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• Perplexing Results of Failed HIV Vaccine Grow More Puzzling

The spread of HIV appears to have peaked, according to new data from the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization.

In a report issued today, the two agencies say the number of new infections every year has been dropping since 1996, when 3.5 million people acquired the virus.

In 2008, the agencies said, 2.7 million people got HIV, down about 30% from the 1996 figure.

A little more than half of the decrease — about 17% — came in the past eight years, since the 2001 United Nations Declaration of Commitment on HIV/AIDS was signed.

At the same time, more people are living with HIV, according to the 2009 AIDS Epidemic Update.

In 2008, 33.4 million people were living with the virus, more than 20% higher than in 2000 — an increase that the agencies said reflects a combination of continuing high rates of infection and the beneficial effects of antiretroviral therapy.

As of the end of 2008, about four million people in low- and middle-income countries were getting antiretroviral treatment, which marks a 10-fold increase over five years.

Despite wider access to therapy, the report says, AIDS-related illnesses claimed two million lives in 2008.

But that number is 10% lower than in 2004, which the agencies said may have been the peak of AIDS-related mortality. In that year — eight years after the 1996 peak in infections — 2.2 million AIDS-related deaths occurred.

Although the pandemic “appears to have stabilized” in most regions, the report said, other areas — notably Eastern Europe and Central Asia — are continuing to see increases in new cases.

“The good news is that we have evidence that the declines we are seeing are due, at least in part, to HIV prevention,” according to Michel Sidibé, executive director of UNAIDS.

But, Sidibé said in a statement, the report also showed that prevention planning often misses the mark.

“If we do a better job of getting resources and programs to where they will make the most impact, quicker progress can be made and more lives saved,” he said.

For the first time in more than two decades, the International AIDS Conference will return to the U.S.

The 2012 meeting will be held in Washington 22 years after the last AIDS conference in the U.S., which was held in San Francisco in 1990, the International AIDS Society (IAS), which organizes the world meeting, has announced.

The decision comes after President Obama’s announcement in October that the U.S. would end its entry restrictions on people living with HIV effective next Jan. 4.

“The return of the conference to the U.S. is the result of years of dedicated advocacy to end a misguided policy based on fear, rather than science,” according to society President-Elect Elly Katabira, MD, of Uganda’s Makerere University.

It also “represents a significant victory for public health and human rights,” Katabira said in a statement.

AIDS activists welcomed the announcement, although they said there remains much to be done to improve the way HIV and AIDS are dealt with in the U.S.

It’s “great news,” said Mitchell Warren, executive director of the New York-based AIDS Vaccine Advocacy Coalition.

Warren called the decision “an acknowledgement of the U.S. government’s important move to overturn the HIV entry ban and right a decades-long human rights travesty.”

And, he added in an e-mail, “it is fitting that the conference will be held in Washington, highlighting the tragedy of that city’s severe HIV epidemic.

IAS president, Julio Montaner, MD, of the B.C. Centre for Excellence in HIV/AIDS in Vancouver, said the new unrestricted entry policy of the U.S. “reflects its key role in global efforts to combat AIDS.”

“We urge other nations with similar discriminatory policies still in place to follow suit,” Montaner said in a statement.

The U.S. restrictions, imposed by Congress in 1987, had been an embarrassment to American researchers and activists because it put the country — at the forefront in AIDS research and treatment — in the company of such states as Iraq, China, Saudi Arabia, Libya, and Sudan.

Because of the travel ban, there was a partial boycott of the 1990 meeting in San Francisco and the 1992 meeting, planned for Boston, was shifted to Amsterdam.

But the choice of Washington is also significant because the city is home to some of the key players in the fight against HIV/AIDS — including the Office of the U.S. Global AIDS Coordinator (which directs the President’s Emergency Plan for AIDS Relief), the NIH, and the World Bank.

In its announcement, the AIDS society noted that HIV/AIDS has a “disproportionate impact among racial and ethnic minorities in the U.S,” and some 3% of Washington residents are known to be living with HIV.

An HIV epidemic is defined to be “generalized and severe” when it reaches 1% in a geographic area, the society said, adding that African-Americans make up 53% of the population of Washington, but account for 76% of those living with HIV.

But the society was faulted for ignoring gay men in its statement.

