Generic HIV Treatment Could Save $1B Annually

This article published with permission from The Burrill Report.

Using generic HIV medications in place of brand-name drugs could shave nearly $1 billion a year from the $9 billion spent annually on antiretrovirals in the United States, but there's a catch: moving patients from a single-pill branded drug regimen to a multi-pill course of generics may diminish the effectiveness of HIV treatment, says a new study.

“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,” says Rochelle Walensky, one of the study’s authors and co-director of the Medical Practice Evaluation Center at Massachusetts General Hospital. “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.”

The recommended single-pill treatment for newly diagnosed patients with HIV is Bristol-Myers Squibb's Atripla, a daily medication that combines three brand-name antiretrovirals: Gilead's Viread and Emtriva, and the BMS medication Sustiva. In January 2012, a generic form of the antiretroviral drug lamivudine, which has a similar mechanism of action to Emtriva, became available. A generic version of Sustiva is expected soon.

While replacing two of the three branded drugs with generics could significantly reduce costs, such a strategy would also have disadvantages, write the authors of the study, appearing in the Jan. 15 issue of the Annals of Internal Medicine. A more complicated treatment regimen, requiring three daily pills instead of one, increases the risk that some patients will miss doses, leading to the loss of antiretroviral effectiveness called treatment failure.

To evaluate the impact of a switch to a generic-based antiretroviral regimen, the research team employed a widely used mathematical model of HIV progression to simulate the effects of a daily three-pill regimen of generic Sustiva and lamivudine plus brand-name tenofovir — the active substance in Viread — compared with the current one-pill combination drug. They adopted a worst-case scenario to project the efficacy of the generic drugs and their impact on viral resistance.

Their results suggested 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 four-and-a-half 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,” says the study's senior author, Bruce Schackman, associate professor of Public Health at Weill Cornell Medical College.

Meanwhile, Gilead’s Stibild, a four-in-one daily approved in August by the U.S. Food and Drug Administration for adults with HIV-1 infection who have not been previously treated with HIV medications, could become the preferred drug. Two late-stage trials showed the Stribild was as effective as Atripla or a combination of Truvada plus atazanavir and ritonavir, but with a slightly better safety profile.

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