Once-a-Day Pill for HIV is approved; U.S. AIDS patients aren’t cheering.

by pharmacy on September 19, 2012

Once-a-Day Pill for HIV is approved; U.S. AIDS patients aren’t cheering.

In August, the FDA approved a new four-in-one pill for HIV that only needs to be take once a day – a vast improvement over previous treatments. The drug cocktail treatment comes from Gilead Sciences, and it would be good news but for one minor detail. The pill comes with a whopper of a price tag. It will cost about $28,500 per year, a price that is unsustainable for both patients and insurance companies.

Gilead responded to price objections by saying that the price is in line with other HIV treatment regimens. Erin Rau, a spokeswoman for Gilead, told the New York Times via email that the price of Stribild “reflects a reasonable return on our product development investment.”

History and Development

In the late ’90s, combinations of drugs appeared as viable treatments for HIV, but patients often had to take two dozen pills on a schedule throughout day and night. These treatments were successful, but hardly convenient.

The new pill, called Stribild (formerly named Quad) is the third once-a-day HIV treatment that Gilead has released. They introduced Atripla in 2006 and Complera in 2011. Stribild does not seem to be a significant leap forward in medicine, rather it is a successful combination of drugs already in use. And the company has the advantage of owning all of the components, unlike previous combination drugs.

Stribild is an improvement over earlier drugs. Patients experience less psychiatric side effects compared to Atripla, and 88% to 90% of patients in the clinical trials had undetectable amounts of HIV after 48 weeks.

What’s in Stribild?
Two of the ingredients, emtricitabine and tenofovir, are in use in former drugs marketed by the company. They are included in Atripla, Complera, and Truvada, a combination drug with just those two ingredients. Stibild also contains an integrase inhibitor called elvitegravir and cobicistat, a component that boost the effect of elvitegravir. Neither of those ingredients is approved for independent use.

Price points

In her email to the New York Times, the Gilead spokeswoman also volunteered the information that Gilead had granted rights to companies in India for manufacture of low-cost generic versions of Stribild for distribution in poor countries. Some would argue that given the growing economic crisis in the U.S., perhaps we should get a price break as well. Should we be solely responsible for exorbitant development costs of drugs that benefit the world?

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