Tag Archives: PrEP

Scotland first in UK to approve anti-HIV drug

Today the Scottish Medicines Consortium announced that PrEP is now approved for prescription on the NHS in Scotland, making it the first of the UK countries to make PrEP available on the NHS.

(Story via HIVScotland)

Availability and prescribing details are currently being confirmed by health boards but we understand patients should be able to access NHS funded PrEP within the next month in Scotland.

HIV Scotland believes this is a fantastic outcome towards reducing HIV transmissions, and shows what progress can be made when professionals and the community are able to join together to learn from each other and find solutions. Hundreds of community members across Scotland got in touch with us and other charities, attending information events, contributing to consultations and decision making groups, appealing to clinics. This outcome was only made possible by these collaborations.

We are promoting a live Twitter videocast tonight (10 April) between 9PM and 10PM – where a panel from HIV Scotland, Terrence Higgins Trust Scotland, and Waverley Care will answer initial questions from the community.

HIV Scotland will continue to offer our support to decision makers and service providers to make sure that PrEP and related HIV prevention services are ready.

We are making up-to-date information available on our website, and we will host an additional live twitter videocast for community to hear from a panel of doctors, nurses and other experts in April or May 2017 (specific date to be decided so stay tuned) by which time we expect implementation details to have been decided.

From our conversations with community over the past six months it is clear to us that there is a growing demand for access to PrEP in Scotland, and also a large amount of uncertaintly. If you consider that almost everyone knows fundamentally what a condom is and how it works, but few people as yet understand the basics of PrEP. This has implications not only for the people who are interested in taking or already use PrEP, but also for their sexual partners. In addition to this we need to ensure that service providers are confident in their own knowledge.

To address this we have partnered with the University of Edinburgh to develop very basic PrEP information resources, using the HIV Literacy work developed by Dr Ingrid Young, and will continue to support work through the SHBBV Executive Leads, NHS Education Scotland, and SHIVAG to make PrEP information available to professionals.

In the meantime if you have any questions at all please get in touch with Kelsey Smith.

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(Scotland): Decision due on ‘game-changer’ Prep HIV drug

Medical chiefs in Scotland are due to announce whether a “game-changing” drug which can prevent HIV infection will be made available on the NHS.

(Story via BBC)

Research suggests a daily dose of a drug known as Prep can protect people at risk of contracting the virus.

HIV Scotland said it was “very hopeful” the Scottish Medicines Consortium (SMC) would approve the medication.

It means Scotland would become the first place in the UK to make it available on the NHS.

Campaigners estimate that up to 1,900 people north of the border could benefit from the drug, which has the brand name Truvada.

The anti-retroviral drug is currently licensed for use in Scotland, where it is used by people already diagnosed with HIV.

However, the SMC’s decision relates to its use on a preventative basis by people who do not have the virus.

What does Prep do?

Pre-exposure prophylaxis (or Prep for short) is a small, blue pill.

The pill works by protecting cells in the body and disabling the virus to stop it multiplying – should it enter the body.

Taking it once a day has been found to reduce the risk of HIV infection by 86%.

It is currently used in the US, Canada, Australia and France to help protect gay men at the highest risk of contracting HIV.


There is a growing demand for the treatment in Scotland, according to HIV Scotland’s chief executive George Valiotis.

He estimates that “a couple of dozen” Scots are using variants of the drug after buying generic versions online.

The Scottish government wrote to Gilead, the manufacturer of Truvada, to urge them to make an application to the SMC last year.

It followed a series of legal battles in England over whether the NHS or local authorities should pay for the medication.

The Court of Appeal eventually ruled that NHS England had the power to fund the drug,

The decision did not mean that NHS England had to fund Prep but in December it announced plans for a large scale clinical trial of the drug, expected to involve 10,000 participants over three years.


‘Why I buy Prep online’

Gordon Garioch is one of around “a couple of dozen” people in Scotland thought to be taking Prep regularly.

He told BBC Radio Scotland’s Good Morning Scotland that he was initially prescribed the drug by a private clinic but it was too expensive.

He now spends around £50 a month on a generic form of the drug he purchases from an online pharmacy.

“It gives me reassurance,” he said. “I’ve always been careful.

“My friends have always been careful but for some reason they became positive. So I take this extra reassurance for me to prevent myself becoming positive.”

Asked what the benefits of the decision would be, he replied: “To me personally, obviously it would be the cost.

