AIDS Treatment News #164, December 4, 1992
John S. James

Atovaquone was approved for second-line not first-line treatment because a major comparative trial found that TMP/SMX worked better for those who could tolerate it; overall the two drugs had about the same "therapeutic success" (defined as sustained improvement over four weeks without having to discontinue the medication), but TMP/SMX had higher survival after eight weeks, 97 percent vs. 92 percent for atovaquone in that trial. However, 20 percent of those given TMP/SMX had to discontinue its use because of side effects; now atovaquone is available as second-line treatment for such patients. (Another trial found that atovaquone worked about as well as injected pentamidine, the existing second-line treatment, but had far fewer side effects serious enough to require drug discontinuation.)

It is important to take atovaquone with meals, because in its current formulation at least, the drug is much better absorbed when taken with food.

Burroughs-Wellcome, atovaquone's developer, announced a price to the wholesaler of $2.13 per 250 mg. tablet. The recommended dose is 2250 mg. per day (three tablets three times a day with meals) for 21 days, meaning that the wholesale price to treat one case of pneumocystis is about $402. (It is difficult to give a retail price, since markups by pharmacies can vary greatly.) Burroughs-Wellcome has announced a program to cap the annual cost for patients without third-party coverage who use more than 411 grams in a calendar year -- about $3500 wholesale. This cap may alleviate some cases of hardship, although presumably few will reach the limit. Burroughs-Wellcome also has other programs for providing drugs to patients with financial difficulties.

Development History, Activist Involvement

Atovaquone went from human trials to FDA approval in a remarkably short time. Yet during this time, Burroughs- Wellcome conducted the largest controlled trial yet of a pneumocystis treatment, at 37 sites in the U. S., Canada, and Europe. And while the trials were continuing, the company provided atovaquone without charge to over 900 patients who had no other treatment option, through a "treatment IND" approved by the FDA. Credit belongs to Burroughs-Wellcome, the FDA, and also to AIDS activists, especially in ACT UP/Boston, who have done much to expand access to this drug.

The following is from a press statement released by David Peck of ACT UP/Boston after the approval of atovaquone:

"Atovaquone's approval today represents a quantum leap in AIDS drug development -- cooperation between activists, government, and industry, large-scale access during early development (which should be the rule rather than the exception), and the sheer speed of the approval process...

"ACT UP knocked on Wellcome's door 18 months ago, and asked for access to atovaquone during its development. Our agenda specified drug access guidelines, such as: the target patient population, 24-hour drug delivery, an 800 number, etc., and Wellcome implemented this expanded access program with FDA approval a year ago. Over 900 people got atovaquone free of charge during the program -- and ACT UP/Boston is proud of this accomplishment.

"ACT UP/Boston applied constant pressure on the FDA to move this drug through the approval process. This included my testimony to the FDA antiviral drug advisory committee, which voted unanimously in September to recommend approval. As recently as last week, at our urging, the FDA changed the proposed labeling on atovaquone to make its use more inclusive...

"Atovaquone proves that ACT UP and drug companies, despite our differences and our seemingly endless demands, can work together. For now, our role is key: we provide the power lines to carry community concerns to drug companies. If others in the industry are tired of our screaming, they can take lessons from the Wellcome of the 90s -- and put the pressing needs of the community at the top of their drug development agenda. Atovaquone's success proves how well this works."

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