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Posts Tagged ‘CD4 Counts’

The idea of HIV treatment as prevention got a major boost yesterday in the wake of a WHO meeting in Geneva on the use of antiretroviral therapy as a way to curb new HIV infections.

“In the past, there has been a false dichotomy between prevention and treatment,” Teguest Guerma, interim director of the WHO’s AIDS department, told Bloomberg news, according to this story, as the WHO meeting wrapped up. “That is really what has been corrected. Prevention and treatment are two faces of the same coin.” Guerma said providing wider access to ARV drugs “will achieve a significant transmission benefit.”

His comments are likely to bring fresh attention to the debate over scale up of HIV programs. They come at the same time the WHO is considering changing in its HIV treatment guidelines to support earlier initiation of antiretroviral therapy, reflecting scientific evidence that such a move significantly enhances survival. With evidence mounting that wider access to ARVs would have benefits for everything from HIV prevention to AIDS mortality to tuberculosis control, the chasm between the need for ARVs and the funding for treatment seems to be getting wider by the minute. Let us know what you think about Guerma’s statement and these related issues.

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As Obama’s new global AIDS coordinator, Dr. Eric Goosby has no shortage of burning issues on his plate—from reports of ARV stock-outs in the developing world to questions about the long-term sustainability of PEPFAR. At a 1 ½ hour community meeting at the State Department Friday, the unassuming California doctor tried to reassure the global AIDS community that he has his eye on both the immediate and the far-reaching.

So even as he’s pushing aggressively forward to develop country ownership and building capacity for taking over AIDS programs, Dr. Goosby said he’s also urgently aware of the need to scale up prevention of mother to child transmission, to find ways to expand ARV treatment in a tight budget climate, and to meet new PEPFAR mandates, including recruiting 140,000 new health care workers.

In a wide-ranging session with more than 100 advocates and experts, Dr. Goosby said his overarching goal as head of PEPFAR is to build an enduring program that will be there to serve the sick and poor in developing nations for decades. “We are at an exciting point in PEPFAR’s evolution,” he said from the dais of an auditorium in the State Department. “Our charge now is to make sure that contribution is realized into the future, not for five years but for 25.”  

“… The economic downturn has created an urgency to this discussion that wasn’t there before,” Dr. Goosby said. But he acknowledged the country-ownership effort will take a decade or longer to achieve.

“No country is in a position to take over” these PEPFAR programs, but US and other leaders need to start the dialogue now, he said. (more…)

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You’ll find the answer to that question, and other fresh insights into the Administration’s plans for PEPFAR, in this ScienceInsider interview with Dr. Goosby, President Obama’s global AIDS coordinator.

Among the highlights, Dr. Goosby tells SI that efforts to nix the ban on needle-exchange programs are well underway within the Administration and the PEPFAR office. “I have spent much of my life focused on matching demographics to responses. If you do not base responses to the demographics of your epidemic, you will not be successful at reaching the populations who are already infected,” Dr. Goosby says. When asked how he plans to get around the ban, Dr. Goosby notes that it’s domestic prohibition and PEPFAR is not subject to it.

Asked about what it’s like to take over such a successful initiative, Dr. Goosby gave this answer: “I’m grateful to PEPFAR for the work it has done, putting a finger in the dike, but we have by no means reached the threshold by which we can relax or view this as a job well done. The job that has been done is precariously positioned to not sustain itself.”

On what direction PEPFAR is headed, he offered this: “We need to look at how to build country-based, country-run, country-owned delivery systems. We can’t just build islands of excellence with HIV care and not address the larger health needs of that same individual. That’s shortsighted. The president and Secretary Clinton have been very clear about wanting all the vertical programs—HIV, TB, malaria, immunization, maternal and child health—to now look at expanding the service constellation and bringing in those broader health needs of what is a complete overlap in populations. The discussion is mostly focused on using women as that access point to children, husbands, and partners.”

At the end of the interview, Dr. Goosby talked about the mismatch between the current scientific and budget realities:

“It’s a no brainer in terms of the science to use tenofovir instead of d4T [an ARV that has serious side effects]. The problem is the cost. The same with using the current policy of 200 CD4 cells to start treatment versus 350 CD4s as the cutoff. The science has been there for a long time. That’s why no else is doing 200. The United States has been at 350 forever. You could argue we should be in the 400 to 500 range. The science is clear. What isn’t clear is how we can pay for that. We need to be honest: We’re in the business of trying to find resources to cover that extraordinary expansion of need. And the elephant in the room again is the second-line treatment cost, going up three, four times the cost of first-line for the most part. That’s the final thing that keeps me up at night.”

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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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In a significant development, the National Institute of Allergy and Infectious Diseases announced that it a trial in Haiti–investigating the impact of earlier ART therapy in HIV-positive patients—would be ended early because the results were overwhelming; the findings showed that HIV-infected adults are more likely to survive if they start antiretroviral drugs before their immune systems are severely compromised.

