Access to Efavirenz and Amprenavir

As reported in last month's TI, efavirenz (Sustiva), the newly approved nonnucleoside analog from DuPont, is embroiled in a dispute over its exceptionally high price. DuPont's negotiations with various state AIDS Drug Assistance Programs over efavirenz's price remain at an impasse. DuPont has offered a 5% discount off the current ADAP price, but the largest state programs, including New York, California and Texas, are still holding out. These ADAPs may not cover efavirenz for some months, and the uninsured people of moderate income relying on them may have trouble obtaining efavirenz.

Those who need the drug to create a successful antiviral regimen should remember that DuPont has committed itself to providing free efavirenz as a last resort. The efavirenz financial assistance program may be reached at 800/334-4486. Note that the program is first and foremost a reimbursement counseling service that will attempt to find some third party to pay for applicants' drug. Only if all else fails will DuPont provide free efavirenz to "financially needy patients." As of the end of October, DuPont was supplying free efavirenz to 200 people, many of whom receive their other drugs through the ADAPs.

Another new HIV drug is the protease inhibitor amprenavir (Agenerase, formerly known as 141W94). On September 21, Glaxo Wellcome announced the start of an expanded access program for amprenavir. The program is open to persons who have tried at least one protease inhibitor and can fit into one of three protocols. The first is for persons who are experiencing high blood lipid levels or abnormal fat deposits while on their current protease inhibitor. Based on its observations in current clinical trials, Glaxo is hoping that such effects will be reduced in those on amprenavir. The second and third protocols are for those who have high viral loads despite antiviral therapy and are left with few remaining treatment options. Enrollees are advised to start at least one other new antiviral drug when going on amprenavir. They may also combine amprenavir with a second protease inhibitor. For further information, call 800/248-9757.

Amprenavir is taken twice a day with or without food. Each dose consists of eight large capsules containing 150 mg of the compound. Nausea and vomiting are common side effects. Problems with ingesting amprenavir have been the main reason for limiting the dose to 2,400 mg a day. As with other drugs metabolized by the liver, combining amprenavir with Abbott's protease inhibitor ritonavir will increase blood levels of the drug. Glaxo has not tested this interaction, though, so its exact extent remains unknown. Several individuals failing other protease inhibitors already have reported good results with this combination, but the current lack of ritonavir capsules (see article) may well discourage others from trying it or Glaxo from testing it.

Note that the amprenavir expanded access program will not last long: On October 16, Glaxo filed a New Drug Application seeking the FDA's approval for marketing the drug. Such approval is expected early next year.

Back to GMHC Treatment Issues October 1998 contents page.