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Taking Truvada and need for practicing safer sex (TRUVADA PrEP, 2010)
Dec 10, 2010

I am HIV-. If I decide to take Truvada to lessen my chances of getting the virus from HIV+ partners, do I need to use condoms or will taking the medication be enough.

Response from Dr. Frascino

Hi,

Condoms remain absolutely essential. Truvada does "lessen" the risk of HIV transmission, but it certainly doesn't completely eliminate it. See below. Condoms also provide protection from a variety of other STDs as well.

Dr. Bob

Statement by Project Inform

A study showing that a daily pill reduces HIV risk in gay men is reason for great hope. US agencies should waste no time in assessing the ability of Pre-Exposure Prophylaxis to slow the HIV/AIDS epidemic Background

Data released today from the iPrEx study concluding that the daily use of an HIV antiretroviral medication can prevent new cases of HIV among gay and bisexual men and trans females represents the most promising development in HIV/AIDS since the introduction of triple combination drug therapy in 1996. iPrEx evaluated the safety and efficacy of Truvada, a single pill combining two drugs, tenofovir (TDF) and emtricitabine (FTC) as part of a study package that included counseling to continue condom use, medication adherence counseling, regular HIV testing and monitoring of side effects. 2,499 participants came from the United States (San Francisco and Boston), Peru, Ecuador, Brazil, South Africa and. Trial subjects were at high risk for HIV infection based on self-reports of multiple sex partners, engagement in unsafe sex, history of sexually transmitted infections and high rates of alcohol use. Thirty-four infections occurred among participants in the drug arm of iPrEx and sixty-six in participants in the placebo arm. Researchers calculated that, overall, TDF/FTC cut new HIV infections by 43.8 percent compared to placebo (95% CI 15.462.6%; p = 0.005). Adjusted for participants who adhered to medication 50 percent of the time or more, overall efficacy was 50.2 percent (95% CI 17.969.7%; p = 0.006). Importantly, increased adherence to TDF/FTC improved efficacy as well. Overall, participants reported increased condom use and decreased sexual partners. Some side effects, notably nausea, were experienced by participants receiving medication, but there were no major adverse events. Drug resistance did not occur among those who seroconverted and were quickly switched to triple combination treatment. But long-term safety of TDF/FTC among HIV-negative individuals and drug resistance merit additional study. A compete report of iPrEx findings can be seen at www.nejm.com. Project Inform wants to thank and congratulate the 2,500 altruistic individuals who participated in the iPrEx trial, the researchers who conducted it, and the agencies that provided funding. The world is deeply indebted to each and every one of them for their contribution to controlling HIV/AIDS. More than 20,000 men and women around the world are currently participating in additional PrEP efficacy trials, including heterosexual couples with one HIV-infected partner, women at high risk of HIV infection and injection drug users. These trials will provide much needed answers for how PrEP might work in different populations, against different routes of HIV transmission and in different geographic and cultural contexts. Additional PrEP trials testing efficacy of different drugs and less than daily dosing are also needed. (More information about ongoing PrEP trials is available at www.avac.org/prep.) Project Inform's advice to the community about PrEP use As promising as the iPrEx results are, Project Inform strongly urges gay and bisexual men and trans females not to attempt PrEP on their own. We strongly discourage HIV-negative people from acquiring Truvada from HIV-positive people for PrEP, thus threatening the health of both individuals. We stress that iPrEx data are based on taking TDF/FTC daily along with participation in behavioral counseling, condom use, medication adherence counseling and clinical monitoring. There are no data whatsoever to suggest that using PrEP episodically or around the time of sex is at all effective. HIV-negative gay and bisexual men and trans females at high risk for infection wishing to consider initiating PrEP at this time should only do so in consultation with and under supervision of a qualified physician. Conversely, physicians seeing individuals known to them to be at high risk for HIV infection should only offer PrEP if they can do it as part of the package of services described above. At the current time, insurance companies are unlikely to pay for Truvada for PrEP, the cost of which may be as high as $14,400 per year in the US. Public health care programs will not currently pay for Truvada for PrEP, and significant advocacy will be required to assure payment for this preventive intervention if and when it is fully implemented. Project Inform will be actively involved in that advocacy. PrEP's potential, and that of HIV antiretrovirals, in slowing the spread of HIV Gay and bisexual men continue to be severely and disproportionately impacted by the HIV/AIDS epidemic in the United States, accounting for 53 percent of the 56,300 new HIV infections each year. The rate of new HIV diagnoses among gay and bisexual men is more than 44 times that of other men. Most new HIV infections among black and Latino gay and bisexual men occur in those aged 1329. PrEP therefore represents a long-awaited and extremely exciting opportunity to reduce the impact of HIV in this hard-hit community. Project Inform eagerly awaits data from trials of PrEP in women, particularly women of color, who are also in great need of a prevention intervention that gives them the ability to prevent infections if their partners will not use condoms. We also eagerly await the results of trials with injection drug users. Promising indicators of the role of ARVs in