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Posts Tagged ‘ARVs’

If there’s any question about the value of U.S. investments in scientific research on HIV/AIDS, Anthony Fauci probably put it to rest today by noting that in the period since HIV first emerged, “we went from a 26-week lifespan to a 40-year-plus life span” for those infected with the virus. Talk about measureable outcomes.

That dramatic change—from death sentence to chronic manageable disease—is thanks, in large part, to the 30-plus antiretroviral drugs developed through scientific inquiry over the last three decades. Fauci’s remarks came at congressional briefing today, entitled “AIDS Research at NIH: New Opportunities to Change the Course of the Epidemic,” sponsored by the HIV Medicine Association, IDSA’s Center for Global Health Policy, and several other groups.

Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, and other presenters, including two IDSA physician-scientist experts, spoke of the vital need to maintain and increase U.S. support to combat the HIV/AIDS epidemic, whether through an eventual vaccine or biomedical and behavioral prevention strategies.

There is a presumption in some quarters, Fauci said, “that we really have our arms around this and things are stable.”  But with 2.7 million new infections each year, the epidemic is still spiraling.

“In the U.S.,” Fauci added, “yes, things are stable, but they are stable at a completely unacceptable level.” There are about 1.1 million people living with HIV in the U.S., with 56,300 new infections each year–a number that has stayed intractably level for the last decade.

Right now, “we are not winning the game,” Fauci said, which means it is imperative to continue the search for a cure.

“Some have thought this is an impossible goal,” he said. But while there have been many disappointments in the vaccine arena, Fauci said there is great hope of a “functional cure,” in which HIV patients are treated aggressively and early enough that they  go into permanent remission and no longer requirement ARV therapy.

“This is eminently feasible,” he said, describing novel prevention approaches now under study, including microbicides and “test and treat” strategies.

Dr. Wafaa El-Sadr, director of Columbia University’s International Center for AIDS Care and Treatment Programs, said that with ARVs, an estimated 3 million lives have been saved.

“I call that success,” she said. But noting there’s still much “unfinished business,” she said, “we should be energized to continue this work” both in expanding access to treatment, finding new drugs, and researching new prevention tools.

She noted that in parts of the U.S., including D.C., the prevalence of HIV surpasses the rates in some African populations, but that here, it is a very localized epidemic, with African Americans disproportionate impacted. That requires distinct approaches to treatment and prevention.

“We have to reconceptualize our approach to the epidemic,” she said, and look for more structural, socio-economic interventions. But to do that, and be successful, requires more research. She pointed to a study she’s involved with that is trying to identify the risk factors for HIV among women. Once the study gives them some answers, she said, they will need to do another study to figure out what interventions work to mitigate those risk factors.

Dr. El-Sadr also described the “test and link-to-care” study underway in Washington, D.C., and the Bronx, which will look at whether it’s possible to significantly reduce transmission with such an approach.

“This is the epitome of a complex study,” she said, “but it’s the future of what HIV prevention will look like.”

“… We have an emergency in this country and an emergency around the world,” she concluded.  “There’s a need to continue an ambitious, innovative, courageous research agenda.”

Dr. Adaora Adimora, a professor of medicine and epidemiologist at the University of North Carolina, took the audience in a different direction, with a talk about why it is vitally important to cultivate and support minority researchers in this field.

She joked that the subtitle of her presentation should have been: “Why can’t white men solve all our problems?” But  Dr. Adimora quickly turned serious in noting that HIV disproportionately affects minorities, particularly those who are disadvantaged and therefore  vulnerable to forces that put them in the path of the virus.

“Minority investigators bring a unique perspective” on the health issues that affect their community, and are likely to think of research questions and connections that other researchers do not.

For example, until the early 1990s, the HIV-STD field focused research questions on “numbers of parents and sexual behaviors,” she said. “Poverty was recognized as a risk factor but it wasn’t clear how being poor could get you an STD, including HIV. Through the efforts of researchers, many of whom are minorities, this view broadened to include the importance of social forces and the pathways that link these social forces to HIV and other STDs.”

