Truvada approved to reduce the risk of sexually transmitted HIV in people who are not infected with the virus.
16th July 2012. Source: Food and Drug Administration
On July 16, 2012, the Food and Drug Administration approved Truvada (a fixed dose combination of emtricitabine/tenofovir disoproxil fumarate) to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.Truvada is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. Truvada is the first drug approved for this indication.
Truvada for PrEP is meant to be used as part of a comprehensive HIV prevention plan that includes risk reduction counseling consistent and correct condom use, regular HIV testing, and screening for and treatment of other sexually-transmitted infections. Truvada is not a substitute for safer sex practices
FDA previously approved Truvada (August, 2004) to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.
As part of PrEP, HIV-uninfected individuals who are at high risk will need to take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. Again, PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.
As a part of this action, FDA is strengthening Truvada’s Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use to reduce the risk of development of resistant HIV-1 variants. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status.
Truvada for PrEP is being approved with a Risk Evaluation and Mitigation Strategy (REMS). The central component of this REMS is a prescriber training and education program to assist prescribers in counseling and managing individuals who are taking or considering Truvada for PrEP. The training and education program will not restrict distribution of Truvada but will provide information about the important elements of a comprehensive HIV prevention strategy, the importance of adhering to the recommended daily dosing regimen, the serious risks of taking Truvada for PrEP if already infected with the virus or becoming infected with HIV while taking Truvada for the PrEP indication.
“The REMS for Truvada for the PrEP indication is aimed at educating health care professionals and uninfected individuals to help ensure its safe use for this indication without placing an unnecessary burden on health care professionals and patients who use Truvada for treating HIV infection.
Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials. The iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection, such as inconsistent or no condom use during sex with a partner of positive or unknown HIV status, a high number of sex partners, and exchange of sex for commodities. Results showed Truvada was effective in reducing the risk of HIV infection by 42 percent compared with placebo in this population. Efficacy was strongly correlated with drug adherence in this trial.
The Partners PrEP trial was conducted in 4,758 heterosexual couples where one partner was HIV-infected and the other was not (serodiscordant couples). The trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner. Results showed Truvada reduced the risk of becoming infected by 75 percent compared with placebo.
No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported with Truvada include diarrhea, nausea, abdominal pain, headache, and weight loss. Serious adverse events in general, as well as those specifically related to kidney or bone toxicity, were uncommon.
As a condition of approval, Truvada’s manufacturer, Gilead Sciences, Inc., is required to collect viral isolates from individuals who acquire HIV while taking Truvada and evaluate these isolates for the presence of resistance. Additionally, the company is required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada for PrEP and to conduct a trial to evaluate levels of drug adherence and their relationship to adverse events, risk of seroconversion, and resistance development in seroconverters. Gilead has committed to provide national drug utilization data in order to better characterize individuals who utilize Truvada for a PrEP indication and to develop an adherence questionnaire that will assist prescribers in identifying individuals at risk for low compliance.
FDA approves new home-use HIV test.
03rd July 2012. Source: Los Angeles Times
The first over-the-counter HIV test would allow people to get preliminary results within 30 minutes.
WASHINGTON — The Food and Drug Administration approved the first over-the-counter HIV test Tuesday, allowing people to test themselves in private at home and get preliminary results in less than 30 minutes.
"Knowing your status is an important factor in the effort to prevent the spread of HIV," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."
The test, manufactured by OraSure, already had been approved for medical clinics. The new at-home test, called OraQuick, will be sold in supermarkets and pharmacies beginning in October.
Tests for the human immunodeficiency virus, which causes AIDS, have become increasingly simpler and quicker to use since their introduction in the 1980s. In 2002, the FDA approved the first on-the-spot tests for clinics. In 2005, the FDA began exploring the possibility of approving a home test.
The FDA emphasized that any results from a self-administered test, which works by detecting antibodies in a swab from the gums, should not be considered final. In trials, the test failed to detect HIV in 1 in every 12 patients known to be infected, and returned false positives in 1 in 5,000 cases. Anyone receiving a positive result should follow up with a medical provider, the agency said.
In May, an FDA advisory panel unanimously recommended that the test be approved, saying the benefits outweighed the risks. One concern has been that people who learn that they are infected may not have immediate access to counseling or support.
The agency said it hoped the new tests would reach people who were not getting tested, which, in turn, could lead to early treatment and reduce the transmission rate of the virus.
Previously, the FDA approved an HIV home test, but the samples had to be sent to a laboratory for analysis.
The federal Centers for Disease Control and Prevention estimates that of the 1.2 million people in the U.S. with HIV, 1 in 5 is not aware of the infection. And it says that a disproportionate number of the 50,000 new cases of HIV each year is linked to people who have not been tested.
OraSure has not said how much the test will cost, only that it will be more than the $18 cost for the professional kit.
Kevin Frost, chief executive of the Acquired Immune Deficiency Syndrome research group amfAR, said although he thought home testing was a good idea, a high price tag could put it beyond the reach of those who needed it most.
