News (Updated July 18, 2009)

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HIV: Male circumcision does not shield women

Friday, July 17, 2009

AFP Circumcision of men with HIV does not reduce the risk of infection for women, according to a study published on Friday by The Lancet.

Male circumcision unleashed a wave of optimism among AIDS campaigners three years ago when trials in Kenya , Uganda and South Africa found foreskin removal more than halved men's risk of infection by the human immunodeficiency virus (HIV).

Last year, longer-term analysis of one of the trials found the benefit to be even greater than thought, with a risk reduction of 65 percent.

One of the big questions, though, is whether male circumcision could also reduce the risk for women who have intercourse with an HIV-infected man.

The answer, according to a randomised trial carried out in Uganda , is a clear "No."

Doctors enrolled 922 uncircumcised Ugandan men aged 15-49 who were badly infected with HIV but who did not show any symptoms.

Half of the group then had circumcision, while the other half remained uncircumcised.

The researchers also enrolled HIV-uninfected women who were partners of the male volunteers. These numbered 90 women in the circumcised group, and 70 in the uncircumcised groups.

All participants were intensively schooled in HIV prevention.

The trial was halted at a partway stage because it would have been futile and questionable to carry on.

Analysis of data after two years made it clear that there was no protection: 18 percent of women in the circumcised group who were examined at the follow-up point had become infected, as opposed to 12 percent in the control group.

Most of the infections in the circumcised group occurred within six months after circumcision.

This may have been because some of the men had intercourse without giving time for the circumcision wound to heal properly, thus exposing the woman to HIV-infected blood in the vagina.

That finding was surprising and provides a lesson for programmes to promote male circumcision as a cheap, effective method of preventing HIV among men, say the authors.

Men who undergo circumcision must be closely counselled about strictly observing sexual abstinence until the wound heals, and about also using condoms to stop infecting their partner.

The doctors, led by Maria Wawer of the Johns Hopkins Bloomberg School of Public Health in Baltimore , Maryland , say they were disappointed with the outcome.

They stress, though, that circumcision campaigns are still valid.

Even if women do not directly benefit from male circumcision, they get an indirect advantage, because the fewer men who are infected with HIV, the lesser the risk to women.

A study published in October last year in the Journal of the American Medical Association (JAMA) found that the protective benefit of circumcision to male heterosexuals does not appear to extend to male homosexuals.

Among 53,567 men who reported having male sexual partners, researchers found little difference in the rate of HIV infection between those who were circumcised and those were not.

The theory behind the effectiveness of circumcision is that the inner foreskin is an easy entry point for HIV. It is rich in so-called Langerhans cells, tissue that the AIDS virus finds particularly easy to latch on to and penetrate.

Other questions surrounding circumcision campaigns are the need to ensure that operations are done hygienically and with the full knowledge and consent of the male.

 

Hormones could explain why women progress faster to AIDS

Monday, July 13 08:00 pm

Scientists in the United States said on Monday they could help explain why women infected with the human immunodeficiency virus (HIV) advance faster to AIDS than men.

One of the enigmas about the AIDS pandemic is why women, after infection with HIV-1, seem better able to combat the virus in its early stages but then advance faster to AIDS compared to men infected with a similar level of the virus.

The answer lies in the response of a key component in their immune system, and hormonal differences may account for it, according to a paper published online by the journal Nature Medicine.

If right, it throws up new possibilities for drugs that would hinder the process, its authors added.

The study focuses on plasmacytoid dendritic cells (pDCs), which are "first responders" in the immune system. They detect a microbial intruder and then alert other defenders.

The pDCs recognise the AIDS virus through a little docking point called Toll-like receptor 7, or TLR7. Once their TLR7 is switched on, the pDCs call up an important immune-system molecule called interferon alpha.

Researchers at the Ragon Institute of the Massachusetts General Hospital were intrigued by lab-dish tests that showed higher levels of the female hormone progesterone intensified pDC activation.

The team then linked interferon alpha to the activation of one of the heavy artillery of the immune system -- CD8 cells.

Previous research has already spotted an intriguing phenomenon.

The more CD8 cells that are stimulated, the faster a patient progresses to acquired immune deficiency syndrome (AIDS), the stage whereby the immune system is so devastated that the body becomes prey to opportunistic disease. Why this is so is unclear, though.

Ragon Institute investigator Marcus Altfeld said that the results suggest men and women may differ in an important way in how their immune systems respond to HIV.

In the early stages of infection, a stronger activation of their immune system could be beneficial to women, he said.

