Microbicide News

Fall-Winter News

GLOBAL:
"Group to Test Merck AIDS Drug in Gel"
Reuters , (03.11.2008) Maggie Fox
On Tuesday, the International Partnership for Microbicides (IPM) announced it has received permission to use Merck and Co.’s experimental HIV drug L’644 in testing as a potential vaginal microbicide. L’644 is a gp41 inhibitor that would block HIV from attaching to immune cells.

“It’s a completely different mechanism of action to what we have currently under development and what the field has under development,” said Dr. Zeda Rosenberg, IPM’s CEO. “It’s pretty early in the life cycle for HIV. Most of us feel that, for a microbicide to be really effective, it has to get at the infection in its earliest time points.”

While condoms can protect men and women, in many countries a woman who insists on condom use can face rejection or violence. In contrast, a woman could take it upon herself to use a microbicide gel or cream to prevent HIV infection. In sub-Saharan Africa, about 61 percent of adults with HIV are women, according to UNAIDS.

“L’644 is a peptide that would need to be injected to act as an effective antiviral,” said Dr. Daria Hazuda, vice president of scientific affairs for infectious disease at Merck Research Laboratories. “As such, it was not deemed to have a favorable profile for patient convenience.” Merck, therefore, is not developing L’644 as a drug to treat HIV.

IPM has agreements with other drug firms to develop microbicides, said Rosenberg. Other microbicide candidates include Merck’s L’167/CMPD167 compound, a CCR5 blocker; Pfizer’s CCR5 inhibitor maraviroc; Gilead Sciences’ tenofovir, in collaboration with Bristol-Myers Squibb; and Johnson & Johnson’s Tibotec Pharmaceutical’s dapivirine.

 

The 6-month study, conducted by the NIH's Microbicide Trials Network, included 200 women from India and the United States. There were no differences seen in adverse events between women using the tenofovir-based gel compared to women using a placebo. Adherence was approximately 80% and none of the women in the study became infected with HIV while using the tenofovir-based gel.

More information is available:

• MedlinePlus: Full Story
• AIDSinfo: Tenofovir drug fact sheet
• AIDSinfo: Investigational Microbicides
• AIDSinfo: Microbicide Health Topics
  

Group Releases Report on Rectal Microbicides
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=50738

Microbicides 2008: Third-generation microbicides might act as ‘bacterial vaccine’

Studies are underway of genetically engineering naturally-occurring vaginal bacteria to produce microbicides against HIV, and in one case such a strategy has already proved effective in preventing HIV infection in monkeys, the Microbicides 2008 Conference heard last week in Delhi. Read More >>

Microbicides 2008: Will adherence issues affect all the first-generation trials?

There are still two ongoing trials of the ‘first generation’ non-ARV-based microbicide candidates ongoing, and at the Microbicides 2008 Conference last week Sharon Hillier, Principal Investigator of the Microbicides Trial Network (MTN) gave delegates an update of data from these studies. Read More >>

Microbicides 2008: Cellulose sulphate has unexpected tissue toxicity

Investigations into the candidate microbicide cellulose sulphate (Ushercell) using the substance on vaginal tissue samples have revealed that it causes loss of tissue integrity by destroying proteins that bind cells together. This allows HIV to leak into the underlying tissues.
Read More >>

Microbicides 2008: Microbicides might benefit men more than women

An antiretroviral-containing microbicide could have some very paradoxical effects, according to epidemiologist Sally Blower, speaking at the Microbicides 2008 conference last week in Delhi. Read More >>

Microbicides 2008: the second generation is on its way

The next generation of microbicides designed to protect women against HIV infection will rely on maintaining a high level of an antiretroviral drug in the genital fluids and tissue rather than using a barrier gel, Sharon Hillier, Principal Investigator of the Microbicides Trials Network, told the Microbicides 2008 conference this week in Delhi.
Read More >>

