ACT UP is Watching: HIV self-test rollout fails to meet WHO guidelines

Mylan ‘Autotest VIH’ rollout fails to meet WHO guidelines for HIV self-testing

ACT UP Dublin expresses serious concerns about the HIV self-testing kit (“Autotest VIH”) Mylan has brought to market in Ireland. In this statement, we highlight ways that the product fails to meet World Health Organization (WHO) standards in this area, and we make suggestions regarding how the product should be improved.

Increasing access to HIV testing is a critical part of Ireland’s response to HIV and we believe HIV self-testing (HIVST) holds considerable promise for increasing rates of HIV testing, for connecting people living with HIV to care, and therefore also for reducing new infections. However, it is important that it be properly implemented, in particular, ensuring that consumer and patient interests are protected. We are concerned about a number of serious shortcomings in the way that Autotest VIH is being packaged and brought to market.

Recently, ACT UP Dublin conducted a review of current policy guidelines with respect to HIVST in anticipation of the possible widespread availability of this type of product in Ireland. There are currently no Irish national policy guidelines regarding HIVST.  The HSE Sexual Health and Crisis Pregnancy Programme has informed us that it is awaiting guidance from ECDC on a new set of HIV testing guidelines for Europe, which will include guidance specific to HIVST. This means that Mylan’s product is being brought to market in Ireland in the absence of a coherent and well-thought out national strategy encompassing HIVST.

In the absence of relevant national guidelines, we reviewed WHO guidance on HIVST.  We looked carefully at the packaging and instructional insert for the Autotest VIH in order to understand how or whether the product fits with current international best practice, as specified by WHO. 

Overall, WHO strongly recommends that “HIV self-testing should be offered as an additional approach to HIV testing services”. By increasing the options available, self testing can help increase uptake of HIV testing, particularly among people who are less likely to avail of conventional testing services. 

WHO emphasises that to maximise the benefit while reducing potential harms, HIV self testing programmes “should adhere to the WHO 5 Cs: Consent, Confidentiality, Counselling, Correct test results and Connection (linkage to prevention, care and treatment services).” Here we highlight two of particular concern in the Irish context: “counselling” and “connection.”

Counselling

Regarding counselling, WHO advises:  “All HIV testing must be accompanied by appropriate and high-quality post-test counselling, based on HIV test results.  Quality assurance (QA) mechanisms, as well as supportive supervision and mentoring systems, should be in place to ensure the provision of high-quality counselling.”

In regard to Autotest VIH for Ireland, for the purposes of counselling, users of this product are directed to contact GOSHH in Limerick.  However:

  • This GOSHH service is offered on a very limited, ‘office-hours’ basis.  It is not even available over the lunch hour. Moreover, the hours of available counselling are not printed on the external packaging.  When we contacted GOSHH outside of office hours, we heard a recording that made no mention at all of HIVST.
  • It is extremely likely that individuals will use this test not during normal business hours, but during evenings and weekends. The lack of availability of counselling during these times is serious and troubling.
  • Users of Autotest HIV will be also be provided with information regarding HSE’s HIV helpline by pharmacists.  This helpline also has limited hours of consultation. Moreover, if this additional resource is to be provided to users, it should be included in the packaging of the test itself (otherwise it is liable to being misplaced).

We have some additional questions and concerns:

  • What training or information will be made available to dispensing pharmacists regarding HIV, HIV testing, or how to access HIV care and services? Will pharmacists be able to provide appropriate and accurate support and advice to users of this product?
  • Because the counselling services offered with the test are not always accessible, it is extremely important that information regarding living with HIV today be included in the product itself.  Users should be clearly informed that today HIV is treatable with medications with very few side effects, that people living with HIV have a normal life expectancy, and that people with HIV who are effectively treated cannot transmit the virus.  This is especially important in Ireland, where knowledge about HIV is very low, especially in hard to reach populations. It is not unlikely that those receiving a reactive test result will believe that they (a) have AIDS and are (b) likely to die from it.  It is absolutely vital that Mylan guard against this misapprehension and the extremely harmful psychological consequences.
  • WHO advises that HIVST product users be directed to websites and video demonstrations of a product.  Autotest VIH directs users to a French-based website and video demonstration. This website and this video should be recreated in a culturally- and market-specific way for Ireland.
  • Although HSE has no specific guidelines about HIV self testing, the HSE Sexual Health and Crisis Pregnancy Programme did distribute a short statement that noted that because of the 3-month window period “this test is NOT suitable for monitoring individuals taking HIV PrEP.” SHCPP recommends that PrEP users “engage with services for appropriate monitoring and follow up.” This information should also be included in the packaging.

