March 2008

[Etravirine showed sustained efficacy at 48 weeks in NNRTI-experienced patients with HIV]
[Premasticated food recognized as transmission route for HIV/AIDS]
[Microbicide candidate safe but ineffective against HIV transmission]
[NYC unveils new city brand condom and safe sex campaign]
[Newly-diagnosed cases of HIV/AIDS reach record high in Japan]
[Raltegravir associated with viral load suppression, increased CD4 cell counts]

Etravirine showed sustained efficacy at 48 weeks in NNRTI-experienced patients with HIV

Etravirine (Intelence, Tibotec) demonstrated efficacy for patients with HIV with nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance at 48 weeks, according to two new studies presented at the 15th Conference on Retroviruses and Opportunistic Infections, held recently in Boston.

The two phase-3 studies, which are ongoing, examined treatment with etravirine, previously known as TMC125, as part of a regimen also consisting of darunavir, NNRTIs, and optional enfuvirtide. In DUET-1, patients (n=612) were enrolled in Argentina, Brazil, Chile, Costa Rica, France, Mexico, Panama, Puerto Rico, Thailand and the United States and treated with etravirine or placebo. Sixty-percent of patients in the etravirine group achieved undetectable viral load of less than 50 copies/mL, compared with 39% of patients in the placebo group. The mean increase in CD4 cell counts from baseline was 103 cells/mm³ in the etravirine arm and 74 cells/mm³ in the placebo arm.

In DUET-2, a similar study was conducted in 591 patients in Australia, Belgium, Canada, France, Germany, Italy, the Netherlands, Poland, Portugal, Spain, the United Kingdom and the United States. Sixty-one percent of patients in the etravirine arm achieved undetectable viral loads; 41% of patients in the placebo arm did. The mean increase in CD4 cell count from baseline was 94 cells/mms³ in the etravirine arm vs. 72 cells/mm³ in the placebo arm.

Premasticated food recognized as transmission route for HIV/AIDS

The practice of offering premasticated food to weaning infants could be a transmission route for HIV/AIDS, according to data from a recent CDC study.

Three cases of possible HIV transmission through premasticated food from two United States cites were presented at the 15th Conference on Retroviruses and Opportunistic Infections, held recently in Boston. The study cases, which number only three in 10 years in the U.S., are the first to link premastication and HIV transmission.

An investigation to rule out alternative modes of transmission was conducted for all cases. A mother with HIV reported premasticating food for her 4-month old child. By 9 months of age, the child had contracted HIV. Two other cases, both in Miami, involved caregivers with HIV providing premasticated food for infants who later tested positive for HIV. In both of these cases, the caregivers reported having bleeding gums while masticating food for infants. Officials said blood, not saliva, was the transmission route in those cases.

Two of the three cases provided compelling evidence linking premastication to HIV transmission to infants. Officials noted the global impact of these findings because premastication practices are more common in developing nations where pre-packaged infant foods are not always readily available.

Microbicide candidate safe but ineffective against HIV transmission

Results from the phase-3 trial of microbicide candidate Carraguard found the product safe but ineffective in preventing male-to-female HIV transmission during vaginal intercourse, according to a press release from Population Council.

Carraguard is a key component of next-generation microbicide candidates being developed by Population Council, a non-profit organization based in New York City. According to information from Population Council, the risk of HIV infection was 3.3 per 100 woman years among women who used Carraguard. In comparison, the rate was 3.7 per woman years among women who used a placebo. The difference was not statistically significant.

Carraguard is the first product developed as a microbicide to complete the final phase of testing.

“We are disappointed that this trial did not show Carraguard to be effective; nonetheless the completion of the trial is a milestone in HIV prevention research,” said Peter J. Donaldson, PhD, president of Population Council. “The trial has contributed significantly to the field’s body of knowledge regarding product development, trial design and women’s and their partners’ willingness to use a vaginal gel consistently.

Data from the trial will be used by Population Council and other research organizations to improve future products and trials, Donaldson added.

“We have always known that the path to developing a successful microbicide would be a ongoing one,” said Jeff Spieler, PhD, senior science advisor in population and health at NIAID. “The Population Council has done groundbreaking work in completing this trial, even though we are terribly disappointed that the product was not shown to be effective.”

