Microbicides and Prevention

posted: 01/03/2011

There’s been much more progress in developing gels that help prevent HIV infection. The first trial of rectal use of a tenofovir microbicidal gel has produced useful results and boosted hopes.

Last year we heard of the first successful trial of a vaginal HIV prevention gel. Using this gel in the rectum for HIV prevention caused some side effects and may not be safe, the 18th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, USA, has just heard. However the problems found are already being solved and new microbicides are under exploration.
 

80% preventive but few liked it
Although the gel was 80% effective in inhibiting HIV from infecting rectal cells, it caused stomach side effects as cramps and discomfort among some, and was unpopular, with only 25% of users liking it.
 

Next: 2nd attempt at anal gel
They are now working out a new version designed just for rectal use, and they are seeing if tenofovir can be given as a HIV prevention douche or enema.
 

Complex rectal microbicide study

• The study was complex and needed a lot of commitment from the 18 people who took part – all HIV-negative, 14 men and four women. First they had a single dose of oral tenofovir and then waited two weeks. During this time they had five rectal examinations and biopsies.
   
• Then they were either given one dose of either the CAPRISA tenofovir gel, or a placebo (fake) gel and again waited two weeks and had five more biopsies taken.
   
• Then, at last they were offered either the tenofovir or placebo (fake) gel once a day for seven days and had some final biopsies done.

Altogether 2000 biopsies were taken (they were very dedicated patients in this trial - on average each person had 111 biopsies!)
 

Why were there so many biopsies?
Somehow we need to test the gel against HIV in real life. The biopsies allowed the microbicide-treated cells to be kept alive in the laboratory to see how they respond to large doses of HIV. This is the closest we can get to doing the normal drug safety and safe doses tests.
 

Blood and rectal response
The researchers compared how much tenofovir was in the blood and rectal tissues after taking the pills and using the gel. Take the tablet and there was 30 times more tenofovir in the blood than after using the rectal gel, while using the gel meant there was 100 times more tenofovir in rectal tissues after just one rectal dose and after using it for 7 days it was 500 times higher. After seven days of rectal use HIV had 80% less viral infectivity.
 

Works, but side effects and unloved
So the gel shows signs of working well, but there were significant side effects and, perhaps most importantly, it was disliked by most.
 

Two volunteers reported grade three adverse events, meaning diarrhoea, cramps and discomfort. These were bad enough for the two to stop before completing the seven-day course. There were also some signs of cell damage being caused.
 

Only 25% of users said they liked the tenofovir gel, although 75% of people said they would be prepared to use it again if it proved protective against HIV.
 

Enemas and new versions, new microbicides
The tenofovir gel is now being reworked to be less toxic to cells.
The first trials of an enema delivering the anti-HIV drug involved nine gay men trying two different enema formulations and distilled water as the base for the enemas. Men preferred the enema which was designed to be in balance with the body (so it doesn’t draw out moisture from the tissues), and they found it went much further up the colon so would protect more, and found it was also the least toxic to cells.
 

Other experimental microbicides
Results for other experimental microbicides were also presented at the conference, including hi-tech ones containing broadly neutralising antibodies, which would act like a short-lived ‘mucosal vaccine’.
So there is more work to be done but microbicides are looking much more hopeful now than even 2 or 3 years ago.
 

Source with abstracts and references

HIV Sperm Washing NorthWest

posted: 08/02/2011

Sperm washing for people with HIV is now available in North West England. Sperm washing cuts the risk of HIV transmission for couples who want a baby, when the male is living with HIV but his female partner is HIV negative. Sperm washing cuts the risk of passing HIV to the female partner and of the mother then passing HIV to the baby.
 

More information on sperm washing and HIV here

New sperm washing service in Liverpool

A Liverpool clinic now offers sperm washing and fertility services to people with HIV and other blood borne viruses.
People wanting sperm washing before now have had to travel around 200 miles to London.

Dr Chitra Babu (from the Hathersage Clinic at Manchester Royal Infirmary), has worked with the Greater Manchester Sexual Health Network to arrange in principle for funding to pay for this sperm washing, as a way of reducing the risk of HIV transmission.

