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The criminalisation of men who have sex with men is driving gay relationships underground in Africa and this discrimination is contributing to the spread of HIV on the continent.
The urgent need for access to health services for men who have sex with men, respect for their sexual orientation and protection in law, and lobbying for their human rights, emerged clearly at the M2010 Microbicides: Building Bridges in HIV Prevention conference in Pittsburgh, in the US, this week.
That was a key point in my article in the Sunday Times today – but I feel concerned that the headline “Secret gay sex fuels HIV spread in Africa” conveys a negative message.
What I feel negative about is the intolerable discrimination against men who have sex with men and how that isolates them from prevention, care and treatment.
As Michel Kazatchkine, executive director of the Global Fund to fight Aids, TB and Malaria, said in response to the recent imprisonment in Malawi of two men for having a gay relationship: “The criminalisation of individuals based on their sexual orientation is not just a human rights issue – it also … drives sexual behaviour underground and creates an environment where HIV can more easily spread.”
NOW that the M2010 Microbicides conference in Pittsburgh, in the US is over, the next big date on the microbicide and HIV prevention calendar is the 21 July 2010.
On that day the results of the first microbicide trial with a candidate using antiretrovirals will be announced at the XVIIIth International AIDS Conference in Vienna, Austria.
Professor Salim Abdool Karim, the director of Centre for AIDS Programme of Research in SA, will present data from the CAPRISA 004 study “to assess the safety and effectiveness of a vaginal gel containing the antiretroviral drug tenofovir” at the conference.
Tenofovir is an antiretroviral drug that is very effective in treating AIDS and it is also being tested in another big microbicide study.
“If a tenofovir gel is found to be safe and effective in preventing HIV infections in this trial, confirmatory studies involving more women will likely be required before the product could undergo an approval process by the relevant drug authorities, such as the SA Medicines Control Council,” Karim said.
The safety of over-the-counter and mail order lubricants commonly used in receptive anal sex needs to be comprehensively studied, says Jim Pickett from the organisation International Rectal Microbicides Advocates.
Findings presented at the M2010 Microbicides conference today suggested that some of the aqueous-based lubricants – with higher concentrations of dissolved sugars and salts than normally found in cells (hyperosmolar nature) – could increase the risk of getting a sexually-transmitted infection like HIV since they are associated with “cellular toxicity”.
Pickett said: “We need more data on lubricants which have not been tested for safety.”
This latest research was conducted in the laboratory and more trials are needed to get clear, validated information and to assess the clinical outcomes, said the investigator Dr Charlene Dezzutti from the University of Pittsburgh.
“One silicone (lubricant) tested seems to do much less damage than the aqueous lubricants,” she said.
She said the aqueous products damaged to the epithelial cells – the lining found in our mouth, nose, rectum and other parts of the body.
“This might lead to increased infection…these are not regulated compounds. If you are using a lubricant you might want to check the ingredient list and check it is condom friendly.”
The safest lubricants of the six tested were PRE and Wet Platinum.
Another study on lubricants in use by the participants seemed to confirm the lab findings.
Dr Pamina Gorbach from the University of California, Los Angeles, said: “Charlene showed in the lab what we found in large studies in two cities.”
The researchers were investigating the rectal health and behaviour of nearly 900 men and women in Baltimore and LA, in the US.
“More people who were using lubricants before their last receptive anal intercourse had sexually transmitted diseases. They were three times more likely to have a rectal STD.”
The participants were tested for the bacterial STDs gonorrhea and Chlamydia.
About half of them reporting using a lubricant when they last had anal sex and the majority preferred water-based lubricants.
Gorbach said: “So many types of lubricants were being used and they changed every day. Most men remembered the brand (not product) name and 20% were using more than one type.”
AN unlikely speaker took the stage this morning at the M2010 Microbicides: Building Bridges in HIV Prevention plenary, a prominent HIV vaccine researcher.
Dr Susan Buchbinder, the director of HIV research at the San Francisco Department of Public Health, presented 10 lessons from vaccine studies in which she has been involved including the STEP/Phambili Phase III efficacy trial.
Her lessons were:
# 10: Good science often yields surprising results. The findings in the RV144 Thai trial were unexpected, she said. The vaccine only provided weak cell-mediated immunity and not broadly neutralizing antibodies, yet it offered some protection against infection (an estimated 31%).
#9: Results take time to process and that analyses of the STEP/Phamibili data down the line have yielded some clues. For example, in the first three months the vaccine seemed to suppress the virus even though this effect was transient.
#8: It takes many villages for a trial: more than 16 000 volunteers were recruited for the Thai trial which was well conducted.
#7: Statistics are confusing to almost all of us. Buchbinder reported on the different analyses of the Thai trial result statistics which were released last year -and generated much controversy.
#6: Behaviour change is difficult. This is particularly relevant for microbicides, in which trials have shown that it is challenging to get volunteers to use the product appropriately.
#5: Mucosal responses are important and difficult to measure.
