U.S. health officials urge use of HIV pill for at-risk individuals

CHICAGO Wed May 14, 2014 7:11pm EDT

(Reuters) - U.S. health officials on Wednesday issued new recommendations urging healthcare workers to consider offering an HIV prevention pill to healthy individuals who are at substantial risk for HIV infection.

The guidelines, issued by the U.S. Centers for Disease Control and Prevention and the U.S. Public Health Service, involve the use of pre-exposure prophylaxis or PrEP, a strategy in which at-risk individuals take a daily dose of an antiretroviral drug to reduce their risk of HIV infection.

The strategy builds on a landmark 2010 study that found Gilead Sciences Inc's Truvada - a pill already widely used to treat the human immunodeficiency virus - was more than 90 percent effective at preventing HIV infections among test subjects who took the drug as prescribed.

According to the new guidelines, healthcare providers should consider PrEP for anyone who meets specific risk criteria, such as being in a relationship with an HIV-infected partner or having sex without condoms with partners known to be at risk for HIV, such as injecting drug users.

The guidelines offer the first comprehensive guidance from the CDC, replacing interim guidance that emerged after studies showed PrEP to be effective in different patient populations.

The CDC now estimates as many as 275,000 uninfected gay men and 140,000 heterosexual couples, in which one partner is HIV-infected, could benefit from PrEP.

Some 1.2 million people in the United States live with HIV, and new infections are estimated at 50,000 each year.

(Reporting by Julie Steenhuysen; Editing by Tom Brown)

Source

Sexual behaviour of heterosexual men and women receiving antiretroviral pre-exposure prophylaxis for HIV prevention: a longitudinal analysis

The Lancet Infectious Diseases, Early Online Publication, 17 October 2013

doi:10.1016/S1473-3099(13)70226-3 Cite or Link Using DOI

This article can be found in the following collections: Infectious Diseases (HIV/AIDS)

Copyright © 2013 Elsevier Ltd All rights reserved.

Original Text

Kenneth K Mugwanya MBChB a b, Deborah Donnell PhD c d, Prof Connie Celum MD a d e, Katherine K Thomas MS d, Patrick Ndase MBChB d, Nelly Mugo MBChB d f g, Prof Elly Katabira MBChB h, Kenneth Ngure PhD d g i, Dr Jared M Baeten MD a d e, for the Partners PrEP Study Team†

Summary

Background

Scarce data are available to assess sexual behaviour of individuals using antiretroviral pre-exposure prophylaxis for HIV prevention. Increased sexual risk taking by individuals using effective HIV prevention strategies, like pre-exposure prophylaxis, could offset the benefits of HIV prevention. We studied whether the use of pre-exposure prophylaxis in HIV-uninfected men and women in HIV-serodiscordant couples was associated with increased sexual risk behaviour.

Methods

We undertook a longitudinal analysis of data from the Partners PrEP Study, a double-blind, randomised, placebo-controlled trial of daily oral pre-exposure prophylaxis among HIV-uninfected partners of heterosexual HIV-serodiscordant couples (n=3163, ≥18 years of age). Efficacy for HIV prevention was publicly reported in July 2011, and participants continued monthly follow-up thereafter. We used regression analyses to compare the frequency of sex—unprotected by a condom—during the 12 months after compared with the 12 months before July 2011, to assess whether knowledge of pre-exposure prophylaxis efficacy for HIV prevention caused increased sexual risk behaviour.

Results

We analysed 56 132 person-months from 3024 HIV-uninfected individuals (64% male). The average frequency of unprotected sex with the HIV-infected study partner was 59 per 100 person-months before unmasking versus 53 after unmasking; we recorded no immediate change (p=0·66) or change over time (p=0·25) after July, 2011. We identified a significant increase in unprotected sex with outside partners after July, 2011, but the effect was small (average of 6·8 unprotected sex acts per year vs 6·2 acts in a predicted counterfactual scenario had patients remained masked, p=0·04). Compared with before July, 2011, we noted no significant increase in incident sexually transmitted infections or pregnancy after July, 2011.

Interpretation

Pre-exposure prophylaxis, provided as part of a comprehensive prevention package, might not result in substantial changes in risk-taking sexual behaviour by heterosexual couples.

Funding

The Bill & Melinda Gates Foundation and the US National Institute of Mental Health.

Source

Experts address ethical issues raised by FDA's approval of Truvada for HIV prevention

Published on August 1, 2013 at 2:36 AM

The Food and Drug Administration's approval last year of the drug Truvada for prevention of HIV infection was a milestone in the fight against HIV/AIDS, but experts are cautioning that it is only the beginning of new ethical concerns for health care professionals, policy makers, researchers and those taking Truvada to prevent HIV infection.

"For the first time, we will have a large number of individuals who are not infected with HIV taking medication for HIV, which introduces ethical concerns of well-being and justice," says Jeremy Sugarman, Deputy Director for Medicine at the Johns Hopkins Berman Institute of Bioethics. He and Kenneth Mayer, the director of HIV prevention research at Beth Israel Deaconess Medical Center, advocate for ethical issues to be considered along with medical data in the Journal of Acquired Immune Deficiency Syndromes.

