VA Attacks HIV Transmission with Aggressive Treatment

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VA Attacks HIV Transmission with Aggressive Treatment - Prophylaxis

Categorized in: 2012 Compendium of Federal Medicine, Department of Veterans Affairs (VA), HIV

Risk Reduction

HIV Prophylaxis Only for High-Risk Transmitters Could Be Cost Effective
PALO ALTO, CA — Prophylaxis for HIV can be effective in preventing spread of the disease but is economically feasible only if used in very select, high-risk groups, according to a study funded by VA and the National Institutes of Health.
Researchers from Stanford University and the VA Palo Alto Healthcare System looked at the cost-effectiveness of once-a-day administration of the combination drug tenofovir-emtricitabine. A 2010 trial found that the drug combination reduces risk of HIV infection by 44% in a daily dose, with patients who strictly followed the regimen reducing their risk as much as 73%.
The recent study, published in the Annals of Internal Medicine, used an economic model focused on men who have sex with other men (MSM); that group makes up more than half of the estimated 56,000 new HIV infections in the United States each year, according to the Centers for Disease Control and Prevention.
"Promoting [prophylaxis] to all men who have sex with men could be prohibitively expensive," said Jessie Juusola, a PhD candidate in management science and engineering in Stanford’s School of Engineering and first author of the study. "Adopting it for men who have sex with men at high risk of acquiring HIV, however, is an investment with good value that does not break the bank."
Researchers estimated that using the medication for the entire MSM population would cost $495 billion over 20 years, but would cost much less --$85 billion— when those at particularly high risk were targeted. The cost of the drug is about $26 a day, or almost $10,000 a year, and the study also added in expenses for physician visits, periodic monitoring of kidney function and regular testing for HIV and sexually transmitted diseases.
Earlier studies had found that pre-exposure prophylaxis (PrEP) was not cost-effective when compared with other prevention programs. This study also assumed that high-risk individuals would stop taking PrEP after 20 years and not stay on the drug for life, as assumed in some previous studies.
Interim guidelines on the use of the combination drug, marketed under the brand name Truvada, were issued more than a year ago by the CDC, which suggested that practitioners regularly monitor patients for side effects it they use PrEP and also counsel them on adherence, condom use and other methods to reduce infection risk.
"We're talking about giving uninfected people a drug that has some toxicities, so it's crucial to have them monitored regularly," said senior author Eran Bendavid, MD.
Researchers estimated that, without PrEP, the MSM population would develop 490,000 new HIV infections over the next 20 years. With just 20% of those men taking the daily pill, the number of new infections would decline by 63,000. Treating even 20% of that group would be cost-prohibitive at $98 billion over 20 years, the authors reported.
On the other hand, if PrEP were only used by 20% of high-risk individuals, defined as those who have five or more sexual partners in a year, the 41,000 new infections would be prevented at a cost of about $16.6 billion over 20 years.
That would be less than $50,000 per quality-adjusted life year gained, arguably a relatively good value, according to Juusola.
"However, even though it provides good value, it is still very expensive," she said. "In the current healthcare climate, PrEP's costs may become prohibitive, especially given the other competing priorities for HIV resources, such as providing treatment for infected individuals."
A pill that could be used intermittently, rather than on a daily basis, would substantially cut the cost of prophylaxis, she added.

An earlier study, the Pre-Exposure Prophylaxis Initiative (iPrEX), found that seronegative men who have sex with men (MSM) who took a daily combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) substantially reduced their risk of HIV, with an average risk reduction among study participants of 44%. Risk reduction rose to 78% among participants who had 90% or greater adherence to the protocol.

The Partners Pre-Exposure Prophylaxis (PrEP) study also showed that the TDF/FTC combination reduced HIV-1 acquisition risk by 90% in seronegative heterosexual individuals in whom TDF was detectable in plasma, according to researchers at the 2012 Conference on Retroviruses and Opportunistic Infections. TDF alone provided 86% protection when at a detectable level. Earlier analyses of the Partners-PrEP results, which did not look for detectable drug levels, did not find a benefit for prophylaxis in heterosexuals.

In response to the iPrEX results, the Centers for Disease Control and Prevention (CDC) issued interim guidance in 2011, Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men. Because the initial analyses had not shown a clear benefit in heterosexuals, the CDC’s interim recommendation did not cover that population. To educate providers about the new recommendations, the VA offered a webinar series for clinicians in primary care, HIV, mental health, pharmacy and other areas involved in treatment of HIV-positive veterans.

“In addition to the education programs, we have worked closely with pharmacy management to ensure that seronegative veterans who were at risk and interested in prophylactic treatment could get the medications,” recounted Czarnogorski. “So far, though, we haven’t had any requests.”

“We can’t treat partners who are not veterans, but we do encourage local VA facilities to form partnerships in their communities to which they can refer nonveteran partners. We also encourage partners to come in for education and for everyone affected to join or create support groups,” she said.

Research results recently published in AIDS tempers some of the good news presented during the past year. That study provided some insight into conditions that might reduce the effectiveness of highly active ART (HAART) treatment. According to researchers at the Boston University School of Medicine and Fenway Health, individuals with undetectable viral loads in their blood can still pass on HIV if they have other sexually transmitted infections (STIs) or genital inflammation. At the VA, integrated programs that focus on prevention and treatment of HIV and other STIs minimize the number of HIV-positive veterans with infections that could increase the likelihood they would pass the virus onto their partners.

Final recommendations on prophylactic treatment are expected from the CDC in 2012.

“The controversy over the benefit for women has delayed finalization of the recommendations, but when the CDC releases expanded guidelines for treatment and prevention, we will respond and implement immediately,” said Czarnogorski. “As one of the six lead agencies in the National HIV/AIDS Strategy, the VA is committed to ensuring the highest standard of care throughout the country.

“We’ve been at the forefront of the HIV epidemic since it started. We saw our first cases in 1981, when AIDS was first described. Since then, the VA has treated 64,000 veterans. Today we have 24,000 diagnosed and in care,” making the VA the largest single provider of HIV healthcare in the United States, she noted. “With our EMR, HIV Clinical Case Registry and other databases, we can contribute a lot to the evolving science. We can track how the combination prophylactic therapy is used, who uses it and any side effects.”

Because veterans with HIV tend to be older than in the general population, with two-thirds over the age of 50, the VA has the unique opportunity to monitor treatment in individuals with comorbidities such as renal disease, diabetes and cardiovascular disease, she noted.

While the CDC recommends HIV testing for individuals between the ages of 13 and 64, the VA does not have an age limit for testing. The expanded testing range and the VA’s EMR have enabled the Clinical Public Health Group to see some interesting trends. Last year, for instance, the VA saw the same number of new HIV cases in veterans over the age of 70 as in those under the age of 30. And, Czarnogorski noted, in 2010 the VA had 80 HIV-positive veterans over the age of 80; in 2011 the number climbed to 180.

“I hope we really can get to the ‘AIDS-free generation,’ Secretary [of State Hillary] Clinton talked about in her speech at the National Institutes of Health,” said Czarnogorski. “HIV/AIDS is a completely different epidemic than it was 30 years ago — and the VA has an important role in educating other agencies and international groups about effective strategies in prevention and treatment.”

More information can be found on the VA website: www.HIV.va.gov.

VA HIV Testing Information for Health Care Providers

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