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HIV—bridging the research gap in Sydney
Editorial
On July 22–24, the 4th International AIDS Society (IAS) Conference on HIV/AIDS pathogenesis, treatment, and prevention will take place in Sydney, Australia. To coincide with the meeting, this issue of The Lancet contains articles describing advances in the knowledge, treatment, and prevention of HIV/AIDS. The meeting is expected to draw around 5000 delegates and has received a record number of abstracts (3200)—a 50% increase from IAS 2005 in Rio de Janeiro, Brazil. Despite criticism over the years that IAS meetings lack scientific and clinical focus, this year promises to be different. Among highlights at the meeting will be the latest data for new drugs in both old and new classes, as well as new data for several drugs in development from early phase trials. The results of three phase III randomised trials, DUET-1, DUET-2, and TITAN, published in this week’s issue, will help to alleviate the unmet clinical need of patients who have exhausted all other treatment options. The drugs in these trials were fortunately part of the expanded access programmes (EAPs) that provide patients who have few or no therapeutic options with early access to new therapies. They extend the reach of standard clinical trials to those patients who may not have been able to enrol because of exclusion criteria or geographic access. EAPs have contributed to the survival of thousands of patients living with HIV. Undoubtedly, it is an exciting time in HIV drug development—a new protease inhibitor and new entry and integrase inhibitors —are all in the pipeline. However, a recent report warns that EAPs that provide access to experimental drugs are fragmented and underfunded, and discourage academic health centres and private physicians from participating. Presently, no systematic mechanism exists to quantify the number of patients whose treatments have failed, but the report estimates it could be as high as 13% in the USA. The current system “serves neither patients, companies, or regulators”, the report’s authors argue. They justifiably call for a radical reform of the system. A welcome addition to this year’s IAS programme is a new track on biomedical prevention which reflects the increased interest of the research community in the area of new prevention technologies. New data from the prematurely stopped cellulose sulphate microbicide trial and the diaphragm study will be presented at the meeting. However, the spotlight on new prevention www.thelancet.com Vol 370 July 7, 2007
technologies should not offset the fact that strong evidence of effectiveness currently exists for a broad array of HIV-prevention strategies. But the challenge is reaching the people who need them. According to a new report by the Global HIV Prevention Working Group, most prevention strategies are accessible to fewer than one in five people who could benefit from them—a level too low to have a substantial impact on the epidemic. Indeed, the prevention of mother–to-child transmission (PMTCT) is one such intervention. The poor coverage of PMTCT in the developing world, as highlighted by Philip Goulder and colleagues, is unacceptable. A dramatic push is needed to move the PMTCT agenda forward, including support for a comprehensive approach that addresses all the four prongs of this strategy, and which intensifies efforts related to paediatric diagnosis, treatment, and care. An interesting new insight into cancer as a major cause of morbidity in people with HIV/AIDS is provided by Andrew Grulich and colleagues. In a meta-analysis that compares cancer incidence in people with HIV, mostly from the USA, with transplant recipients from Europe and Australia, the range of infection-related cancers associated with immune deficiency was higher than previously thought. These findings will have huge implications for the long-term management of people with HIV. Perhaps one of the most important things to come out of the meeting will be the Sydney Declaration, which proposes that all HIV programmes should spend up to 10% on research. There are currently many examples of research for which an evidence base is lacking. For example, does the high early mortality on antiretrovirals occur because patients are entering the programmes too late or are there underlying toxicity issues? Could lower drug doses be used to treat more people? Should antiretrovirals be started earlier to prevent more cases of tuberculosis? This Declaration should catalyse the involvement of clinicians and scientists from the developing world as the roll-out of HIV/AIDS programmes expands, and create opportunities for more critical evaluation of the public-health response to the epidemic. It is imperative that funders are not allowed any excuses to say that the best possible outcomes on treatment and prevention for people with HIV are not being achieved. The Sydney Declaration should pave the way for that. ■ The Lancet
Robert Harding
HIV—bridging the research gap in Sydney
For more on DUET-1, DUET-2, and TITAN see Comment page 3 and Articles page 29, 39, and 49 For more on biomedical prevention see Comment page 10 For more on HIV entry inhibitors see New Drug Class page 81 For more on paediatric HIV infection see Seminar page 68 For more on cancer incidence see Comment page 6 and Articles page 59 For more on the Sydney Declaration see Comment page 7
For more on the IAS conference see http://www.ias2007.org/ For more on EAPs see http:// hivforum.org/uploads/EAP/ EAP%20Final%20Report.pdf For more on prevention see http://www.globalhivprevention. org/