"If the people who go out and pay for this test end up being sorority girls who had a one-night stand and worry if they're infected, that's not going to be a net positive," he said.
Doug Michels, president of OraSure, acknowledged that pricing was a "fine balance," but said his company's product was not designed to replace other options.
Chip Lewis, a spokesman for Whitman-Walker Health, which provides AIDS care in Washington, said at-home testing could reach some people who didn't want to go to a clinic. But removing medical professionals from the process could cause problems, he said.
"It's not like a home pregnancy test," he said. "You need really a lot of information about how to read the test, how to use the test properly."
Michels said OraSure's research showed that the vast majority of people receiving a positive result said they would seek medical advice. The FDA also required OraSure to run a call center to support users of the test. Michels said trained counselors would answer the calls.
FDA panel recommends approval of drug to prevent HIV infection
11th May 2012. Source: CNN.
For the first time in the 30-year battle against the HIV epidemic, a panel of experts has recommended that the Food and Drug Administration approve a drug to give to healthy people to protect against the infection.
The committee voted 19-3 in favor of approval for the prevention indication -- PrEP for HIV-uninfected men who have sex with men and 19-2 with one abstention for HIV-uninfected partners in couples where the other partner is infected. The committee recommended by 12-8 with two abstentions in favor of approving the drug for individuals who engage in risky sexual behavior that could result in their contracting the virus.
Truvada, manufactured by Gilead Sciences, Inc., is a once-a-day pill used in combination with other HIV drugs. The nucleoside reverse transcriptase inhibitor does not rid the body of HIV. Instead, it prevents the virus from replicating in the body.
The FDA doesn't have to follow the recommendations of its advisory committees, but it often does.
Most of the more than 40 health care professionals, AIDS advocates and patients who addressed the committee implored its members not to recommend the drug for the new indication.
"There is no question that, if efforts on using PrEP is widespread, condom use and other means of preventing HIV infection will decrease," said Robert Elliott, a registered nurse. "At this point we simply don't know enough about how to increase adherence rates to work with the PrEP or how to counteract the risk compensation and the use of PrEP. Until then, PrEP is not and cannot be considered safe and effective for preventing HIV infections."
AIDS Activist Miki Jackson agreed. "A recommendation for the use of Truvada as PrEP is akin to issuing an engraved invitation for lawsuits," she said. "To knowingly recommend a drug as powerful as Truvada with such serious serious side effects and given to people who are perfectly healthy is frightening."
Michael Weinstein, president and founder of the AIDS Healthcare Foundation, said he was concerned that approval could lead a decrease in condom use. "Approving PrEP would be a reckless act," he said.
The FDA panel looked at safety and efficacy data from three clinical trials:
Committee members also heard concerns about the drug's side effects, which can include nausea, vomiting, dizziness, loss of appetite and diarrhea, liver and kidney toxicity and loss of bone density.
- iPrEx, a study of men who have sex with men, found 43.8% fewer infections in men who got the drug versus those who got placebo;
- in a Truvada study carried out by the Centers for Disease Control and Prevention in Botswana, infection rates were reduced by 63% overall in healthy men and women considered to be at high risk of infection;
- the University of Washington's Partners PrEP study of serodiscordant couples in Uganda and Kenya, of which KCRC was one of the sites saw 62% fewer infections in those taking Truvada and a 73% reduction in those who took a combination of Truvada and the HIV drug tenofovir.
But, after assessing the data, they concluded that Truvada is safe for men and women and effective in preventing infection.
And they had supporters. "What we need currently is additional tools for our powerful tool box," said Dr. Richard Elion, director of clinical research at the Whitman Walker Clinic in Washington. "We are not winning the battle. Please, were asking today to allow a modality that's still being developed to be added to our toolbox."
Kirk Myers, founder and CEO of Abounding Prosperity Inc., made a plea on behalf of African-Americans. "People need to be given the option to choose," said Myers, who is HIV-positive. "This drug is wanted. Another tool we can use. The right thing to do. Without this option, desperation will continue to drive up statistics of new incidents."
Chris Collins, vice president and director of public policy for the American Foundation for AIDS Research, said the data on the drug's prophylactic use were compelling and urged the committee not to limit access to it. "We need new tools to fight this epidemic that include treatment, condoms and education," Collins said. "PrEP is certainly not for everyone, but it may have a role in bringing HIV-infection rates down. It's time to learn how PrEP may be useful in the real world."
According to Dr. Peter S. Miele, a medical officer in the agency's Center for Drug Evaluation and Research, Truvada's safety and efficacy for the prevention of HIV-1 infection in high-risk individuals is supported by two large clinical trials. "Regular HIV testing, adherence and behavioral counseling on safer sex practices, including condom use, are essential components of healthcare delivery around PrEP," he said.
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.
(206) 520-3825 (office); (206) 399-2415 (mobile); firstname.lastname@example.org
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.