The study is particularly timely, as policy-makers consider essentially flat-funding PEPFAR. Such a move, at a time when research shows that earlier treatment could vastly improve survival, would be devastating to the millions of people living with HIV across the globe.

Here’s the NIAID news release: 

STARTING ANTIRETROVIRAL THERAPY EARLIER YIELDS BETTER CLINICAL OUTCOMES Interim Review Leads to Early End of Clinical Trial in Haiti 

A clinical trial has demonstrated that HIV-infected adults in a resource-limited setting are more likely to survive if they start antiretroviral therapy (ART) before their immune systems are severely compromised.

On May 28, 2009, an independent data and safety monitoring board (DSMB) met to conduct an interim review of an ongoing clinical study known as CIPRA HT 001, which is being conducted in Haiti. The DSMB found overwhelming evidence that starting ART at CD4+ T cell counts — a measure of immune health — between 200 and 350 cells per cubic millimeter (mm3) improves survival compared with deferring treatment until CD4+ T cells drop below 200 cells/mm3. In light of these results, the DSMB recommended that the trial sponsor — the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health — end the trial immediately, before its scheduled conclusion. NIAID agreed with the DSMB recommendation, and all study participants who have fewer than 350 CD4+ T cells/mm3 will be offered ART.

The study investigators say this new finding has the potential to change the standard of care for HIV infection in dozens of countries around the world where ART is initiated only when CD4+ T cell counts drop below 200 cells/mm3. Like the results of several recent epidemiologic studies in developed countries that examined the optimal time to begin ART, the new finding underscores the importance of identifying people who are HIV-infected earlier in the course of their infection and starting ART earlier.

“The public health community now has evidence from a randomized, controlled clinical trial — the gold standard — that starting ART at CD4+ T cell counts between 200 and 350 cells/mm3 in resource-limited settings yields better health outcomes than deferring treatment until CD4+ T cell counts drop below 200 cells/mm3,” says NIAID Director Anthony S. Fauci, M.D.

“The number of people who meet the medical criteria for receiving ART likely will grow as treatment guidelines are revised as a consequence of this finding, challenging the global community to supply antiretroviral drugs to all who need them,” adds Carl Dieffenbach, Ph.D., director of the NIAID Division of AIDS. “Today, only 30 percent of HIV-infected individuals in low- and middle-income countries who need ART are receiving it.”

The clinical trial CIPRA HT 001 began in 2005. It is funded by NIAID through the Comprehensive International Program of Research on AIDS (CIPRA) and is being carried out by the Haitian Group for the Study of Kaposi’s Sarcoma and Immune Deficiency Disorders (GHESKIO) Centers in Port-au-Prince, Haiti. The principal investigator is Jean William Pape, M.D., the director of the GHESKIO Centers and a professor of medicine at Weill Medical College of Cornell University.

The trial enrolled 816 HIV-infected adults ages 18 and older with early HIV disease and CD4+ T cell counts between 200 and 350 cells/mm3. Half of the participants were assigned at random to begin ART within two weeks of enrollment, and the other half were assigned to defer treatment until their CD4+ T cell counts dropped below 200 cells/mm3 or they were diagnosed with AIDS. This deferred treatment is in keeping with the standard of care in Haiti and the current guidelines of the World Health Organization (WHO). The first-line treatment regimen consisted of the anti-HIV drugs zidovudine, lamivudine and efavirenz.

At the time of the DSMB interim review, six participants in the early treatment group had died, while 23 participants in the standard-of-care group had died — nearly four times as many. The DSMB also found that, among participants who began the study without tuberculosis (TB) infection, 18 people in the early treatment group had developed TB, while 36 people — twice as many — in the standard-of-care group had developed TB. These results were statistically significant.

In light of these results, the DSMB recommended that NIAID end the trial immediately and that the study team offer ART to all participants in the standard-of-care group who have fewer than 350 CD4+ T cells/mm3. The DSMB also recommended that the study team continue to follow all participants for another year and make every effort to ensure that participants receiving ART continue their therapy. NIAID concurred with these recommendations.

The study investigators are notifying all participants and have notified institutional review boards and national ethics committees involved with CIPRA HT 001 as well as the Haitian Ministry of Health about the findings of the DSMB. Investigators also have shared the information with WHO, the U.S. President’s Emergency Plan for AIDS Relief, and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

For more information about CIPRA HT 001, see Questions and Answers: The CIPRA HT 001 Clinical Trial <http://www3.niaid.nih.gov/news/QA/CIPRA_HT01_qa.htm>.

For more information about HIV/AIDS prevention, treatment and research, go to www.aids.gov <http://www.aids.gov/>.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at <http://www.niaid.nih.gov>.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit <www.nih.gov>.

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