PEPFAR Program Outlines End of Year Progress to the Congress

via Science Speaks, by Meredith Mazzotta

PEPFAR releases 8th annual report to Congress: The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program delivered its 8th annual report to Congress recently. The five-page document outlines the program’s progress as of the end of fiscal year 2011 in various areas including:  supporting 3.9 million people on antiretroviral treatment; testing 9.8 million pregnant women for HIV in the course of the year; providing prevention of mother-to-child transmission services to more than 660,000 HIV-infected pregnant women allowing 200,000 babies to be born HIV-free; and providing care and support for nearly 13 million people, including more than 4.1 million orphans and vulnerable children. The report also stressed the importance of “leading with science” as we respond to the pandemic, smart investments including spurring private-sector engagement, country ownership, and shared responsibility.

TB institute confirms 8 patients resistant to all known TB drugs:  According to this article in the Hindustan Times, eight of the 12 patients originally reported as having what was coined “totally” or “extremely” drug resistant TB (neither term is recognized by the World Health Organization) have received confirmatory sputum sample testing that show resistance to all first- and second-line TB drugs. Since the original diagnoses of the dozen patients, three have died and, according to a city TB officer, of the six patients that remain in Mumbai, five are undergoing treatment for extensively drug-resistant TB, and one is being treated at Hinduja hospital.

Nonprofit TB Vaccine Developers Sign MOU to Accelerate Progress: Aeras announced it will be joining with the Tuberculosis Vaccine Initiative (TBVI) to “enhance and strengthen collaborative efforts to advance the world’s most promising TB vaccine candidates.” The memorandum of understanding between the two organizations will work to address opportunities and challenges in TB vaccine development that were outlined in the strategic blueprint released by advocates in late March, and published in the journal Tuberculosis, just before World TB Day. According to the Aeras press release, the two organizations will advise each other on vaccines in development, work to streamline the process of candidate selection and review, as they work together to achieve the goals outlined in the blueprint.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Global Fund to Fight AIDS, TB and Malaria Cancels Funding

via The Guardian, by Sarah Boseley

"If we lose the ground we have gained, we will be back to square one – all that effort and investment, lost. The decisions you make here today will determine the outcome."

In what must be seen as a serious setback in the progress made against the major infectious diseases in poor countries, a board meeting of the Global Fund to Fight Aids, TB and Malaria in Accra, Ghana, has effectively cancelled its next round of grant-making.

The fund has been staring at a financial black hole ever since its big replenishment meeting in New York a year ago failed to deliver the sums it hoped for. It wanted $20bn. It got $11.7bn. That was in spite of exhortations to donors to pledge money from the UN secretary general, Ban Ki-moon, who warned that the stakes were high and that lives would be lost if pressure on the big killer diseases was not maintained.

It once seemed unthinkable that the money would not continue to stream into programmes to treat people with Aids, TB and malaria and to prevent others becoming infected. But that is what is happening. There is no doubt that people who could have been spared will instead fall ill and die as a result of the drying up of funds. There is also a Damoclean sword hanging over the heads of people who are alive and well thanks to drug treatment for their HIV infection. The Global Fund – together with Pepfar (the President's Emergency Plan for Aids Relief) – has been the main source of money to pay for drugs. Those who start the combination treatments to prevent HIV causing Aids must stay on the drugs for life. If they stop, there is a danger the virus will become resistant to the drugs they are on.

The Global Fund's board is buying time by telling governments not to put in new applications for funding for round 11, which is supposed to provide money for 2011 to 2013. It is offering a "transitional funding mechanism", which will allow countries to ask for money to cover essential needs. In recognition of the danger of stopping HIV treatment, this should allow countries to continue to supply drugs to people who are already taking them.

But, as Secretary of State Hillary Clinton said in her recent address, the need now is to step up the fight against HIV by providing more drugs – not less. Scientific studies showed this year that treatment makes people with HIV less infectious. Failure to keep rolling out the drugs to more and more people will waste an opportunity to deliver what she and others have hopefully termed "an Aids-free generation".

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Integrating ART in Patients with TB

via The New England Journal of Medicine, by Salim S. Abdool Karim, M.B., Ch.B., Ph.D., Kogieleum Naidoo, M.B., Ch.B., Anneke Grobler, M.Sc., Nesri Padayatchi, M.B., Ch.B., Cheryl Baxter, M.Sc., Andrew L. Gray, M.Sc.(Pharm.), Tanuja Gengiah, M.Clin.Pharm., M.S.(Epi.), Santhanalakshmi Gengiah, M.A.(Res.Psych.), Anushka Naidoo, M.Med.Sci.(Pharm.), Niraksha Jithoo, M.B., Ch.B., Gonasagrie Nair, M.B., Ch.B., M.P.H., Wafaa M. El-Sadr, M.D., M.P.H., Gerald Friedland, M.D., and Quarraisha Abdool Karim, Ph.D.