And understanding these pathways is critical to developing successful interventions, she added.

Lack of funding is the main reason that minority researchers leave the field, she said, noting that an early NIH grant was the key to her own successful career in research.

“It’s unlikely my career would have survived” if not for that grant because, she said, she would have had to devote all her time to seeing patients. “An increase in grant funding is critical to ensure that more talented investigators of all races and ethnicities are not lost,” she said.

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A delegation of HIV-positive Haitains recently visited Washington to lobby for robust funding for PEPFAR. Read their compelling stories in this blog, which details how HIV-positive patients have access to HIV drugs but not necessarilly to a glass of water to wash the pills down or food to make the medicines tolerable and effective.

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The case for earlier and wider initiation of antiretroviral therapy just keeps getting stronger.

First, there’s the increasing solid consensus that initiating ART earlier significantly increases an HIV patient’s chances of survival. Then there’s the fact that initiating ART earlier reduces the number of people needing more costly second-line therapy. We also know that the best way to stave off tuberculosis-related deaths in HIV-positive individuals is to put those patients on ART.

Add to all that this latest news: New mothers receiving highly active antiretroviral therapy (HAART) for HIV-1 infection are much less likely than untreated mothers to transmit the virus to their newborns through breastfeeding. Those findings, published online today in the Nov. 15 issue of The Journal of Infectious Diseases, suggest HAART regimens should be initiated “as early as possible in eligible mothers in areas with limited resources, such as Africa, where most infant HIV-1 infections occur, and breastfeeding is common,” according to a news release from JID.

The study, conducted in mother/infant pairs in Malawi and led by Taha E. Taha, MBBS, PhD, of Johns Hopkins University Bloomberg School of Public Health, found that HAART was associated with an 82 percent reduction in postnatal HIV-1 transmission.

“While acknowledging more research is needed to develop safe, effective, and affordable ways to prevent postnatal transmission in settings with few resources, the study’s authors recommend that women presenting late in pregnancy who have low CD4 counts and require antiretroviral treatment start HAART as soon as possible during pregnancy or postpartum,” the JID news release says.

In an accompanying editorial, Grace C. John-Stewart, MD, PhD, of the University of Washington School of Public Health, writes of the need “accelerate many incremental steps” to make PMCTC programs more successful.

“As research informs new PMTCT policy recommendations, it is critical to improve the logistics of CD4 cell count testing and HAART integration to increase the effectiveness of PMTCT and lay the foundation for even more effective programs,” he writes.

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Federal officials today celebrated the approval of the 100th antiretroviral drug authorized under an expedited regulatory framework created five years ago, as a way to fast-track the delivery of cheap HIV drugs to the developing world through the PEPFAR program. A panel discussion, held at the Pan American Health Organization Headquarters to mark the milestone, featured FDA Commissioner Margaret Hamburg, OGAC Director Ambassador Eric Goosby and ambassadors from Haiti and Tanzania.

The FDA process was launched in May 2004, in response to a call from activists, clinicians and members of Congress to use the WHO’s pre-certification drug list to make purchases of generic medications for PEPFAR-funded programs. Instead, a process was devised to allow the FDA to certify generic antiretrovirals (ARVs) for PEPFAR purchase, even if the branded drug was still protected by U.S. patent laws.

According to the first speaker, Dr. Mirta Roses Periago, director of the Pan American Health Organization, more than 4 million people now have access to lifesaving HIV medications, including 455,000 in Latin America and the Caribbean region. Periago noted that these numbers reflect only 42 percent of those who need ARVs and commented on the urgent need to bring down prices and increase availability of second-line treatments. (more…)

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The end of today’s UNAIDS progress report, detailing the latest figures on access to ARVs, is in some ways more important than the beginning. “The Way Forward,” the report’s conclusion, lays out important next steps in the campaign for universal access, at a time when the global economic crisis and questions about sustainability have cast a cloud over global AIDS initiatives.

