NIH advice on early HIV treatment could boost sales at Gilead, GSK, J&J and BMS

NIAID Director Dr. Anthony Fauci

Getting HIV patients to stick to their meds is a familiar challenge. HIV drugmakers often look to patient adherence programs to keep sales coming. Now, the same companies are celebrating good news from U.S. health officials: Patients should take antiretroviral meds as soon as they are diagnosed instead of waiting to start therapy, they say, citing data from a new clinical trial. And that obviously could increase scripts--and sales.

The National Institutes of Health (NIH) is halting the largest-ever clinical trial of HIV treatment after finding that patients who received antiretroviral drugs first thing were 53% less likely to die during the trial or develop serious conditions such as AIDS, compared with those who waited for treatment. Preliminary data showed that only 41 patients in the early treatment group died or saw their health problems escalate, while 86 in the deferred treatment group died or suffered from more serious conditions such as cancer or AIDS.

"We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later," Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a statement. "These findings have global implications for the treatment of HIV."

NIAID launched the 4,685-patient trial to settle disputes over when to begin treatment, The New York Times reports. Centers for Disease Control and Prevention guidelines called for starting therapy when a patient's CD4 count--a measure of immune system health--fell below 500, but the World Health Organization (WHO) suggested waiting until the count dropped below 350. Individuals are considered to have "full-blown AIDS" at a count below 200, the NYT article notes.

The news bodes well for drugmakers such as GlaxoSmithKline ($GSK), Gilead ($GILD) and Johnson & Johnson ($JNJ). GSK in particular has counted on its HIV-oriented venture, ViiV Healthcare, to offset recent R&D setbacks and generic competition. And the company is not wasting any time drumming up business: ViiV last year scored the FDA's blessing for antiviral combo drug Triumeq, a pill pegged at $5 billion in peak sales. Earlier this month GSK said it would commit $4 million annually over 5 years to an HIV-focused biotech startup, planning to commercialize products from ViiV through the new venture.

Gilead, meanwhile, has collected billions in sales from two newer HIV meds, Stribild and Complera, and it has filed for FDA approval for two more combo-pill entries that include a new antiviral, TAF. In January the agency approved a couple of two-drug combos from other companies that include Gilead's cobicistat (Tybost)--Johnson & Johnson's Prezcobix and Bristol-Myers Squibb's ($BMY) Evotaz.

- read the NIH statement
- here's the NYT article (sub. req.)

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