Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Reuters NewMedia, Inc.; Friday September 18, 1998
Ransdell Pierson

The medication can be used with or without a protease inhibitor -- drugs of another class that in recent years have also helped reduce HIV infection and AIDS from a certain death sentence to a chronic condition. Protease inhibitors are a component of most anti-HIV cocktails.

The unit of DuPont Co. said patients should take three 200 milligram Sustiva (efavirenz) pills together at any time of the day, with or without food, in two-drug, three-drug, or four-drug combinations.

The 11 other anti-HIV drugs sold in the United States must be taken at multiple times during the day, typically in three-drug combos. Confusing dosing requirements create lifestyle difficulties that have caused some patients to abandon therapy.

"Typical patients are now taking 15 to 25 pills a day on regimens that are hard to adhere to. Their entire lives revolve around complicated schedules of taking a pill, maybe waiting two hours to eat, and then taking another pill," DuPont Pharmaceuticals president Nicholas Teti told Reuters.

"Sustiva will help patients live more normal lives," Teti said, adding it was shown in studies of up to 24 weeks to reduce HIV levels below detectable amounts. Long-term effectiveness has not yet been demonstrated.

DuPont said side effects included nervous system problems such as dizziness, insomnia, impaired concentration and abnormal dreaming that generally lasted only for the first few weeks of treatment.

The prescription drug will be priced at about $10.95 a day, or $3,942 a year, which DuPont described as the "mid-range" of anti-HIV medications. ABN-AMRO Securities analyst Mario Corso said Sustiva could become a leading anti-HIV drug because of its combination of potency, safety and easy dosing, garnering potential annual sales of $1 billion within five years.

"In the United States, only 50 percent of people who have tested positive for the HIV virus are on drug therapy and a big reason is that existing regimens are just too cumbersome," Corso said.

Protease inhibitors are particularly unwieldy. It is not unusual for patients to take them at three intervals each day, five pills at a time, Corso said. By using Sustiva in combination only with reverse transcriptase inhibitors, Corso said the total number of pills taken by eligible patients could thereby be reduced to a minimum, without sacrificing efficacy.

Moreover, Corso said protease inhibitors, which include Merck & Co.'s Crixivan (indinivir) and Agouron Pharmaceuticals Inc.'s Viracept (nelfinivir), cause more serious side effects than reverse transcriptase inhibitors -- including nausea, diarrhea and unattractive fat deposits.

People who discontinue treatment with any HIV drugs can allow the virus to mutate, rendering patients unresponsive in the future not only to drugs they had been taking but to chemically similar anti-HIV drugs.

The current standard of treatment is a three-drug cocktail consisting of one protease inhibitor and two reverse transcriptase inhibitors.

Reverse transcriptase inhibitors include two types, the non-nucleoside variety and the more-common nuceloside variety which includes Glaxo Wellcome Plc.'s Epivir (lamivudine), also known as 3TC.

Protease inhibitors and reverse transcriptase inhibitors interfere at different sites of an enzyme vital for replication of the HIV virus.

DuPont on July 1 secured marketing rights to Sustiva in the United States, Canada and several European countries when it bought for $2.6 billion Merck's interest in their former 50-50 joint venture, DuPont Merck Pharmaceutical Co.
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