From 'What if' to 'What Now': Implementing the New Prevention Technologies

Via AIDSMap, by Gus Cairns.

Two consecutive sessions at the sixth International AIDS Society conference in Rome yesterday were devoted, now we have convincing scientific data on the benefits of treatment as prevention and PrEP, to putting these new prevention methods into practice.

“We have moved from ‘What if?’ to ‘What now?’” was the comment of Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC), on what else we need to know, what barriers need to be addressed , and what resources might be required, to maximise the promise of antiretroviral-based prevention.

Anthony Fauci, Director of the US National Institute of Allergies and Infectious Diseases (NIAID), said: “We now have a solid scientific foundation to say that even in the absence of a vaccine we have the capacity to end the epidemic. I can’t go to the US President and say: 'We can cure HIV.’ But I can say ‘Ending the epidemic is scientifically doable’.”

Earlier, however, Nancy Padian from the Office of the US Global AIDS Coordinator had outlined formidable challenges still to be answered if antiretroviral treatment could bring about this goal.

She said that questions still needing answers include whether antiretroviral drugs (ARVs) really are a durable and reliable means of viral load suppression over a period of years and whether increasing the proportion of people on treatment would lead to increased levels of resistance. The biggest practical question, however, was whether treatment as prevention would work in situations where a high proportion of transmissions came from people with acute, recent HIV infections.

The biggest barriers to treatment as prevention, however, are stigma and lack of resources. Implementing ARV-based prevention would not only be expensive in terms of drugs; it would require added human resources and increased training and task-shifting for prevention counsellors so they can deal with biomedical data. There would also be added costs in terms of tests and monitoring.

The other big barrier will be the stigma of being tested, she said, particularly for at-risk populations in societies where injecting drug use, male-male sex, or sex work were criminalised and stigmatised. Treatment as prevention would require people not simply to test and then go to more supportive community organisations for prevention advice; it required a much closer relationship with medical personnel who might be prejudiced or feared to be so.

Mitchell Warren issued a call to action to implement the new strategies, but his presentation was tempered by realism. “We have evidence, we have data, and we now need to make decisions,” he said.

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

IAS 2011: Day 2 Press Release

OFFICIAL PRESS RELEASE – DAY 2

16.30 (CET), MONDAY JULY 18

Antiretroviral Treatment is HIV Prevention: The proof is here

Leading researchers and international experts to discuss the policy and prevention implications of three groundbreaking trial results: the HPTN O52 study, the Centers for Disease Control and Prevention TDF2 study and the University of Washington Partners PrEP Study

Monday, 18 July, 2011 (Rome, Italy) -- A special press conference at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) will today feature a panel consisting of researchers from the CDC TDF2 study, the Partners PrEP Study and the HPTN 052 study. They will be joined by Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), Gottfried Hirnschall, Director of the HIV Department of the World Health Organization (WHO) and Elly Katabira, IAS 2011 International Chair and President of the International AIDS Society (IAS). The IAS 2011 conference opened yesterday, Sunday 17 July and runs until Wednesday 20 July and is being attended by over 5000 researchers, clinicians and community leaders.

In light of announcements this past week about new data on PrEP effectiveness, both the HPTN 052 abstract session (16.30, SR1) and press conference have been expanded to include presentations on the Partners PrEP Study and the CDC’s TDF2 study, both of which were released on 13 July in the US. The presentation on the CDC study was originally scheduled for a late breaker session at IAS 2011 on Wednesday 20 July.

“Treatment is prevention and these three studies provide the proof,” said Katabira.

“The XI International AIDS Conference in Vancouver in 1996 is remembered as the conference that heralded the arrival of combination antiretroviral treatment. The IAS 2011 Conference will be remembered as the beginning of the treatment as prevention revolution.”

“These studies mark a turning point in HIV science and in HIV prevention,” said Stefano Vella, IAS 2011 Local Co-Chair and Research Director at the Istituto Superiore di Sanità (ISS). “The urgent challenge now is to implement treatment as prevention in the developing world.”


