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Report: Generic HIV Treatment Strategy Could Save Nearly $1 Billion Annually

But treatment may be less effective (Jan. 15)

Replacing the combination of brand-name, antiretroviral drugs currently recommended for the control of human immunodeficiency virus (HIV) infection with soon-to-be-available generic medications could save the U.S. healthcare system almost $1 billion a year but may diminish the effectiveness of HIV treatment, according to a new study from Massachusetts General Hospital. The report appears in the January 15 issue of Annals of Internal Medicine.

“The switch from branded to generic antiretrovirals would place us in the uncomfortable position of trading some losses of both quality and quantity of life for a large potential dollar savings,” said lead author Rochelle Walensky, MD, MPH. “By estimating the likely magnitude of these offsetting effects now — before generic antiretrovirals actually hit the shelves — we can confront our willingness as clinicians, patients, and as a society to make these difficult choices.”

In 2011 the cost of antiretroviral drugs in the U.S. was approximately $9 billion, most of which was paid for by government sources. The currently recommended treatment for newly diagnosed patients is a single daily pill (Atripla, Bristol-Myers Squibb/Gilead Sciences) that combines three brand-name antiretrovirals: tenofovir (Viread), emtricitabine (Emtriva), and efavirenz (Sustiva). A generic form of the antiretroviral drug lamivudine, which has a similar mechanism of action to that of emtricitabine, became available in January 2012, and a generic version of efavirenz is expected in the near future.

Replacing two of the three branded drugs with generics could significantly reduce costs, the authors note, but such a strategy would also have disadvantages. A more complicated treatment regimen, requiring three daily pills instead of one, increases the risk that some patients will miss doses, leading to treatment failure. Laboratory studies have also found that lamivudine may be slightly less effective and more vulnerable to the development of drug-resistant viral strains compared with emtricitabine.

To evaluate the effect of switching to a generic-based antiretroviral regimen, the researchers used a mathematical model of HIV progression to simulate the effects of a daily three-pill regimen of generic efavirenz and lamivudine plus brand-name tenofovir, compared with the current one-pill combination drug. They adopted a worst-case scenario to project the efficacy of the generic drugs and their effect on viral resistance.

The results indicated that switching all HIV-infected patients in the U.S. to the three-drug generic strategy would produce lifetime savings of $42,500 per eligible patient. In the first year alone, the nationwide savings would reach nearly $1 billion. However, the quality-adjusted loss of life expectancy could be as much as 4.5 months.

“Diverting patients from the most effective, branded treatment alternative could be made more acceptable if the savings were directed to other HIV-related needs,” said senior author Bruce Schackman, PhD. “For example, fewer than half the state-funded AIDS drug assistance programs include the effective protease-inhibitor–based treatment for hepatitis C virus (HCV), which infects up to 25% of HIV-infected individuals. We calculated that, for every 15 patients switched to the generic-based regimen, one who is also infected with HCV could be treated and potentially cured of that infection."

Source: Massachusetts General Hospital; January 14, 2013.

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