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News:
PIVOTAL STUDY FINDS THAT HIV MEDICATIONS ARE HIGHLY EFFECTIVE AS PROPHYALXIS AGAINST HIV INFECTION IN MEN AND WOMEN IN AFRICA
12th July 2011.
The PrEP trial among discordant couples that is being implemented by Kabwohe as one of the study sites has found that negative partners, who took certain ARVs daily, received up to 73% protection from infection from their partners. The study, known as the Partners PrEP Study, was coordinated by The International Clinical Research Centre, US and funded by the Bill & Melinda Gates Foundation. Below is the press release from the International Clinical Research Center:
Seattle, WA – In a result that will fundamentally change approaches to HIV prevention in Africa, an international study has demonstrated that individuals at high risk for HIV infection who took a daily tablet containing an HIV medication – either the antiretroviral medication tenofovir or tenofovir in combination with emtricitabine – experienced significantly fewer HIV infections than those who received a placebo pill. These findings are clear evidence that this new HIV prevention strategy, called pre-exposure prophylaxis (or PrEP), substantially reduces HIV infection risk.
The study is led by the University of Washington’s International Clinical Research Center and involves 4,758 HIV serodiscordant couples, in which one partner has HIV and the other does not, from nine research sites in Kenya and Uganda. “This study is the largest study to date looking at the effectiveness of PrEP,” said Dr. Connie Celum, a UW professor of global health and medicine and the principal investigator of the study, known as the Partners PrEP Study. The study is funded by the Bill & Melinda Gates Foundation.
“This study demonstrates that antiretrovirals are a highly potent and fundamental cornerstone for HIV prevention and should become an integral part of global efforts for HIV prevention,” said Celum.
Study results through May 31, 2011 were reviewed on July 10, 2011 by the Partners PrEP Study Data and Safety Monitoring Board (DSMB), an independent group of experts that monitored the study’s conduct, safety, and effect of PrEP on preventing HIV infections on an ongoing basis. Due to the strong HIV prevention effect seen, the DSMB recommended that the Partners PrEP Study results be made public and the placebo arm of the study be discontinued. The DSMB also recommended that the study continue: those receiving TDF and FTC/TDF PrEP will remain on those medications and those receiving placebo will start receiving TDF or FTC/TDF PrEP.
Through May 31, 2011, a total of 78 HIV infections occurred in the study: 18 among those assigned tenofovir (TDF), 13 among those assigned to tenofovir combined with emtricitabine (FTC/TDF), and 47 among those assigned placebo. Thus, those who received TDF had an average of 62% fewer HIV infections (95% CI 34 to 78%, p=0.0003) and those who received FTC/TDF had 73% fewer HIV infections (95% CI 49 to 85%, p<0.0001) than those who received placebo.
“This is an extremely exciting finding for the field of HIV prevention. Now, more than ever, the priority for HIV prevention research must be on how to deliver successful prevention strategies, like PrEP, to populations in greatest need,” said Dr. Jared Baeten, co-chair of the study and a UW associate professor of global health and medicine. “We are incredibly grateful to the investigators, participants, and communities for their dedication to this research and to HIV prevention. The level of investment and motivation from each of these groups was tremendous.”
TDF and FTC/TDF were statistically similar in their levels of protection against HIV and reduced HIV risk in both women and men. Importantly, PrEP was found to be safe: the rate of serious medical events was similar for those assigned to TDF, FTC/TDF, and placebo. Ten percent of women annually became pregnant during the study and they were discontinued from the study medication during pregnancy; pregnancy rates were similar across the three arms and there was no evidence that TDF or FTC/TDF was associated with pregnancy complications.
The study was designed to find out whether TDF or FTC/TDF would reduce the risk of acquiring HIV for persons who had an HIV infected sexual partner. Of the 4,758 couples enrolled in the study, one-third of the HIV uninfected partners were randomly allocated to receive TDF, onethird FTC/TDF, and one-third a matching placebo. The study was double-blinded, meaning that both study participants and the researchers who interacted with them did not know which treatment the participants were receiving. All study participants received a comprehensive package of HIV prevention services, which included intensive safer sex counseling (both individually and as a couple), HIV testing, free condoms, testing and treatment for sexually transmitted infections, and monitoring and care for HIV infection.
In the study, adherence to the daily PrEP medication was very high – more than 97% of dispensed doses of the study medications were taken. More than 95% of participants were retained in study follow-up.
The medications used in the Partners PrEP Study, TDF (300 mg) and combination FTC (200 mg) / TDF (300 mg), are marketed by Gilead Sciences, Inc. under the brand names Viread® and Truvada®. They are available generically in many countries at prices as low as approximately 25 cents (U.S.) per tablet. Gilead Sciences donated study medication for, but did not provide funding or otherwise participate in the design, implementation, or analysis of the
Partners PrEP Study.