HIV positive men with HIV negative partners who want to have children should both go together and talk with their HIV clinic about sperm washing and other ways to cut HIV transmission risks. Liverpool can also provide other fertility treatments – talk with your local HIV clinic.
 

Leaflet for patients and guidelines for clinics

Within the next couple of weeks there will be a leaflet for couples affected by HIV and guidelines for clinics, and we will then add these here.

Information Sessions - HIV and having a family

Positively UK are holding two HIV and Pregnancy information sessions at George House Trust:

Preconception and Pregnancy:
Saturday 19 February 2011
13:00 – 15:00

Delivery and After Care:
Saturday 19 March 2011
13:00 – 15:00

Both men and women are welcome to attend.

If you need a space for a child at the crèche, please book this in advance

For further information contact Jill Cooke at GHT on 0161 274 4499 or email her, or Angelina from Positively UK on 0207 713 0444 or email her

More information on HIV and pregnancy

• i-Base booklet HIV, Pregnancy and Women's Health
• MyHIV - having a family pages from the new website for people with HIV in the UK
• Aidsmap's booklet for Women
• HIV and Sexual Health in Pregnancy - Manchester Maternity Hospitals HIV Information Pack from Manchester Public Health

HIV and Pregnancy Sessions

posted: 08/02/2011

Find out more about safely having a family with HIV. We have two information talks and discussions for people with HIV who are thinking about having children or who want to find out more.

• HIV positive and pregnant?
• Thinking of starting a family?
• Would you like to find out more about HIV and pregnancy?

Positively UK are holding two HIV and Pregnancy information sessions at George House Trust:

Preconception and Pregnancy - planning for a baby
Saturday 19 February 2011
13:00 – 15:00

Delivery and After Care - having and caring for your baby 
Saturday 19 March 2011
13:00 – 15:00

Both men and women are welcome.

Crèche?

If you need a space for a child at the crèche, please book this in advance with Jill by phone or email - please tell her which date you need the crèche

More information

For more information please call Jill Cooke at GHT on 0161 274 4499 or email, OR Angelina from Positively UK on 0207 713 0444 or email

New - sperm washing in Liverpool

A clinic in Liverpool is now able to provide sperm washing and fertility services to people with HIV and other blood borne viruses. People with HIV will no longer need to go to London.
 

More information on HIV and pregnancy

i-Base booklet HIV, Pregnancy and Women's Health 

MyHIV - having a family pages from the new website for people with HIV in the UK

Aidsmap's booklet for Women

HIV and Sexual Health in Pregnancy - Manchester Maternity Hospitals HIV Information Pack from Manchester Public Health

HIV and Teenage Pregnancies

posted: 26/01/2011

Behind the good news that 58 London teenagers with HIV successfully gave birth to 66 babies, there’s another story.

This is a saga of sex education that isn’t working, major gaps in HIV prevention, little or no use of contraception, unplanned pregnancies, vulnerable teenagers and sexual abuse, domestic violence, undiagnosed HIV, late diagnosis, further pregnancies after the birth, and complex psycho-social problems. 
 

We learn this from the first British study to look at pregnant teenagers with HIV, in the latest issue of the British HIV Association journal, HIV Medicine.

Over the seven years up to 2007, 12 London hospitals found 58 teenage (13 – 19) women with HIV who became pregnant. 66 babies were born live to the 58 mothers and only one baby developed HIV. The mothers (and the babies) have done well and that is what the study was looking into.
 

Gaps and needs

But the study uncovered evidence of significant gaps, and exposed teenagers’ needs and some of the life problems that can help explain these pregnancies, and how HIV pregnancies and HIV transmissions to vulnerable teenagers might be avoided.
 

The young women here faced “difficult medical and social circumstances,” used condoms infrequently, and a quarter became pregnant again within one year. Other studies have shown many young people with HIV have complex psychosocial problems, take high levels of sexual risk and have significant recreational drug and alcohol use. This study found this too.
 

11% of the new HIV diagnoses in the UK are young people aged 16 to 24.

Ethnicity
Four out of five pregnant teenagers have ethnic minority backgrounds:

• Black African, 59%
• Black Caribbean, 17%
• Other ethnicities 10%
• Only 14% were white females.

Almost three quarters (72%) were born abroad.
 

When infected?

