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Posts Tagged ‘ART’

The Center’s Rabita Aziz describes a visit to Livingstone General Hospital’s antiretroviral therapy (ART) ward in Zambia during a recent Congressional delegate trip to Africa.

In a dark room so small and cramped that the door won’t even close, Ndabila Singango, a provincial clinical mentor employed by the Center for Infectious Disease Research of Zambia (CIDRZ), tests and counsels HIV/AIDS patients at the Livingstone General Hospital. The hospital, built more than 60 years ago and used only by white colonists before Zambia gained independence, is the only hospital in all of Southern Province, which has a population of 1.6 million. With an HIV prevalence rate of 30 percent in Livingstone, it is not surprising that 80 percent of admissions to the hospital are HIV-related.

Gertrude, an HIV positive mother with newborn twins, explained that the lesions on her face appeared two weeks ago.

The ART ward of the hospital sees an average of 70 patients daily, and provides ART to 3500. When we met one such patient, Gertrude, she was breastfeeding one of her three-month old twins while the other – strapped to her back – slept peacefully.

Gertrude learned that she was infected with HIV/AIDS three years ago when she felt ill and was advised to take an HIV test. She had not disclosed her HIV status to her husband as she feared reprisal from him and the community. Like many African women, Gertrude was unable to negotiate the terms of sex, and therefore did not use protection.

When she started ART in November of 2008, Gertrude’s CD4 count was at 129. Six months of therapy later, it rose to just 130. (more…)

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This post is by Global Center Director Christine Lubinski.

Viet Nam was an fitting spot for last week’s meeting of the Stop TB Partnership Coordinating  Board, since the country’s anti-TB efforts demonstrate both the challenges and the potential for progress in  combating this deadly disease.

Viet Nam’s Vice Prime Minister and Minister of Health welcomed members of the Stop TB Partnership Coordinating Board and expressed pride about the pace of Viet Nam’s economic development, as it stands on the threshold of moving from status as a low-income country to a lower middle-income country.

Viet Nam is one of the world’s 22 high burden TB countries, with significant rates of HIV/TB co-infection that have  contributed to an increase in TB prevalence in young adults.  Viet Nam’s national TB manager outlined the dimensions of the TB problem in the nation, as well as the response that began with a nationwide expansion of DOTS coverage in the 1990s. That effort now includes responding to co-infection and officials have also started to address the 2.7 percent of TB cases that are drug-resistant.  The country just began providing treatment to multidrug-resistant TB patients in 2009 and still only reaches a fraction of those infected with deadly resistant TB disease.  He outlined a number of critical challenges that plague highburden developing countries:

  • Human resources—about 50 percent of TB district staff are brand new and require additional training
  • Inadequate regulation of  TB drugs in the pharmacy market, leading to self-medication
  • ART access for patients co-infected with HIV and TB has improved but remains inadequate.  The 3 Is—Isoniazid preventive therapy, intensified case-finding, and infection control–also need to be strengthened.
  • MDR-TB is an emerging threat and the supply mechanism for second-line TB drugs is insufficient
  • Addressing TB in  so-called “closed settings”—prisons and re-education centers–and the coordination of these institutions with the national TB program
  • Strengthening the role of civil society in TB  control
  • Monitoring and evaluation

The TB manager identified scaling up TB/HIV activities, the response to pediatric TB, and responding to TB human resource needs as key next steps.

Viet Nam’s national TB program hosted a site visit to the Hanoi Hospital on Tuberculosis and Lung Disease, as well as a district health center making great strides in TB control with a burgeoning migratory population moving to the Hanoi area from rural areas of the country.

Outside the Hanoi Hospital on Tuberculosis and Lung Disease

The hospital director described the hospital’s key role in patient care, training, scientific research and providing leadership to the network of 29 district level clinics and providers providing T B services.

Viet Nam treats TB patients for 8 months, with the first two months using the DOTS model at the clinic daily.  After this, patients are given several weeks of medication and must check in with health providers frequently. There are more than 5,000 TB cases a year in Hanoi, and in 2009, almost 12 percent of these cases were TB/HIV co-infection.  Only about half of the TB patients were actually tested for HIV, so the number of co-infected patients is likely to be higher.  The mortality rate among the co-infected patients is 21 percent.  Half of all deaths at this hospital occur among co-infected individuals.  Notably, only 45 percent of the co-infected patients have access to ART.  

