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Generic HIV Drugs Save Money, But Could Impair Effectiveness

Pills and drug bottles (FDA.gov)

(FDA.gov)

Researchers at Weill Cornell Medical College in New York, Massachusetts General Hospital in Boston, and Yale University in New Haven calculate that switching generic for branded HIV drugs would provide substantial financial savings, but could impede the treatments’ effectiveness. The team’s findings appear in today in the journal Annals of Internal Medicine (paid subscription required).

Current treatment guidelines in the U.S. for HIV infection recommend a once-daily tablet combining antiretroviral drugs efavirenz, emtricitabine, and tenofovir marketed under the brand name Atripla by the drug’s developers, Bristol-Myers Squibb and Gilead Sciences. Generic forms of the individual drugs are already on the market or expected soon: a generic form of the antiretroviral drug lamivudine — which reportedly works like emtricitabine — became available in January 2012, and a generic version of efavirenz is expected shortly.

The researchers used a mathematical simulation to test the financial and clinical effects of switching to generic versions of the individual drugs. Among the measures in the model were costs, quality-adjusted life expectancies — an index combining years added to life expectancy adjusted for the quality of life — and incremental cost-effectiveness for each quality-adjusted life-year.

The calculations indicate changing to current or planned generic forms of the drugs in the U.S. would yield substantial cost savings. Replacing the branded Atripla with the two known generics and keeping a branded tenofovir, would offer each patient a lifetime savings of some $42,500. In the first year alone, those savings nationwide would total nearly $1 billion.

Those savings, however, would come at a cost in health effects. Requiring three daily pills instead of one call for more attention and adherence, increasing the risk that some patients will miss doses, leading to reduced antiretroviral effectiveness. In addition, the authors report lab studies indicate generic lamivudine may be somewhat less effective than emtricitabine and more vulnerable to the development of drug-resistant viral strains. The researchers calculate the quality-adjusted loss of life expectancy could be as much as 4.5 months.

The researchers conclude the significant cost savings from switching to generics are still worth the trade-off if patients can adjust to the more complicated drug regimen. “For patients who take their medications well and adhere to the medical regimen, the generic option will be a bit more complex but could be as effective as the standard regimen,” says lead author Rochelle Walensky of Mass. General. “But a patient who relies heavily on the simplicity of taking a single pill is more likely to suffer detrimental effects, since missing doses will increase the risk of treatment failure.”

Senior researcher Bruce Schackman of Weill Cornell recommends directing the savings to address related public health needs, such as the hepatitis C virus (HCV), which infects up to one in four people with HIV. “We calculated that, for every 15 patients switched to the generic-based regimen,” notes Schackman, “one who is also infected with HCV could be treated and potentially cured of that infection.”

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