Important changes to HIV-related rules announced by Department of Health

Legal barrier to self-testing in the UK lifted

The Department of Health announced an important change to HIV testing policy for the United Kingdom this week. From April 2014, HIV self-testing kits approved by the Medicines and Healthcare Regulatory Authority will be available for sale to the public.

Any device designed for home testing will be required to carry the CE mark, which indicates that it conforms to minimum European standards regarding sensitivity and specificity (see here for further details of these standards).

The opportunity for self-testing has been welcomed by HIV organisations, although concerns are frequently expressed regarding the potential for failed linkage to care after a positive test.

A recently published systematic review of studies on self-testing found it to be acceptable across a wide variety of populations, but identified few data on linkage to care after testing positive.

The Department of Health said in its press statement: “If a test indicates a positive result people are advised to get a follow-up confirmatory test at an NHS clinic. Clear information about how to interpret the result and what to do afterwards will be included with the kit.”

Dr Richard Ma, Sexual Health lead for the Royal College of General Practitioners, said that GP practices should also prepare for patients seeking a confirmatory test after receiving a positive result on a home test.

At present, the only device specifically designed for home testing and approved by a stringent regulatory authority is the Orasure OraQuick HIV antibody test, licensed in the United States in April 2013. This test samples fluid from the gums on a swab. The swab is then placed in a tube of solution and will give a visual result 20 minutes later. (A video showing how the testing process works can be viewed here.)

In practice, this test can already be ordered online for purchase from US vendors for around £25. How much this test will cost and when it will be marketed in the United Kingdom are still unknown.

Contrary to reports in The Independent newspaper there is no commitment at present to make self-testing kits available free through the NHS, the Department of Health told NAM.

Home-sampling kits supplied by Terrence Higgins Trust and Public Health England have been available since January 2013 for gay men and Africans living in England. Approximately 9000 people have requested the kits to date.

The Mortimer Market Centre, one of London’s largest sexual health clinics, is due to begin distribution of home-sampling kits to gay and bisexual men leaving clubs in the Vauxhall area of south London from the August bank holiday weekend.

Health care workers with HIV and medical procedures

The Department of Health also announced that healthcare workers with HIV will no longer be barred from carrying out some surgical and dental procedures – provided that they are on treatment, have an undetectable viral load, and receive regular medical monitoring.

Rectal STIs predict HIV infection

A study from New York has found that a diagnosis of rectal gonorrhoea or chlamydia is strongly associated with subsequent HIV infection, regardless of sexual risk behaviour.

The study found that between two and three times as many HIV-negative men diagnosed with rectal gonorrhoea or chlamydia became HIV positive over the following year as men with identical levels of condom use who did not have one of the two STIs.

This study’s findings are similar to a European one that found a strong association between STIs and HIV diagnosis in 2011. The European study, however, looked at all STIs rather than rectal ones alone, and it found an association between having an STI and already having undiagnosed HIV, whereas the New York study found that a rectal STI predicted subsequent HIV infection. 

In the present study, 276 HIV-negative gay men attending a clinic in New York, who were diagnosed with one of the two rectal STIs between 2008 and 2010, were followed for at least one year to see how many then acquired HIV.

Sixty-nine per cent of these men reported no condom use or inconsistent use, and the investigators selected a comparison group of men who had identical levels of sex without condoms but no rectal STIs.

During the course of the following year, 11% of the men with rectal STIs acquired HIV compared with 4% of those without rectal STIs – 2.6 times as many.

One important aspect of the study was that 70% of the rectal infections detected were asymptomatic and would not have been detected had participants not attended for a routine STI check-up.

Diagnosis of any acute STI should automatically trigger a recommendation of an HIV test. Given the strong association with subsequent HIV infection, rectal STIs could also in the future serve as triggers for an offer of pre-exposure prophylaxis (PrEP) or other intensified prevention measures.

What will it take for treatment to work as prevention?

Public health officials, donors, epidemiologists, researchers and clinicians need to factor in the relevance of people’s social circumstances and cultural beliefs if they are to see biomedical HIV prevention strategies – including treatment as prevention (TasP) and pre-exposure prophylaxis (PrEP) – succeed in real-world settings, speakers told the 2nd International Conference for the Social Sciences and Humanities in HIV, held recently in Paris.

“TasP is a simple acronym that masks considerable complexity,” commented Professor Gary Dowsett of La Trobe University in Melbourne, Australia.

