Four-in-one HIV pill may be exception among combination drugs – Nature Medicine News Story
The 1960s cartoon The Jetsons envisioned a future where single pills provided the same nutrition, taste and satiation as food that required chewing. That time-saving tablet remains a pipe dream, but the drugmaker Gilead is trying to deliver a similarly inspired pill for HIV medicines. On 27 October, the California company submitted an application to the US Food and Drug Administration (FDA) for its four-in-one HIV pill, which, if approved, would contain more medicines than any pill currently on the US market. The so-called ‘Quad’ pill promises the same virus-controlling ability as the four drugs separately but should be easier to use for people with the infection.
The idea of combining multiple medicines is seen by some as an easy shortcut to reinvigorating old products. Drugmakers can often simply repackage what’s already on the market, and, because the individual components have already been approved, the hassle of large clinical trials is off the table. The FDA generally requires only simple bioequivalence tests to ensure that drug dosing is consistent with the individual medicines, and, at most, a small human trial to prove similar efficacy.