Sugarman and Mayer argue it is ethically critical to ensure that use of an antiretroviral drug like Truvada for "pre-exposure prophylaxis"(PrEP) does not have the ironic consequence of making individuals and communities less safe and healthy. Inconsistent, rather than daily, use of PrEP could result in HIV transmission and the evolution of drug-resistant strain of HIV, the authors warn. Likewise, misunderstanding of PrEP's prevention capacity could lead to the spread of other sexually transmitted infections.

"Communication and careful monitoring by health care professionals is essential for PrEP to be successful," says Sugarman. "Reinforcing the importance of daily dosing, incorporating safer sex counseling and frequent HIV testing will help meet the moral imperative that HIV be prevented and not exacerbated by PrEP," he says. He and Mayer recommend training programs for health care professionals that include explicit consideration of PrEP's ethical issues and their management.

Additionally, Sugarman and Mayer highlight what they say are 'critical, unanswered questions' of access and allocation. When limited antiretroviral drugs are available, should prevention be prioritized over treatment for those already infected with HIV, or vice-versa? Is a clinic environment the best setting to provide necessary counseling as part of PrEP? These questions, as well as how much PrEP should cost and who should pay for it, need to be answered as PrEP continues to be used and evaluated, the authors say.

"The fundamental moral claim for using PrEP, or any other HIV prevention strategy, is decreasing the burden of new HIV infections," Sugarman says. "For PrEP's full promise and medicine's moral obligations to be fulfilled, these complex ethical issues must be monitored along with the performance of PrEP."

Source: Johns Hopkins Medicine

Source

Antiretroviral Treatment IS Prevention

Medscape HIV/AIDS

Benjamin Young, MD, PhD

Jun 14, 2013

It is well established that antiretroviral treatment (ART) can prevent HIV/AIDS-related morbidity and mortality in HIV-infected individuals. Published in 2011, the landmark HPTN 052 study confirmed that ART (and an undetectable plasma viral load) can virtually eliminate the risk for transmission of HIV to sexual partners.^[1] These and other advances in our understanding of how the use of ART can work to prevent new HIV infection are changing the lexicon of HIV medicine.

The notion of treatment as prevention (TasP) is now firmly established in language of World Health Organization and US Department of Health and Human Services treatment guidelines as components of counseling and testing of serodiscordant couples. Indeed, expansion of access to treatment and earlier initiation of treatment can even be viewed not only as a strategy to reduce the burden of HIV disease, but also as a way to reduce new HIV infections in some resource-limited settings,^[2] although much additional research and debate is needed to ascertain the feasibility and challenges of scaling up this approach worldwide at the level of communities or nations.

Giving medications to HIV-uninfected individuals to reduce risk for infection dates to the earliest days of ART, when postexposure prophylaxis strategies were introduced. Several recent reports, including the iPrEx study,^[3] demonstrated the feasibility of preexposure prophylaxis (PrEP), or the use of ART to prevent HIV infection before exposure in at-risk individuals. Together, these data led to approval by the US Food and Drug Administration of oral tenofovir/emtricitabine for PrEP and the release of interim guidance on PrEP by the Centers for Disease Control and Prevention.^[4]

However, enthusiasm for PrEP has been tempered by appreciation of the critical role of adherence to PrEP. Two large studies -- FEM-PrEP and VOICE -- were halted early because of lack of efficacy, at least in part driven by suboptimal adherence to medication.^[5] Many other investigations continue into strategies to address these limitations, such as alternative dosing strategies and newer medications with long half-lives.

Appreciating the rapid pace of investigations into these issues, in 2012 the International Association of Providers of AIDS Care (IAPAC) convened an international summit in London to review the scientific literature and to bring together global thought leaders for the purpose of generating discussion and clarifying areas of consensus and controversy.

The Consensus Statement of the summit, published in the current issue of the Journal of the International Association of Providers of AIDS Care, summarizes of the state of the science from the perspective of a diverse panel of experts representing healthcare providers, researchers, policy-makers, pharmaceutical companies, governmental and nongovernmental agencies, and advocacy groups.^[6]

The advisory committee concluded that the current evidence for TasP's effectiveness justifies ART use in persons who wish to start treatment early. However, the committee noted that additional research is needed to evaluate the effectiveness and cost-effectiveness of TasP, particularly at the national level, and that effective deployment of TasP requires efforts to scale up HIV testing and improving the cascade of engagement in HIV care.

In addition, the advisory committee acknowledged the considerable challenges for the implementation of successful PrEP programs, including financial constraints, the need to identify and reach at-risk populations, and the importance of training a cadre of healthcare providers in this new discipline. Nevertheless, the committee agreed that the current evidence on the effectiveness and safety of daily oral PrEP supports its use in high-risk groups. The committee also recommended that PrEP be part of a comprehensive risk-reduction package and that safety monitoring and adherence counseling are required.