Eligibility for ART in Viet Nam is a CD4 count of under 200 or clinical symptoms of WHO Stage IV HIV infection.  Officials hope to move to a CD4 count of 250 soon for ART eligibility and to generally improve access to ART for co-infected individuals.  They have been successful in providing ART to some HIV patients with pulmonary TB.  It is also worth noting the CD4 diagnostic capability is not available everywhere.

Not all TB services are free in Viet Nam.  Patients must pay for physician services, chest X-rays and medical care related to extra-pulmonary TB, which occurs much more frequently in persons living withy HIV infection.

A visit to a district health facility offered an inspiring picture of dedicated staff working to provide TB and HIV services to a growing population of migrants.   This center has substantially ramped up screening of HIV-infected persons for tuberculosis and now ensures that nearly 100 percent of  TB patients are screened for HIV infection. The staff have engaged peer educators in their work to support co-infected patients.  The majority of persons living with HIV infection are injection drug users and center’s staff were excited to report that they are now offering methadone – the first pilot program in north Viet Nam.  They credit donor support for their ability to respond to the multiple health care needs of this complex and vulnerable population.  That donor is PEPFAR. 

The clinic director identified the need for strong support from local political leaders and the engagement of community members as key ingredients of this successful program.

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This post is by Global Center Director Christine Lubinski, reporting this week from CROI in San Francisco.

The notion of treatment as prevention got a significant boost this week at CROI, where the results of a new study were presented by Deborah Donnell, MD, of the Fred Hutchinson Cancer Research Centre in Seattle. Dr. Donnell detailed exciting evidence that ART can prevent HIV acquisition, at least in the context of heterosexual, HIV discordant couples. 

In a multinational prospective study, researchers followed of a large cohort of couples in south and east Africa and looked at the role of ART in reducing transmission risks. The study tested the uninfected partner at the beginning of the study and at 3 month intervals, while providing free condoms and intensive prevention counseling to the couples. The infected partners were placed on ART when their CD4 counts dropped below 250.  Thirty-one percent of the infected female partners and 28 percent of the infected male partners reported unprotected sex.

The study was able to confirm whether HIV transmission occurred within the partnership through special testing.  There were 151 HIV transmission events, 108 of which were linked to partnerships.  Only one transmission event was found within a partnership where the infected person was on ART, while 102 HIV infections occurred within partnerships with no ART.  There was a 92 percent reduced risk of infection for the discordant partnerships where the partner was on ART. 

HIV transmission occurred at all CDR levels, but transmission rates were highest when the infected partners CD4 count was under 200.  This finding emphasizes the prevention imperative to expand ART access to the 40-some percent of persons in developing countries with CD4 counts below 200 who do not yet have access.

Interestingly, there was a significant reduction in unprotected sex in the partnerships where ART was introduced, from 6.2 percent to 3.7 percent.

Dr. Donnell noted that further research and more data is needed to evaluate whether prevention benefits would persist during long-term ART use. Click here to read a Reuters story on the study.

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There’s fresh evidence out today that greater access to AIDS treatment for women will help keep their babies healthy.

A new article in Clinical Infectious Diseases reports that a higher maternal viral load during the 30th week of pregnancy significantly increased the risk of HIV transmission to the baby—a finding that provides additional confirmation of the nexus between HIV/AIDS and child & maternal health. The results suggest that pregnant women’s viral loads should be controlled “well before delivery,” the study authors report. Click here to get to CID and here to read a story about the study by aidsmap.

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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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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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A new study suggests that HIV infected patients should start antiretroviral treatment earlier.

 

Here’s the editor’s note accompanying the article in today’s online version of the Lancet:

 

“When to start antiretroviral treatment has been a problem for physicians dealing with patients with HIV infection. Most commonly the decision is based on CD4 counts, but just what is the best CD4 count for the start of treatment has not been clearly defined. This paper pools data from a number of large patient cohorts and provides the strongest evidence available for when to start HAART. These data should inform, and change, treatment of HIV patients.”

 

And here’s a link to the Lancet piece:

 

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)60612-7/fulltext

 

Reuters news service also reported on this study. Click here to read their story, which says, in part, “An analysis of more than 45,000 people with HIV in Europe and North America found they were 28 percent more likely to develop full-blown AIDS or die if they deferred treatment until the point currently recommended in many countries.”

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