But in the long run, the persistent viral replication and chronic activation of the immune system -- as indicated by the CD8 cells -- can lead to faster progression to AIDS.

Altfeld said the study raised new questions about how sex hormones modulate the molecular cascade to HIV infection. One interesting idea, he added, could be a drug that stops or slows the TLR7 alarm system.

"Focussing on immune activation separately from viral replication might give us new therapeutic approaches" to tackling the virus, he said in a press release.

 

Condoms offer partial protection against herpes

Mon Jul 13, 2009 5:20pm EDT

By Anne Harding

wpeA.jpg (9795 bytes)NEW YORK (Reuters Health) - Using condoms consistently can help prevent people from contracting genital herpes, new research in the Archives of Internal Medicine shows.

"It's the consistent use of the condom that's important," Dr. Emily T. Martin of Children's Hospital Research Institute and the University of Washington , Seattle , the study's lead researcher, told Reuters Health.

Genital herpes is caused by infection with herpes simplex virus-2 (HSV-2). The infection can cause painful sores in the genital area. Treatment for outbreaks and long-term suppression of the virus is available, but once a person contracts HSV-2 they will carry it for life.

While the benefits of condom use for preventing the spread of HIV infection , Chlamydia, gonorrhea and other STDs is well established, evidence on whether condoms are an effective barrier against HSV-2 virus has been mixed, Martin and her team note.

The researchers combined data from six different studies of HSV-2 incidence and condom use, including 5,384 people in total, to provide a more definitive answer. All study participants were free of HSV-2 infection when the studies began. During follow-up, which averaged just over a year, 415 contracted genital herpes.

People who reported always using condoms were 30 percent less likely to contract the infection than people who didn't use condoms, Martin and her team found, while the risk of becoming infected rose steadily with the number of unprotected sex acts.

Condoms are only partly protective, the researcher noted, because HSV-2 can spread by skin-to-skin contact, which could occur in areas not covered by the condom. Also, she pointed out, even when people with genital herpes don't have a visible outbreak of infection, they may be able to infect others with the virus.

Nevertheless, Martin added, "30 percent is partial protection, but it's protection."

SOURCE: Archives of Internal Medicine, July 13, 2009.

 

Gilead enters HIV pill partnership with Tibotec

On Thursday July 16, 2009, 6:35 pm EDT

FOSTER CITY, Calif. (AP) -- Drugmaker Gilead Sciences Inc. said Thursday it entered a partnership with Tibotec Pharmaceuticals to develop a single daily antiretroviral HIV pill.

The proposed drug would combine Gilead 's Truvada with a drug Tibotec is developing called TMC278, or rilpivirine. Terms were not disclosed, but Gilead said it would take the lead in manufacturing and testing the combined drug, working to get it approved by regulators, and selling it.

Gilead said the product would be the second complete antiretroviral treatment for HIV available in one pill. The first is Gilead 's Atripla, which combines three HIV drugs. The company said the combined pills make treatment simpler for patients.

Tibotec, a unit of Johnson & Johnson, would be responsible for developing rilpivirine as a standalone drug.

In aftermarket trading, Gilead shares rose $1.13, or 2.4 percent, to $48 after the partnership was announced. The stock rose $1.05 to close at $46.87 in the regular session.

 

Gilead Sciences shares rise on J&J deal

On Friday July 17, 2009, 10:04 am EDT

NEW YORK (AP) -- Shares of Gilead Sciences Inc. edged higher Friday after the company said it is working with a unit of Johnson & Johnson to develop a single daily antiretroviral HIV pill.

The stock gained $1.31, or 2.8 percent, to $48.18 in morning trading. Shares have traded between $35.60 and $57.63 over the last 52 weeks.

The company, known for its blockbuster HIV treatments, will work with Tibotec Pharmaceuticals to develop a single-pill combination of TMC278, or rilpivirine, and Truvada. Financial terms of the deal were not disclosed.

Gilead will take the lead in making and testing the drug candidate.

Gilead already sells a daily antiretroviral pill called Atripla, which is a combination of three HIV drugs including Truvada.

"Based on the deal terms, it appears that Gilead had the dominant hand at the negotiating table, as it reads to us more like a licensing agreement than a partnership," said Leerink Swann analyst Dr. Joshua Schimmer, in a note to investors.

He said it is difficult to assess the value of the program without late-stage study data, but Gilead 's lead role in the market gives it more opportunities to capitalize on Truvada.

Schimmer reaffirmed a "Outperform" rating on the stock.