In short, antiretroviral treatment is prevention. For persons already infected with HIV, ART prevents disease progression and death; for those recently exposed to HIV and for those at risk for HIV infection, postexposure prophylaxis and PrEP can prevent the establishment of infection. At its best, ART can reduce the burden of the HIV/AIDS epidemic and perhaps portend the beginning of an AIDS-free generation. There will be tremendous additional challenges in finding the political will to accomplish this goal and in defining an optimal way forward.

I look forward to seeing how much further the community has traveled down this pathway when we reconvene at the second International Summit on Controlling the HIV Epidemic with Antiretrovirals, in London, in September 2013.

References

Source

CDC Updates HIV Preexposure Prophylaxis Guidelines

Medscape Medical News

Troy Brown

Jun 12, 2013

The Centers for Disease Control and Prevention (CDC) has updated its recommendations on the use of preexposure prophylaxis (PrEP) in individuals at high risk of acquiring HIV to include its use in injection drug users (IDUs) as well as those with high-risk sexual behaviors, the agency announced today.

The recommendations follow the results of a clinical trial, published online June 12 in the Lancet, that showed that a daily oral dose of 300 mg of tenofovir disoproxil fumarate (TDF) is effective at reducing HIV infection acquisition among injection drug users.

On July 16, the US Food and Drug Administration approved the use of a fixed-dose combination of TDF 300 mg and emtricitabine (FTC) 200 mg (Truvada, Gilead Sciences) for the indication of PrEP against sexual transmission of HIV by men who have sex with men (MSM) and heterosexually active women and men. The recommendations were based on the results of clinical trials in MSM and heterosexually active men and women. Those trials did not evaluate the use of PrEP among IDUs.

On the basis of the trial results published today, the CDC recommends that PrEP be considered as one of several prevention options for persons at very high risk for HIV acquisition through the injection of illicit drugs.

Reported injection practices that place persons at very high risk for HIV acquisition include sharing of injection equipment, injecting 1 or more times a day, and injection of cocaine or methamphetamine.

PrEP Recommendation for Injection Drug Users

Daily TDF/FTC is the preferred PrEP regimen for IDUs for the following reasons:

• TDF/FTC contains the same dose of TDF (300 mg) that has been shown to be effective for IDUs,
• TDF/FTC demonstrated no additional toxicities when compared with TDF only in PrEP trials that studied both regimens,
• IDUs are at risk for sexual exposure to HIV for which TDF/FTC is indicated, and
• TDF/FTC is approved for PrEP to prevent sexual HIV transmission in the United States.

The use of TDF/FTC for prevention of HIV transmission in those without sexual acquisition risk is at present an off-label use. The CDC recommends providing services for IDUs that include PrEP as well as measures aimed at decreasing injection and risky sexual behaviors.

In all individuals, PrEP use:

• is contraindicated in those with positive or unknown HIV status or with an estimated creatinine clearance lower than 60 mL/minute,
• should be focused on adults at very high risk for HIV acquisition,
• should be given as part of comprehensive prevention services, and
• should be given with quarterly monitoring of HIV status, pregnancy status, adverse effects, medication adherence, and risk behaviors, as directed in previous interim guidance.

Adherence to daily PrEP is vital to decrease HIV infection risk, and achieving high adherence was challenging for many participants in PrEP clinical trials.

"Providing PrEP to IDUs at very high risk for HIV acquisition could contribute to the reduction of HIV incidence in the United States," the CDC notes in the statement. "In addition, if PrEP delivery is integrated with prevention and clinical care for the additional health concerns faced by IDUs (e.g., hepatitis B and C infection, abscesses, and overdose), substance abuse treatment and behavioral health care, and social services, PrEP will contribute additional benefits to a population with multiple life-threatening physical, mental, and social health challenges."

The CDC is collaborating with other federal agencies to prepare comprehensive US Public Health Service guidelines on PrEP use with MSM, heterosexually active men and women, and IDUs. Those guidelines are scheduled for release later this year.

The complete updated interim guidelines IDUs can be found here on the CDC Web site.

Source

Also See: Daily Pill Cuts HIV Risk in IV Drug Users

Daily Pill Cuts HIV Risk in IV Drug Users

By Michael Smith, North American Correspondent, MedPage Today

Published: June 12, 2013

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Action Points

• Tenofovir (Viread) once a day can prevent HIV transmission among injection drug users.
• Note that the study suggests that pre-exposure prophylaxis should be considered as an additional prevention method, along with such things as needle exchanges, promotion of safer sex and injecting practices, and counseling

(Viread) once a day can prevent HIV transmission among injection drug users, researchers reported.

In a randomized, phase III trial, daily tenofovir reduced the risk of HIV by nearly half, compared with placebo, in a cohort of injection drugs users in Bangkok, according to Michael Martin, MD, of the CDC, and colleagues.