Press conference line up:

Chair: Stefano Vella: IAS 2011 Local Co-Chair and Research Director at the Istituto Superiore di Sanità (ISS)


Myron Cohen: HPTN 052 Protocol Chair and Associate Vice Chancellor for Global Health and Director of the Institute of Global Health and Infectious Diseases at the University of North Carolina

About the HPTN 052 study:

The HIV Prevention Trials Network (HPTN) 052 study found that men and women, who were already infected with HIV, had a reduced risk of transmitting the virus to their uninfected sexual partners by 96% through early initiation of combination antiretroviral therapy (cART). HPTN 052 also found that early initiation of cART benefits the HIV-infected individual.

HPTN 052 was designed to evaluate whether early versus delayed use of cART by HIV-infected individuals would reduce transmission of HIV to their uninfected partners and benefit the HIV-infected individuals as well. During the course of the study, 39 participants who had been HIV-uninfected at the start of the study became infected with HIV. Of those, 29 were linked transmissions, where the virus from the originally-infected partner was confirmed by genetic analysis to be the source of infection in the newly infected sexual partner. Only one of the 29 infections occurred in the early cART arm. Based on the latest analyses, this one transmission most likely occurred close to the time the couple enrolled in the study and before HIV viral replication could have been suppressed by cART in the infected participant.

The new analyses also provide more insight as to how early initiation of cART benefits the HIV-infected person. Individuals who were put on early cART maintained higher absolute CD4 counts than those in the delayed arm, who received treatment when their CD4 counts fell below 250 cells/mm³ or an AIDS-related event occurred. Early cART was also associated with a 41% reduction in HIV-related illnesses or death, a direct benefit for the HIV-infected partner. The reliable suppression of HIV among HIV-infected people in the early treatment arm suggests potential impact on adherence when the infected individual is informed that their cART may also benefit their partner.


Michael C.Thigpen: Principal study investigator and epidemiologist at the Centers for Disease Control and Prevention (CDC), USA

About the TDF2 study:

The CDC TDF2 study was a randomized, placebo-controlled trial examining the safety and efficacy of a once-daily tablet containing tenofovir disoproxil fumarate and emtricitabine (TDF/FTC, known by the brand name Truvada) for reducing the risk of HIV acquisition among heterosexual men and women at two sites in Botswana. In addition to study medication, all participants received a comprehensive package of HIV prevention services. The study provides strong evidence that a daily oral dose of antiretroviral drugs used to treat HIV infection can reduce HIV acquisition among uninfected individuals exposed to the virus through heterosexual sex. The study, conducted in partnership with the Botswana Ministry of Health, found TDF/FTC reduced the risk of acquiring HIV infection by roughly 63 percent overall in the study population (95% CI, 21.5 to 83.4; p= 0.0133) ,and by 78 percent among trial participants believed to be taking study medications (95% CI 41.2 to 93.6, p=0.0053). Adherence (as measured by pill count) was high, both among those receiving TDF/FTC and those receiving placebo (84.1 percent and 83.7 percent, respectively). Reported sexual risk behavior was similar between the two study arms. Consistent with other PrEP studies, preliminary analyses did not identify any significant safety concerns associated with daily use of TDF/FTC.


Jared Baeten: Co-leader of the Partners PrEP Study and epidemiologist at the University of Washington, USA

About the Partners PrEP Study:

This is a phase III, randomized, double-blind, placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir for the prevention of HIV-1 acquisition among HIV-1 seronegative partners in heterosexual HIV-1 serodiscordant partnerships. The study is funded by the Bill & Melinda Gates Foundation. The University of Washington coordinated the trial, in collaboration with investigators at nine sites in Kenya and Uganda. The study enrolled 4758 HIV-1 serodiscordant couples; HIV-1 uninfected partners were randomly assigned in equal numbers to one of three study groups: one group received tenofovir, one emtricitabine/tenofovir, and one matching placebo. All study participants received a comprehensive package of HIV-1 prevention services. On 10 July 2011, the Partners PrEP Study independent Data and Safety Monitoring Board (DSMB) recommended, after review of the study data, that the study results be publically reported and the placebo arm be discontinued, because of definitive demonstration of HIV-1 protection from pre-exposure prophylaxis (PrEP) in the study population. Tenofovir reduced HIV-1 risk by 62% (95% CI 34 to 78, p=0.0003), emtricitabine/tenofovir by 73% (95% CI 49 to 85, p<0.0001). Efficacy for tenofovir and emtricitabine/tenofovir were not statistically different. 62% of HIV negative participants were male, 38% were female: both PrEP medications reduced HIV-1 risk in men and women. 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. Safety parameters were comparable across the three study groups.