Connection

Regarding connection to clinical care, WHO advises: “Linkage to prevention, treatment and care services should include the provision of effective and appropriate follow-up. Providing {HIV testing} in situations where there is no access or poor linkage to care, including ART, has limited benefit for those with HIV. In the context of HIVST, connection also includes linkage to further HIV testing in a stigma-free community- or facility-based setting, where test results can be confirmed and an HIV diagnosis given by a trained provider.”   

  • It is vital that information about the treatability of HIV be included in information provided with the test kit. It should also be made explicit that care and treatment for HIV is available for free to anyone living with HIV in Ireland.
  • We insist that Mylan build a website for users of Autotest VIH in Ireland that provides specific, detailed information on where to seek care in the event of a positive test result.  This should include details on where and when clinical services are available at various sites across the country. It should also inform users that HIV care and treatment in Ireland is free.

What’s next?

ACT UP Dublin believes that HIV self-testing is a promising new way to increase HIV testing and to overcome some of the barriers to testing and treatment that lead to, among other things, a high rate of late diagnosis in Ireland.  We believe a comprehensive and properly instituted national strategy for HIV testing should include national guidelines for self-testing and a programme for making self-testing kits freely available to the most vulnerable communities.  Such a strategy should be part of a new commitment from the State and other stakeholders to ‘Get To Zero’: to make zero new HIV infections a realisable goal in the coming decade. Because Mylan stands to make more money from each new HIV diagnosis, government should encourage Mylan to underwrite subsidies to make the kits affordable and easily accessible, whether in Dublin or in Donegal.  ACT UP Dublin will continue watching.

[An earlier version of this post included questions regarding the services available to self-test users. We were contacted by GOSHH who provided additional information that addressed those specific concerns and we have removed those questions from the post.]

‘We are the solution’ anti-stigma campaign for Irish AIDS Day

Marking Irish AIDS Day, ACT UP Dublin and masc.life today launched a new social media campaign highlighting the health and prevention benefits of HIV treatment. 

The “We are the solution” campaign features men living with HIV explaining how effective treatment keeps them healthy and eliminates the risk of HIV being passed on during sex. 

This new initiative is part of the international “U=U” campaign. That campaign, started in 2016 by the US-based Prevention Access Campaign, promotes the message that “undetectable equals untransmittable”.

When someone is on effective HIV treatment with an undetectable viral load, there is no risk of the virus being transmitted sexually—even when other prevention methods (condoms, PEP, or PrEP) are not used. 

Read our full press release here.

View and download materials from the campaign here.

HSE joins consensus on U=U

ACT UP Dublin Applauds New HSE Statement: People on Effective Treatment Can’t Pass on HIV

New language recently added to the HSE’s “Health A-Z” HIV and AIDS information page offers the strongest statement yet from the Health Service Executive on the prevention power of HIV treatment. Joining UNAIDS, the US CDC, the Lancet journal, Public Health England, and other health authorities, the HSE has placed its official imprimatur on the medical consensus that when a person is on effective HIV treatment there’s “effectively no risk” that they will pass on the virus to a sexual partner.

In the “Treating HIV” section of the revised page the HSE writes that treatment not only “enables most people with HIV live a long and healthy life,” but that “[w]hen the treatment is working properly, there is effectively no risk that a person with HIV can pass on HIV to another person.”

ACT UP Dublin member, Thomas Strong, said, “Knowing that treatment not only keeps us healthy but keeps our partners safe is of enormous value to people like me living with HIV. The risk of passing on the virus is something that weighs heavily on us. It’s reassuring to know that there’s something we can do to eliminate that risk.”