The study is the latest to show that so-called pre-exposure prophylaxis (PrEP) can protect people at high risk for HIV from infection, Martin and colleagues reported online in The Lancet.

Previous research has shown that tenofovir PrEP -- either alone or in combination with emtricitabine (Emtriva) -- can reduce the risk of infection in men who have sex with men, in heterosexual men and women, and in heterosexual couples where one partner has HIV and the other does not.

"This study completes the picture of PrEP efficacy for all major HIV risk groups," Martin said in a statement. "We now know that pre-exposure prophylaxis can be a potentially vital option for HIV prevention in people at very high risk for infection, whether through sexual transmission or injecting drug use."

But an outside expert cautioned that the study does not show clearly that PrEP prevents HIV transmission caused by sharing needles.

There's "no biological marker" that can distinguish between HIV acquired through sex and HIV transmitted by needles, noted Salim Abdool Karim, MBChB, PhD, of the University of KwaZulu-Natal in Durban, South Africa.

It's likely that at least some of the observed efficacy was due to reduced sexual transmission, he argued in an accompanying commentary piece.

Nonetheless, Karim concluded, "the overall result is that daily tenofovir does reduce HIV transmission in injecting drug users" and PrEP should be considered as an additional prevention method, along with such things as needle exchanges, promotion of safer sex and injecting practices, and counseling.

The researchers enrolled 2,413 volunteers -- ages 20 through 60, HIV-negative, and reporting injecting drugs within the previous 12 months -- from 17 drug-treatment clinics in Bangkok.

Study participants were randomly assigned on a one-to-one basis to either tenofovir or placebo and followed for an average of 4 years. They were offered condoms and methadone treatment and got monthly HIV testing, combined with risk-reduction and adherence counseling and blood safety tests every 3 months.

Two participants had HIV at enrollment (both in the placebo group) and 50 became infected during follow-up.

Of those, 17 were in the tenofovir arm, for an incidence of 0.35 per 100 person-years, and 33 were in the placebo group, for an incidence of 0.68 per 100 person-years.

Those rates yielded a 48.9% reduction in HIV incidence among those taking the drug, which was significant at P=0.01.

The drug was safe and well tolerated, the researchers reported, with only two significant differences in adverse events: 8% of those getting tenofovir reported nausea and or vomiting, compared with 5% in the placebo arm, which was significant at P=0.002.

And 53% of tenofovir volunteers had grade 1 or 2 elevations in alanine aminotransferase, compared with 49% of those getting placebo, which was significant at P=0.003.

As in previous PrEP trials, adherence was an important factor in efficacy, Martin and colleagues noted.

For instance, in a case-control substudy among participants in the tenofovir arm, the risk of HIV infection was reduced 70% for those in whom tenofovir was found, compared with participants without detectable tenofovir in their blood, the researchers reported.

"These results underscore the importance of helping people using pre-exposure prophylaxis achieve effective levels of adherence," Martin said.

The study had support from the CDC and the Bangkok Metropolitan Administration. One author reported financial links with Gilead. but all other authors, including Martin, said they had no conflicts, according to the journal.

Abdool Karim was the co-principal investigator of the CAPRISA 004 tenofovir gel trial, and is a co-inventor on two pending patents of tenofovir gel against HSV-1 and HSV-2 with scientists from Gilead Sciences, according to the journal.

Primary source: The Lancet
Source reference:
Choopanya K, et al "Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial" Lancet 2013; DOI: 10.1016/S0140-6736(13)61127-7.

Additional source: The Lancet
Source reference:
Abdool Karim SS "HIV pre-exposure prophylaxis in injecting drug users" Lancet 2013; DOI: 10.1016/S0140-6736(13)61140-X.

Source

Widespread Ignorance of Medication That Prevents HIV

Fran Lowry

Jun 10, 2013

Many teens and young adults at high risk for HIV in Washington, DC, would be willing to take pre-exposure prophylaxis every day to prevent infection, if only they were aware that such a thing existed.

In a study conducted to ascertain knowledge, acceptability, and willingness to use prophylaxis in sexually active at-risk people, only 10% said they had ever heard of it.

And when they learned that medication could protect them from HIV infection, most said they would take it, if offered by their healthcare provider.

The findings were presented at the 8th International Conference on HIV Treatment and Prevention Adherence in Miami, Florida. The meeting was jointly sponsored by the International Association of Physicians in AIDS Care, the National Institute of Mental Health, and the Post Graduate Institute for Medicine.

"As our study showed, there is very limited knowledge of pre-exposure prophylaxis overall," lead investigator Amanda Castel, MD, MPH, from George Washington University in DC, told Medscape Medical News. "There is a definite and urgent need for a lot of education and social marketing if pre-exposure prophylaxis is going to be an effective HIV prevention intervention."

In the past 18 months, several studies have shown that the option is an effective method of reducing HIV incidence in a variety of populations, including men who have sex with men, heterosexuals, and serodiscordant couples, where one person is negative for HIV and the other is positive.

