A leading drug manufacturer Tuesday announced a new and potentially life-saving therapy for pneumocystis carinii pneumonia, an extremely serious respiratory infection that is the leading cause of death in AIDS patients.
The firm, Burroughs Wellcome Co., also developed and manufactures the AIDS antiviral drug AZT.
In a separate action, meanwhile, Gov. Pete Wilson announced in Sacramento that California will greatly expand the availability of AIDS treatments by subsidizing the cost of 11 other drugs for AIDS patients who do not have health insurance.
While medications already exist to combat the AIDS-related pneumonia, Burroughs Wellcome said its new drug, 566C80 or 566, provides an alternative for the estimated 30% to 50% of AIDS patients who cannot tolerate the significant side effects of the standard treatments or for whom other drugs are ineffective. These include the antibiotic trimethoprim-sulfa, which is sold under the brand names Septra and Bactrim, and intravenous pentamidine.
The drug, originally developed as a malaria therapy, is still experimental but the federal Food and Drug Administration said Tuesday it has given permission for the drug to be widely distributed before it is officially approved for sale.
The decision to make the drug available under a mechanism known as a Treatment IND was based on clinical studies showing that 566 is effective in patients with mild to moderate pneumocystis. In that study, which compared 566 to Septra, fewer than 7% of the patients taking 566 were forced to discontinue the drug because of side effects, compared to almost 20% of the patients taking Septra. Septra is also manufactured by Burroughs.
The drug will be made available free to patients with mild to moderate pneumocystis who cannot take the other medications. Severely ill patients, however, will also have access to the drug under a special companion study, the FDA said.
The most serious side effects of 566 include severe rashes, which have been experienced by a small number of patients, milder rashes, fever, digestive problems and minor blood abnormalities.
In California, Wilson’s announcement means that the drug ddI, recently approved by the FDA, will be among the AIDS drugs subsidized by the state.
“The new drugs will help our fellow Californians with AIDS by not only easing their pain, but reducing the tremendous costs for hospitalization and in-home attendant care,” the governor said in a statement issued by his office.
Until now, the state has subsidized the cost of only two AIDS drugs, AZT and aerosolized pentamidine for the uninsured. Gay activists and AIDS health care advocates have pushed the state to widen the number of subsidized drugs.
Adding the 11 drugs to the list will cost the state up to $6 million annually, but provide better care for thousands of AIDS patients who will be able for the first time to afford drugs that help their specific conditions.
All 13 drugs are already available to Medi-Cal patients, but many of the state’s 38,000 AIDS patients are not eligible for Medi-Cal and have no private health insurance.
Cimons reported from Washington, Paddock from Sacramento.