The [him] moderator finds these two studies directly relate to HIV prevention and care in Myanmar / Burma. The first demonstrates that antiretroviral therapy is cost effective in South Africa. And the second studies the prophylactic use of tenofovir – in North America! Watch this space for more in the future.
Study finds antiretroviral therapy cost-effective in South African setting
Theo Smart
10 January 2006
Contrary to expectations about the expense of antiretroviral therapy (ART), using ART in people with AIDS should be cost-effective for South Africa’s public health sector according to a study published in January’s PLoS Medicine (an 'open-access' medical journal). The cost of not using ART to treat people with AIDS is significantly greater — as patients with AIDS required more expensive time in the hospital and other medical care.
In less ill patients with HIV, the study also found that using ART was still less expensive than medical care without ART, but only if lower cost generic drugs rather than brand name drugs are used.
Cost-effectiveness studies
In industrialised countries, like the United Kingdom and the United States, studies in the late 1990s demonstrated that ART was very cost-effective. ART led to dramatic improvements in health and a shift from inpatient hospital care to outpatient clinic visits. In addition, patients on ART underwent fewer diagnostic procedures and needed fewer costly treatments for opportunistic infections. Finally, ART in industrialised countries extended life, and added years of productivity for people with HIV who were able to get back to work again or continue working.
Until recently, there seemed to be little point in conducting similar studies in the developing world, but in the past few years, dramatic reductions in the cost of antiretroviral drugs has allowed the rollout of ART through the public health sector of several resource-constrained countries, including South Africa.
South Africa’s health system was already under severe stress from the impacts of the HIV epidemic. By the year 2000, HIV-related conditions accounted for nearly one fourth of all public hospital admissions and one eighth of the total public health budget, and the problem is only expected to worsen. Given the scale of the epidemic in the country, the fate of South Africa’s health care system is dependant upon how efficiently the government manages the crisis.
The trial
A team from the University of Cape Town (collaborating with researchers from Chelsea and Westminster Hospital in London and McGill University in Montreal) conducted a study to calculate the cost of HIV care for persons receiving ART and a comparison group not receiving ART in order to determine the cost-effectiveness of ART in the South African setting. The analysis also compared clinical outcomes, in terms of disease progression and how many years of life were gained (LYG) by the clinical stage of HIV infection (with AIDS: WHO stage 4, and without AIDS: WHO stages 1, 2, and 3).
Subjects were drawn from the Cape Town AIDS Cohort (CTAC), a prospective cohort study that accrued patients before ART was freely available in public sector hospitals (between 1995 and December 2000). All of those receiving ART in the study (292 patients: 265 without-AIDS and 27 with AIDS) were actually participating in phase III clinical trials. These were compared to a group of patients from the CTAC — matched for baseline WHO stage, CD4 count, age, and socio-economic status — who received care for HIV but who were not fortunate enough to receive ART. Hospital records were used to compare outcomes (the number of clinic outpatient visits, days spent in the hospital, lab tests and other costs).
The HIV care costs were based on public sector costs in the year 2000 (adjusted for inflation in 2004), using an exchange rate of 7.6 Rand to the US dollar. For the cost of antiretroviral therapy, they used two figures: Scenario 1) the actual cost of branded drugs to the public sector in 2004, $730 per year, and Scenario 2) the cost for generic ART that was expected to be negotiated by the South African government, $181 per year. (This was indeed close to the cost that was negotiated, at least for the first line nevirapine-based regimen).
Results for people with AIDS
Patients with AIDS on ART spent a mean of 2.04 (95% CI: 1.63–2.52) days in the hospital per patient year (PPY) compared to 15.36 (95% CI: 13.97–16.85) days for the group not on ART. Patients on ART were more likely to utilise outpatient services: mean outpatient visits PPY was 7.62 (95% CI: 6.81–8.49) compared to 6.60 (95% CI: 5.69–7.62) for those not on ART.
The average cost PPY of providing services to people with AIDS not on ART was $3,520 versus $1,513 for scenario 1 and $964 for scenario 2 for people with AIDS on ART. The incremental cost per LYG was cost-saving for both scenarios.
Results for people without AIDS
Patients without AIDS on ART spent a mean 1.08 (95% CI: 0.97–1.19) days in the hospital PPY versus 3.73 (95% CI: 3.55–3.97) for the No-ART group, and 8.71 (95% CI: 8.40–9.03) versus 4.35 (95% CI: 4.12–5.61), respectively, for mean number of outpatient visits PPY. Average service provision PPY was $950 for the No-ART group versus $1,342 and $793 PPY for the ART group for scenario 1 and 2, respectively, whereas the incremental cost per life-year gained (LYG) was $1,622 for scenario 1 and $675 for scenario 2.
Limitations and commentary
Current South African guidelines recommend treatment for people with HIV with symptomatic disease and CD4 cell counts below 200. Because the study used clinical definitions for AIDS (WHO stage 4) but not CD4 cell counts, about a third of the patients not considered to have AIDS would have qualified for treatment in South Africa today. It is unfortunate that a separate analysis did divide the two groups into 'those who would qualify for treatment' today and 'those who would not.' The study noted that, indeed, CD4 cell counts were predictive of progression (and hospitalisation) in a univariate analysis so presumably the cost savings from ART would apply to this group as well. However, the other two thirds of the group without AIDS would not be considered to be in immediate need of treatment — and using ART in such patients may not be cost-effective.
The costs in the study included were only direct costs and did not add in the indirect or intangible costs, such as loss of productivity or quality of life associated with HIV/AIDS. In the UK, such indirect costs can comprise between 45% and 124% of total treatment costs. "Currently no such data exist in South Africa,' the authors note, however, "if these costs were all included, it is likely that the cost-effectiveness ratio would even be more favourable."
