cost-effective, and what the criteria should be for accessing them.
PrEP has been available to at-risk groups in the United States since 2012.
The Proud trial, which took place across 12 NHS trusts in Brighton, London, York, Manchester, Birmingham and Sheffield, was set up to provide real-world evidence on the pill’s effectiveness, and to answer outstanding questions, such as whether providing it would lead to reduced use of condoms.
Some 545 HIV-negative gay men, who were sexually active and had recently had unprotected sex, were recruited to the study. Early findings proved so encouraging that in October last year the trial was sped up to ensure 269 men whose access was going to be deferred were given the drug straight away.
Among the 276 men given PrEP immediately, there were only three HIV infections in the first year of the study, compared with 19 among the deferred group.
Infographic credits: pharmacy.unc.edu
Men taking part in the study reported they did not change their condom use because of PrEP – evidence that was borne out by the fact that infection rates of other STIs were similar in both groups.
An estimated 2,800 gay men acquired HIV in the UK in 2013 and the rate of new infections has remained high for a decade. Six per cent of gay and bisexual men are now living with HIV, rising to 13 per cent in London.
Campaigners argue that providing Truvada to high-risk groups could bring about a net saving for the NHS because of the huge costs of treating HIV that would be avoided if new infections were prevented.
“During the study period there were 19 HIV infections in the group not taking PrEP,” said Deborah Gold, chief executive of the National Aids Trust. “If we can stop people getting HIV by giving them PrEP, we have an ethical duty to do so. Furthermore, over the course of their lifetime the treatment of those 19 men will cost the NHS nearly £7m. So the financial argument is clear, as is the ethical one. PrEP needs to be available on the NHS as soon as possible for all those who need it.”
Professor Simon Barton, chair of the HIV Clinical Reference Group for NHS England, which will review the cost-effectiveness of PrEP, said the Proud trial findings were “very important”.
“The challenge now is to translate the benefits demonstrated in the study into practice,” he said. “We have already begun work to carefully consider how this treatment could be delivered equitably and most efficiently by liaising closely with the Local Government Association, Public Health England, clinicians and patient representatives.”
Dr Michael Brady, medical director of sexual health charity the Terrence Higgins Trust, said: “PrEP is, quite simply, a game-changer. We know that most gay men use condoms most of the time, and that this has prevented tens of thousands of HIV infections since the epidemic began in the UK. However, we also know that condomless sex vastly increases the risk of HIV being transmitted.
“This research shows just how effective PrEP can be in preventing transmission of the virus in groups at greatest risk; offering another line of defence alongside condoms and regular testing. It is not a vaccine and it won’t be for everyone, but once approved, we expect it to significantly increase the momentum in our fight against the virus. Therefore, we urge the Government, NHS England and local authorities to make PrEP a key priority in the fight against HIV.”
Truvada costs £361 for 30 pills – one month’s provision. On top of that, the cost of providing the drug through clinics costs about £62.50 per month. This gives a full monthly cost of £5,081 per year.
The next question is how many people would be given the pill. It would probably only be available for high-risk people – those who are having sex with several partners, sometimes unprotected.
About 18,000 men who have sex with men are diagnosed with a sexually transmitted infection each year (an indicator of a high-risk lifestyle). If around a quarter of these were deemed likely to benefit from PrEP that would mean 4,500 people taking PrEP a year, at a total cost of £22.8m.
This cost needs to be offset against the lifetime cost to the NHS of treating someone with HIV, which is estimated to be as high as £360,000 per person.
Another consideration is the high cost of post-exposure prophylaxis drugs, which the NHS already provides to stop the infection developing in people recently exposed to the virus. These cost nearly £1,000 for every course of treatment.
Cost of this drug in the EU was not stated as at the time this report was filed
The WHO estimates that some 36.7 million people worldwide were living with HIV at the end of 2015.
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