The HSE’s new statement builds on last year’s “Antiretroviral Therapy for People Living with HIV in Ireland” booklet, which noted that “HIV treatment is also beneficial from a population perspective in that it prevents HIV being passed on to others,” and that “for many people living with HIV, the reduction of infectiousness and relief from anxiety about passing on HIV are very important benefits of HIV treatment.” 

That publication explained that in the large-scale PARTNER study “people with HIV who were taking treatment with an undetectable viral load did not pass on HIV to their partner.” The Opposites Attract study—which looked specifically at gay male couples—found the same result: no HIV transmissions from someone on effective HIV treatment to partner who was HIV-negative.

ACT UP Dublin was the first organisation in Ireland to become a community partner with the Prevention Access Campaign’s “Undetectable=Untransmittable” initiative. To promote this information, we have organised direct actions, produced educational materials, published articles and produced a short video called Love & Suppression which features a Dublin couple who were part of the PARTNER study.

This news underscores the importance of testing and treatment in an over-all strategy to reduce new HIV transmissions in Ireland. 


This post originally distributed as a press release, 24 April, 2018. The original press release can be viewed here.

Speak up for #ourGMHS

The Gay Men’s Health Service (GMHS) clinic on Baggot Street in Dublin has provided sexual healthcare services for gay and bisexual men and trans people for 25 years. In the last ten years—as new diagnoses of HIV and other STIs among gay and bisexual men have climbed dramatically—the HSE has slashed the budget for GMHS.

Regular testing and treatment is one of the most effective ways to bring rates of STIs down. But there’s no use telling people to go for testing if they can’t get access to the services they need. Overcrowding and long waits are the norm—and that’s if you’re lucky enough to not be turned away at the door.

Despite the massive budget cuts, despite the challenges of working in a neglected and run-down building, the GMHS has done its best to meet the growing needs of the community. In 2016 they added a new Monday afternoon screening clinic and, last November, a Thursday-morning PrEP support clinic.

These are important steps in the right direction, but we’ve got a long way to go. We need to let the Government and the HSE know how important these services are to the community. We need to see a commitment to increase funding, to expand available services, and to improve the condition of the clinic facilities.

We urge you to write to Minister for Health Simon Harris at
simon.harris@oireachtas.ie and Assistant National Director of Health Promotion Kevin Kelleher at kevin.kelleher@hse.ie.

Let them know that #ourGMHS needs proper funding and support. Let them know that we won’t stand for further neglect of this vital service. We deserve better, #ourGMHS deserves better.

Generic PrEP now in Irish pharmacies

This week community pharmacies in Ireland began stocking a generic PrEP product made by Teva Pharmaceuticals. This medication is available only with a prescription.

PrEP is not currently covered by any HSE scheme so users must pay the full price themselves. Currently reported prices range from €85 to €95 for a bottle of 30 pills.

A list of pharmacies currently stocking Teva’s Emtricitabine/Tenofovir disoproxil tablets is available from HIV Ireland’s PrEP information page. This list is expected to continue to grow, and you can ask your local pharmacy to order it if they do not currently stock it.

Although this is good news for some PrEP users in Ireland—at least those who may be able to afford to buy PrEP at this price—it is important that we recognise that we are still a long way from PrEP being available and accessible to everyone in Ireland who could benefit.

If you are using PrEP it’s important to get proper medical support and a prescription. Currently there are two clinics in Dublin that provide support specifically for PrEP users.

Dublin’s Gay Men’s Health Service on Baggot Street runs a walk-in PrEP support clinic for gay and bisexual men and trans people. They offer information on how to get and use PrEP, along with a consultation with a supportive doctor who can answer questions and provide a prescription. This GMHS clinic is open every Thursday morning from 10am to noon.

The Mater Hospital runs a Prevention Support Clinic providing the same range of services to anyone interested in using PrEP. This clinic is by appointment, and there’s information available about it here. To make an appointment you can email psc@mater.ie, or just print out and mail in this referral request form.

