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HIV: the road to zero

By Dermot - 18th Nov 2015

Declarations for World Aids Day have varied with the passing years, a reflection of changing dynamics around HIV/Aids. In 2001, it was ‘I care: do you?’ In 2002 and 2003, it was ‘Stigma and Discrimination’, while back in 1993, it was the more urgently-toned ‘Time to Act’.

This year’s World Aids Day (1 December) is themed ‘Getting to Zero’, for the fifth consecutive time. This means zero discrimination, zero new HIV infections and zero Aids-related deaths.

In Ireland, as elsewhere, ‘zero’ is not yet in sight. Diagnoses of HIV in Ireland are rising and half are late presentations, while NGOs report of significant societal stigma. For people diagnosed with HIV, however, there is general consensus that excellent specialist care is accessible.

<h3><strong>MSM</strong></h3>

Last year, 377 new HIV diagnoses were notified in Ireland, an increase of 11 per cent on 2013. According to the <em>HIV in Ireland—2014 Report </em>published by the Health Protection Surveillance Centre (HPSC), the rise was connected to increasing notifications among men who have sex with men (MSM) and people who inject drugs. The annual rate of new diagnoses was relatively stable between 2010 and 2013.

Last year, MSM accounted for the highest proportion of new diagnoses (183; 49 per cent) — the biggest number ever reported in MSM in Ireland. Since 2005, new diagnoses among MSM have increased threefold (from 60 to 183).

Heterosexual contact was the second most commonly reported mode of transmission in 2014, (125; 33 per cent). Since 2010, diagnoses among heterosexuals have ranged from 125 to 133 notified cases per year. “The majority of heterosexuals (62 per cent) diagnosed in 2014 were born in countries with generalised HIV epidemics,” the report noted.

Late presentation continues to be a major problem. Some 49 per cent of new diagnoses in 2014 were late presenters (with CD4 less than 350cells/µl or an AIDS-defining illness at diagnosis). Late presentation was less common among MSM (38 per cent) and people who inject drugs (44 per cent) than among heterosexuals (56 per cent in females and 71 per cent in males).

Of the 377 notifications in 2014, one person was reported to have died. Last year, some nine deaths were reported to the CSO, where the cause of death was “AIDS or HIV”.

<h3><strong>Sexual health strategy</strong></h3>

Between the early 1980s and the end of 2014, 7,353 people in Ireland were newly diagnosed with HIV. Within this timeframe, HIV in wealthier countries has transitioned from a veritable death sentence to a chronic condition, largely owing to antiretrovirals (ARVs). Chronicity has its own price tag, however, in human and economic terms.

In 2013, a review in <em>The Lancet </em>(‘The end of AIDS: HIV infection as a chronic disease’) noted that while Aids-related illnesses were no longer the primary threat (for people on ARV therapy), there was an emerging “new set of HIV-associated complications”, resulting in a “novel chronic disease that for many will span several decades of life”. Illnesses could arise from absence of full immune health and cumulative toxic effects from exposure to ARV drugs over decades.

ARVs are also costly for health systems. At St James’s Hospital, Dublin, one of the country’s leading HIV treatment centres, spend on ARVs in 2014 was €31,328,982 and &euro;27,745,178 in 2013, accounting for approximately 2,250 patients each year. This included ARVs for HIV treatment and post-exposure prophylaxis (PEP), according to data provided to the <strong><em>Medical Independent</em></strong> (<strong><em>MI</em></strong>).

‘Getting to zero’ is therefore crucial on all fronts.

Ireland’s first ever blueprint for nationwide sexual health, the <em>National Sexual Health Strategy 2015-2020</em>, was published last month. It contains a number of important provisions around HIV prevention and education. It comes in tandem with the appointment of Dr Fiona Lyons, Consultant in Genitourinary and HIV Medicine at St James’s Hospital, as the HSE National Clinical Lead for Sexual Health Services.

The Strategy has a number of HIV-related measures, including around increasing testing and developing guidelines for the appropriate use of ARV therapy in HIV prevention.

Mr Niall Mulligan, Executive Director of HIV Ireland, says the plan “puts HIV within a national policy framework and that is good”.

But there is no specific budget for its implementation, which presents a concern.

“The Minister [Leo Varadkar] did said at the launch that he had a commitment to resourcing it, but it would be coming out of the agreed 2016 health budget [initially]…We’ll have to see how that one goes,” says Mr Mulligan.

<h3><strong>PrEP</strong></h3>

Resourcing is always crucial. However, given the emergence of what many describe as a medication-based ‘game-changer’, it is even more relevant in combating HIV.