Anthony Fauci: Director, NIAID, USA

Fauci will remark on the implications for prevention research. He will talk about the collective importance of these studies in finding new HIV prevention methods and the optimism that these combinations when viewed in total will help to end the HIV/AIDS epidemic.


Gottfried Hirnschall: Head of the HIV Department at the WHO, Switzerland

Over the past year, WHO has been developing recommendations for couples HIV testing and counseling. More than half of all people living with HIV do not know their infection status, and therefore, may transmit HIV unknowingly. By partners testing together and mutually disclosing their test results, couples can learn about their options for HIV prevention and treatment.

The findings of the three cited studies above will be reflected in WHO guidelines for couples HIV testing and counseling and also to develop broader guidance on the strategic use of antiretrovirals for treatment and prevention of HIV.


Elly Katabira: International Chair IAS 2011 and IAS President

Katabira will talk about the implications of the three cited studies for HIV professionals


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Fauci - AIDS: Let Science Inform Policy

via Science, by Anthony S. Fauci

Thirty years have passed since the first cases of acquired immune deficiency syndrome (AIDS) were reported by the U.S. Centers for Disease Control and Prevention. How does this anniversary compare to the 20th or the 10th? The differences are considerable, because we now have an unprecedented opportunity, based on solid scientific data, to control and ultimately end the AIDS pandemic.

More than 60 million people have been infected with human immunodeficiency virus (HIV) worldwide. More than 30 million have died, and 34 million are currently living with HIV infection. In 2009, the most recent year for which data are available, 2.6 million people became newly infected. The burden of HIV/AIDS is overwhelmingly felt in resource-poor countries, especially in sub-Saharan Africa, which are least equipped to deal with the disease. Although the toll is staggering, the scientific progress in HIV/AIDS research over 30 years has been extraordinary, particularly in the development of antiretroviral therapy (ART), which has proven to be life-saving to many millions.

For decades, the idea of ending or even controlling the pandemic was a distant aspiration because we lacked sufficient evidence-based tools to convert the hope to reality. At this 30th anniversary, the situation has dramatically changed: We finally have scientifically validated prevention modalities that clearly work, suggesting that ending the pandemic is feasible. Older, proven prevention tools include the proper use of condoms, needle exchange programs for injection drug users, and antiretroviral treatment of HIV-infected pregnant women to prevent transmission of the virus to their newborn infants. Building on this foundation, recent HIV prevention research also has provided strong scientific evidence that adult male circumcision is highly effective in preventing infection in heterosexual men, that an antiretroviral-based topical gel prevents infection in heterosexual women, and that pre-exposure prophylaxis with ART in men who have sex with men is effective at preventing infection. And in May 2011, a randomized controlled clinical trial demonstrated that early initiation of ART by the infected partner in heterosexual couples, where one partner is HIV-infected and the other not, is highly effective in decreasing transmission of HIV to the uninfected partner.

The fact that treatment of HIV-infected adults is also prevention gives us the wherewithal, even in the absence of an effective vaccine, to begin to control and ultimately end the AIDS pandemic. Of course, the development of an AIDS vaccine would be the ultimate game-changer, and efforts toward this goal are intense. However, the existing armamentarium of scientifically proven interventions immediately offers an unprecedented opportunity to make major gains in the fight against HIV/AIDS. Global implementation of HIV interventions, including scale-up of the delivery of ART, must be accelerated, and this will be costly. Certainly, there are many competing priorities for scarce resources in the global health arena, such as other infectious diseases, maternal and child health, and tobacco control. But if one accepts the tenet that science should inform policy, then the scientific data are speaking loud and clear. Global policy-makers must seriously consider these new data in their priority-setting and decision-making.