Although modelling studies have shown that - in theory - programmes of testing and treatment could eliminate some countries’ HIV epidemics, in practice a whole number of conditions have to be satisfied, said Dowsett. These are as follows.

Large numbers of people who are at risk of HIV infection:

  • need to understand that they are personally at risk;
  • need to find the idea of testing for HIV acceptable;
  • need trusted, convenient and affordable HIV testing services;
  • and need to be willing to test repeatedly, perhaps once every year or more.

Those diagnosed with HIV:

  • need time to come to terms with the result;
  • need to believe that there are benefits to engaging with health services now, even though they may not feel ill;
  • need to stay in touch with their doctors and nurses, which may mean overcoming barriers that may have made it hard for them to attend a clinic in the first place.

Those advised to start HIV treatment, or contemplating it:

  • need to believe that it will benefit them personally;
  • or need to understand the possible advantage for a sexual partner and consider this a good enough reason to take the drugs;
  • and need to feel that perceived or actual problems such as side-effects or other people finding out their HIV status are manageable in comparison with the advantages.
  • All these, trusted, convenient and affordable health services need to be available.
  • An efficient healthcare system is needed to provide the drugs, in a way that is affordable for the patient, without interruptions in drug supply.
  • Alternative anti-HIV drugs need to be available in case of treatment failure.
  • And all these things need to happen, not just for a short period of time when the conditions are favourable, but for decades.

For all these reasons, Professor Susan Kippax, conference co-chair, argued that we cannot expect to see similar results to HPTN 052 (the study which found that HIV treatment reduced the risk of passing on HIV to a regular partner by 96%) when early HIV treatment is used a population strategy.

“Some of the biomedics seem to fail to understand that people live in cultural and social worlds,” she said. “Populations are likely to differ from one another and may respond very differently from one another.”

The great diversity of results seen in trials of PrEP (from 73% reduction in risk in one trial to having no effect in two others) suggests the importance of attending to the social and cultural.

Dr Marsha Rosengarten, another conference co-chair, summed it up by saying that the conference’s key message was that “biomedical technologies do not – in and of themselves – prevent transmission of the virus”.

We should provide HPV vaccine to young gay men, UK experts say

There is a strong argument for extending the UK vaccination programme against the human papillomavirus (HPV) to young gay men, say a group of sexual health physicians. HPV vaccination is not currently recommended specifically for gay men in the UK.

The writers argue that this should change. Immunisation would be of benefit to the vast majority of sexually experienced younger gay men, they say.

Persistent infection with high-risk strains of HPV (especially types 16 and 18) can lead to the cancer of the cervix or anus. Gay men have high levels of HPV infection and, in those with HIV, immune suppression can cause it to persist for longer. As a result, cervical and anal cancers are much more common in gay men and people with HIV.

The UK HPV vaccine programme has prioritised adolescent girls because people tend to start acquiring HPV infections soon after they start sex and the theory has been that ‘herd immunity’ (a form of immunity when the vaccination of a significant portion of a population provides a measure of protection for individuals who have not developed immunity) would also benefit boys. This has been partially borne out by data from Australia’s national HPV vaccination programme.

However, Australia extended its HPV vaccination scheme to include school-aged boys after data from the state of Victoria showed that HPV infections had fallen dramatically in young heterosexual men and women, but not in gay men. The US Centers for Disease Control and Prevention also now recommends universal vaccination for boys aged 11 and 12, and for gay men up to the age of 26.

Studies in gay men have shown that Gardasil, the vaccine used in the UK school programme, is very effective at preventing HPV infection with types 16 and 18 and offers significant protection against some other cancer-causing types. The vaccine is most effective in people without any current HPV infection but has acceptable levels of efficacy in individuals with existing HPV 16 or 18 infections. One recent study found that although HPV 16 and 18 are very common in gay men with HIV, vaccination by Gardasil could prevent as many as 20% of them acquiring new infections per year.

The UK's Joint Committee on Vaccination and Immunisation will decide whether vaccination of gay men under 27 is cost-effective in 2014.

European women with HIV having unnecessary caesareans

There are “missed opportunities” for HIV-positive pregnant women with a suppressed viral load to give birth vaginally, European research shows.

Guidelines in Europe recommend or permit a vaginal delivery when a woman has an undetectable or very low viral load. However, investigators found that over a third of women with viral suppression and no other contraindications continue to have a caesarean section.

“Rates of vaginal deliveries were lower than expected,” comment the authors. “Our results suggest that the policy for vaginal delivery among women among women with undetectable or very low VL [viral load] is only slowly becoming established within practice over time.”