To be sure, today’s report, put out by UNAIDS, WHO, and UNICEF, leads with some excellent news:

*1 million new HIV patients in need of life-saving treatment were added to the ARV rolls in the developing world last year, for a total of 4 million people now getting HIV therapy in low- and middle-income countries

*HIV testing and counseling became more widely available and more frequently used last year

*Almost half, 45 percent, of HIV-positive pregnant women received ARVs to prevent transmission of the virus to their babies in 2008, up from 35 percent in 2007

Now for the hard part. More than five million people who desperately need treatment still aren’t getting it, concludes the report, “Toward Universal Access, Scaling up priority HIV/AIDS interventions in the health sector.” And although 1 million new HIV-positive people were put on ARVs last year, there were an estimated 2.7 million new infections in 2007, not exactly a good ratio. And many patients are not being diagnosed until they have end-stage disease, when HIV therapy may be too late. Click here for the news release, which summarizes the report.

“Without significant acceleration in the rate at which services are expanded and people are reached, millions of new infections will occur, more lives will be lost and the human and economic burden on future generations will continue to increase,” the report’s authors write in the conclusion.

And all these new numbers must been seen through the prism of new evidence demonstrating that earlier initiation of ART has a significant positive effect on mortality and survival; indeed, the authors of today’s report make a passing reference to the WHO’s plans to review the new scientific evidence on that matter and “proceed with any necessary revisions to its treatment guidelines” later this year. (more…)

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Dr. Robin Wood, director of the Desmond Tutu HIV Centre in Cape Town, has many startling slides to illustrate the astronomical problem of tuberculosis in South Africa—from photos of desperately poor, overcrowded shantytowns in the Western Cape to graphs that document the escalating rates of HIV/TB co-infection in his native country.

But there’s one image that gets at the crux of a perplexing problem in this epidemic:  A photo of a TB clinic door plastered with awards for successfully implementing the DOTS strategy, or Directly Observed Treatment, Short-course. Juxtaposed to that is a graph showing exponential growth in TB rates in the clinic’s community.

“Why is TB control failing in South Africa?” asks Dr. Wood, a renowned physician-scientist who has been on the front lines of HIV/AIDS treatment, research and prevention for two decades and has recently done cutting-edge research on the deadly intersection of HIV & TB in South Africa.

It is obviously not a failure to implement DOTS, a strategy at the heart of most TB control programs in the developing world. Instead, Dr. Wood suggested at a briefing with USAID staff today in Washington, it’s an overreliance on DOTS in settings where transmission is a “pressure infection” being transmitted at nearly unprecedented rates. He said the situation today in South Africa is similar to what happened in New York in the 1840s, when Irish immigrants with very little natural TB immunity came to the U.S., and the epidemic spread like wildfire.

“If you live in a sea of TB,” as so many South Africans do, DOTS is just not enough to control the disease, Dr. Wood said.

So what is needed? Dr. Wood isn’t calling for anything radical. (more…)

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This post is by Center Director Christine Lubinski, reporting from the 2009 IAS conference in Cape Town.

Pedro Cahn, president of Huésped Foundation, an Argentinean AIDS organization involved in HIV/AIDS clinical research, prevention and care, offered a refreshingly candid and provocative HIV treatment update as the second plenary speaker at the IAS conference today. Cahn, a past president of IAS, provided an overview of drugs in development, but he focused most prominently and pointedly on treatment in the developing world. 

 

On the thorny issue of “when to start” HIV patients on antiretroviral therapy, Cahn stated categorically that there is widespread agreement that a CD4 level of 350 should be the minimum threshold.  He highlighted the results of the CIPRA study which compared outcomes of ART below 200 versus access from 200-350.  In those started below 200 CD4 cells, researchers found four times the mortality and twice as much TB disease. It is also clear that initiation of ART at higher CD4 levels lowers the frequency of drug resistance, thereby preserving the durability of treatment regimens.  From his perspective, a change in the treatment threshold of the WHO guidelines is long overdue, although he acknowledged that he served on the guidelines panel.  

Cahn expressed concern about the high percentage of patients lost to follow-up in many developing countries and identified the major reasons for this as advanced disease and the requirement of payment for health care services. (more…)

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