We’ll be providing a more detailed update about these recent developments shortly.

 

PrEP in Ireland Update: High Court clears the way for generic Truvada in Ireland

On Tuesday, November 7, the High Court in Dublin rejected an application from Gilead Sciences for injunctions that would have prevented two companies from marketing generic versions of Truvada in Ireland. With initial prices for these generics expected to be about 60% lower than what Gilead charges for brand-name Truvada, the timeline for PrEP access in Ireland could be shortened dramatically.

Gilead has faced global criticism for price gouging and tax dodging, and the high price it demands for Truvada is the single biggest obstacle to PrEP access in Europe. We protested at Dublin’s Four Courts to demand that Gilead drop the price of Truvada when they were in court at the beginning of October.

This Irish Times article covers the details of the judgement, and we published this report after the hearings at the High Court.

So what does this actually mean right now? Unfortunately, not much.

PrEP still won’t be available through the HSE, people wanting to use PrEP now will still be sourcing it online, and Irish Customs will still seize any shipments of generic PrEP that it intercepts.

Although generic manufacturers Teva and Mylan appear to be ready to enter the Irish market, generic versions of Truvada won’t be in pharmacies here next week. And when the generic versions do become available they’ll likely cost around €180 per month. That won’t be much use for individual users, but it makes a big difference for the HSE’s cost-effectiveness calculations.

So what’s happens next? First a generic manufacturer must submit an application for reimbursement for their product as PrEP to the HSE. This will go through a “rapid review” process that will assess whether or not it’s cost effective at the price offered. If not, it will start a more in-depth and lengthy review process.

Gilead Sciences submitted an application in June, but it failed to pass the initial “rapid review” process. Although Gilead is now involved in the drawn-out pharmacoeconomic assessment process (much of which involves haggling over price), an application from a generic manufacturer could make that process irrelevant.

Even after the HSE agrees to reimburse for PrEP, there are significant challenges to be addressed in actually providing PrEP. Although rates of STI and HIV testing in Ireland are low to begin with, the rates of diagnoses are increasing and the existing sexual health services in Ireland are already badly overstretched. Without a commitment to provide funding to properly support and expand the capacity of these services, access to PrEP may be severely limited.

Although we welcome this ruling and hope that it will hasten PrEP access in Ireland, it’s imperative that we keep pressure on the HSE and the Government. We need a real commitment from the highest levels of the HSE and the Government to make PrEP available without further delay.

The Irish response to the HIV crisis has been shamefully inadequate. We have an opportunity to change that, but it’s not going to happen unless we demand it.

Online PrEP and the law

Last year the HSE obtained legal advice regarding accessing medicines over the internet and related issues of concern for prescribers, users of generic PrEP, and non-medical groups sharing information about accessing online PrEP.

The full legal advice was published in June of this year and we’ve uploaded it here.

Of particular note for people currently using PrEP or considering it, the advice makes clear: “There is no law in Ireland prohibiting an individual patient from accessing medicine via the internet with a prescription.” However, it also notes that “It is a criminal offence to obtain prescription medicine without a prescription.”

So what does that mean? It means that the biggest risk you face if you get a prescription and order PrEP online is that it will be seized by customs. It seems unlikely that the authorities would want to prosecute people for ordering generic PrEP without a prescription, but since getting proper medical support is an important part of using PrEP safely, it’s probably a good idea for people to talk to a doctor about using PrEP and ask the doctor for a prescription.

The advice letter goes on to state that “there is no law restricting the specific information that a physician can and cannot provide to their patient” about PrEP, including referring them to sites like iwantprepnow.co.uk that provide comprehensive information about PrEP as well as links to sites that can supply generic PrEP.

Doctors will also be glad to know that they’re “not under a legal obligation when providing a prescription to either state where the medicine is to be sourced, or to satisfy himself/herself that a patient is not sourcing the medicine online.” You don’t necessarily have to talk to your doctor about where you’re going to get PrEP, but it’s not something they need to ask you about as a condition for writing a prescription or not.

