Adult mortality of HIV patients in Malawi has been significantly reduced after the introduction of free antiretroviral therapy (ART), according to a study published online in The Lancet, with effects large enough to detect at the population level.
Malawi, a country with a population of approximately 13 million people and located in southeastern Africa, witnesses some 80,000 deaths from AIDS each year. Between 2004 and 2006, the country offered free ART to over 80,000 patients. To evaluate the effectiveness of this program, researchers from the London School of Hygiene and Tropical Medicine collected and analyzed population data on HIV-related mortality both before and after the free ART program was introduced.
The population under study included 32,000 Northern Malawians. Mortality measurements were taken from August 2002, before the availability of free ART, to February 2006, eight months after the opening of a free ART clinic.
The study reports that before June 2005, the mortality rate among adults aged 15–59 years was 9.8 per 1000 person-years of observation. The researchers found that the probability of both men and women dying between these ages was approximately 43%, and 65% of deaths (229 of 352) were related to AIDS. The data collected 8 months after the opening of the free ART clinic indicated that of approximately 334 people who needed treatment, 107 accessed it.
“Our findings of a reduction in mortality in adults aged between 15 and 59 years, with no change in those older than 60 years, suggests that deaths from AIDS were averted by the rapid scale-up of free antiretroviral therapy in rural Malawi, which led to a decline in adult mortality that was detectable at the population level,” conclude the authors.
Matthias Egger and Andrew Boulle of the University of Cape Town, South Africa, add that the idea of universal access to ART is a remarkable challenge. They conclude: “Continued monitoring of the public-health effect of ART at the population level, including of such inequalities, is required as the scale-up of treatment in resource-limited settings continues.”
Source: Jahn A, Floyd S, Crampin AC et al. Population-level effect of HIV on adult mortality and early evidence of reversal after introduction of antiretroviral therapy in Malawi. The Lancet 371(9624) 1603–1611 (2008).
Tipranavir approved for suppression treatment of HIV by European Commission
The European Commission has given the full marketing authorization to its HIV protease inhibitor, Aptivus® (tipranavir) for the suppression of HIV in highly treatment-experienced patients who have developed resistance to other protease inhibitors.
The decision to grant full marketing authorization was taken on the evidence of two large multicenter pivotal trials that compared the superiority of tipranavir across several efficacy measures with that of a group of comparator protease inhibitors boosted with ritonavir. Treatment response rates over 156 weeks were nearly three times higher in the patients assigned to tipranavir compared with those taking ritonavir (20.9 vs 7.5%, respectively). Response rates were markedly higher for those patients who also started a new class of HIV therapy.
The data also demonstrated that tipranavir enabled treatment-experienced patients to achieve and sustain undetectable viral loads.
Andreas Barner, a Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine said: “We welcome this decision by the EU Commission to grant full marketing authorisation for Aptivus®. This full approval demonstrates the confidence that the authorities have in the benefit of Aptivus® for patients with resistant virus.”
Currently, Phase II and III studies in pediatric and other populations are fully enrolled and ongoing.
Source: www.boehringer-ingelheim.com/corporate/home/home.asp
Major shift in HIV prevention funding needed
Since the substantial investment in condom promotion, HIV testing and vaccine research has had limited success in Africa. Instead, male circumcision and reducing multiple sexual partners should be emphasized, according to a new study published in the May 9, 2008 issue of the journal Science.
According to the new policy analysis led by researchers at the Harvard School of Public Health and the University of California, Berkeley, the most common HIV prevention strategies – condom promotion, HIV testing, treatment of other sexually transmitted infections (STIs), vaccine and microbicide research, and abstinence – are having a limited impact on the predominantly heterosexual epidemics found in Africa.
Furthermore, some of the assumptions underlying such strategies, such as poverty or war being major causes of AIDS in Africa, are unsupported by rigorous scientific evidence. The researchers argue that the two interventions currently getting less attention and resources – male circumcision and reducing multiple sexual partnerships – would have a greater impact on the AIDS pandemic and should become the cornerstone of HIV prevention efforts in the high-HIV-prevalence parts of Africa.
“Despite relatively large investments in AIDS prevention efforts for some years now, including sizeable spending in some of the most heavily affected countries (such as South Africa and Botswana), it’s clear that we need to do a better job of reducing the rate of new HIV infections. We need a fairly dramatic shift in priorities, not just a minor tweaking,” said Daniel Halperin, lead researcher of the study.
The AIDS pandemic continues to devastate some populations worldwide. In most countries, HIV transmission remains concentrated among sex workers, men who have sex with men and/or injecting drug users and their sexual partners. In some parts of Africa, HIV has jumped outside these high-risk groups, creating “generalized” epidemics spread mainly among people who are having multiple and typically “concurrent” (overlapping, longer term) sexual relationships. In nine countries in southern Africa, more than 12% of adults are infected with HIV.
The authors state that the current widely used prevention strategies, while having value in some instances, are not as effective at preventing HIV transmission as male circumcision and reducing multiple sexual partners and thus should not continue to receive the bulk of donor investments for prevention, especially in Africa.