Some ongoing trials are focusing on adolescents and young adults, but not many are looking at whether youth are even interested in pre-exposure prophylaxis or willing to take it, Dr. Castel said.

To find out, she and her colleagues surveyed 293 patients attending a clinic for sexually transmitted infections, a community-based general clinic for gay men, and a general adolescent health clinic at Children's National Medical Center in Washington, DC.

“The prevalence of HIV in Washington is higher than anywhere in Russia.”

All participants were HIV-negative and had had sex in the previous 6 months. Participants 13 to 24 years of age accounted for 45% of the cohort and those 25 years and older accounted for 55%.

"We were able to get waivers of parental consent so that we could include participants younger than 18," Dr. Castel noted.

The participants completed their surveys using iPads. "It takes away some of the interviewer bias because we were asking sensitive questions about sexual behaviors, condom use, that kind of thing," she said.

Just 31 participants had previously heard of pre-exposure prophylaxis, 9 of whom were in the younger age group.

Significantly more people in the older group than in the younger group reported that they were more likely to use the medication if it had few or no adverse effects (78% vs 62%; P = .02).

In addition, more older than younger participants reported that they would take medication if it were offered by their healthcare provider (70.6% vs 62.4%; P = .02) and would be able to follow a provider's instructions (76.9% vs 67.7%; P = .03).

Also, significantly more of the older group would prefer to take it after sex than as a daily medication (32% vs 20%; P = .004).

Finally, 64.7% of youth reported they would consider participating in future studies.

"Overall, there is very limited knowledge about pre-exposure prophylaxis and potentially poor adherence. Those things may pose pretty distinct barriers to implementation in this population," Dr. Castel said.

She conceded that taking medication every day for a condition that you don't have is difficult and requires strong motivation and organizational skills.

"A provider might have a patient who fits the high-risk-for-HIV profile, but that person might be terrible at adherence, so may not be a good candidate for pre-exposure prophylaxis, which requires taking it on a daily basis. In that situation, perhaps another prevention intervention, like encouraging condom use, could be tried," she said.

Injections of a long-acting antiretroviral might also be particularly useful for teens and young adults, she suggested.

Medscape Medical News asked Benjamin Young, MD, vice-president and chief medical officer of the International Association of Providers of AIDS Care in Washington, DC, to comment on the study. "This is a really interesting paper because we know from a number of large studies that pre-exposure prophylaxis can work in people who are at risk and who can be adherent to medication."

The study is particularly relevant in a place like Washington, DC, which has the highest prevalence of HIV in the United States, if not the world, Dr. Young added.

"I used to work part time in Russia, and the Russian Ministry of Health used to point out that the prevalence of HIV in Washington is higher than anywhere in Russia and approaches the prevalence in certain capital cities in East Africa. The United States takes on enormous efforts and spends all this money around the world, yet here in Washington, rates are super high, especially among young gay men and young gay men of color."

"I thought it was a travesty that Barrack Obama didn't walk the 3 or 4 blocks from the White House to the convention center during the AIDS conference last summer. It wasn't that he was tied up doing important state business or was out of the country. He was in the White House at the time and the flag was flying during the conference. That was particularly poignant if not outrageous to me, and I'm a supporter," Dr. Young said.

The failure on the part of President Obama to attend the AIDS conference highlights the problems that lead to such a high HIV prevalence in the nation's capital, he added.

"State-level programs work on prevention, but Washington, DC, because it doesn't have a state government but a somewhat dysfunctional city government and doesn't have adequate representation in congress, is forgotten," he said. "The AIDS epidemic is probably just one symptom of this. The study by Dr. Castel's team speaks to this problem. That is why it is important."

Dr. Young said he agrees that much more awareness about pre-exposure prophylaxis is needed.

"The amazing thing is that 90% of at-risk people didn't even know that it exists. It's probably the same nationwide; I don't think this is unique to Washington. But the study shows that people would use pre-exposure prophylaxis if they knew about it and could get it," he noted.

Dr. Castel reports no relevant financial relationships. Dr. Young is an employee of the International Association of Providers of AIDS Care and reports financial relationships with Bristol-Myers Squibb, GlaxoSmithKline, Merck & Co, ViiV Healthcare.

8th International Conference on HIV Treatment and Prevention Adherence. Presented June 3, 2013.