#4: Clinical efficacy trials are an important part of the discovery process (whether they yield the hoped for outcome or not). They provide data that cannot be gathered from non-human primates (like rhesus macaques monkeys).
#3: Transparency yields many rewards, in scientific circles and in communities. Buchbinder said the Thai researchers released their findings first to the community and subsequently opened up their data and specimens to the broader scientific community, which was a positive move.
#2 : There will be no silver bullet for HIV prevention any time soon but combined approaches can have an effect.
#1: Discovery is a multi-step process and all partners must work together. “We need multiple pieces to build combined prevention strategies,” she declared.
ANYONE who is going to take antiretroviral drugs for prevention – either orally or through a microbicide – must know his or her HIV status to avoid drug resistance developing, Dr John Mellors from the University of Pittsburgh said at the M2010 Microbicides conference today.
”If someone is infected and takes PrEP (pre-exposure prophylaxis) this would be really bad,” he said, explaining how that person would promote the spread of resistant HIV strains.
An expert on resistance, Mellors said some drug resistance among people taking antiretroviral therapy was inevitable.
About 80% of people currently on treatment have suppressed their virus. Most (4/5) of the 20% who have not, have some resistant virus.
Mellors expressed concern at the “substantial overlap in the drugs being used for treatment and those being studied for prevention”.
He said in a worst case scenario widespread resistance at a population level to these drugs could end up rendering them ineffective for both treatment and prevention.
But he added: “It is very rare to become infected with a virus we can’t treat today.”
Dr Susan Schader from McGill University said in reality resistance wasn’t an “all or nothing” problem.
Patients could increases doses, and could switch therapies if the higher levels proved toxic to them, she said.
But in South Africa and other African countries the latest, sophisticated drugs are relatively inaccessible because they cost far more than the first line treatments.
Dr Ume Abbas from the Cleveland Clinic Foundation said she had done a mathematical model on drug resistance if PrEP were to be rolled out at a population level.
“We found if an individual was already infected at baseline (in other words the person wanted PrEP not realising it was too late since they had HIV) that would be a major factor in fuelling the spread of drug resistance,” she said.
Dr Regina Osih from Wits University listed the public health concerns if PrEP were to be rolled out as adherence, resistance, the capacity of the health care system, identifying the ideal target populations and ethical choices.
Rhesus macaques monkeys
Hasse said that glycerol monolaurate (GML) had protected eight out of 11 rhesus macaques from infection after a high-dose challenge, compared to three out of 11 among the control group.
“GML is efficacious, safe, cheap and could be formulated to encourage adherence,” he said. “GML represents a new opportunity to block HIV at the portal of entry.”
But this approach would work only in the first few days of infection before the virus has a chance to spread through the body leading to systemic infection.
“The maximum opportunity (to stop HIV) is in the mucosal and sub-mucosal tissues,” he said.
Microbicides are being developed for this, to be applied topically in the vagina or rectum.
“The second chance is if you can prevent local expansion of the virus (via the genital lymph nodes and bloodstream).”
Hasse said, for example, that GML is intended to inhibit the body’s innate inflammatory response to viral infection – and in this way block an influx of new CD4+ T cells for the virus to infect.
HIV (or SIV) needs the influx of new target cells to expand beyond its small founder population of HIV, which are in clusters, and without these new cells it cannot spread effectively, he said.
SCIENTISTS today presented “promising data” on what drugs could prove effective in the next generation of microbicides to stop the sexual transmission of HIV.
Dr Walid Heneine said that an integrase inhibitor (the compound L-870812) had protected two out of three monkey models from infection.
This is the first gel with an integrase inhibitor to be tested and it was found to offer the macaques significant protection.
Integrase inhibitors prevent the HIV integrase protein from inserting HIV genetic information into the infected cell’s own DNA.
Professor Robin Shattock from St George’s, University of London, spoke about the potential of several new drugs – tested in cell and tissue studies – for developing microbicides.
He said that those showing promise down the pipeline were the protease inhibitor darunavir and even further down the fusion inhibitor L’644.
Protease inhibitors block the maturation of new virus particles once they have infected the cell, preventing them from being passed on.
Daruvanir shows potential, particularly when combined with dapivirine, a non-nucleoside reverse transcriptase inhibitor, laboratary studies show.
The compound L’644 is coming first in the class of drugs known as fusion inhibitors – which act to stop the virus from binding to healthy target cells. They have already been used in treatment.
This drug is active even after being washed off the tissue, suggesting it locks on the cell surface and could offer a wider window of protection over time, said Shattock.
Microbicide gels are acceptable to most women during sex, the results of three studies presented today at the M2010 Microbicides conference showed.
Microbicides are substances, like gels, designed to stop HIV or other sexually-transmitted infections when applied topically inside the vagina or rectum.
Significantly the one study showed that the male partner’s willingness to accept the gel was a more accurate indication of whether women would use it than whether they thought it was effective at stopping HIV.