Evidence has been accumulating on the ability of ARVs to significantly reduce incidence of HIV infection, when used as pre-exposure prophylaxis (PrEP)

This year, following what it says is further evidence of the effectiveness and acceptability of PrEP, the World Health Organisation (WHO) recommended that people at “substantial” risk of HIV should be offered preventive antiretroviral treatment. This new recommendation builds on 2014 WHO guidance to offer PrEP to MSM. PrEP should be seen as an additional prevention choice based on a comprehensive package of services, including HIV testing, counselling and support, and access to condoms and safe injection equipment, the WHO says.

In the US, the Centres for Disease Control and Prevention has also recommended that PrEP be considered for people who are HIV-negative and at substantial risk for HIV infection.

<blockquote> <div> <p class=”QUOTEtextalignedrightMIstyles”>In Ireland we have a HIV epidemic that remains largely unaffected by current strategies…In 2015, we will have more than 400 new HIV infections reported, numbers not seen since before the recession.  

</div> </blockquote>

This year, the PROUD study in the UK reported that daily PrEP reduced the risk of HIV infection by 86 per cent for high risk gay and other MSM. It gauged effectiveness of Truvada as PrEP in a “real world situation” where participants knew they were taking an active drug.

Participants were randomised to receive PrEP immediately or after 12 months. The participating sexual health research clinics integrated PrEP into their routine HIV risk reduction programmes.  The study found no difference, in the two cohorts,in the number of men diagnosed with other STIs. 

Mr Shaun Griffin of the Terrence Higgins Trust, UK, says the publication of the data in <em>The Lancet</em> in September marked “an essential step towards ensuring access to PrEP on the NHS for those who need it”.

The Trust has been campaigning for PrEP to be made available for people at greatest risk.

In the UK, an evaluation process is ongoing as to the potential availability of PrEP on the NHS. A number of NHS England decision-making stages are involved, beginning with a multidisciplinary clinical reference group that is considering effectiveness of PrEP in HIV prevention, and cost effectiveness.

Mr Griffin tells <strong><em>MI</em></strong>: “The NHS spends over £500 million a year on HIV treatment with estimated individual lifetime HIV treatment costs of up to £360,000. A year of PrEP (Truvada) costs £4,331 and the PROUD data shows that we would only need to treat 13 men for a year to prevent one HIV infection.

“In reality, it is unlikely that all men would need to take Truvada all the time as HIV risk­—and therefore PrEP need—changes over time. Two health economic analyses, while taking different approaches, have agreed that fundamental to ensuring PrEP is cost effective is both our ability to focus treatment on those with the highest HIV incidence, and the cost of the drug. One model demonstrated that a reduction in drug cost by 50 per cent would even make PrEP cost saving.

This could be achieved by negotiating price reductions, utilising the IPERGAY [study] regime where men took half as much Truvada as in the PROUD study and using generic drug when it is available in 2017.”

In the UK, PrEP is available privately at a price of £400 for a 30-day supply of Truvada, which is “vastly out of the price range of most people who need it”.

<h3><strong>HIV epidemic</strong></h3>

The use of PrEP as a HIV-prevention tool is not an entirely new concept in Ireland. Dr Paddy Mallon, Director of the UCD HIV Molecular Research Group (HMRG) at the Mater Hospital, Dublin, says it has been used occasionally as part of clinical care, in special circumstances in serodiscordant couples. It is also now being sought by some MSM in sexual health clinics, one specialist in the field told <strong><em>MI</em></strong>.

Dr Mallon believes PrEP needs to be implemented urgently in this country. “In Ireland we have a HIV epidemic that remains largely unaffected by current strategies,” he tells <strong><em>MI</em></strong>.  “In 2015, we will have more than 400 new HIV infections reported, numbers not seen since before the recession. PrEP has been demonstrated in clinical research in Europe to be a very effective way of assisting people to avoid becoming infected with HIV. To ignore this research and not to implement PrEP, alongside the other interventions that are currently available, would be to continue to place people at risk of infection and help further contribute to this costly and arguably poorly controlled epidemic.”

Dr Mallon says physicians in Ireland are at the stage of defining what a PrEP programme should look like. It would need to combine accurate risk assessment, sexual health screening and HIV testing, education on ways to avoid contracting HIV and provision of interventions to help prevent HIV, including the drug. “Only through a combined programmatic approach can proper and safe use of PrEP be introduced,” he says.

