Treating to Prevent HIV

posted: 03/03/2011

Could people who do not have HIV use HIV treatment drugs (PrEP) to stop themselves from getting HIV? The detailed results just out for gay and bi men are better than the early findings. This means PrEP could be approved for use in the USA by the end of the 2011.

Last year, the first results from a study of gay and bisexual men appeared. Taking PrEP cuts gay and bi men’s risk of getting HIV. But there were worries because many of the men did not take all the tablets. Some men got HIV.

HIV infection
Much better updated results were announced at the CROI conference in Boston, USA, that has just ended.

In the different places where the trial took place, including South Africa, the taking of PrEP (HIV drugs to prevent HIV infection) varied a lot.

Gay and bi men in the two USA cities (Boston and San Francisco) of the international iPrEx study of tenofovir/FTC (Truvada) had near-perfect HIV-prevention drug taking, compared with 50% tablet taking at the other sites.
 

And the men taking the greatest sexual risks for HIV, by having unprotected receptive anal sex, were taking the prevention treatment better than men taking less HIV risks – which is good to know.
 

USA approval within a year?
Lead investigator Bob Grant announced that the US Food and Drug Administration (FDA) had agreed that the trial results were good enough for the FDA to consider allowing the use of Truvada to prevent HIV. PrEP, as a result, might be approved in the USA by the end of this year.
 

First USA Guidelines for gay men published

Interim Guidance: Pre-exposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men from USA Centers for Disease Control and Prevention. 

2500 men and the results

There were almost 2500 men in this trial and 130 of them got HIV by the end. Like most drug trials men were randomly split into two groups and told they would either get Truvada, or a dummy pill, but no-one would know who was taking what, until the end. The men were therefore warned they should still use condoms, because half were using the dummy pill.
 

48 of the men who got HIV took the Truvada and 82 of the men who were taking the dummy pills, a HIV infection rate of 2.6% a year. Another 10 other men have HIV, but they already had the symptoms of HIV infection when they joined the study.
 

This means that the final ‘how well does it work’ rate in the ‘modified intent to treat’ analysis, (this leaves out the 10 men who started the study with HIV, and ignores things like different rates of tablet-taking and the men’s level of sexual risk-taking), was 42%.
 

PrEP worked better when men were over 25 (56%), among men who took more than 9 out of 10 of the tablets (68%), and among the men who were circumcised (76%).
 

Would PrEP be cost effective? 

Other new studies have now looked at the value for money of treating people to prevent HIV in South Africa. The answer is mixed. 

It is usually cheaper to treat the person with HIV than treating one or more HIV negative people with PrEP. Treating the person with HIV should reduce their viral load so it becomes undetectable and their chance of passing on HIV then becomes very small. In mixed status couples, that may be enough protection for many. But PrEP would help protect negative partners who have unsafe sex outside the main relationship and who don't use condoms.  

Source and more details

Pill Prevents HIV for Gay Men

posted: 24/11/2010

A once-daily pill can protect gay men from HIV infection, a ground-breaking and independent study shows today. The results of the international trial have been hotly awaited. The study proves that pills used to treat HIV can also prevent people getting HIV.

Campaigners greeted the results, published today in the New England Journal of Medicine, with enthusiasm, suggesting that they could fundamentally change the approach to preventing HIV.
 

Good but not perfect
The findings are good news for men who have sex with men, the group tested in this international drugs trial. The gay men who took Truvada, a once a day tablet using two drugs (emtricitabine and tenofovir) had 43.8% fewer HIV infections than the men who did not. The better the men were at taking the prevention treatment every day, the better the protection from HIV. Those who took the tablet 90% or more of the time were 72.8% less likely to get HIV.
 

Experts warning
But HIV experts warn gay and bisexual men that this preventative use of HIV treatment drugs is not an instant and easy answer. Protection is lowest among men who did not take the pills regularly.
The Centres for Disease Control in the United States issued guidance that pre-exposure prophylaxis "should never be seen as the first line of defence against HIV". Men who participated in the trials were counselled to use condoms, reduce their number of sexual partners and get tested and treated for other sexually transmitted diseases which can increase the risk of HIV infection.
 