Source

AHF Advocacy Against Gilead’s Truvada as HIV Prevention Yields Stronger FDA Drug Warning Label

October 11, 2012 09:52 PM Eastern Daylight Time

New warning label is welcomed by AIDS advocates who were astounded by recommendation by an FDA Advisory Panel earlier this year to allow Gilead to market use of its blockbuster AIDS treatment as a form of HIV prevention in uninfected individuals without any HIV testing requirement whatsoever

AHF and other advocates strenuously opposed use of the AIDS treatment as a form of HIV prevention pill, concerned about efficacy, medication adherence issues among uninfected high-risk populations; ‘Black box warning’ label on Truvada for prevention now recommends HIV testing every three months

WASHINGTON--(BUSINESS WIRE)--AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, welcomed the news today the boxed warning label (also called the ‘black box warning’) on Gilead Sciences’ blockbuster AIDS treatment Truvada for use as a form of an HIV prevention pill appears much stronger than proposed versions of the label earlier this year. The new warning label is being welcomed by AIDS advocates from AHF and other organizations who were astounded by a recommendation by a Food and Drug Administration (FDA) Advisory Panel to allow Gilead to market use of Truvada as a form of HIV prevention in uninfected individuals, particularly when the panel—comprised of 23 physicians, scientists and members of the general public—also recommended that the FDA allow Gilead to market the drug for such use without any requirement for HIV testing whatsoever.

“From the beginning, AHF and many other advocates strenuously opposed use of this well-established AIDS treatment as a form of an HIV prevention pill, concerned about both the efficacy of the treatment as well as medication adherence issues among uninfected high-risk populations,” said Michael Weinstein, President of AIDS Healthcare Foundation. “It is difficult for many of those who are already infected with HIV to properly comply with daily drug regimens. Expecting uninfected people to remember to take a drug every day for a disease that they don’t have is an even more daunting challenge. At least now the ‘black box warning’ label on Truvada for prevention recommends HIV testing every three months. It is good to see that the FDA and Gilead have finally come to this realization. I believe it was in part because of our advocacy over the past year opposing the drug for this use that this warning label is now stronger.”

The FDA Advisory Panel took place in May in Silver Spring, MD, at FDA headquarters. Nearly 30 advocates from AHF and other groups spoke against use of the drug for HIV prevention to the panel, which nevertheless indicated it would give preliminary approval to Gilead for use as HIV prevention.

Later in the summer, at the ‘Controlling the HIV Epidemic with ARVs’Summit, held in London June 11-12, a Gilead official publicly disclosed in a plenary session in which he was participating that use of its blockbuster AIDS treatment Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to prevent possible HIV infection would have labeling indicating that a negative HIV test will be required before a prescription.

Following is what the Truvada packaging and printed drug warning inserts now state regarding use of the drug for pre-exposure prophylaxis (PrEP) for HIV prevention:

For PrEP:

"When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must:

• prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection [See Warnings and Precautions (5.9)];
• counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials [See Warnings and Precautions (5.9)];
• confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. [See Warnings and Precautions (5.9)]; and
• screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP."

About AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 176,000 individuals in 27 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

Source

New Website Sets the Record Straight on Groundbreaking HIV Prevention Strategy Known as PrEP

SAN FRANCISCO, Sept. 17, 2012 /PRNewswire-USNewswire/-- Getting reliable, easy-to-understand information about a groundbreaking new HIV prevention strategy just got easier. The strategy, known as pre-exposure prophylaxis (PrEP), is the focus of a new website, PrEPfacts.org, developed by San Francisco AIDS Foundation in collaboration with the San Francisco Department of Public Health (SFDPH), National Institute of Allergy and Infectious Diseases, and other community partners.

"Ever since PrEP first emerged as a viable and effective strategy to prevent new HIV infections, we have seen a lot of misinformation about it," said Neil Giuliano, CEO of San Francisco AIDS Foundation. "So we set out to create a website that delivers all the facts, in a way that's engaging and interactive, so that gay and bisexual men and transwomen in our community have the best possible information to determine if PrEP might be a valuable tool in their lives."

In July, the U.S. Food and Drug Administration approved the drug Truvada for PrEP. It is for use by HIV-negative individuals at risk for infection as part of a comprehensive prevention package that includes regular condom use, HIV testing, and risk reduction and adherence counseling.

"Right now in San Francisco, we are launching the first demonstration project to determine how best to implement PrEP in different communities," said Dr. Albert Liu, Director of HIV Prevention Intervention Studies at SFDPH. "This new website, PrEPfacts.org, is an important resource to provide our community with accurate, timely, and relevant information about this new HIV prevention strategy."

PrEPfacts.org boldly states that "love may have a new defender" in the fight against HIV/AIDS. The site gives an overview of PrEP, answers commonly asked questions and dispels many of the myths about the strategy, provides information about the upcoming demonstration project in San Francisco, and looks ahead to other HIV prevention interventions that are on the horizon.

The website is a collaboration between San Francisco AIDS Foundation; Project Inform; San Francisco HIV Vaccine Trials Network and HIV Prevention Trials Network; Bridge HIV; Magnet, a program of San Francisco AIDS Foundation which is leading demonstration project recruitment efforts in the Castro neighborhood; and San Francisco City Clinic, which is enrolling participants for the demonstration study. The website is sponsored and funded by Be The Generation, an initiative of National Institute of Allergy and Infectious Diseases.

For more information, visit www.PrEPfacts.org.