The legal advice was obtained in July of 2016, but was released in June as an appendix to the “Action plan: Response to the national increase in HIV and STIs in MSM” report from the HSE’s National MSM HIV/STI increase response group interventions subgroup.

Press release for HPRA demonstration

Today ACT UP Dublin held a demonstration outside the HPRA offices in Dublin to demand action from the Government and HSE to make PrEP available in Ireland without further delay. Our press release is available for download here.

This is the full text of the press release:

FOR IMMEDIATE RELEASE
August 4, 2017  2:00pm

Contact: act.up.dublin@gmail.com
www.actupdublin.com

PrEP STOPS HIV: Ireland needs PrEP now.

ACT UP Dublin today called on the Irish Government to make PrEP (Pre-Exposure Prophylaxis) available through the HSE immediately.

Angered by recent reports of increased seizures of generic PrEP by Irish Customs, and the HSE’s failure to provide even limited access through a pilot PrEP programme, advocates gathered in front of the HPRA offices on Earlsfort Terrace at lunch time to demand that the Minister for Health, Simon Harris, make a commitment to address Ireland’s HIV crisis and make PrEP available and accessible in Ireland without further delay.

New HIV diagnoses in Ireland are at record levels with one new HIV diagnosis every 18 hours. Delays on PrEP lead directly to entirely avoidable new HIV infections.

We know more about HIV treatment and prevention than ever before…
yet new diagnoses continue to rise.

Powerful new tools like PrEP have the potential to dramatically impact the epidemic…
yet they are unavailable here.

It’s time for this Government to show that it’s serious about Ireland’s HIV crisis. 

It’s time for leadership instead of foot dragging.

It’s time for PrEP in Ireland.

————————

In 2015, Ireland reported the highest number of new HIV diagnoses in the history of the epidemic. Preliminary figures from 2016 are even higher. The LGBT community has been particularly impacted as new HIV diagnoses among gay and bisexual men quadrupled between 2005 and 2015.

Pre-Exposure Prophylaxis for HIV—better known as PrEP—is a safe and highly effective way for HIV-negative people to prevent HIV using antiretroviral medication. The World Health Organization recommends that PrEP be offered to people at substantial risk of HIV as part of a comprehensive HIV prevention package.

Currently only one medication, Truvada, has been approved for use as PrEP in Europe. Although doctors in Ireland can prescribe Truvada as PrEP, the HSE does not yet provide reimbursement for the medication. Purchased privately through a pharmacy in Ireland, Truvada would cost hundreds of Euro per month—much more than anyone can realistically afford.

A growing number of people in Ireland, fed up with the Government’s failure to provide access to PrEP, are taking responsibility for their own and the community’s health. Following a model established in the UK (where it is legal to import generic medication for personal use) they are purchasing generic versions of PrEP online. In the UK, the widespread use of these generics is credited with helping to produce a dramatic reduction in new HIV diagnoses among gay and bisexual men in the last year.

UK-based websites like iwantprepnow.co.uk provide comprehensive information about PrEP—how it works, how to use it, how to get the necessary clinical support—and provide links to sites known to be reliable sources for authentic generics.

Unfortunately, the HSE currently provides no formal, dedicated clinical support services for PrEP users. Although the tests can be obtained through existing health services, those who are able to source more affordable generic versions online must manage their own clinical care. There is no consistent clinical monitoring by properly-trained medical providers, no systematic data about current PrEP users is being collected, no official information is available for current or potential PrEP users.

Instead of making PrEP available directly, or offering badly needed clinical support services to those who are taking initiative and already using PrEP, Irish health authorities are seizing packages, harassing suppliers, and trying to undermine public confidence in the only available route to obtaining PrEP for people in Ireland.

It’s time for Minister of Health, Simon Harris, to show leadership in tackling Ireland’s HIV crisis. 

Making PrEP available in Ireland without further delay must be a priority of this Government. 

What is ACT UP?

ACT UP Dublin is a local chapter of ACT UP, The AIDS Coalition to Unleash Power, an international HIV activist organisation. ACT UP Dublin was founded in July 2016 to take action on Ireland’s HIV crisis. We seek a more urgent and effective response to HIV from government, community organisations, and the public at large.