The Carraguard trial began in March 2004 and ended in March 2007. The trial enrolled 6,202 women from three sites in South Africa. Half of women enrolled in the study were given Carraguard gel and condoms while the other half received placebo gel and condoms.

No safety-related differences were found between women using Carraguard and women using placebo in the randomized, double-blind study.

Carraguard is made of carrageenan, a seaweed derivative. Initial laboratory research showed Carraguard effective in blocking cells from HIV. Other research showed Carraguard protected mice from sexually transmitted diseases. The trial was funded by USAID and the Bill and Melinda Gates Foundation.

NYC unveils new city brand condom and safe sex campaign

The New York City Department of Health and Mental Hygiene unveiled its new NYC Condom on Feb. 13. The launch of the city’s latest safe sex campaign, “get some,” coincided with the introduction of the new condom.

Teams handed out condoms at New York City’s busiest commuter areas on Feb. 14. The campaign features a new condom wrapper design and a new dispenser, which is available in more than 200 city venues, according to a New York City Department of Health and Mental Hygiene press release. The condom wrapper and dispensers were styled by designer Yves Behar.

“Good design can help bring condoms out of the closet,” Behar said. “The brand’s friendly design and the dispenser’s approachable shape convey openness and acceptance.”

New ads for the condoms, set to hip hop, jazz and Latin music, will air in English and Spanish on television and radio. Display ads are also featured on more than 1,000 subway cars, telephone kiosks and in check cashing outlets citywide.

“The NYC Condom has shown us what a sexy brand can do for safer sex,” said Monica Sweeney, MD, Assistant Commissioner for HIV Prevention for the NYC Health Department. “We gave out more than 36 million of them last year and I hope the fresh look will help even more New Yorkers protect themselves from infection and unintended pregnancy in 2008.”

Last year, the first city brand condom, which featured a subway theme, was introduced on Valentine’s Day. The latest changes are in wrapper design only. The same lubricated Lifestyles latex condom is used in this year’s campaign.

Newly-diagnosed cases of HIV/AIDS reach record high in Japan

The number of newly-diagnosed HIV cases in Japan reached a record high of 1,048 in 2007, according to data released by the Japanese government AIDS Surveillance Committee on Feb. 12.

There were also 4,000 newly-diagnosed AIDS patients in 2007. Last year was the first time newly-diagnosed HIV cases were higher than 1,000 cases. The number of newly-diagnosed HIV/AIDS cases represent a trend of greater HIV acquisition in Japan. The record is its fifth consecutive record high.

Data showed that 1,336 of HIV/AIDS cases diagnosed in 2007 were in men. In the report, 849 people acquired HIV were men who have sex with men and 367 cases were categorized as acquired through heterosexual contact. Six people acquired HIV through injection drug use. Most of the newly-diagnosed patients with HIV were aged 30 years or more; 348 people were aged 20 years or more, 568 people were aged 30 years or more, and 292 were aged 40 years or more.

One AIDS Surveillance Committee member said that the number of people in Japan with HIV/AIDS is growing, but attributed the sharp increase in newly-diagnosed patients in part to the greater number of people getting tested.

Raltegravir associated with viral load suppression, increased CD4 cell counts

Raltegravir (Isentress, Merck), taken in combination with other anti-HIV medicines, helped to maintain significant HIV viral load suppression and increased CD4 cell counts through 48 weeks, according to data presented at the 15th Conference on Retroviruses and Opportunistic Infections, held recently in Boston.

Raltegravir, used in combination with other antiretroviral therapy for treatment-experienced patients with HIV, was recommended for accelerated approval by the FDA in September 2007.

The latest data are based on double-blind, placebo-controlled, randomized trials that enrolled treatment-experienced patients (n=699) who had failed antiretroviral therapies.

Patients were given raltegravir at a dose of 400 mg or placebo twice daily, in combination with optimized background therapy.

In one of these studies, BENCHMRK-1, 74% of the patients treated with raltegravir and optimized background therapy maintained suppression of HIV RNA levels below 400 copies/mL.

In comparison, 36% of patients treated with placebo and optimized background therapy achieved this.

In the companion study, BENCHMRK-2, raltegravir plus optimized background therapy was associated with suppressed viral loads below 400 copies/mL in 71% of patients, compared with 38% of patients in the placebo arm.