Wrapping up CROI 2013, Part I: TB on the verge, VOICE trial point to future research needs, sequestration consequence points to rough road ahead

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Science Speaks spent March 3 – 6 at the Conference on Retroviruses and Opportunistic Infections, covering breaking research news and discussions. Today and tomorrow we will wrap up with summaries of sessions, and questions they raised. Today Science Speaks will look at a obstacle for researchers, while presentations pointed to directions for future studies

First a question: Who didn’t make it to the conference because of sequestration? This question was raised as the conference began in the wake of automatic across the board cuts in broad areas of federal spending, including to the National Institutes of Health, which supplies funding for and direction of research pivotal to the conference. According to the NIH, with sequestration tightening the purse strings, only those staff who were presenting research or had other leadership activities at CROI were sent to the conference. “As a result, the number of NIH attendees was reduced by 69 percent from 203 who planned to attend to 63 who actually attended,” a statement released by NIH continued. “Additionally, those staff who did attend did not attend a number of ancillary events around the meeting.” The statement sums up the immediate impact of missing one of the most important scientific meetings on HIV: “[T]he reduction in NIH attendance at the meeting will have an impact on the important work that occurs at the meeting in scientific exchange, establishing collaborations, and moving science forward at a time when AIDS research is making critical advances.”

Earlier, as sequestration loomed, the NIH also posted its Operation Plan in the Event of a Sequestration saying it would reduce funding levels of some grants, and make fewer competing awards.

All of which puts the future of the robust research to come — those outlined CROI’s final  tuberculosis session, and those raised by the VOICE trial results released at the conference — in question.

TB on the verge: “You can interpret ‘on the verge’ anyway you like,” session convener Constance Benson said, introducing the session, “but my intention in entitling this was ‘on the verge of great discovery and new therapies.'” The optimism of that view was warranted by much of what followed, in discussions on strategies for prevention of active tuberculosis, progress in diagnostic technology, emerging data on pediatric tuberculosis, and new directions in managing drug-resistant tuberculosis.

A series of disappointments in the durability of preventive therapy against tuberculosis has highlighted the need to scale up continuous preventive treat with combinations of other approaches, including community-wide interventions as well as improved diagnosis and screening, Gavin Churchyard of the University of the Witwatersrand in Johannesburg, South Africa said. A rigorous combination approach, he said could have a significant impact.

In turn the diagnostic landscape has never looked this good, with the World Health Organization moving quickly over the last six years to recommend six new approaches to diagnosis, Catharina Boehme, of FIND, the Foundation of Innovative New Diagnostics in Geneva Switzerland, said. Offering an opportunity to enhance case detection, identify drug resistance, reduce time to treatment, and decrease initial treatment default, these tools enable a more efficient overall response to tuberculosis. The greatest uptake, she said, has been of the GeneXpert, which by getting “the right patients on treatment,” makes possible the best use of resources, and improved prevention of drug resistance. Still, she identified “major gaps” in diagnostic technology, along with reasons to hope they will be filled. While improving detection of extrapulmonary and pediatric tuberculosis remains critical, the World Health Organization will review the evidence for a urine test in 2013. Stool tests for children under five are promising, she said.

Soumya Swaminathan of the National Institute for Research in TB in Chennai, India, delivered more good and bad news about pediatric tuberculosis in a single point: The burden of TB in children was estimated for the first time in 2011. The information those estimates provide, including nearly half a million new cases and 65,000 deaths annually, should add impetus to learning more about the disease in children. That includes how tuberculosis fighting drugs work with children’s metabolisms. “Children are not just little adults,” she pointed out. New dosing guidelines have helped raise drug levels in children, she said. Among the research priorities she recommended: better point of care diagnostic tools for children.

Wrapping up that session, Alexander Pym of the Nelson Mandela School of Medicine at the University of KwaZulu-Natwal in Durban, South Africa, pointed to the development of new drugs — the recently FDA-approved Situro, or bedaquiline, and delamanid, pending approval by the European Medicines Agency, saying they have not only created the possibility of new approaches to multidrug-resistant tuberculosis, but “we may have in our hands a testable regimen for XDR tuberculosis.”

Finally, the results of the VOICE trial, released at CROI March 4, and covered here, were disappointing in what they did reveal. But they were critically important in the path they pointed to: What were the reasons most women did not adhere to a daily regimen in the trial that sought to determine value two oral and one vaginal products, used daily, to prevent HIV acquisition? In addition, how will that trial change the direction of future research, in adherence monitoring, in participant screening, and in product development? These were questions a Webinar on the trial results presented by AVAC earlier today took on, with lead researcher Jeanne Marrazzo presenting key points of the research and its conclusions and taking questions from listeners. While the trial did track adherence through self-reporting as well as the return of empty pill bottles and applicators, the proof of adherence, or nonadherence — the level of drug found in blood tests throughout the trial was not known to researchers until the end. Yes, she said, the trial could change the course of future trials, and the way adherence is monitored. She also answered questions on incentive for participation. While in South Africa a monetary payment is required, participants in the study’s other two countries received a package of health services that, she said, was “quite generous and compelling.” The draw of “a community of people who were organized and dedicated” to participants well-being seemed strong, she said, but, she added, until researchers know what kept women from adhering to the regimen of a daily prevention method, “we won’t get anywhere.”


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