“But it’s a generation thing as well, to prevent HIV for future generations for people who are not as lucky as myself who can pay for it.”


Speaking on BBC Radio 4’s Today programme, Mr Valiotis, of HIV Scotland, said: “Prep makes good sense. We know that it works. We know that it stops people from getting HIV, and we know that it’s cost-effective.

“And because it’s cost-effective, what that means is that it makes more money available in the long-term on the NHS to treat lots of other things as well.”

Asked if he thought the SMC would approve the drug, he said: “I’m feeling pretty hopeful because the cost-effectiveness is clear, as is the clinical-effectiveness.

“We know this works. I would be surprised if it’s a no but it’s too hard to guess.”

HIV Scotland believes the use of Prep has played a part in reducing the number of HIV infections in Scotland.

The latest figures from Health Protection Scotland show 285 new cases of HIV were reported in 2016, down from an annual average of 359 over the last five years.

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New HIV prevention treatment can only work if perception improves – DMU experts

de_montfort_university_logo-svg

A De Montfort University Leicester (DMU) professor and his PhD student have urged the medical profession and media to change the way in which a new HIV prevention treatment is represented if they want it to work.

Professor Rusi Jaspal carried out the first study to find out what men in the UK felt about PrEP – a new HIV prevention treatment said to reduce the risk of infection by 86% if taken daily.

He found that men who would benefit most from taking PrEP were being put off by its association with “high risk” people – as they did not want to place themselves in this category.

Professor Rusi Jaspal

Professor Rusi Jaspal

The article, published in Cogent Medicine, illustrates how misconceptions and fear of social stigma is hindering the fight against HIV/AIDS in the UK.

Prof Jaspal called on the medical profession and media to do more to improve perceptions and understandings of the potentially life-saving drug.

He said: “The bottom line is that PrEP works. If we are serious about wanting to prevent HIV infections, we need to roll out PrEP to those at highest risk of infection. This needs to be coupled with awareness-raising and stigma reduction. Many people misunderstand PrEP and believe that it’s only for  ‘promiscuous people’. This is misleading. Our research clearly shows that the biggest barrier to accessing PrEP is the stigma that often underpins it. We must challenge this.”

Men who have sex with men (MSM) are the group most affected by HIV in the UK. Around 45,000 MSM were living with HIV in the UK in 2014.

Pre-exposure prophylaxis (PrEP) is a novel HIV prevention option which has been available in America since 2012 and is in clinical trials in the UK. Prof Jaspal’s study involved in-depth qualitative individual and focus group interviews with MSM, comprising HIV-positive and HIV-negative individuals. The interviewees were asked about their views on PrEP in terms of their knowledge of the treatment and their feelings towards it.

They found that many were unconvinced by its efficacy as a method of protection. Some said they would not use condoms consistently while taking PrEP, which is recommended given that PrEP does not provide protection against other sexually transmitted infections (STIs).

Many people said they would feel stigmatised at the idea of being “high risk” by taking PrEP. It also highlighted a general lack of understanding about what constituted high-risk activities.

One HIV-negative participant said he thought PrEP would not benefit him because he did not perceive himself as “high-risk”, despite reporting multiple condomless sexual encounters, because he was not “Someone who is out at chemsex parties every weekend.”

Other participants made reference to the stigmatising label “Truvada Whore”, namely someone who engages in frequent reckless sexual behaviour because they believe they are made safer by taking PrEP. The authors said this reflected negative press reporting of the treatment, leading ultimately to ‘individuals perceiving the treatment as a potentially viable HIV prevention tool at a population level, but unsuitable for themselves personally.

The study’s co-author Christos Daramilas, a PhD researcher in sexual health psychology said: “PrEP would benefit various groups in society, not just MSM. PrEP could also facilitate what we call ‘serodiscordant relationships’, that is, relationships between people who do not have the same HIV status, because it provides both physical and psychological protection.”

The authors also argued that perceptions of PrEP would only change if healthcare professionals and the media altered their approach to representing the treatment. They said it would be more effective to present PrEP as a “further level of protection” against HIV, in addition to condoms and other prevention strategies.

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Call to fund #PrEP on NHS

prepworks

Calls are being made to get a drug that prevents HIV infection in people at high risk of the virus available on the NHS in Scotland.  It follows legal battles in England over whether the NHS or local authorities should pay for it.