The authors argue that HIV prevention priorities need to shift significantly to reflect the best available scientific evidence. They note that only 1% of total prevention funding requested by the United Nations AIDS Program is earmarked for male circumcision, and that reducing multiple sexual partnerships would probably garner only a small fraction of “community mobilization and mass media,” “workplace” or other HIV prevention investments.
Michael Carter, spokesperson for Aidsmap said: “There is undoubtedly a growing sense of frustration about HIV incidence figures and this inevitably leads to the search for methods of prevention that appear more effective. If we’ve learnt anything from the past quarter of a century it’s to be pragmatic in our approach to HIV prevention. Circumcision and partner reduction do have a role and will have greater success in some settings than others.”
Source: Potts M, Halperin DT, Kirby D et al. Public health: reassessing HIV prevention. Science 320(5877), 749–750 (2008).
Synexus increases osteoporosis clinical trial capacity
Synexus has significantly increased its capacity to recruit and run global osteoporosis trials by increasing the number of DEXA scanners at its hub sites by one third. According to the American College of Radiology, the DEXA scan is the most reliable way of identifying osteoporosis and is the best test for measuring bone mineral density.
Osteoporosis affects one in three women aged over 50 years and one in five men around the world increasing to one in two and one in three in the over 60s. It is estimated that the worldwide cost of osteoporosis will increase to US$131.5 billion by 2050.
Synexus has complemented its DEXA investment with the provision of heel scanners to hundreds of primary care practices to boost enrolment. The company has recently carried out tens of thousands of heel tests and followed up with thousands of DEXA scans to recruit patients onto osteoporosis studies.
Michael Fort of Synexus said: “We have dramatically increased our capacity in the area of osteoporosis due to demand from our clients. With our network of fourteen clinics in the UK, Eastern Europe, South Africa and India we are able to randomize thousands of patients.”
Source: www.synexus.com
Medicare expenditures expected to top US$21.1 billion for 5 years of care for elderly cancer patients
The cost of cancer care for elderly Medicare patients varies by tumor type, stage at diagnosis, phase of care and survival, according to a new study published online in the Journal of the National Cancer Institute.
The 5-year cost is highest for patients with lung, colorectal, and prostate cancers. The estimated cost for 5 years of care for elderly Medicare patients diagnosed with cancer in 2004 is $21.1 billion, and these costs are expected to increase dramatically as the population ages, according to the study.
Cost estimates for cancer care are useful for the development and implementation of national cancer programs and policies. As the US population expands and ages, the incidence of cancer and its associated costs are expected to rise.
“Because the US population is aging and growing, we think that these costs are going to get higher in the future,” said lead researcher Robin Yabroff, an epidemiologist at the US National Cancer Institute, Bethesda. “We think there are going to be a lot more cancer patients in the future.”
“The main goal of this study,” Yabroff added, “was to provide cost-of-care estimates that could be useful for policy makers and health planners and researchers that might want to do cost–effectiveness analyses.”
To estimate the cost of cancer care in the US, Yabroff and colleagues used the Surveillance, Epidemiology, and End Results (SEER) and SEER-linked Medicare files to identify 718,907 cancer patients and 1,623,651 control subjects without cancer. The team subtracted the Medicare expenses for matched control subjects from the Medicare expenses for individuals diagnosed with cancer. The balance was the estimated net cost of cancer care per individual.
The mean net 5-year costs of care for elderly individuals varied widely, from less than US$20,000 for patients with breast cancer or melanoma to more than US$40,000 for patients with lymphoma, brain or other nervous system cancers or cancers of the esophagus, ovaries or stomach. Across all cancers, mean net costs were highest in the first 12 months of care and the last 12 months of life, and lowest in the period between the initial phase of care and last year of life.
The authors note that the study does not evaluate the cost-of-care in younger cancer patients. As these individuals frequently opt for more aggressive therapies, the cost of services may differ from those reported here. Additionally, as newer, more expensive therapies become routine care, the costs could soar.
Despite these limitations, “these estimates represent a basis for projections of cancer costs that will be particularly important with the growth and aging of the US population,” the authors write.
In an accompanying editorial, Joseph Lipscomb from Emory University, Atlanta, analyzes the methods used by Yabroff and colleagues and compares them with other cost-estimate approaches. The high-quality methods lead to solid, if not surprising results. “Few of these individual findings are startling; yet taken together, they provide the scientifically strongest picture yet of the incidence costs of cancer in aggregate and by tumor type for the elderly in the United States,” he writes.
Yabroff and colleagues’ choice to analyze cost based on the phase of patient care means that long-term projections are possible. Additionally, “the costing framework … would naturally facilitate the estimation of intervention-specific, patient-specific costs over time – precisely what cost-effectiveness analyses in cancer usually require,” Lipscomb writes.
Source: Yabroff KR, Lamont EB, Mariotto A et al. Cost of care for elderly cancer patients in the United States. J. Natl Cancer Inst. 100(9), 630–641 (2008)