 

Disruptions in HIV drug supplies and funding endanger patient lives

17 Jul 2009 17:06:00 GMT

Source: Medecins Sans Frontieres (MSF) - International

Disruptions in the supply of anti-retroviral (ARV) drugs and other essential medical items in at least six African countries are putting HIV patients' lives at risk. Funding gaps and supply management problems have led to the delay, suspension, or risk of suspension of the supply of life-saving HIV drugs.

MSF and podcasts: Cape Town - Disruptions in the supply of anti-retroviral (ARV) drugs and other essential medical items in at least six African countries are putting HIV patients' lives at risk. Funding gaps and supply management problems have led to the delay, suspension, or risk of suspension of the supply of life-saving HIV drugs.

The inaction of national governments, donors, and their partners must end and they must take urgent and concrete measures, says MSF, speaking one day ahead of the 5th International Aids Society Conference in Cape Town , South Africa .

The consequences of disruptions in funding and supplies are potentially catastrophic: if the start of new patients on treatment has to be suspended or delayed, then the lives of many in urgent need of drugs are at risk. For those already on treatment, the interruptions or lowering of the dosage will lead to treatment failure and a higher risk of developing drug-resistance. In recent months, disruptions have directly affected MSF's HIV programmes.

In South Africa , the government budget for health was cut due to the financial crisis and finding alternative funding seems difficult in the short term.

"All around us, clinics stop enrolling patients because there are just not enough ARV supplies," says Eric Goemaere, MSF Head of Mission in South Africa . "The waiting lists are growing by the day, risking that patient die before they start ARVs. It's unbelievable that a relatively well-functioning ARV programme has been allowed to be crippled in the space of just a few weeks. MSF will not be able to fill the gaps, and we seriously question why we should have to do so, in view of declared international commitments."

In Malawi , delays in funding disbursements from the Global Fund for AIDS, tuberculosis and malaria have already caused worrying shortages in ARV supplies. As a result, ARV stocks are running dangerously low in several health facilities. In order to avoid further ruptures the Ministry of Health, with the help of MSF and other NGOs, is currently re-distributing ARV supplies to different districts. MSF has also had to buy additional backup stocks, to ensure a steady supply for patients in its projects. For now, MSF is able to start new patients on treatment, but there is a real risk that this will have to slow down.

MSF teams in Uganda , the Democratic Republic of Congo, Zimbabwe , and Guinea are also seeing stock-outs and disruptions.

Disruptions are a result of a shortage of in-country funding and delays by donor governments in fulfilling their commitments. Major international funding institutions such as the Global Fund for AIDS, tuberculosis and malaria and PEPFAR face budget caps or uncertainty in the replenishment of funding. Supply management and procurement issues at country level compound the problem, as any delay in funding puts the supply chain in danger.

"MSF is extremely concerned about the lack of effective action from governments, their partners, and international donors in assuring the continued funding and supply of ARVs and other medical items for treatment," adds Meinie Nicolai, MSF Director of operations. "They are playing with fire. No ARVs means no HIV/AIDS treatment. Governments and donors must respond to funding and supply problems urgently and effectively."

Glaxo investing 60 mln pounds in AIDS drugs for Africa

Tuesday, July 14 12:23 pm

It has also agreed a new free voluntary licensing agreement for AIDS drug abacavir, or Ziagen, with South African generic drugmaker Aspen Pharmacare , in which it has a 16 percent stake. Aspen will manufacture a cheaper generic version of the drug.

The latest steps, announced by Glaxo Chief Executive Andrew Witty on a visit to Kenya , follow pressure from campaigners and some governments for drug companies to do more to get life-saving medicines to the poor, particularly in sub-Saharan Africa .

Glaxo took a lead in February by promising to place many of its patents on drugs for tropical diseases into a free "pool," but it stopped short of offering patents on medicines for HIV/AIDS, which it does not consider to be a neglected disease.

"Up until now I've not really seen the articulation of how a patent pool in this particular area (HIV/AIDS) would change things dramatically," Witty told reporters in conference call.

"The patent pool on neglected diseases was because there was really no research going on in that area -- HIV is not a neglected disease."

So far Glaxo is the only big drug company to have committed to pool some of drug patents, although it was joined in the initiative last week by U.S. biotech Alnylam Pharmaceuticals . Glaxo hopes others will follow suit. Its new investments will see up to 50 million pounds channelled into a fund to support non-governmental organisations working with pregnant women to prevent mother-to-child transmission of HIV.

A further 10 million pounds in seed funding will go to support public-private partnership work in developing AIDS medicines specifically for children.

(Reporting by Ben Hirschler; Editing by Greg Mahlich)


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