Story via BBC Scotland

The drug, described as a “game-changer” by experts, is used for a process known as pre-exposure prophylaxis, or Prep.  The Scottish government wants its makers to apply for it to be assessed for use in Scotland.

In England, the NHS had previously said that local authorities should provide Prep because they are responsible for preventative health but the Court of Appeal insisted this fell within the remit of the NHS.

An estimated 14,000 people would be eligible for the drug – which is called Truvada.

Unlike in England, the Scottish Medicines Consortium assesses all drugs used in the NHS in Scotland so campaigners hope its transition for use in Scotland will be smoother.

BBC Radio Scotland’s Good Morning Scotland programme has learned that the Scottish government has written to Gilead, the manufacturers of the drug, to urge them to make an application.

The SMC said it was anticipating a submission from Gilead so it could make a formal judgement on whether to approve its usage.  The SMC will also make a decision on the cost-effectiveness of the drug, which costs about £450 a month to buy privately.

What does Prep do?

Pre-exposure prophylaxis (or Prep for short) is a small, blue pill.

The pill works by protecting cells in the body and disabling the virus to stop it multiplying – should it enter the body.

Taking it once a day has been shown to reduce the risk of HIV infection by 86%.

It is currently used in the US, Canada, Australia and France to help protect gay men at the highest risk of contracting HIV.

George Valiotis, the chief executive of the charity HIV Scotland, said: “People who take Prep – they don’t get HIV.”

HIV diagnoses in Scotland have continued at an average rate of 359 per year for the past five years, according to Health Protection Scotland.

Across the UK as a whole 100,000 people are believed to be living with virus.

“We have seen no change in our HIV transmission rates over the last 10 years. They haven’t really gone down at all,” he said.

“It’s been an average in Scotland of one person a day for the last 10 years, so we know we need to do something else, and Prep is that something else.”

A spokesman for Gilead said it had been in discussions with the Scottish Medicines Consortium.

He said: “We will make our submission in the coming weeks, in accordance with the required SMC timelines and expect the review to follow normal timelines as well.”

A spokesman for the SMC said it was aware of a report which has been compiled by the charity HIV Scotland, which sought to highlight the benefits of the drug and had support from health professionals.

He said: “The SMC is awaiting a submission from the company for Truvada for use as Pre-Exposure Prophylaxis (PreP) in HIV infection.

“We are aware of the report by the HIV PreP Short Life Working Group. While this report itself does not form part of the submission and therefore cannot be considered by the committee, we expect and encourage patient groups to submit evidence as part of the review for this medicine.

“This will be considered by our committee alongside the information submitted by the company.”

A spokesman for the Scottish government said: “The Scottish government has written to its manufacturer of Truvada to request they make a submission to the Scottish Medicines Consortium, at a fair price, so its routine use in Scotland can be considered as quickly as possible.

“Prevention of HIV infection remains a priority for the Scottish government and there is absolutely no room for complacency on such communicable diseases.”

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Norway provides #PrEP for free! Well done Norway!

ms-files

Yes, you did read that headline correct! – While our NHS is arguing why it shouldn’t be providing, cost effective, life saving and game changing anti-HIV medicine, Norway has become the first country in the world to offer at-risk citizens the pre-exposure prophylaxis (PrEP) drug at no cost, as part of its National Health Service.

Norway joins Canada, France, South Africa, and the United States in offering the HIV prevention drug, although Norway is currently the only country to distribute it for free.

Multiple studies have found PrEP to be highly effective in preventing the transmission of HIV. One study found people could reduce their infection risk by 92-99% depending on how many pills they take per week.

Norway’s government lobbied for the last two years to bring PrEP to those who face an increased risk of contracting HIV — gay and bisexual men and trans women.

“PrEP will contribute to reducing the rate of new infections in the gay community, as gay men are facing a risk of infection much higher than the general population,” Leif-Ove Hansen, the president of HIV Norway, said in a statement, New Now Next reports.

An estimated 2.1 million people around the world were newly infected with HIV in 2015, bringing the current total to approximately 36.7 million people.

While many of the HIV management drugs now allow people living with the condition to enjoy a similar quality of life to healthy populations, prevention is still the cheaper and safer option.

In other countries where PrEP is available, prices for users can range. In the US, many insurance companies cover most of the cost so that patients are only responsible for the co-pay.  In France, the drug is reimbursable once patients submit a receipt.