Background

We previously reported that integrating antiretroviral therapy (ART) with tuberculosis treatment reduces mortality. However, the timing for the initiation of ART during tuberculosis treatment remains unresolved.

Methods

We conducted a three-group, open-label, randomized, controlled trial in South Africa involving 642 ambulatory patients, all with tuberculosis (confirmed by a positive sputum smear for acid-fast bacilli), human immunodeficiency virus infection, and a CD4+ T-cell count of less than 500 per cubic millimeter. Findings in the earlier-ART group (ART initiated within 4 weeks after the start of tuberculosis treatment, 214 patients) and later-ART group (ART initiated during the first 4 weeks of the continuation phase of tuberculosis treatment, 215 patients) are presented here.

Results

At baseline, the median CD4+ T-cell count was 150 per cubic millimeter, and the median viral load was 161,000 copies per milliliter, with no significant differences between the two groups. The incidence rate of the acquired immunodeficiency syndrome (AIDS) or death was 6.9 cases per 100 person-years in the earlier-ART group (18 cases) as compared with 7.8 per 100 person-years in the later-ART group (19 cases) (incidence-rate ratio, 0.89; 95% confidence interval [CI], 0.44 to 1.79; P=0.73). However, among patients with CD4+ T-cell counts of less than 50 per cubic millimeter, the incidence rates of AIDS or death were 8.5 and 26.3 cases per 100 person-years, respectively (incidence-rate ratio, 0.32; 95% CI, 0.07 to 1.13; P=0.06). The incidence rates of the immune reconstitution inflammatory syndrome (IRIS) were 20.1 and 7.7 cases per 100 person-years, respectively (incidence-rate ratio, 2.62; 95% CI, 1.48 to 4.82; P<0.001). Adverse events requiring a switching of antiretroviral drugs occurred in 10 patients in the earlier-ART group and 1 patient in the later-ART group (P=0.006).

Conclusions

Early initiation of ART in patients with CD4+ T-cell counts of less than 50 per cubic millimeter increased AIDS-free survival. Deferral of the initiation of ART to the first 4 weeks of the continuation phase of tuberculosis therapy in those with higher CD4+ T-cell counts reduced the risks of IRIS and other adverse events related to ART without increasing the risk of AIDS or death. (Funded by the U.S. President's Emergency Plan for AIDS Relief and others; SAPIT ClinicalTrials.gov number, NCT00398996.)

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.] 

The Inevitability of Antibiotic Resistance

via The Atlantic, by Megan Mcardle

On Christmas Eve 1947, George Orwell was admitted to a Scottish hospital with a case of galloping consumption. Orwell had first been diagnosed with tuberculosis almost 10 years earlier, but nonetheless, in what a biographer called “one of the many ill-judged decisions in a life littered with misjudgements,” he had recently moved to a remote and primitive Scottish cottage, where he began work on Nineteen Eighty-Four. There, he developed the night sweats, fever, and weight loss that are hallmarks of active TB. By the time he was admitted to the hospital, Mycobacterium tuberculosis had husked nearly 30 pounds off his already slender frame.

When I was younger and more romantic, I imagined that tuberculosis made you a good writer. After all, so many great ones, from Keats to Chekhov to all three Brontës, seemed to have died of it. Indeed, in 19th-century Europe, the “White Plague” may have caused as many as a quarter of all deaths. Though that proportion had fallen by Orwell’s time, writers from Camus to Bukowski were still contracting tuberculosis, as were millions of their less famous countrymen. Only antibiotics finally conquered the disease.

Victory arrived just barely too late for Orwell. His friends actually managed to obtain a supply of streptomycin, the brand-new anti-TB drug, from America, but it caused such a violent reaction that every morning when he woke, blood from the ulcers in his mouth had glued his lips shut. It had to be soaked off before he could speak. After several weeks, his doctors had to give up. A less powerful new drug called PAS, which he tried in 1949, didn’t make him so sick, but apparently didn’t much bother the tuberculosis bacilli, either. In January of 1950, an artery burst in his lungs, and at the age of 46, George Orwell drowned in his own blood.

It seems a medieval end for a very modern man. But we are not as far from TB as we like to think. It remains endemic in the developing world and is coming back in richer countries, thanks to travel and immigration, but also to a phenomenon that Alexander Fleming, the discoverer of penicillin, warned of in the 1940s: antibiotic resistance.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]