About San Francisco AIDS Foundation
No city experienced epidemic levels of HIV faster than San Francisco. At San Francisco AIDS Foundation, we work to end the epidemic where it first took hold, and eventually everywhere. Established in 1982, our mission is the radical reduction of new infections in San Francisco. Through education, advocacy, and direct services for prevention and care, we are confronting HIV in communities most vulnerable to the disease. We refuse to accept that HIV transmission is inevitable. For more information, visit www.sfaf.org.

Contact: Ryan McKeel
(415) 487-3071
rmckeel@sfaf.org

SOURCE San Francisco AIDS Foundation

RELATED LINKS
http://www.PrEPfacts.org

Source

Analysis: Use of pill to prevent HIV may be limited in U.S

September 07, 2012|Deena Beasley | Reuters

LOS ANGELES (Reuters) - The first preventive pill for HIV has been hailed as a landmark in the fight against AIDS in the United States, but experts say only a small percentage of those at risk will benefit from it.

U.S. health regulators last month approved Gilead Sciences Inc's Truvada -- already used globally to treat the human immunodeficiency virus -- for preventing the infection in healthy people at high risk of contracting the virus that causes AIDS.

A number of factors will limit the drug's use for preventing HIV, including the fact that in the United States many people most at risk of infection, as well as their sexual partners, do not have consistent access to healthcare. Even for those with coverage, insurance reimbursement for a $14,000-a-year drug is expected to be tricky.

In addition, therapy with the drug would require otherwise healthy young people to take a pill each day, plus show up for HIV testing every three months.

"There are a number of rather significant implementation challenges," said Dr. Stephen Morin, director of the Center for AIDS Prevention Studies at the University of California at San Francisco. "Part of it has to do with the requirement to take a pill a day, which could be addressed by a more long-term administration of the drug."

Scientists are exploring a variety of tactics for using AIDS drug formulations to prevent HIV infection, including long-acting injections, gels and vaginal rings.

About 50,000 new HIV infections are reported each year in the United States. The number of patients taking Truvada to prevent HIV will likely be "a lot less" than that, said Howard Jaffe, head of the Gilead Foundation and a member of the company's senior management since 1991.

Gilead declined to give its own sales estimate.

"We are not expecting a meaningful increase or uptick in Truvada use from it," Jaffe said, referring to the FDA prevention approval. "We do expect it to enter into the conversation with regard to certain high-risk populations."

He said use of Truvada to prevent HIV infection will likely be most important outside of the United States, as developing countries where AIDS remains an epidemic look for additional ways to curb transmission of the virus.

Gilead has deals, mainly with generic drugmakers in India, to produce low-cost versions of its drugs for use in sub-Saharan Africa and other developing regions.

Dr. Paul Volberding, director of the Center for AIDS Research at the University of California at San Francisco, says Truvada could become a valuable tool for "a small fraction of people" who understand they have a high risk of exposure -- mainly female sex workers whose clients won't use condoms and gay men who decide they are going to engage in riskier sex.

"There is an easy consensus now that somebody that is on treatment and fully suppressed has either zero, or close to it, risk of transmitting the virus," Volberding said.

He and others emphasized that wider testing for HIV -- and treatment of already infected patients -- are the keys to reducing HIV incidence.

Of the 1.2 million Americans estimated to be infected with human immunodeficiency virus, almost 20 percent of them do not know it, according to the U.S. Centers for Disease Control and Prevention .

A recent study by the CDC found that 41 percent of U.S. HIV patients are under continual care of a doctor and just 28 percent had the viral infection under control.

PREVENTION THROUGH PREP

The U.S. Food and Drug Administration in July approved Truvada for adults who do not have the virus but may engage in sexual activity with HIV-infected partners, a concept known as pre-exposure prophylaxis (PrEP). The approval was for use in combination with safer sex practices, such as condoms.

The drug, which combines two anti-HIV drugs in one pill, was already approved for use with other antiretroviral agents to treat patients 12 and older who are infected with the virus. Antiretrovirals are designed to block various steps in replication of the virus.

Critics, including the AIDS Healthcare Foundation, a non-profit provider of HIV/AIDS medical care, argue that Truvada was shown to be only partially effective in preventing HIV transmission, can cause side effects including kidney problems and may cause healthy people to become resistant to it.

No U.S. public money has been allocated for treating uninsured individuals who do not already have AIDS, and some doctors question the degree to which insured patients would be covered.

"I would find it very difficult for there to be a provision to support funding for such a program when we have (HIV-positive) patients on waiting lists," said Murray Penner, deputy executive director at the National Alliance of State and Territorial AIDS Directors, which represents public-health departments.

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FDA Decision Delayed for Truvada in HIV PrEP

From Medscape Medical News

Emma Hitt, PhD

June 11, 2012 — The US Food and Drug Administration (FDA) has delayed its decision on allowing the use of tenofovir disoproxil fumarate/emtricitabine (Truvada, Gilead) as preexposure prophylaxis (PrEP) so that the proposed risk evaluation and mitigation strategy (REMS) can be reviewed.