What about women and heterosexual men?
The big unanswered question is whether drugs can also prevent infection among others at risk such as women in sub-Saharan Africa whose partners will not use condoms, and drug users. The study showed the pill offers some protection in sex between men, but it does not follow that drugs would protect during heterosexual sex, where the route of transmission is different. However it is likely to work for others.
 

Other studies are already under way among heterosexual couples and injecting drug users and there is good reason for hope. One of the drugs used in this trial, tenofovir, has already been shown to prevent some HIV infection in women when it is used in a vaginal gel before sex.
 

Dr Kevin Fenton, director of the CDC National Centre for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, said the results "represent a major advance in HIV prevention research ... Given the heavy burden of HIV among gay and bisexual men, a new tool with potential additive benefit is exciting and welcome news."
 

The findings provided hope that prophylactic drug treatment could protect other at-risk groups around the world. "Given the continued severity of the HIV epidemic, safe and effective new approaches are urgently needed for all populations at risk," he said.
 

Call to action
HIV campaigners called for swift action on the findings. More clinical research is needed, said Chris Collins, the vice president of Amfar (the Foundation for Aids Research), "but given the severity of the [men who have sex with men] MSM epidemic, we also need to move forward with implementation studies that can assess adherence, safety, and the potential to impact HIV incidence".
 

Study details
The study was carried out by the independent Gladstone Institute, on behalf of the US National Institutes of Health, in six countries: Brazil, Ecuador, Peru, South Africa, Thailand and the United States.
 

Nearly 2,500 men and transgender women who have sex with men and were at high risk of HIV infection took part in the study which began in 2007. Half the volunteers were given Truvada and the others were given a dummy pill.
 

Source

Aidsmap report

global iPrex - the study website
 

Children’s HIV Mental Support

posted: 27/11/2009

Ways to meet children’s mental health support needs before, during, and after a parent (or other close relative) dies with HIV, are given in a new international review from aidsmap / NAM.

It's written for resource-limited settings, but the how-to advice is excellent for children here and everywhere. Most useful in the UK are sections on ‘addressing grief and bereavement,’ checking for childhood mental health problems, and basic and more advanced ways to support children affected by HIV-related deaths.

A useful overview to helping children cope with death and grief the review recommends is the recently published guide Children’s Palliative Care in Africa, (download the whole book free - the only price to pay is taking part in a quick survey). 

One chapter in this book provides advice about

• making memory boxes (to collect items that remind them of the person who has died and times they shared)
• making a family record to help a child or young person gain a sense of where they and the person who has died fits into the family. This is particularly important when a child is to be removed from their old home, or separated from siblings or cousins, and hence when there is a danger of losing a sense of his or her ‘roots’
• telling the story by helping the child write or tell (with an adult writing) their story so that they remember clearly what happened — which can provide carers an ideal opportunity to pick up misconceptions and misunderstandings
• handprints: a print of their hand and their parents and other loved one’s touching
• writing a “children’s will”: children are sure to have some items that they treasure and they might have a clear idea of what they wish to happen to these
• permanency planning so that children have a clear idea about what will happen to them (if they are bereaved)
• a “bereavement tree” (a practical tool that sensitises people to the feelings and behaviours of individuals and expectations of society, to create awareness about bereavement in order to encourage community support to all bereaved people — there is an appendix with this tool in the book.

The book also highlights the importance of spiritual development (as well as play), and describes a number of beliefs and practices surrounding death in Africa.

Another fine resource

Some other useful resources can be found in the April 2009 issue of Together Now, the newsletter of the International HIV/AIDS Alliance in India, including using art therapy for children and child-centred counselling. The article also usefully describes different mental health screening tools for children.
 

Children’s Palliative Care in Africa

download the whole book free here

The international review After my parents died: The effect of HIV on the mental health of children: a clinical review