One woman was definitely HIV-positive from birth, but as many as 43% of the women might have got HIV as babies from their mothers. These young women were diagnosed with HIV in their teens, but after they begun their sexual lives, so we don't know how they became HIV positive. 
 

Late diagnosis too

Some of the young women were diagnosed at a late stage of HIV : 5% of the young women had already developed symptoms of HIV illness, and 9% had an AIDS-defining condition.

However, most of the women (87%) had no HIV symptoms.
 

Almost two-thirds of the young women (63%) were diagnosed with HIV during the normal antenatal checks, and the others were diagnosed before they became pregnant.
 

How infected?
How might these young women have got HIV?

• 1 (but possibly 25) infected from mother to baby 
• 42 (63%) migrated from a high-HIV-prevalence country (so possibly mother to baby, possibly sexual, possibly through infected blood or tissue)
• 24 (36%) sexually through a ‘high-risk’ partner, or someone with HIV

Most (92%) were sufficiently sexually active before they became pregnant to have had a sexual health screen the year before, and 45% have had another sexually transmitted infection.

No condoms or contraception
Most of the pregnancies (82%) were unplanned, and only four were taking anti-HIV treatments when they conceived.

• Only 1 in 3 used condoms, and often condom use was inconsistent 
• 2 out of 3 didn’t use any contraception.

2nd pregnancies

Despite this, the hospital notes show that less than half (43%) of the new mums were advised about contraception after they had their baby, and not surprisingly 1 in 4 of the women then had a second pregnancy within a year. Contraception advice (and having a baby as a positive teenager) is not enough to prevent conception again. 47% of the second pregnancies followed contraception advice, 88% of the second pregnancies were unplanned and 12% ended with a termination.
 

Life problems
“Significant and complex psychosocial problems” were very common, for example 

• Almost half (45%) were sexually abused
• 58% had housing problems
• 63% had financial problems : only 8% were in paid work, the rest were unemployed (54%) or students (38%).

94% took anti-HIV treatment during pregnancy and for most (81%) this was to prevent mother-to-child transmission of HIV. By the time of the birth 62% of women had an undetectable viral load.
 

Good results for mums and babies

The investigators emphasise that despite their vulnerability and difficult social and medical circumstances, these HIV-positive teenagers had a “favourable” result – they did well themselves and their babies are fine.
 

The authors say the good results were due to the “multidisciplinary care the patients received.” This was provided by expert teams working closely together at major London hospitals - HIV physicians, obstetricians, paediatricians and specialist midwifes.
 

They say their study identifies “a need for more effective strategies in the management of HIV-infected teenagers with particular emphasis on sexual and reproductive health.” To meet these needs, the authors call for the establishment of “a one-stop shop including HIV care, sexual and reproductive health input and psychosocial support in an appropriate environment provided by skilled staff in a sensitive and nonjudgmental manner.”
 

UK Guidance Managing the sexual and reproductive health of teenagers with HIV

Acute HIV prevention needs of vulnerable teenagers

While this study says nothing about HIV prevention needs, (they were studying how well the the care for HIV positive pregnant teenagers and babies worked), it is very plain that these pregnancies, and teenagers becoming HIV positive exposes a major failure to meet HIV prevention needs.

At least a third of these teenage women were sexually infected with HIV. 

Almost all of these teenagers were sexually active in the year before they became pregnant, when they may not yet have got HIV. 92% of them had a sexual health screen in the year before they became pregnant. Almost half have had an STI.

Four out of five have an ethnic minority background; three quarters were born abroad and are migrants.

Most have complex psycho-social needs and are likely to be in contact with other services.

Target vulnerable teens for intensive HIV prevention

All services providing sexual health checks and contraception services to teenage women matching this profile should particularly target HIV information and support services to meet those needs.

The teenagers' male partners are invisible in this study - some must have HIV. There is a risk that those males without HIV might get HIV from their girlfriends, because few of the males are using condoms consistently.

We know nothing about their male partners' ages, ethnicities, whether they are migrants, use of sexual health services, or whether they are also vulnerable because of complex psycho-social problems. We need more information before we can meet the male partners' HIV and contraception support needs.       

Source, with reference

Related news - Unplanned pregnancies in teenagers infected from their mothers

Disadvantage Affects HIV Futures

posted: 25/01/2011

Low incomes and social disadvantage strikingly affects the life and health prospects of people newly diagnosed with HIV, according to a multi-national study.