The <em>National Sexual Health Strategy</em> did not overtly signpost PrEP. However, a priority action involves developing and implementing guidance to support clinical-decision making on “the appropriate use of antiretroviral therapy in HIV prevention”. This guidance should be “developed in line with the National Clinical Effectiveness Committee (NCEC) <em>National Standards for Clinical Practice Guidance </em>(for publication in 2015)”.

Dr Lyons says PrEP is “absolutely implicit” in this priority action. She says use of ARV therapy for prevention has three aspects, namely PrEP, treatment as prevention, and PEP. 

“[PrEP] needs to be explored in the overall context of HIV prevention. It is part of the jigsaw puzzle—it can’t be done in isolation. It clearly works, but it needs to be done as part of an overall HIV-prevention approach,” she tells<strong><em> MI</em></strong>.

Key NGOs in this area also support PrEP as part of HIV/Aids prevention. “We would be advocates of PrEP as part of a multi-faceted approach to prevention work,” says Mr Mulligan at HIV Ireland.

<h3><strong>Testing</strong></h3>

The <em>HIV in Ireland-2014 Report </em>stated that “ready access” to HIV testing is needed to reduce late presentations. This would benefit the individual detected early and reduce the likelihood of transmission to others. The report noted that initiatives offering HIV screening to attendees of some emergency departments at large hospitals in Dublin “may result in earlier detection of infections in people that may otherwise be unaware of their infection”.

One of these initiatives is at St James’s Hospital. In July, the hospital announced the commencement of routine HIV, hepatitis B and hepatitis C testing for all patients attending its EDs. This opt-out testing is for every patient in the ED, who are already having bloods taken.

It follows a pilot programme conducted in March 2014. A hospital spokesperson comments: “Implementation of the programme is the result of a successful collaboration between the Departments of GU Medicine and Infectious Diseases, Emergency Medicine, Hepatology and Microbiology, the Irish Hepatitis C Outcomes Research Network (ICORN), the Infectious Diseases Society of Ireland (IDSI), HSE Social Inclusion Unit and pharmaceutical partners who helped fund the pilot study and are funding the permanent implementation.”

In recent years, the Mater-Bronx Rapid HIV Testing Project (M-BRiHT), a collaboration between researchers at the Mater Hospital and the Jacobi Medical Centre in the Bronx, New York, US, offered routine attenders to the Mater ED a confidential, rapid HIV test combined with novel video-based counselling and information. 

Results showed HIV to be present in 2.85 cases of every thousand patients taking the test.

According to Dr Mallon, the plan is to introduce M-BRiHT post-pilot within the Mater’s ED. “We’d plan to fund this through requests within the normal hospital budgeting processes, which are still being developed,” he explains. 

The <em>National Sexual Health Strategy</em> has a priority action to assess, develop and implement guidance on STI and HIV testing in various settings “to improve access and ease of testing and to include guidance on home-based testing and the use of point of care HIV testing”.

In tandem with the Strategy’s launch was an announcement of €150,000 in funding for the Gay and Lesbian Equality Network (GLEN) to implement a rapid HIV testing pilot. This will lead to Dublin’s first free, rapid HIV testing service and support similar services in Cork and Limerick. Key data will be recorded to evaluate efficacy.

Policy Director at GLEN, Mr Tiernan Brady, tells <strong><em>MI</em></strong> the pilot will examine a range of locations for testing, likely to include gay bars outside opening hours.

Trained volunteers will deliver the testing and there will be “strong referral pathways”. The 12-month pilot is expected to run from the beginning of 2016.

At HIV Ireland, Mr Mulligan says there is a need to be “quite innovative” around testing. Currently, the organisation runs community-based testing in association with St James’s Hospital.

Dr Lyons says there is a lot of testing happening, and “there are probably some testing opportunities being missed”.The best model will most likely involve “a mixture of different things” and should be “data-driven”. Meanwhile, on resourcing, Dr Lyons says the Strategy is a means of assessing the ‘state of the nation’, which “will inform resource need”.

 

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<h3>Concern over health impact of prostitution law</h3>

“A massive step backwards.”

This is how sex worker Ms Kate McGrew describes proposed legislation that will criminalise the purchase of sex.

Ms McGrew is a member of Sex Workers Alliance Ireland (SWAI), which is campaigning against section 20 of the Criminal Law (Sexual Offences) Bill 2015.

The provision is “purported to protect women” but it will rather promote interactions that lead to “health crises” among sex workers, she says.

She suggests that with potentially less buyers of sex, there will be reduced opportunity for sex workers to oppose certain practices.