prevention place the world at a significant crossroads in the HIV/AIDS epidemic. Data show that individuals effectively treated for HIV are less likely to transmit the virus to their sex or injection drug using partners. ( www.projectinform.org/pdf/tlc_caps.pdf) The CAPRISA study concluded that a vaginal gel containing the HIV antiretroviral TDF (tenofovir) prevented 39 percent of infections in a study of African women. ( www.projectinform.org/news/2010/081310.shtml) Studies of a rectal microbicide for use in women and gay and bisexual men are also underway. With the release of iPrEx, the world has the opportunity, if advocates and policy makers seize upon it, to achieve progress against the epidemic unimaginable only a few years ago. This is particularly true for developing nations, where the cost of ARVs is substantially lower than in developed nations (as little as .40 per day). Although the world must proceed cautiously and thoughtfully in further assessing the effectiveness of ARV-based prevention, we must not delay. Urgent Next Steps for PrEP Based on the extremely hopeful iPrEx data, Project Inform believes that the US Centers for Disease Control & Prevention and National Institutes of Health should immediately move to fund demonstration projects that establish optimal strategies for delivering PrEP outside of existing clinical trials, including strategies for supporting maximum adherence to the PrEP regimen, the effectiveness of its delivery in real world settings, cost and cost-effectivness of this intervention. Gilead, its manufacturer, should pursue FDA approval for the use of Truvada for prevention, and discussions need to begin to make its use affordable. We also hope that the results of iPrEx and CAPRISA ignite a movement among HIV-negative individuals demanding the delivery of effective and affordable biomedical prevention interventions. Concerns about PrEP and Project Inform's view of those issues We understand that there will be substantial concerns about PrEP in the US: The cost of this intervention is potentially high, including the cost of Truvada, regular HIV testing and monitoring for side-effects, and counseling to encourage adherence to the drug and to ongoing condom or sterile syringe use. In developed nations, PrEP may only be shown to be cost-effective in individuals at highest risk for HIV infection. But just as we have fought to make sure that ARVs are available to HIV-positive people despite their high cost, we should fight for the protection of HIV-negative people despite the cost of PrEP. Many HIV-positive people will be concerned that the cost of ARVs are part of PrEP threatens access to HIV treatment, particularly through the AIDS Drug Assistance Program. By law, ADAP cannot pay for medications for HIV-negative individuals and no HIV agency is likely to advocate that it should. Project Inform does not believe that HIV care and treatment funding should be pitted against HIV prevention funding. Both must be adequately financed. We believe that a key way to protect access to care and treatment for people who are currently HIV-positive is to prevent more people from becoming infected in the first place. Many will be concerned that only those who can afford PrEP will have access to it, exacerbating already serious disparities in the epidemic. Project Inform believes that all people have a right to remain HIV-negative. If and when PrEP is ready for widespread implementation, we will advocate for its delivery to those groups epidemiology shows are most affected by HIV, as well as for equal access for individuals of all incomes, with an emphasis on low-income individuals. Many will be concerned that PrEP threatens resources for behavioral prevention interventions. We believe that PrEP must be only one of a set of prevention interventions available to HIV-negative people, including behavioral counseling, mental health and substance abuse counseling, condoms, sterile syringes, microbicides, and vaccines. We also believe, however, that limited prevention funding should be directed to those interventions proven to be the most effective. Many will be concerned that PrEP may result in a further deterioration in rates of condom and sterile syringe use by HIV-negative people. Thus far, studies do not show that "behavioral disinhibition" results from PrEP. But this possible effect has to be carefully studied and responded to so that it does not render this new intervention useless, or even counter-productive. However, due to its cost and intensity as a prevention intervention, it is critical that the gay male community continue to encourage condom use as the first line of defense against HIV, with PrEP being a strategy for high risk men. Finally, many will oppose PrEP, even if proven to be capable of slowing the epidemic, believing that it encourages irresponsible risk-taking. Similar arguments were intense in the early years of availability of the birth control pill. The idea that a lifesaving prevention intervention should be denied to people is not without precedent, but it is immoral and unethical. It flies in the face of fiscal responsibility, as the cost of preventing a case of HIV, even if PrEP is costly, greatly outstrips the cost of a lifetime of HIV care and treatment. Additionally, federal, state and local budgets support without question huge costs for the prevention of many health conditions affecting the general public, including hypertension and heart disease. Declining to pay for PrEP, or any other effective form of biomedical HIV prevention, would be transparently hateful and discriminatory. Additional Information on PrEP On November 30, Project Inform will release a document prepared with advocacy partners further discussing thoughts and recommendations about the issues involved in implementing PrEP. That document will be available at www.projectinform.org. Additional resources regarding iPrEx and PrEP are available at www.globaliprex.net; www.preparesf.org; and www.avac.org.