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On July 22–24, the 4th International AIDS Society (IAS) Conference on HIV/AIDS pathogenesis, treatment, and prevention will take place in Sydney, Australia. To coincide with the meeting, this issue of The Lancet contains articles describing advances in the knowledge, treatment, and prevention of HIV/AIDS. The meeting is expected to draw around 5000 delegates and has received a record number of abstracts (3200)—a 50% increase from IAS 2005 in Rio de Janeiro, Brazil. Despite criticism over the years that IAS meetings lack scientific and clinical focus, this year promises to be different. Among highlights at the meeting will be the latest data for new drugs in both old and new classes, as well as new data for several drugs in development from early phase trials. The results of three phase III randomised trials, DUET-1, DUET-2, and TITAN, published in this week’s issue, will help to alleviate the unmet clinical need of patients who have exhausted all other treatment options. The drugs in these trials were fortunately part of the expanded access programmes (EAPs) that provide patients who have few or no therapeutic options with early access to new therapies. They extend the reach of standard clinical trials to those patients who may not have been able to enrol because of exclusion criteria or geographic access. EAPs have contributed to the survival of thousands of patients living with HIV. Undoubtedly, it is an exciting time in HIV drug development—a new protease inhibitor and new entry and integrase inhibitors —are all in the pipeline. However, a recent report warns that EAPs that provide access to experimental drugs are fragmented and underfunded, and discourage academic health centres and private physicians from participating. Presently, no systematic mechanism exists to quantify the number of patients whose treatments have failed, but the report estimates it could be as high as 13% in the USA. The current system “serves neither patients, companies, or regulators”, the report’s authors argue. They justifiably call for a radical reform of the system. A welcome addition to this year’s IAS programme is a new track on biomedical prevention which reflects the increased interest of the research community in the area of new prevention technologies. New data from the prematurely stopped cellulose sulphate microbicide trial and the diaphragm study will be presented at the meeting. However, the spotlight on new prevention www.thelancet.com Vol 370 July 7, 2007
technologies should not offset the fact that strong evidence of effectiveness currently exists for a broad array of HIV-prevention strategies. But the challenge is reaching the people who need them. According to a new report by the Global HIV Prevention Working Group, most prevention strategies are accessible to fewer than one in five people who could benefit from them—a level too low to have a substantial impact on the epidemic. Indeed, the prevention of mother–to-child transmission (PMTCT) is one such intervention. The poor coverage of PMTCT in the developing world, as highlighted by Philip Goulder and colleagues, is unacceptable. A dramatic push is needed to move the PMTCT agenda forward, including support for a comprehensive approach that addresses all the four prongs of this strategy, and which intensifies efforts related to paediatric diagnosis, treatment, and care. An interesting new insight into cancer as a major cause of morbidity in people with HIV/AIDS is provided by Andrew Grulich and colleagues. In a meta-analysis that compares cancer incidence in people with HIV, mostly from the USA, with transplant recipients from Europe and Australia, the range of infection-related cancers associated with immune deficiency was higher than previously thought. These findings will have huge implications for the long-term management of people with HIV. Perhaps one of the most important things to come out of the meeting will be the Sydney Declaration, which proposes that all HIV programmes should spend up to 10% on research. There are currently many examples of research for which an evidence base is lacking. For example, does the high early mortality on antiretrovirals occur because patients are entering the programmes too late or are there underlying toxicity issues? Could lower drug doses be used to treat more people? Should antiretrovirals be started earlier to prevent more cases of tuberculosis? This Declaration should catalyse the involvement of clinicians and scientists from the developing world as the roll-out of HIV/AIDS programmes expands, and create opportunities for more critical evaluation of the public-health response to the epidemic. It is imperative that funders are not allowed any excuses to say that the best possible outcomes on treatment and prevention for people with HIV are not being achieved. The Sydney Declaration should pave the way for that. ■ The Lancet
Robert Harding
HIV—bridging the research gap in Sydney
For more on DUET-1, DUET-2, and TITAN see Comment page 3 and Articles page 29, 39, and 49 For more on biomedical prevention see Comment page 10 For more on HIV entry inhibitors see New Drug Class page 81 For more on paediatric HIV infection see Seminar page 68 For more on cancer incidence see Comment page 6 and Articles page 59 For more on the Sydney Declaration see Comment page 7
For more on the IAS conference see http://www.ias2007.org/ For more on EAPs see http:// hivforum.org/uploads/EAP/ EAP%20Final%20Report.pdf For more on prevention see http://www.globalhivprevention. org/
1