Just in time for National HIV Awareness month, the US Food and Drug Administration on July 3 approved the first rapid HIV test that can be taken in the privacy of one's home.
This simple, noninvasive mouth-swab test, OraQuick from OraSure Technologies, yields a result in 20 to 40 minutes. It is expected to be available in 30,000 pharmacies, retail stores, and online retailers by October 2012, to consumers 17 years of age and older (and possibly with a valid ID required for purchase). The test was found to be 99.98 percent accurate in identifying people not infected with HIV, and 92 percent accurate in identifying those who are HIV-infected. Put another way, 1 person in 5,000 would get a false-positive test, and about 1 person in 12 could get a false-negative result. Positive tests need confirmation in a doctor's office, and contact information for a 24-hour question line will be included with the test.
The test's cost has not been set yet, said Douglas Michels, CEO of OraSure; it will likely be higher than the $17.50 currently charged to medical professionals but priced to be acceptable to people who want to test themselves several times a year.
The FDA emphasized that this home-based test is not intended to replace medical testing.
Heading off long-term HIV-infection comorbidities a growing concern
While the news drew mixed reactions from patient advocacy groups, some of which expressed concern about appropriate counseling for people who learn they're HIV-positive at home, leading AIDS researchers Drs. Robert Gallo and Anthony Fauci said the home test provides an important opportunity to increase access of HIV-infected patients to earlier care.
This should yield two important benefits, one related to cancer:
- The new test may be a turning point in AIDS prevention, given its potential to facilitate earlier treatment of HIV infections, which in turn can dramatically lower (by up to 96 percent) the risk of transmission to others.
- Early anti-HIV treatment can keep the viral load low and the immune system fairly intact. Long-term, this may reduce the population of older HIV-infected patients vulnerable to comorbidities such as cancer, an increasing concern in the HIV/AIDS healthcare community.
This concern of comorbidities such as cancer is growing because the number of older HIV-infected patients is increasing, thanks to HAART (highly active antiretroviral therapy), which became available in the mid 1990s. The weakened immune systems of HIV-infected patients with higher viral loads put them at risk, not only for what have long been known as the AIDS-defining cancers (non-Hodgkin lymphoma, invasive cervical cancer, and Kaposi sarcoma), but also for non–AIDS-related cancers, such as certain rare skin cancers; Hodgkin lymphoma and myeloma; and lung, throat, liver, intestinal, and anal cancers, some of which may be triggered by other viruses present in the body.
In late 2010, about 34 million people worldwide were alive with HIV, up 17 percent from 2001 -- reflecting the efficacy of antiretroviral therapy, not just the presence of new infections. In the US, 1.1 million are living with HIV, and there are 50,000 new HIV diagnoses annually.
According to Thomas Frieden, MD, MPH, and director of the Centers for Disease Control and Prevention (CDC), nearly 20 percent of Americans living with HIV do not know they are infected. Researchers and patient advocates hope that the availability of home testing and similar outreach efforts will help to bridge this gap.
Gay Men's Health Crisis HIV prevention researcher John A. Guidry, PhD, and colleagues, in their 2011 journal article, "HIV and Aging: Emerging Issues in the HAART Era," estimate that by 2017, up to half of HIV-infected patients will be aged 50 years and older, and CDC data from 2006 shows that the highest incidence of concurrent HIV/AIDS is in people newly diagnosed with HIV who are at least 50 years old.
Home-based HIV testing is a key opportunity to head off the deadly impact of advanced HIV/AIDS and its comorbidities, and a potentially very valuable addition to the current arsenal against this deadly disease.
What are your thoughts on home-based HIV testing?