Julie Davids, co-director of the new York-based Community HIV/AIDS Mobilization Project, said in an e-mail, “We applaud the IAS for their work against the HIV entry ban, and for the opportunity to bring the conference to Washington.”

But she said her organization is “disturbed” that the society’s announcement — while mentioning disparities in the U.S. and the large-scale epidemic in Washington itself — “completely neglects to mention gay men.”

“Gay men of all races and ethnicities are approximately 50 times — not 50% but 50 times — more likely to be HIV positive than other U.S. residents,” Davids said.

She also said there are “gaping holes” in HIV healthcare and said it’s not clear if the U.S. healthcare reforms now being debated will alter that.

The 2012 meeting is expected to attract more than 25,000 delegates from nearly 200 countries, including more than 2,500 journalists, to the Walter E. Washington Convention Center from July 22 to 27.

The 2010 conference is to be held in Vienna.

• Explain to interested patients that directly observed therapy has been touted as a way to improve adherence to treatment among patients with HIV.
• Note that this meta-analysis found no evidence of a benefit for the approach in general, although it might have some value in a population at high risk for nonadherence to the drug regimen.

Watching people take their HIV medications appears to have no advantage over self-administered treatment in improving adherence, researchers said.

In a meta-analysis, patients on so-called directly observed therapy — or DOT — were no more likely to have viral suppression than those who were not observed while taking their drugs, according to Nathan Ford, MPH, of Médecins Sans Frontières (Doctors Without Borders) in Cape Town, South Africa, and colleagues.

In the study, viral suppression was used as a stand-in for adherence to medication, which is regarded as important not only for its effect on the outcome of therapy but also to avoid the rise of drug resistance, Ford and colleagues said online in The Lancet.

The finding “calls into question” the use of DOT to promote drug adherence in a general population of people with HIV, the researchers concluded.

But it may be “over-reaching” to conclude that DOT has no benefit at all, according to Julie Myers, MD, and Simon Tsiouris, MD, both of Columbia University in New York City.

In an accompanying commentary, they argued that DOT may not be useful in a general population, but might still have value among those at high-risk for nonadherence.

DOT was first used with tuberculosis patients, where it is promoted as a way to ensure that the disease is adequately treated. But whether such an intensive intervention would be possible and useful in HIV therapy — which is a lifetime affair — remains unclear.

To shed light on the issue, Ford and colleagues analyzed 12 randomized trials that assessed the effect of DOT versus self-administered therapy, four of them in groups thought to be at high risk of poor adherence, such as drug users and homeless people.

The method of DOT varied among the studies, with some having an observer watch all doses being taken, and others observing only once a day or less often.

Ten of the studies — with a total of 1,862 patients — reported viral suppression at study completion, Ford and colleagues found, but there was no evidence of a difference between the interventions.

Specifically, the pooled relative risk was 1.04, with a 95% confidence interval from 0.91 to 1.20, which was nonsignificant at P=0.55, they found.

On the other hand, in the four studies that enrolled populations at high risk of nonadherence, the relative risk was 1.31 in favor of DOT (with a 95% confidence interval from 1.00 to 1.71, which was significant at P=0.0464).

The latter finding, among others, suggests that “important differences in population groups could still lead to substantial differences in outcomes,” the researchers said.

Analysis of secondary outcomes showed that self-reported adherence was not significantly different for the two groups.

And adherence in both groups was high — 89% on average for DOT and 88% for self-administered treatment.

The study was limited by the lack of a gold standard for adherence, the researchers said, adding they used viral load as a marker because it was unlikely that pharmacodynamics would be affected by a placebo effect.

Another possible limitation is that the analysis may not have captured all the trial data, they said, especially since six studies were derived from abstracts and have yet to be published.

Ford and colleagues argued that even if the treatment effect was at the higher end of the confidence interval — a 20% benefit — “widespread use of directly observed therapy would not be justified” because of the difficulty and cost of DOT in HIV.

In the accompanying comment, Myers and Tsiouris said that concluding that DOT might not be suitable in a general population is “reasonable,” especially given the relative lack of data.

“A real world, widespread rollout of directly observed therapy would be impractical,” they argued.

Instead, they called for HIV adherence programs that are multimodal, tailored to the target population, and easily integrated into public health treatment systems.