In early May, the FDA's Antiviral Drugs Advisory Committee strongly backed approval of the first-ever drug for the prevention of sexually acquired HIV-1 infection.

However, concerns by the panel at the time included that people may neglect condom use if they feel they are protected by PrEP. Panelists were also concerned that uninfected people taking PrEP who become infected with HIV may not switch to a 3-drug regimen as recommended.

According to the company, the FDA has postponed the target date to September 14 so it can review Gilead's REMS plan to help ensure that patients will not misuse the drug.

The committee's recommendation for supplemental approval of tenofovir/emtricitabine for PrEP is based on the findings of 3 large randomized controlled clinical trials in men who have sex with men and transgender women (iPrEx) and in heterosexual men and women (Partners PrEP and TDF2).

The drug's efficacy was highest in people who adhered to daily dosing (about 10% of participants), and overall, PrEP resulted in a 44% to nearly an 80% reduction in risk of contracting HIV, depending on the level of adherence and drug availability.

After the PrEP trial results came out, the US Centers for Disease Control and Prevention (CDC) developed interim guidance in January 2011 for physicians electing to provide PrEP for HIV prevention among men who have sex with men.

At this time, the CDC recommends that PrEP be used only men who have sex with men. In addition, to minimize the risk for drug resistance, PrEP should not be started in persons with signs or symptoms of acute viral infection unless HIV-negative status is confirmed by HIV RNA testing or a repeat antibody test is performed after the viral syndrome resolves.

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A Potential Game Changer in the Fight Against HIV/AIDS

Sean Cahill Director of Health Policy Research, The Fenway Institute

Posted: 05/09/2012 4:11 pm

Imagine what it would mean to have a medication that would make it harder for HIV to enter a person's body. Tomorrow, May 10, may lead to just such a turning point in the fight against HIV/AIDS. On this date the U.S. Food and Drug Administration will review a supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate (FTC-TDF) to reduce the risk of acquiring HIV in men and women by pre-exposure prophylaxis (PrEP), offered as part of a comprehensive HIV-prevention package including risk reduction counseling.

Before Westerners go to some African countries, they take malarial drugs as a preventive strategy. PrEP works much the same way: HIV treatment medications are taken to make it harder for HIV to enter the body.

PrEP has shown efficacy with men who have sex with men (MSM) and heterosexual women and men. Biomedical prevention interventions such as PrEP have great potential, especially if coupled with traditional prevention approaches such as condom use, expanded testing, and linkage to treatment and care. Modeling demonstrates the most effective deployment of PrEP will be in combination with scaled-up HIV treatment of people who are known to be HIV-positive, as this was shown to reduce infections.

The FDA's Antiviral Drugs Advisory Committee will consider and vote on whether to recommend approving FTC-TDF for PrEP with MSM, serodiscordant couples, and others at risk of HIV through sexual activity. The FDA is expected to issue a final decision in mid-June.

We are hopeful that the full dossier of submitted PrEP research, based on multiple clinical trials with a number of different populations vulnerable to HIV, can lead to a responsible regulatory and marketing plan that allows for safe use in the populations that may benefit most from this innovative development. If the FDA approves the additional indication of the use of tenofovir-emtricitabine for PrEP, health programs and individuals will have improved choices to address one of the administration's domestic health priorities, and save lives.

Some have raised concerns about PrEP related to potential side effects, risk compensation (the idea that people will stop using condoms if PrEP becomes available), and drug resistance. However, reviews of five major clinical trials involving about 6,000 participants by the Forum for Collaborative HIV Research found no greater risk of side effects, no risk compensation, and no clinically significant development of drug resistance in participants.

Recent press coverage has emphasized the cost of FTC-TDF. Last year the Centers for Disease Control and Prevention estimated the medications would cost $8,030 per person per year. While the cost of PrEP in the U.S. would be substantial, private insurers and state Medicaid departments are open to providing coverage. Low-cost generic medications could enable access in low-income countries. The prioritization of highly vulnerable populations could increase the cost-effectiveness of PrEP. Providing PrEP is also much less expensive than treating someone for HIV over the course of a lifetime. Recent modeling of PrEP implementation coupled with scaled-up treatment (focusing on MSM in San Francisco, the general adult population in Botswana, and serodiscordant couples in South Africa) predicts that PrEP could significantly reduce HIV incidence and prevalence, saving health care costs and lost economic productivity.

We therefore urge the FDA to approve the application of Gilead Sciences Inc.'s supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate for reducing the risk of acquiring HIV by means of pre-exposure prophylaxis (PrEP) offered as part of a comprehensive prevention package including risk reduction counseling.

We believe that if the FDA looks closely at the science, it will see the merit of allowing PrEP to be added to our toolkit to prevent HIV infections. We must deploy new tools to prevent new infections, which are affecting 50,000 Americans each year and more than 2 million people worldwide, most in Africa. PrEP combined with sustained behavioral interventions and medical care to maintain adherence could help us finally begin to turn the tide with this virus.

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