But Norway is the first to offer the drug to patients without any cost whatsoever.

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The Next Generation of PrEP is here.

next-gen-prep2

New pre-exposure prophylaxis (PrEP) drugs that offer protection against HIV infection, including bimonthly injections, are in the works, but they will not be available before 2020, and they are not without their shortcomings, experts said at the Controlling the HIV Epidemic With Antiretrovirals Summit 2016 in Geneva.

Article via Medscape

The combination of emtricitabine and tenofovir disoproxil (Truvada, Gilead Sciences) remains the gold standard, and uptake should be encouraged to slow the spread of HIV, said Karen Hoover, MD, from the division of HIV/AIDS prevention at the Centers for Disease Control and Infection (CDC).

“It is overwhelmingly effective in demonstration projects,” she told Medscape Medical News. If it’s taken every day, protection against HIV infection is “nearly perfect.” Even when it is taken only four times a week, “we’ve seen that it has 90% efficacy.”

But the combination is not without adverse effects, including a mild decrease in kidney function and a small decrease in bone marrow density. When patients stop taking the drug, though, bone marrow density returns to normal. However, Dr Hoover pointed out, “the importance of these side effects is still unknown in adolescents and young people.”

One size does not fit all.

Although the combination is relatively safe, the daily dosing regimen can cause problems with adherence, especially for young people. “It would be nice to have another choice. One size does not fit all,” she pointed out. “Some people would do well with an injectable option.”

In fact, several second-generation PrEP drugs are in development and several clinical trials are underway, Dr Hoover reported.

Next-Generation PrEP

Cabotegravir, a long-acting injectable from ViiV Healthcare, showed promise in the phase 2a ÉCLAIR study, as reported by Medscape Medical News.

The dosing regimen for cabotegravir — an injection once every 2 months — virtually eliminates problems related to adherence.

“Injectable PrEP might help those who have trouble taking a daily pill, but it’s not a panacea,” Dr Hoover acknowledged.

Before starting the injections, patients need to take an oral version of cabotegravir to see if any toxicity issues arise, and it usually takes a month of oral daily doses before the patient is fully protected against HIV.

And when a patient stops getting the injections, other problems can arise, she reported.

“This long-acting version stays in the body for weeks, maybe even a year. If a person has insufficient protection with low but inadequate treatment, they can become resistant. So if they stop, they need to take oral medication,” she explained.

Another drug that has shown promise is tenofovir alafenamide, according to Dr Hoover. This prodrug delivers tenofovir diphosphate, the active agent, more efficiently to cells infected with HIV.

Because tenofovir alafenamide is potent, a patient can take a 25 mg dose instead of a 300 mg dose of Truvada, she explained. “That means a lot less renal toxicity and fewer side effects. I look forward to seeing the phase 3 trial results.”

VRC01, a broadly neutralizing human monoclonal antibody to HIV, is a new type of drug being studied as both PrEP and treatment. The antibody is currently in phase 1 studies with intravenous and subcutaneous dosing, and there is hope that the research could lead to a vaccine.

Still, said Dr Hoover, none of these trials will be completed until 2020, and time will then be required for regulatory approval and marketing.

At best, it will be 4 or 5 years before they are available. “We have a safe drug — that’s Truvada. What we need now is to do a better job of implementing PrEP,” she said.

A Matter of Supply and Demand

In the United States, a better response to both supply and demand is needed for PrEP, said Dr Hoover.

“On the demand side, we need to really help patients understand what it is, how it works, and whether it would be appropriate for them. We need to help them find doctors they can talk to about PrEP,” she explained.

In some communities in the United States, awareness of PrEP is still relatively low. One recent study showed that only 40.5% of 622 young black men who have sex with men and who live on the south side of Chicago reported knowing about PrEP, and only 12.1% knew someone who had used PrEP (JAMA Intern Med. 2016;176:136-138).

On the supply side, physicians who provide PrEP care need better support, said Dr Hoover.

A clinical hotline, supported by the CDC and other organizations, offers up-to-date clinical consultation to help healthcare providers learn about PrEP.

“We get all kinds of clinicians calling, from primary care to subspecialists in various fields,” said Ronald Goldschmidt, MD, director of the Clinician Consultation Center at the University of California, San Francisco.

Physicians call for many reasons, including to double-check that a patient is a good candidate for PrEP, to determine whether it is appropriate to give, and to find out what the dosing should be.