Last month, world leaders at the United Nations General Assembly Meeting on AIDS called for providing ART for 15 million people in low- and middle-income countries by 2015, an increase from the 6.6 million currently receiving therapy, plus additional efforts toward universal access to HIV prevention, treatment, and care. An estimated $22 billion to $23 billion annually will be needed by 2015; current spending is approximately $16 billion. Such targeted investments could prevent 12 million infections and 7.4 million AIDS-related deaths by 2020. For the first time in the history of HIV/AIDS, controlling and ending the pandemic are feasible; however, a truly global commitment, including investments by those rich and middle-income countries whose contributions have thus far been limited, is essential. Major investments in implementation now will save even greater expenditures in the future; and in the meantime, countless lives can be saved.

Source.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Despite Strings, NIH Will Focus Money on Science

via Med Page Today, by Emily P. Walker

Although $10.4 billion allocated to the National Institutes of Health (NIH) in the economic stimulus bill is aimed at creating jobs, a top official said the agency will still fund projects based on their science, rather than their economic impact.

However, Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, said NIH will change its scoring procedures with an eye toward projects that could conclude most of their research within two years.

That's because the money came with a hitch: the research should be short-term projects, or those most likely to deliver the most bang to the economy for the stimulus buck.

"In biomedical research, two years is a very short amount of time," Dr. Fauci said at a Monday presentation sponsored by the American Association of Medical Colleges on how NIH plans to spend the stimulus money.

"It's not like we're paying money to build a bridge from here to there and in two years it's finished," he said, referring to the ongoing nature of scientific discoveries.

Still, short-term projects, or those that will likely still have funding after fiscal 2010, are likely be favored.

Regardless of the strings attached, the cash infusion will be welcome for the agency whose funding has remained static for years while the demands of research -- and cost of funding it -- have increased.

Dr. Fauci said NIH will not concern itself with a project's direct pipeline into the economy because it assumes that all projects will provide additional jobs in the field. He said that for every one dollar put toward biomedical research, $2.50 is pumped into the economy.

About $7 billion of the stimulus money will go toward what Dr. Fauci termed "research priorities," while $1 billion will fund construction and capitol improvements at research universities.

Half a billion will go toward improving NIH buildings in Bethesda, Md..

Dr. Fauci's institute, which does research on HIV/AIDs, tuberculosis, influenza, and other infectious diseases, will receive a little over $1 billion, distributed among several funding areas.

The money will fund "challenge grants," which will include a project to examine what happens to a body in the early stages of HIV infection.

"A considerable amount of the immune system is destroyed in the first years, but we don't know how that works," Dr. Fauci said.

Other challenge grants will fund research to develop diagnostic tools for TB -- which infects one-third of the world's population -- and conduct research on neglected tropical diseases. (See NIH Announces New Rare Disease Drug Program)

Dr. Fauci also announced a new research project to test "big and bold" initiatives to stop the spread of HIV.

These include testing the effectiveness of pre-exposure prophylaxis on high-risk individuals, and a "test to treat" model, in which every person in a particular population is tested annually for HIV and treated immediately if the virus is detected.

Source.

A Policy Cocktail for Fighting HIV - by Fauci

[One BIG problem with this cocktail is the ingredient that is missing - MICROBICIDES. Why is this neglected?]

via Washington Post, by Dr. Anthony S. Fauci

In the absence of a vaccine, three bold new approaches to controlling the HIV/AIDS pandemic are being discussed by those working in medicine and public health. These approaches are still in the conceptual and testing phases, but if applied as a group, it's possible they could have a dramatic effect.

Read the whole thing. And then leave a comment on the Washington Post if so inclined.

Fauci Validates Need for RECTAL Microbicides

Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health on National Black HIV/AIDS Awareness and Information Day February 7, 2009

Excerpt:

"Treatment is no substitute for prevention, however. NIAID-funded investigators are working to develop and validate new methods to protect against HIV infection, including microbicides that could be applied vaginally or rectally before sex; antiretroviral drug regimens that could be used to prevent infection in people who are at high risk of becoming infected with HIV; and, of course, vaccines to prevent HIV infection."

Read his whole statement here.

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