HIV serodiscordant couples, where one partner has HIV and the other does not have HIV infection, are in urgent need of prevention strategies. In sub-Saharan Africa, a substantial fraction of new HIV infections occur among HIV serodiscordant couples. The Partners PrEP Study is the first to show that PrEP reduces HIV risk in heterosexual men and women; the results are critically important for Africa, where the majority of new HIV infections occur. Over the past year, studies of PrEP have suggested great promise for this emerging HIV prevention strategy, and important studies of TDF, FTC/TDF, and a vaginal microbicide gel containing tenofovir are ongoing. Results from the full panel of completed and ongoing studies of PrEP will together provide key information about the ultimate prevention benefits of PrEP in different populations.
Media contact:
Toni Maddox
(206) 520-3825 (office); (206) 399-2415 (mobile); tmaddox@uw.edu
Additional information about the Partners PrEP Study and about PrEP:
KCRC closes enrollment of participants into the Partners PrEP study with 531 Enrolled couples
3rd December 2010.
KCRC has today closed enrollment of participants into the partners PrEP Study after 2 years of recruitment. Among the 936 sero-discordant heterosexual couples screened for the study, 531 couples were enrolled at the Kabwohe study site.
The Partners PrEP study is a Phase III, multi-site, randomized, double-blind, placebo-controlled study of tenofovir and emtricitabine/tenofovir for pre-exposure prophylaxis (PrEP) to reduce HIV acquisition among HIV uninfected partners in HIV discordant couples. The objective of the study is to see whether having this medication in the bloodstream prevents the HIV uninfected partner from getting HIV. The study is also being conducted in seven other sites in Uganda and Kenya.
The site enrolled the first couple on 20th August 2008 and the 531 couples are to be followed up for two years. Study results are expected in 2013.
Visit International clinical Research Center (ICRC) for more information.
Daily pill reduces HIV among gay men by 44 pct, Study finds
23rd November 2010.
A landmark study across four continents has shown that a daily dose of an oral antiretroviral drug reduced the number of HIV infections among sexually active gay men by 44 percent, researchers said Tuesday.
Even higher rates of success toward preventing the virus that causes AIDS were shown among those who faithfully took the drug, said the study in the November 25 issue of the New England Journal of Medicine.
The findings were hailed by US President Barack Obama as well as leading AIDS experts as promising, even though a measure of caution remained over the limited scope of the study and the need for more methods of prevention.
Visit AVAC news artical for more information.
KCRC launches FrontlineSMS programs
23rd March 2009.
In order to report patient adherence, ask for medical advice, or request medical care for remote clients, Community Health Workers had to travel long distances to KCRC Clinic doors. In partnership with the Children's AIDS Fund, Josh Nesbit, a Senior in the Human Biology Program at Stanford University, traveled to Kabwohe with 200 recycled cell phones, a donated laptop and a copy of FrontlineSMS – a free computer program developed to act as a central text message hub. Over 8 weeks, a total of 200 CHWs were called to the Clinic, given cell phones, and trained in text messaging. Stationed at the clinic, a laptop running FrontlineSMS coordinates the health network's activities. The day-to-day program operations were handed over to clinic staff within two weeks. Over 200 Community Health Workers (CHWs) will be involved in the program at the clinic, which collectively serve 800,000 people in 29 subcounties and 2,304 villages. FrontlineSMS:Medic is a team committed to supporting community health workers in the developing world using appropriate mobile technology.
As a result of the this inexpensive, community-based SMS network, the clinic will be able to repond to requests for remote patient care, track distant patients, inform CHWs of proper drug dosages and uses, receive and record HIV and TB drug adherence reports, facilitate CHW-to-CHW communication and group mobilization, connect HIV-positive patients to support groups, and relay outreach HIV and CD4 testing schedules.
Dr. Zaramba Warns Parents On Food
27th January 2008
THE Director General of Health Services, Dr. Sam Zaramba, has warned parents in Bushenyi district against selling off most of the food produced, yet the children are not well fed.
He said a recent report indicated that 38% of children in the district were malnourished yet Bushenyi was endowed with abundant food.
"The majority of parents here are producing food for export. You need to first feed your children," Zaramba said.
He was commissioning an X-ray machine at Kabwohe Clinical Research Centre (KCRC) last week. The KCRC president and Sheema North MP, Dr. Elioda Tumwesigye, said the machine worth over sh100m was donated by Children's Aids Fund (CAF), a US-based charity.
He added that the machine would serve especially HIV/AIDS patients who have been going up to Mbarara district to get X-ray services.
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