“Most of the time, we tell them that if there’s any ongoing risk of contracting HIV — especially if the person has risky sex with multiple partners or is an injection drug user — the benefits of PrEP are certainly something the physician should offer,” said Dr Goldschmidt.

“There is also certain testing that has to be done before and during PrEP therapy. Sometimes physicians just want to make sure they have the testing protocols correct,” he told Medscape Medical News.

“Often it’s a question about whether to use PEP [postexposure prophylaxis] or PrEP,” he added. PEP is used to treat patients who have been exposed to the virus in the previous few hours or days. PrEP, in contrast, takes a month to become effective.

“PrEP is never an emergency; PEP is,” Dr Goldschmidt explained. “However, we answer quite promptly for PREP calls.”

 

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The NHS consultation for #PrEP ENDS TOMORROW! Make sure your voice is heard!

Prep Infographic

The NHS public consultation on a proposed clinical consultation commissioning policy on Pre-Exposure Prophylaxis (PrEP) for HIV ends tomorrow (Friday, 23rd September)

This consultation is necessary in order to make PrEP available to people who are at risk of becoming HIV positive.  Multiple studies around the world have shown PrEP to be highly effective in reducing the risk of contracting HIV. The results of the PrOUD trial in England, released in 2015, prove that PrEP works and that concerns about it not working in a real world setting, were unfounded. Read more about the trial here: http://www.proud.mrc.ac.uk/

PrEP has been approved by the World Health Organisation and it’s already available for those deemed at risk of HIV in the United States, Canada, France and Israel.  PrEP can reduce people’s chances of contracting HIV the virus if taken daily.

If you would like more information on both PrEP trials (PROUD and IPERGAY) visit Poz.com for a more detailed look (https://prodlb.poz.com/article/PrEP-CROI-26978-7841)

There are arguments for and against providing PrEP for free on the NHS.  That it could encourage risky sexual behaviour but it’s not always about risky behaviour. You, and you alone are responsible for your own sexual health.  If your sexual partner(s) dislike using condoms, you can stay protected by taking PrEP.  This is about taking ownership of your sexual health.  PrEP is another tool to sexual health which will reduce HIV nationally and help save the NHS vital money it needs for other services.

The following gives a breakdown and suggests the NHS could actually save money on HIV treatments if they were to adopt PrEP.

  • PrEP cost per year: (Media figure) £10m -£20m. Assume higher figure of £20m per year.
  • New HIV diagnoses in the UK per year: Approx 4000 people.
  • Cost over average lifespan estimated at £365,000 for treatment. (Assume average lifespan of 36 years for ease of calculation as some people are diagnosed in their teens, some in the mid 60’s) making an assumed cost of treatment per person per year at approximately £10,000.
  • New HIV diagnoses: Extra cost, year on year of £40m
  • Assume PrEP rolled out on 1st January 2017 and 50% is effective (i.e. that it reduces new HIV diagnoses in the UK by half. Likely to be more effective than this but let’s play out a worst case scenario).
  • In 2017, 2000 new cases of HIV are prevented saving £20m. This is a year on year saving.  PrEP however in an unchanging cost.  In 2018, 2000 new cases of HIV are prevented, saving £20m and the cost of treating the prevented 2017 cases in 2018 is also saved making a total of £40m saved this year.
  • It’s easy to see how this goes, although likely to be an upper limit to savings year on year after a few years, it won’t keep going up indefinitely.
  • PrEP does not merely pay for itself after one year but actively makes savings to the NHS budget in expensive HIV treatments, allowing other drugs to be funded.
  • This calculation assumes worst case figures here, the actual savings are likely to be higher.
  • In 2018 Gilead’s patent on Truvada (the PrEP treatment) may run out. If and when it does, further savings can be made.

Above breakdown via @THTorguk

We have been responding to the challenges of HIV for 30 years.  HIV will not go away unless we invest in, and try out proven methods to reduce the risk of HIV infection.  PrEP has been proven to work and we urge you, as someone who wants to see the end of HIV to respond to the consultation and get your voice heard.  If we work together, we could eradicate HIV in our lifetimes.

The NHS consultation is open until Friday, 23 September.  Many people have felt powerless in the fight to make PrEP available on the NHS, and now you have the power to make it so.

Visit the follow link for further detailed information and to participate in the survey.

https://www.engage.england.nhs.uk/consultation/specialised-services

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