Microbicides 2008: Accurate adherence reporting essential for microbicide trials

Researchers need much better ways of determining adherence to candidate microbicides in trials, and also of ways of determining sexual behaviour, the 2008 Microbicides Conference heard today in Delhi, India.
Read More >>

Microbicides 2008: First hint of efficacy in rectal microbicide trial, thanks to new biopsy assay

Preliminary, still blinded data presented to the 2008 Microbicides Conference in Delhi today offered a strong hint that a rectal microbicide gel containing a non-nucleoside HIV drug may prove to be effective at stopping infection in humans.
Read More >>

Experimental Microbicide Tenofovir Safe for Women To Use Daily, Study Finds
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=50597
 

UNITED STATES; INDIA:
"Tests of New AIDS Gel Show Promise for Women"
Reuters , (02.25.2008)
An experimental vaginal microbicide gel containing the AIDS drug tenofovir has proven safe and acceptable to women in Phase II trials, researchers told the Microbicides 2008 Conference in New Delhi on Monday.

Funded by the National Institutes of Health, the study involved 200 sexually active HIV-negative women in the United States and India. The study was designed to evaluate the gel’s safety, not its efficacy.

“The gel is safe to use and well-tolerated by HIV-negative women,” said Dr. Craig Hoesley of the University of Alabama-Birmingham. “This sets the stage for larger studies to see if tenofovir can prevent HIV infection.”

It is still uncertain how long tenofovir can stay active after it is applied as a vaginal microbicide, said lead investigator Sharon Hillier of the University of Pittsburgh School of Medicine. “Currently, there are very encouraging studies suggesting that even when tenofovir is gone from the vagina, the drug itself is there in the vaginal tissue,” she said.

“The important thing we learned is that covert use, or secret use, is not an important parameter for women, and that in fact we found that 12 percent of the women who used the gel said it made sex more pleasurable and none of the women said that the gel made sex less pleasurable,” said Hillier.

Among participants using the gel, 80 percent followed the experimental regimen.

“We asked women ‘How acceptable is this as a prevention option, is it too messy, is it a nuisance, and will you use it?’” Hoesley said. “Our study showed they will use it and they’re not bothered by the gel.”

“It is a critical time for all of us engaged in HIV prevention, and I truly believe we are turning a corner,” Hillier said.

 

Experimental Microbicide Carraguard Does Not Provide Protection Against HIV, Study Finds
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=50494

Pfizer To License Antiretroviral To IPM for Reformulation as Microbicide
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=50103

Mozambique Launches Initiative To Conduct Microbicide Research
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=49509

HIV Working Group Releases Report on Vaccine, Microbicide Research, Development
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=49219
 

VIRGINIA:
"Eastern Virginia Medical School Awarded $28.5 Million for AIDS Prevention Project"
Virginian-Pilot (Norfolk), (12.01.2007) Nancy Young
CONRAD, an Eastern Virginia Medical School (EVMS) program, has received a $28.5 million grant from the Bill & Melinda Gates Foundation to further its research into developing a microbicide gel to thwart HIV infection, school officials announced Friday.

Henry Gabelnick, the program's executive director, said a preventative topical gel is key since women are especially vulnerable to HIV through sexual activity. "It's clear that women are the majority of the new cases of HIV-positive people," he said. "If their partners won't use condoms, this gives women a product that they can use to protect themselves."

The five-year grant will go toward the development of microbicides that use antiretrovirals to interfere with HIV's replication, said Dr. Gustavo Doncel, director of preclinical research for CONRAD and an OB/GYN professor at EVMS.

"We're poised to deliver something that is significant in the area of HIV prevention," said Doncel.

While there are no microbicides currently on the market, some have made it to later stages of clinical trials. Developing one that is effective against HIV has been difficult, Doncel conceded. "The virus is much sneakier and cheekier than what we thought it would be," he said.
 

Gates Foundation Gives Group $28.5M for Microbicide Research, Officials Say
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=49188

Starpharma, SSL International To Produce Condoms With Microbicide VivaGel
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=48240

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