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PrEP BENEFITS|POTENTIAL|FUTURE About Positive Moving On Positive Moving On CIC is a not-for-profit organisation that benefits the HIV community through advocating, fundraising and promoting awareness to the condition. It also provides support to people living with HIV and other organistions or charities that exist for their benefit. Positive Moving On 50 Bedford Street, Belfast, BT2 7FW. [email protected] Prepared by Andrew Goyvaerts, Positive Moving On CIC. This information may be reused free of charge under the Fair Usage Guidance of Positive Moving On and the guidance of any accredited sources. To view the Fair Usage Guidance please email the above address. PAGE 1 Contents: Page 3……………. Summary. Page 4……………. What about PrEP. Page 5……………. The cost. Page 6……………. The facts. Page 7……………. What could PrEP mean. Page 8……………. PrEP, a future. PAGE 2 SUMMARY In 2012 the FDA approved Truvada (Emtricitabine + Tenofovir) to be used as a preventative treatment for HIV, since then the U.S., France and Australia have made it available to citizens in their countries. After refusing to fund this treatment saying interpretation of the law means they do not have the legal ability to do so, the NHS were challenged in court by the National AIDS Trust. On the 2nd of August 2016 a judge sided with NAT, ruling that the NHS interpretation was incorrect, although an appeal has been lodged this will most likely be futile however, the battle for PrEP is not over. Tuesdays ruling means the drug is back on a list for consideration to be commissioned. With a proposed pilot scheme scheduled to begin this summer, as well as a time consuming review that is to be carried out by the National Institute for Health and Care Excellence (NICE) sighted as a necessary part of the consideration process, there is still a way to go. So many organisations and individuals have stood behind calls for PrEP but more voices are needed to ensure a national rollout happens. This document provides some facts about PrEP and raises some of the issues that should be advocated for as we move forward. PAGE 3 WHAT ABOUT PrEP What is PrEP? “PrEP” is short for preexposure prophylaxis. Prophylaxis means to prevent or control the spread of an infection. What is the aim and how to get there? The aim of PrEP is to prevent HIV from taking hold in the body. This is accomplished by taking Truvada daily. Why take PrEP? HIV is now a manageable chronic condition but it is still a heath condition none the less and who wants to have that extra consideration in life if it can be prevented, also, treatment only works when it is known who to treat. In the United Kingdom, close to 20,000 people are living with undiagnosed HIV, while in Ireland more than 2,000 are unaware of their status, rates that continue to grow yearly and raise concern about late diagnoses as well as further transmissions. How successful is PrEP? The CDC sight PrEP as being successful at reducing the risk of transmission through sexual intercourse by 90% (other studies have placed it as high as 99%), and by 70% for IV transmission. To date there is only one recoded case of HIV being transmitted through intercourse to an individual who was on PrEP and consistently adhering to the regime in what is believed to have been a resistant strain. Who could benefit from PrEP? In reality, anyone who is sexually active and not in a committed/monogamist relationship would benefit from PrEP, however research suggests that a preventative treatment for HIV will be of particular benefit to certain groups in the U.K. such as sex workers, MSM, Trans gender women, Sub-Saharan women and injecting drug users. Is it safe? Truvada is scientifically proven to be a safe treatment, is endorsed by the World Health Organisation (WHO) and has been approved by the Federal Drug Agency (FDA) as well as the European Medicines Agency (MDA). PAGE 4 THE COST The current UK list price of Tivicay, used in conjunction with Truvada to treat HIV is approx. £7,800 per year, Truvada, also used to prevent HIV is approx. £4,500, meaning when healthcare costs are included, the cost of treating surpasses £11,000 per year, while the cost of preventing is approximately £4,500. Having stated this, there will be an opportunity to renegotiate the price in future as more people commence treatment, further to this, at the point of generic brands becoming available it is estimated that PrEP could cost as little as £1,200 per year. Although regular screening is necessary for anyone using PrEP, this is something that sexually active members of the public or at-risk groups are encouraged to do regardless of whether or not they are on this type of treatment and so is an inevitable cost. Also, in official figures, some appear to be missing, they include the cost of regular hospital consultations, other medication taking to counteract the side effects of HIV and non AIDS defining conditions that some people experience, as well as treatment like support and counselling. Most notably missing is the human cost. In 2014, the United Kingdom recorded 6,151 diagnoses of HIV while 613 people died of AIDS-related illnesses. To all involved including senior