Truvada cuts HIV risk significantly in S.F. study Erin Allday, Chronicle Staff Writer Tuesday, November 23, 2010

Gay and bisexual men who took a daily anti-retroviral drug significantly reduced their risk of contracting HIV, according to a study from San Francisco's Gladstone Institutes that public health officials are declaring a major breakthrough in the long struggle to slow down the global AIDS epidemic.

The study, published in today's edition of the New England Journal of Medicine, followed 2,499 men in six countries - including 120 men in San Francisco - with half of them taking the drug Truvada and half taking a placebo. Among the group taking Truvada, which is used to treat people who are HIV-positive, 36 men contracted HIV, compared with 64 men in the placebo group - amounting to a 44 percent reduction in cases.

The drug was meant to be taken daily, but men in both groups often skipped doses. Among men who took the drug at least 90 percent of the time, the group taking Truvada had 78 percent fewer cases of HIV infection.

In other words, when people actually take the drug, it seems to do a very good job of preventing infection, researchers said Monday.

"This is a major advance," said Dr. Robert Grant, a UCSF professor and a researcher with the Gladstone Institute for Virology and Immunology and the lead investigator of the clinical trial. "It will only work if people use it consistently, and the real challenge is how do you use it consistently. Condoms are still our first line of defense, but this could potentially be a very good backup."

eal-world practice

How this study will translate into real-world prevention is the next big question for public health officials, some of whom hailed the study results as the most promising news in HIV/AIDS research in a decade or more.

Several recent studies have revealed some promising new tools toward preventing HIV infection- including circumcision and a gel that, when applied vaginally, offered some protection from infection. And condoms are still the best choice for preventing any sexually transmitted disease.

But with HIV infection still spreading rapidly around the world, and with a vaccine to prevent AIDS proving elusive, public health officials said a drug that appears to be safe and effective is cause for celebration.

"It's an extremely exciting study. The results are very promising," said Dr. Grant Colfax, director of HIV prevention at the San Francisco Department of Public Health. "We need to figure out now if the groundbreaking findings in the study can be used effectively at the community level."

In some developing countries where HIV infections are so widespread that they've become a major burden on the economy and the health care system, a preventive drug would be especially welcome, researchers said. They noted, however, that there could be controversy over whether limited AIDS dollars should go toward prevention or toward treatment of those who are already sick.

Researchers are not recommending that Truvada immediately be used for prevention, and it will probably be at least a year or two before it could be offered widely to people trying to protect themselves.

ocal efforts

Public health officials and representatives from Bay Area HIV/AIDS nonprofits will be meeting right away - starting this morning in San Francisco - to discuss how the trial results might affect local prevention efforts.

"Clearly we need to know more about this therapy, and its effectiveness and how to deliver it, but it appears to have great promise," said Dan Van Gorder, executive director of Project Inform in San Francisco. "I think the world is at a real crossroads in terms of its ability to drive this epidemic to an end."

Truvada is a single tablet that combines the drugs emtricitabine and tenofovir disoproxil fumarate. It is made by Gilead Sciences in Foster City and has been used for HIV therapy since 2002.

There are major questions hanging over the study results, researchers and public health officials said. The study looked only at men who have sex with men, and a small number of transgender women, so it would be premature to apply results to women and heterosexual men. All of the study participants were at high risk for contracting HIV.

Cost would be a major concern when considering Truvada for prevention. The drug costs about $750 to $1,000 a month when used to treat HIV infection in the United States, although a generic version is available overseas that costs about 40 cents a day.

onitoring safety

Drug safety is also something that will need to be monitored closely over time. Side effects from taking Truvada were mostly mild and included headache and nausea, both of which faded after a few weeks, researchers said. Because Truvada has been in use to treat people with HIV infection for almost 10 years, researchers said that at least so far there appear to be no long-term complications from taking the drug, but it's too soon to say for sure.

Perhaps the most critical question for public health officials to consider is adherence. If the drug is to be most effective, people need to take it every day - something that was a struggle in the clinical trial.

Researchers said it is possible that participants didn't feel compelled to take the drug daily because they knew they could be taking a placebo, and they knew that Truvada was untested as a preventive tool. Next year, the study will make Truvada available to all participants, including the placebo group, and researchers hope to find out if people are more likely to take the drug daily if they know more about it.

"This is really just the first exciting step forward," said Dr. Susan Buchbinder, director of HIV research for the San Francisco Department of Public Health. "We are going to be getting more data from this study and other studies that's going to inform how we can expand on this first positive signal.

"We have more than one new infection every day here in San Francisco," she said. "That's a problem that we still have these infections. We need more tools."



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