An international team wanted to find out if sex and ethnicity affect the outcomes people can expect from their HIV treatment and care. The study looked at people in Australia, Brazil, Canada and the US, and found that sex and ethnicity make often striking differences in health prospects for women and men, and for ethnic minority people compared with white people.
 

Lesson - deal with disadvantages

The lesson the study teaches us “is that socioeconomic factors are a critical influence in determining the likelihood of engaging patients in care. As a result, these factors cannot be overlooked when developing programs that aim to increase the percentage of HIV-infected patients on therapy with undetectable viremia [Viral Load].”
 

The editorial in the Journal of Infectious Diseases says that social and economic disadvantages “represent complex challenges that are beyond the traditional influence of public health,” but the failure to deal with these, undermines attempts to deal effectively with HIV.
 

UK – we have the tool but refuse to use it
In the UK, the tool in the policy toolbox that could make a real difference, the new legal socio-economic equality duty on public bodies, has been locked away by the new government. The conservative led government has decided not to implement this part of the new Equality Act.

The government has also introduced a programme of major cuts in welfare benefits, and in funding for the NHS, Councils and community sector, which will all deepen the HIV disadvantages among people in the UK that we already see.
 

Do sex and ethnicity make a difference with HIV?
The new study looked at eight years in the life of people who were diagnosed very soon after getting HIV. They found that women do worse than men, and people of ethnic minority backgrounds living in the South of the USA have the most HIV-related illnesses.
 

Even when people take HIV tests and become diagnosed, poverty and social disadvantage remain real barriers to many people attending clinics, taking treatments properly and having a reasonably healthy lifestyle.
 

This was an observational study of over 2250 people who were diagnosed with early-stage HIV between 1997 and 2007, in Australia, Brazil, Canada and the US. The people were followed for up to eight years.
 

Women and men
Only 5% of the people in the study are women and most of the women (55%) were of ethnic minority backgrounds. Women had a significantly lower Viral Load (VL) count to start with than the men, but significantly higher CD4 counts (not surprising, since women tend to have higher CD4 counts than men). Three quarters of the men were white.
 

It seems there were few women in the study because the women were half as likely as men to have symptoms typical of early HIV infection, and so women were much less likely to be diagnosed than men at this early stage of HIV.
 

Treating women and men
Similar proportions of both women and men began HIV treatment, and their CD4 cell counts matched when treatment began.
 

But women and men of ethnic minority backgrounds were less likely to start HIV treatment than white men and women. And anyone living in the southern states of the USA was significantly less likely to start HIV treatment.
 

Six months after treatment started, men and women were as likely to have their viral load fall below 400 and have similar increases in CD4 counts.
 

Untreated women and men
However, the investigators then analysed changes in the viral load and CD4 cell count of the people who did not start HIV treatment for up to three years. “Despite the fact women had higher CD4 cell counts and lower viral loads at study entry, they subsequently experienced significantly more combined HIV-related and AIDS-defining events,” emphasise the investigators.
 

Nothing to do with biology: it’s poverty and social disadvantage
After they did their detailed analysis there found no grounds for believing biology is causing women to develop HIV-related illnesses. Instead these illnesses “are the result of socioeconomic conditions.” These include “access to health care, health behaviors, lifestyle and environmental exposures.”
 

Stark ethnic treatment divide

Stark significant ethnic differences are plainly seen in the numbers of people getting HIV illnesses or an AIDS diagnosis.  Eight years after diagnosis

• almost 8 out of 10 (78%) of ethnic minority people in the Southern states of the USA got either an HIV-related illness or AIDS,
• compared to less than 4 out of 10 (37%) of white people living in the same states, and
• compared with a quarter (24%) of white people living elsewhere, and
• about two out of ten (17%) ethnic minority people living outside the South.

USA HIV strategy has three goals: cutting the number of people who are undiagnosed; getting more people to clinics and on effective treatment; and cutting HIV-related health inequalities.
 

But the editorial points out “the findings from this study threaten the success of each of these pillars.” They therefore call for “a collaborative policy and research effort across all levels of community, government and science.”
 

Source Aidsmap has references and links to two free journal articles