A U.S. advisory panel may recommend before the end of the year that primary care doctors start routine testing for HIV, a shift that if it occurs, has huge implications for drugmakers with HIV meds.
The U.S. Preventive Services Task force will offer the recommendation for public comment, reports Reuters, citing anonymous sources. The group's current position, made in 2005, says doctors should decide if an HIV test is in order. A move to treating HIV testing like cholesterol will not be an easy change in a country that has not completely shed the stigma attached to the disease. It is considered a very important change since HIV continues to be a significant health threat.
"It still will take culture change for medical providers, but this will be a tremendous leap," said Michael Kharfen, chief of community outreach for the Washington, DC, Department of Health. While significant strides in drug development have moved AIDS from a certain death to a treatable chronic ailment for most people, the HIV/AIDS epidemic continues to be a huge concern. About 60,000 new HIV cases are diagnosed in the U.S. each year. The Centers for Disease Control and Prevention (CDC) estimates that there are 1.2 million people living with the disease in the U.S. but 20% do not know they have it.
That is 240,000, and many more that would be put on a treatment path each year. Many drugs are now in generic form, but there continue to be big strides in HIV/AIDS drug development. The FDA just approved Gilead Sciences' ($GILD) Truvada as a preventative treatment for populations that are at high risk for getting HIV, like the partners of those already infected. The National Institutes of Health has announced a study for another drug, Selzentry, that would be used in the same way. Sold by the Viiv Healthcare joint venture between GlaxoSmithKline ($GSK) and Pfizer ($PFE), Selzentry will be tested in three drug combinations and compared with Truvada.
Gilead also is awaiting the FDA decision later this month on Quad, which is expected to be a huge seller for the company. Studies found that four-drug combo was as effective as its approved Atripla med without bringing on some of that treatment's side effects. And Atripla brought in the bulk of Gilead's $8.1 billion in revenue last year.
There is no guarantee that the recommendation would be adopted. It would be costly at a time when the U.S. is looking for ways to cut healthcare costs. There are suggestions of other approaches, like a one-time screening of the general population, followed up by annual testing in areas with greater prevalence of the disease.
- here's the Reuters story
Gilead's Truvada wins final nod as HIV preventative
Next up for HIV prevention testing: Viiv's Selzentry
Advisory panels take up Gilead's Truvada, then Quad
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