The researchers also had to deal with measuring a moving target, conducting their analysis at a time when antiretroviral prices and purchasing policy were in a state of flux. Also today’s Rand is somewhat stronger (at around 6 Rand to the US Dollar), and it's not clear how this would affect the price of antiretroviral drugs or cost of care for people with HIV in this study. Nevertheless, even though the actual prices are somewhat different, the most common first-line regimen is generic and its cost is similar to what the researchers projected. However, the most common second-line regimen, which is anchored by the brand name protease inhibitor Kaletra, is roughly three times as costly.
After years of inaction, the South African government finally began to provide ART though the public sector about a year and a half ago (and negotiated the antiretroviral drug purchasing contracts about a year later). Yet the pace of the rollout is much slower than hoped.
The study illustrates that delay in the rollout of ART (and failure to negotiate better drug prices) doesn’t just hurt people (which ought be enough), it can also be quite expensive. And perhaps that might motivate the government to expedite the process.
Reference
Badri M et al. Cost-Effectiveness of Highly Active Antiretroviral Therapy in South Africa. PLoS Medicine: 3(1) e4, 2006.
available online http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030004
http://www.aidsmap.com/en/news/DC0E377B-1BC0-4BCA-A86C-8A96A734D99A.asp?type=preview
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Protect or Disinhibit?
Jon Cohen
January 22, 2006
At the end of every year, the Joint United Nations Program on H.I.V./AIDS releases an update on the epidemic. In keeping with tradition, the news for 2005 remained grim: an estimated 4.9 million people were infected with H.I.V. during the year - up from 4.6 million in 2003.
Of course, researchers have made progress in treating patients who already have H.I.V., developing powerful drug cocktails that can stave off disease. But when it comes to preventing the virus's spread, success is spotty. One of the few effective interventions involves the use of anti-H.I.V. drugs to keep a mother from infecting her baby. And an underappreciated facet to this story has far-reaching implications: both mothers and their uninfected babies receive the drugs.
If anti-H.I.V. drugs can help uninfected babies dodge the virus, might the same approach work for uninfected adults? Could the sexually active take antiretrovirals to avoid contracting H.I.V. in the first place? Intrigued by the prospects, some gay men already have experimented with what's known as "pre-exposure prophylaxis" or PrEP: a recent survey conducted by the U.S. Centers for Disease Control and Prevention at gay-pride events in four U.S. cities found that 7 percent of those interviewed said they had tried it.
A half-dozen studies are now under way that will determine whether these men are onto something. The trials all focus on tenofovir (marketed under the brand name Viread), a drug that appears safer than the other AIDS medications on the market. Placebo-controlled trials are enrolling 5,000 people on four continents who are in high-risk groups, including gay and bisexual men, sex workers and injecting drug users. All told, the experiments will cost more than $40 million, which is being paid for by the C.D.C. and the National Institutes of Health, as well as the Bill and Melinda Gates Foundation.
Dr. Susan Buchbinder, head of the H.I.V. research section at the San Francisco Department of Public Health, runs one of those trials, known as Project T. Buchbinder says she initially had "big reservations" about the research, because she worried about what psychologists call "behavioral disinhibition": what if fear of H.I.V. declined in people who took the drug, and they then skipped using condoms or increased their number of sex partners? "It's scary as an investigator, as a public-health official and as a person who has worked with the community for many years to think about doing something that could paradoxically make the epidemic worse rather than better," she says.
Buchbinder decided to conduct Project T because tenofovir PrEP had worked well in research monkeys and because she'd heard the anecdotes about underground use, including a cocktail known in street slang as "the 3V's": Viread, Viagra and Valium. If the intervention worked, she reasoned, then researchers could confront the problem of behavioral disinhibition head-on with education campaigns, much as they do with condom promotion efforts that simultaneously encourage monogamy or even abstinence. And if tenofovir PrEP fails to stop H.I.V. transmission or causes serious side effects, then people urgently needed that information too. (In part because the prospect of harming a healthy person raises formidable liability issues for Gilead Sciences, tenofovir's manufacturer, the company says it has no interest in marketing the drug as a prophylaxis, even if trials prove that it works.)
Optimistic mathematical models show that if tenofovir PrEP is effective 90 percent of the time and is used by 90 percent of the people who are at highest risk of becoming infected, it could cut new H.I.V. infections in a community by more than 80 percent in a few years. That is, if behavioral disinhibition does not undo the benefits.
Dr. Marcus Conant, a San Francisco clinician who has specialized in AIDS since the start of the epidemic, has high hopes that tenofovir PrEP will work wonders. Indeed, he already prescribes it to a half-dozen select patients. "With my patients, it's not even ethical for me to wait for the science," Conant says. "I can identify those patients who I know are at extremely high risk. Should I wait for the scientific evidence to prove that it doesn't work before I give it to someone where it may work?"
Even if it works spectacularly well, tenofovir PrEP will not substitute for an AIDS vaccine, the holy grail of prevention research. With a vaccine, a few shots can train an immune system to ward off a disease for decades. But tenofovir PrEP would work only if people take the drug repeatedly. Then again, no AIDS vaccine is on the near horizon. Tenofovir PrEP, in contrast, could prove its worth by 2008.
Jon Cohen is a correspondent for Science magazine and the author of "Shots in the Dark: The Wayward Search for an AIDS Vaccine."
http://www.nytimes.com/2006/01/22/magazine/22wwln_essay.html?emc=eta1
