LONDON, Dec 5 (APM) - Gilead's Truvada, which dramatically reduces the risk of being infected with HIV, will now be given by the National Health Service in England to people at risk, it has been announced.
The health service lost a court battle recently after arguing this was not its responsibility (APMMA 50368). However, at least 10,000 people will be given the PrEP drug in a three-year-long clinical trial, NHS England said in a Sunday statement, adding that this will help them understand how to offer it more widely.
Pre-exposure prophylaxis or PrEP is a daily pill that disables HIV before it gets a stranglehold in the body. The only approved PrEP treatment in Europe is Truvada (emtricitabine+tenofovir disoproxil fumarate), which costs about 5,000 pounds (5,965 euros) a year per patient. It can cut the risk of being infected by up to 86%. The estimated lifetime cost of treating someone with HIV is 360,000 pounds.
NHS England said has decided to routinely commission 10 new specialised treatments as part of the annual prioritisation process for such treatments. The organisation, which fought not to offer PrEP medication, said there was "strong" evidence that it was effective. However, it said there were still questions to be answered about how it is used on a wide scale across England.
Its trial on at least 10,000 people at risk will try to work out how to get the drugs to the right people, how popular it will be and for how long they would take PrEP. Up to 10 million pounds (11.9 million euros) will be made available over the next three years to fund all aspects of the trial.
Dr Jonathan Fielden, Director of Specialised Commissioning and Deputy National Medical Director, NHS England, said: "We're pleased to be able to announce funding not only for 10 new specialised treatments but also a new ground breaking national programme for PrEP that will benefit at least 10,000 people.
"This has, in part, been made possible by the willingness of many pharmaceutical and device companies to come forward with lower and more responsible prices. Continuing this constructive joint working will enable us to fund more new drugs and treatments in the future.
"We have however, had to make some tough decisions over what we are not able to fund at this point in time within the resources we have available. We will ensure those treatments have the opportunity to be considered as part of the next annual prioritisation round in spring 2017."
Professor Kevin Fenton, Director of Health and Wellbeing at Public Health England, said: "Currently 13,500 people are living in the UK with undiagnosed HIV and we are still seeing around 5,000 new infections each year. Given we are in the fourth decade of this epidemic there are too many new infections occurring, and we need to use all tools available to save lives and money.
"We're delighted to be working in partnership with NHS England on this major new addition to the national HIV prevention programme. This comes after much planning and preparation to ensure we can successfully coordinate this extremely important and large scale clinical trial.
"We encourage all those who may be at risk of HIV to ensure they get tested and we are again working with local authorities to fund the HIV home-sampling test kit as well as issuing joint guidance for the first time with NICE, which supports increased uptake of HIV testing."
In London, it is reported that one in eight homosexual men has HIV, while the proportion in the rest of the UK is one in 26.
The NHS in Wales, Scotland and Northern Ireland have not yet made a decision on PrEP.
The NHS in Wales, Scotland and Northern Ireland have not yet made a decision on PrEP.
Evidence for the clinical effectiveness of PrEP is overwhelming, NAT (National Aids Trust) said in a statement. The clinical trial will aim to answer questions about how to best to implement the treatment in a full national roll-out.
It will include at least 10,000 participants over the next three years and pave the way for a full and effective roll-out.
Deborah Gold, chief executive of NAT, which took the case against NHS England to the courts, said: "We are absolutely delighted that following our wins in court, NHS England, working with Public Health England and local government will be now making PrEP available on a large scale, and quickly, to those who need it.
"We continue to seek reassurance that access to PrEP will not be unduly limited by geography, that routine commissioning will continue seamlessly at the end of the trial and that all those expected to be eligible through routine commissioning will be able to access PrEP via the trial.
"Despite these outstanding questions, there is no doubt that this step in the right direction has the potential to have a transformative impact for thousands of people, as well as prove the decisive point in beginning to combat the HIV crisis, all whilst saving the NHS money in the long term.
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