Demonstrate for PrEP in Dublin!

In response to the news that Irish Customs has been cracking down on imports of affordable generic versions of PrEP into Ireland, ACT UP Dublin has organised a demonstration for Friday, August 4th. We’ll be outside of the HPRA offices on Earlsfort Terrace (across from the National Concert Hall) from 12 to 2pm.

Please join us as we call on the government to show it’s serious about addressing Ireland’s HIV crisis by making PrEP available now.

PrEP in Ireland Update

The Medical Independent published a well-researched and detailed article on July 20th looking at where we are in the campaign to make PrEP available in Ireland. Unfortunately the news isn’t great.

Throughout the last year the HSE and Government pointed to a demonstration project that was set to “commence later this year or in early 2017.” However in the MI article Fiona Lyons, clinical lead for the implementation of the National Sexual Health Strategy, admits that “the window of opportunity for doing a PrEP demonstration project has closed.” This means that until the HSE provides PrEP, the only option for people to access PrEP in Ireland will continue to be self-sourcing affordable generic versions.

Unfortunately, as the MI also reports, that is becoming more difficult. Customs has been seizing shipments of generic PrEP coming into Ireland and the Health Products Regulatory Agency (HPRA) has been investigating the sources that people are using to obtain these drugs. This has resulted in the primary supplier of generic PrEP suspending shipments to Irish addresses, leaving current and potential PrEP users scrambling to find other ways to access the medications.

Following contact with the HPRA, the HSE PrEP Working Group recently circulated recommendations to healthcare providers to discourage patients from self-sourcing PrEP. They specifically request that they “do not direct patients” to iwantprepnow.co.uk, one of the most comprehensive and respected sources for information about how to use PrEP, how to self-source it safely, and how to make sure you get the proper medical support.

The working group’s email doesn’t mention that the generic versions and suppliers listed at iwantprepnow.co.uk are the same ones that the 56 Dean Street clinic in London tested and found, in every case, to be genuine. To this point the HPRA have offered no evidence that would suggest that anything has changed since the 56 Dean Street testing occurred or that anyone who is self-sourcing PrEP has obtained anything but the real thing.

All of this underscores the urgent need for HSE to provide PrEP through conventional channels. In one significant step towards that, Gilead in June applied to the HSE for reimbursement for Truvada as PrEP. This initiates a process where the costs involved in providing PrEP are analysed by the National Centre for Pharmacoeconomics (NCPE).

After an initial rapid review—which is supposed to take “approximately 4 weeks“—the NCPE will either approve Truvada for reimbursement, or (much more likely) will require a full pharmacoeconomic assessment. This process is supposed to take no more than 3 months from the formal submission of evidence, but before that happens there’s a period of notifications and consultations.

Overall, it seems unlikely that PrEP would be available until 2019 if nothing is done to accelerate this process or to provide PrEP on an interim basis. According to a July 26th written answer from Catherine Byrne to a Dáil question, the time frame for the HSE reimbursement process “would be in the order of at least 6 to 12 months.”

However, even when that is concluded, funding needs to be budgeted for PrEP and for the support services that will be required to make it available. That is unlikely to happen mid-year, so even if things go relatively smoothly in the reimbursement approval process, we’re likely to have to wait until the 2019 budget to see funding for PrEP.

One further wrinkle is that Gilead Sciences, the maker of Truvada, has filed suit in the High Court to block generic manufacturers from entering the market in Ireland with significantly cheaper generic versions of Truvada. The original patent for Truvada expired this month, but Gilead has obtained extended protection with a Supplementary Protection Certificate. A lawsuit over the validity of that SPC is currently awaiting a hearing at the European Court of Justice, but a decision isn’t expected before mid-2018.

It’s not clear whether an SPC is currently in force in Ireland or what the basis of the Gilead lawsuit is, but it seems clear that Gilead is not going to allow their patent to expire without a fight.

A lower price for the medication would mean much faster provision of PrEP by HSE and other European national health systems. So the outcome of the suit before the EU Court of Justice is being watched closely across the continent.