politicians and organisations such as Positive Moving On, when looked at with compassion, and proper consideration is given to the wide ranging needs people living with HIV require in order to manage their condition enabling them to live a long healthy life, the cost effectiveness of preventing is far greater than treating. PAGE 5 THE FACTS On average, 17 people are diagnosed with HIV in the UK, daily. In 2014, 51% of diagnoses in Northern Ireland were made at a late stage and 40% in the UK overall. The same year diagnoses rose by 10% in Northern Ireland, the highest of all UK regions. Results from numerous scientific studies have already corroborated the effectiveness of PrEP meaning the Pilot Scheme and NICE review considered necessary by the NHS will only duplicate those results. When taken every day, PrEP reaches maximum protection for receptive anal sex after one week. For insertive anal sex, vaginal sex, and injection drug use, 20 days should be allowed (CDC). PrEP is not a vaccine and must be consistently taking daily. There is no suggestion that it is a case of using PrEP or condoms, Truvada cannot prevent the transmission of other sexually transmitted conditions and should be seen as an extra layer of protection because as we all know, even when used condoms are not affective 100% of the time. Globally, 70 million people have contracted HIV while 35 million have died from AIDS related complications (AIDS gov). PAGE 6 WHAT COULD PrEP MEAN As stated on page 6, the UK recorded 613 AIDS related deaths in 2014 with many of those attributed to late diagnoses, given the UN Fast Track Goal to end AIDS as a global epidemic by 2030, all countries must act now to reduce and effectively eliminate AIDS related deaths if we are to meet this ambitious target. Northern Ireland has a relatively small population when compared to other regions and due to its geographical/constitutional location is in a unique position to be the first region of the UK and the island of Ireland to reach the Fast Track Goal but the road to ending AIDS begins with HIV where there are two main battlefronts, preventing further diagnoses, though they are rising sharply, along with undiagnosed cases of the condition. These cases have affected our response to this epidemic since it emerged and continue to compound the situation. PrEP can provide the extra protection that will prevent further transmission which in turn will enable focus to be placed on testing and identifying the undiagnosed which will undoubtedly reduce the number of AIDS related deaths, though it will not mean we can put HIV/AIDS in the past. Complacency is already considered to be an influencing factor as diagnoses in certain areas and among particular social groups continue to rise and can take form in a variety of ways, as society moves into a future where we can prevent the condition through the use of medicine more forms will emerge. Another area requiring focus is eliminating stigma that has bearing on the lives of those already diagnosed and discourages others from being tested, an essential requirement before starting PrEP. We must also make the public aware of PrEP’ existence as well as how they should go about commencing treatment. Furthermore, as conditions like Gonorrhea and Chlamydia become a growing concern with more viral strains identified, the sexual health sector would considerably benefit from what relief a national roll out of PrEP would bring through a reduction in resources used to treat HIV. PAGE 7 PrEP, A FUTURE A preventative treatment for HIV is something society has dreamed of having at its disposal for decades but can we really expect it alone to end a 30-year epidemic? The simple answer is no, not on its own, to end this epidemic we need the public to act on its availability, to do this there are barriers of stigma that must be addressed, for example, stigma surrounding the use of PrEP and the perception that being on it must mean an individual is having unprotected sex with numerous partners, this unjustifiably prevents, and will prevent future use of Truvada, also, to ensure future use sustainability should be seen as a key element. One of the most prevalent arguments at present concerns the cost, although well within the reasonable threshold, more campaigning for lower drug prices should be undertaking as it would ensure future provision, in doing so we could use PrEP as an opportunity to highlight the pharmaceutical industries existing module which is to develop treatment based on profit, not human need. The use of this module has a profound influence on the availability of treatment and meant conditions such as TB having just two treatments developed in the last 50 years. With London currently considered the EU TB hotspot it would be affective and an equal approach if as an attempt is made to end one epidemic another is halted. Finally, in regards to that word equal. For many people the PrEP battle has been the essence of equality due to an overwhelming range of preventative treatment currently available on the NHS, including contraceptive treatment, if we are going to begin drawing lines of distinction it cannot be perceived as anything other than discrimination. PAGE 8