Sex workers may accept clients that they previously would not have, and offer services they previously did not. In such circumstances, negotiation of condom use would become more difficult, says Ms McGrew.

She also predicts that sex workers will feel less able to present to health services, which is “nerve wracking anyway”.

HIV Ireland is also working for the removal of section 20 of the draft legislation.

“From our point of view, [the provision] is a mistake,” says Mr Niall Mulligan, the organisation’s Executive Director. “What we think will happen is that it will push sex workers and sex work further underground and that will potentially and probably increase HIV rates among sex workers.”

In a submission to the Joint Oireachtas Committee on Justice, Defence and Equality in 2012, the organisation pointed to the<em>Report of the UNAIDS Advisory Group on HIV and Sex Work</em>, published in 2011. This report recommended that states remove criminal penalties for the purchase and sale of sex to establish legal and policy environments conducive to universal access to HIV services for sex workers.

In relation to the ‘Swedish model’ (which criminalises purchase but not sale of sex and is the focus of contested efficacy claims), the UNAIDS paper said “the approach of criminalising the client has been shown to backfire on sex workers”.

The 2012 submission from HIV Ireland stated that, for the purpose of any debate on, or review of, legislation on prostitution, “there is a need to clearly distinguish between human trafficking for sexual exploitation, and those who choose to become involved in sex work”.

It continued: “The commercial sexual exploitation of children or adults must be clearly separated from individuals who freely choose to engage in sex work and those who enter into sex work as a result of conditions that do not involve direct coercion and/or deceit by another; such conditions may include poverty, gender inequality, indebtedness, lack of employment opportunities, and dependent drug use. These issues should be dealt with through national policies and strategies such as the<em>National Drugs Strategy</em>, where sex workers are identified as an at-risk group, and not by further criminal sanctions on sex work.”

However, Ruhama is strongly supportive of section 20. In a statement to <strong><em>MI</em></strong>, it says there was no representation from groups who take an abolitionist approach to prostitution on the UNAIDS Advisory Group on HIV and Sex Work that published the 2011 report.

The organisation noted that, in Ireland, sexual health screening for people in prostitution is “available free and confidentially through the HSE Women’s Health Service (WHS)…. Indeed the whole population irrespective of ethnic status can avail of free testing in GUM clinics nationally”.

According to the organisation, the HSE WHS indicated on enquiry that the numbers screened through its services in 2014, who had HIV, were “extremely low”.

It understood that in nearly every case where a positive screen was found, the cause of infection was more likely to have been either as a result of injecting drug use, or a pre-existing infection contracted in Sub-Saharan Africa or another jurisdiction.

It said full decriminalisation, or legalisation, of the sex trade in Ireland would not “suddenly better ‘empower’ those women to negotiate safe sex”.

About 300 women access the HSE WHS annually. Manager Ms Linda Latham says the service and groups like Ruhama and the Immigrant Council of Ireland are “singing off the same hymn sheet” in considering prostitution a “very harmful practice”.

Ms Latham would like to see a “funded exit strategy, a pathway” out of prostitution, an area on which the service has engaged. She says a model of sexual health promotion “ethically” requires exit strategies. The law, if realised, will “absolutely not” change its work in the area of condom provision. “All of the sexual health promotion work will still be there,” says Ms Latham.

Research published in <em>The Lancet</em> last year found that across both generalised and concentrated HIV epidemics “decriminalisation of sex work could have the largest effect on the course of the HIV epidemic, averting 33–46 per cent of incident infections over the next decade through combined effects on violence, police harassment, safer work environments, and HIV transmission pathways”.

The research formed part of a special series in the publication that called on governments to decriminalise sex work.

Dr Lyons says she has personal concerns about criminalising the purchase of sex.

“I have concerns, these are personal concerns, about criminalising [the] purchase of sex,” she tells <strong><em>MI</em></strong>.

While she could “be proven wrong”, she fears that it may result in sex workers, and sex buyers, being less willing to present to health and other essential services.

“Potentially people who are buying and selling sex would be less willing to engage with services, for fear of the repercussions associated with that. My personal view is one of concern around criminalisation of the purchase of sex.”

Dr Mallon says any legislation around this area needs to consider the safety of those involved in sex work.

This “should include implications of criminalisation on safe sex practices within the trade and the potential for knock-on effects on risk of HIV transmission”.

He adds: “We should be focusing on ways to assist people to get tested regularly and seek treatment early.

“Any legislation that results in the opposite effect will likely have an overall negative impact on HIV transmission rates.”

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