Wha-hoo!! In a long-awaited development, last week the FDA approved two new Fixed Dose Combination pills that will greatly simplify treatment for many HIVers, especially those who are just starting treatment or are still fairly “treatment naive.”
In just one pill daily, each formulation provides some of the best drugs available, and they are particularly good choices for combining. All the meds are from the same class (nucleoside analogue reverse transcriptase inhibitors, or nuke), so they must be taken along with a drug from another class to make a complete cocktail. Still, the total pill burden then could be as little as two or three pills per day. For those already taking the respective drugs, combination pills could also reduce prescription copayments, a meaningful savings for lower-income working people.
Gilead’s Truvada combines Viread and Emtriva (generically: tenofovir plus emtricitabine/FTC). Both have among the fewest side effects of all the HIV meds and are less likely to lose their efficacy because of drug-resistant virus developing.
Glaxo’s Epzicom combines Ziagen and Epivir (generically: abacavir plus lamivudine/3TC). Epivir also has few side effects; Ziagen has great durability, because it doesn’t fall prey to the most common drug-resistant viral mutations. There still will be the occasional patient with a hypersensitivity reaction to Ziagen, so Epzicom will not be an option for everyone.
Before now, the only options for combined pills were in Glaxo’s Combivir (AZT plus 3TC), marketed in 1997, and Trizivir (AZT plus 3TC plus abacavir), from 2000. New combinations have been sorely needed to overcome problems of drug resistance and side effects.
FDA approval was not expected until mid-September, but since the pills are just combining already-approved drugs and the required studies show excellent results, it came earlier. Now to get drugs from more than one class, or even more than one company, all into a single pill …
This article appears in August 27 • 2004.