“The gel’s acceptability was most strongly influenced by a partner’s willingness, even more than her own,” said Sharon Abbott from the Population Council in New York, whose research included information from South Africa trial sites.
“Gender and sexual norms were a better predictor of use than belief in efficacy,” said Abbott, who was assessing the acceptability of Carraguard among women.
Two gels (PRO 2000 and BUFFERGEL) evaluated in another study had about 99% acceptability.
The researcher Nicola Coumi from the Medical Research Council said that nearly half (43%) of the women expressed three or more likes, and only 3% expressed two or more dislikes of these products.
Adherence – using the gel as intended – is higher among the women who expressed positive views (several ‘likes’).
Adherence was also higher among older women, married women, those with a higher education and those who reported male condom use and douching before the start of the trial.
And roughly a fifth of the women in the MRC study found that the gels made sex more pleasurable (22% to 24%).
In another study where most participants were formal or informal sex workers, the women particularly liked the lubricant properties of the gel being tested (CONRAD’S cellulose sulfate 6%).
One woman in India even told the researchers, led by Elizabeth Green from Family Health International, that it allowed her to have more clients a day and thus earn more money.
These women suggested the gel reduced pain and reduced condom breakage.
They liked to use the product with casual partners but did not find it appropriate for their boyfriends or husbands since they thought it might ruin intimacy and trust.
“Most women liked the gel but contextual, interpersonal factors (relationships) had a stronger influence on its actual use,” Green said.
The encouraging results from Abbott’s research were that the women’s partners mostly liked it, it was easy to use during sex and when sex was routine or expected.
On the down side, it was less acceptable during a second round of sex, when partners disliked it, when sex was spontaneous or the women were away from home.
The sex acts covered ranged from 39% to 79% in this study but a biomarker (a stain on the applicator showing it was vaginally inserted) revealed that the gel was used less frequently than the women had claimed.
Pittsburgh, the host city of the M2010 Microbicides conference this week, is also the city where Jonas Salk developed the polio vaccine.
At the opening ceremony tonight delegates watched a short excerpt of a film about the polio vaccine – a vaccine that has virtually eradicated the “dread disease” of the last century.
The title of the documentary, not yet released, was The Shot Felt Around the World.
The lessons for an HIV prevention conference were clear: working together to achieve the “impossible”, a committed effort by a team of scientists thinking outside of the box (daring to use a killed vaccine in the design) and working around the clock.
As important was the overwhelming support of the community including parents and teachers to stop polio – bringing 1.8 million children for shots of the experimental vaccine.
Dr Christopher Bates, director of the Office of HIV/AIDS Policy in the US President’s Office, picked up on the theme of “making the impossible possible”.
He indicated that the release of the national HIV strategy was one month away.
Dr Henry Gabelnick – a chemical engineer when he started his career – was honoured with a lifetime award for his contribution towards microbicides research.
He spoke about what he had learned over the last 20 years, leading up to the latest generation of microbicides using ARVs.
Dr Gina Brown from the US Office of AIDS Research said that microbicide research had applications for many other fields.
For instance, research into how to objectively measure adherence will be relevant to other studies, she suggested.
M2010 co-chair Dr Ian Gowan emphasised the importance of building bridges between all stakeholders in the field – one of the themes of the conference which is being held in the city of bridges.
He also spoke about how gay men are once again at the forefront of the need for HIV prevention just as they were the face of HIV in the early days of the epidemic in the US, before the epidemic shifted to being predominantly heterosexual with most new infections in Africa.
Gowan said men having sex with men on the African continent needed to be a focus.
He urged everyone to stand up to the increasing groundswell of homophobia and human rights violations across the world.
As Sunday Times editor Ray Hartley says in The Wild Frontier today, the sentencing of two gay men in Malawi to 14 years of hard labour “represents a new low-water mark for tolerance on the African continent”.
Sixth microbicides conference taking place this week in US
THE use of ARVs in microbicides to prevent HIV, rectal microbicides, the risks of getting HIV during pregnancy and anal sex, and new formulations like films and vaginal rings are “hot topics” for M2010, according to the co-chairman Dr Ian McGowan.
Microbicides are substances that can be applied to the vagina or rectum to block HIV transmission at that site and prevent infection.
The M2010 MICROBICIDES: Building Bridges in HIV Prevention conference opens in Pittsburgh in the US tonight and will run until Tuesday night.
The first microbicides conference was held in 2000 and this is the 6th such conference, attracting more than 1000 delegates from 47 countries.
The results of the first microbicide using an ARV (tenofovir), which was tested in a human, clinical trial in South Africa, will be released in July.
The results of this trial are on the minds of all participants at this conference – what it will mean if it works and what questions it will raise if it does not – and what will be considered a good result.
So far only five out of 37 randomised clinical trials testing HIV prevention methods have shown some success – three of these on medical male circumcision – so high hopes rest on the efficacy of the tenofovir gel.
I am here, and will file one or two reports a day on this blog, and send stories to The Times, its online site, and the Sunday Times about the findings.
Time to go, the opening ceremony is starting.
