FDA Approves Stribild, an Advancement in HIV Treatment if You Can Afford It

On Monday the F.D.A. approved Gilead Science’s newest all-in-one HIV medication, Stribild. Though Stribild is a cocktail drug that includes two new components, it is not dramatically different from a similar one-a-day pill called Atripla, which was approved back in 2006. However, Stribild does mitigate certain side effects of Atripla, and studies showed a higher percentage of those treated with Stribild with undetectable amounts of HIV in their blood (88%, compared to 84% with Atripla).

The other important difference of the new drug is that the company Gilead owns all the ingredients for Stribild, whereas Atripla contains drugs from multiple companies (so the profits are split among those three companies). What’s the new price tag on treating HIV/AIDS? A nice $28,500. The profits from Stribild are expected to help mitigate Gilead’s inevitable loss come 2018 when many of its HIV drugs will lose patent protection.

The price of HIV/AIDS drugs has been a controversy since the drugs first were manufactured at astronomical costs, with life-threatening implications for individuals both in developing countries and low-income communities in the U.S. While drug research – and AIDS research in particular – incurs astronomical costs and requires years of testing, experimenting and refining to create such a product, (a $28,000 price tag for a life-changing treatment for HIV-positive people) is outrageous and will continue to keep the most important medical advancements out of the hands of those most in need.

Yes, Gilead will grant rights to a handful of Indian companies to manufacture a genetic equivalent for poorer countries; generic drugs along with work by PEPFAR (President's Emergency Plan for AIDS Relief) have in general dramatically lowered the prices of drugs in developing countries. But even the cost of these drugs remains out of reach for many developing countries (like Uganda) that are hardest hit and still find themselves unable to afford HIV medication for all those in need. The latest, most advanced and effective treatments will continue to only remain widely available to first world countries.

However, even for many living with HIV or AIDS in the U.S., new drugs like Stribild offer no relief.  Of the 1.2 million people in the United States infected with HIV, one-third of them are not receiving treatment for the simple reason that they cannot afford it. This isn’t just a tragedy for the health and well-being of these individuals; it is a tragedy as we are continuing to endanger public health and increase the nation's at-risk population by leaving individuals untreated while we have existing medication that can make transmission very rare.

According to the Department of Health and Human Services, only about 13% of HIV positive persons have private health insurance, and 24% have no coverage at all. Alternatives to receiving funding include Medicaid and ADAP (AIDS Drugs Assistance Program). But ADAP programs in states have faced incredible losses in funding, and in 2010 were forced to institute “waiting lists”; in 2011, there were over 9,000 people waiting for drug treatment who could not otherwise afford it. With Medicaid, a person often has to be diagnosed with AIDS before they are able to receive treatment, and thus an HIV infection goes untreated until it is allowed to advance (thankfully, the Affordable Care Act will offer some expansion of coverage here).

Those people who are able to benefit from Stribild will certainly be lucky and grateful to have the drug, but there are so many people who won’t be treated that the drug will not be able to really make a significant impact on public health. While advancements in HIV/AIDS treatment are always a step forward, as long as medical advancements take precedence over public health advancements and access to such treatment, drugs like Stribild will only have a fraction of the impact they could on the health and well-being of this nation and the HIV epidemic abroad.