An elective caesarean section was recommended for HIV-positive women in 1999, but the widespread use of antiretroviral therapy (ART) has reduced the risk of mother-to-child transmission dramatically, with rates of below 1% seen across Europe. Guidelines have been changed over the last decade to recommend that women with very low viral loads aim for a vaginal birth. The additional benefits of an elective caesarean section are open to question, especially as the procedure can also involve risks.

Data collected between 2000 and 2010 from 3013 deliveries to 2663 women were available for analysis.

Only 8% of mothers did not receive ART during pregnancy or delivery and the proportion of women taking ART who achieved a viral load below 400 copies/ml at the time of delivery increased from 83 to 95% (87% of all the women) after the new guidelines were in place.

However, after the change in guidelines, the proportion of women giving birth vaginally only increased from 17 to 52% and the proportion of vaginal deliveries in women with viral loads under 50 copies/ml was actually lower, at 45%. For a third of the remaining women, there was another reason for having a caesarean, but in 35% of cases the woman could have aimed for a vaginal delivery.

Hepatitis C uncommon in HIV-negative gay men – unless they also have syphilis

There was no evidence of a hepatitis C epidemic among HIV-negative gay men in London, according to a community survey done in 2008 but only just published. It found that only 1% of HIV-negative gay men in London had antibodies to the hepatitis C virus (HCV) in 2008. This prevalence was “not significantly higher than in the general population”, the authors comment. In HIV-positive gay men, however, 8% had antibodies to HCV.

Two other risk factors were associated with HCV infection. Prevalence of HCV was four times higher among HIV-positive or negative men reporting unprotected sex with a casual partner.

Men with antibodies to syphilis were over 12 times more likely to have HCV than men without syphilis.

The Gay Men’s Sexual Health Survey (GMSHS) recruited 1121 gay men in community settings such as gay bars, clubs and saunas. Fifteen per cent of them had HIV and 12% had antibodies to syphilis (which may represent a current or former infection).

It is unlikely that HCV prevalence among HIV-negative gay men has increased substantially since 2008. According to the recently published Public Health England report Hepatitis C in the UK, incidence of hepatitis C in HIV-positive men has declined significantly since 2008, to 2.2 new infections per thousand person-years of follow-up in 2012, and there is no reason to expect a different trend in HIV-negative gay men. Another study found that HCV prevalence in HIV-negative gay men was not statistically different from prevalence in heterosexual men.

The authors conclude that there is no reason routinely to test HIV-negative gay men for HCV, but only to do so on the basis of risk.

One limitation of the study was that it did not enquire about injecting drug use. Some doctors now believe that a proportion of the HCV infections among HIV-positive gay men attributed to sexual transmission may in fact be a consequence of sharing injecting equipment. Last month, a study found a high rate of HCV re-infection in HIV-positive gay men who had been successfully treated for the virus.

Other recent news headlines

Women with HIV feel 'under surveillance' during pregnancy and early motherhood

Being pregnant, for women with HIV, is too often a state of “social surveillance, monitoring, interrogation and criminalisation”, according to Canadian researcher Sarah Greene. She told the 2nd International Conference for the Social Sciences and Humanities in HIV that healthcare practice needed to move to a situation in which mothering with HIV is normalised, accepted, and left alone. Women feel that they are not only under the gaze of medical professionals and child protection officials, but also friends and family, who may take a particular interest in women’s infant-feeding choices, she added.

Evidence is not yet sufficient to recommend universal treatment, clinicians and community writers say

We do not yet have sufficiently strong evidence to recommend that antiretroviral treatment (ART) should be offered to all people with HIV, regardless of their CD4 count, a group of clinical and community writers has concluded. They criticise the current inconsistency between various HIV treatment guidelines on when to start ART and add that if all guidelines used a rigorous standard for rating evidence, their recommendations would be more consistent and probably more cautious. Universal treatment upon diagnosis, which two US guidelines now recommend, has been suggested as a way of controlling the HIV epidemic.

What HIV self-testing may mean for couples

A study in Malawi presented to the 2nd International Conference for the Social Sciences and Humanities in HIV is offering glimpses into why couples choose HIV self-testing. The researchers found that participants opted for self-testing for a number of reasons, including risk behaviour, mistrust within the couple, and a desire to either confirm an earlier HIV test result or check the effectiveness of local 'faith healing'. The World Health Organization is working to develop guidelines on HIV self-testing following the first-ever WHO meeting on the subject in April 2013.