Generic AIDS Drugs Hit The U.S. Market
WASHINGTON, Sept. 29 – On its surface, the recent U.S. Food and Drug Administration decision to allow marketing of generic versions of the HIV drug AZT is good news.
The obvious benefit is cost-savings that could provide more patients with access to treatment. But for HIV/AIDS patients in Massachusetts who are already taking sophisticated drug combinations, the availability of a cheaper generic drug may not make a dent in health care expenses.
Zidovudine, or AZT, was the first drug approved for the treatment of HIV and is manufactured by pharmaceutical company GlaxoSmithKline under the brand name Retrovir. A member of a class of drugs called nucleoside reverse transcriptase inhibitors, it helps keep the AIDS virus from reproducing.
With last week’s FDA decision, two companies in India and Roxane Laboratories of Columbus, Ohio, have received authorization to market their generic versions in the United States.
However, AZT is no longer prescribed for adult patients on its own. Instead, according to HIV treatment guidelines issued by the U.S. Public Health Service, it is usually prescribed in combination with three or four other anti-HIV drugs. But drugs other than AZT have yet to hit the lower-priced generic market because of patent and market exclusivity restrictions that are years from expiration.
With advances in HIV research, many of the drug combinations have been consolidated into fewer pills to make treatment easier for patients, explained Donna M. Gallagher, the executive director of The New England AIDS Education and Training Center in Boston.
“Unless insurers insist on unpacking drugs and selling them separately,” she said, the money saving benefits won’t be felt by patients. But Gallagher cautioned that taking away the convenience of fewer pills “could be detrimental to treatment.”
The possibility of more co-payments for each medication also could pose a financial burden to patients, she said.
Pediatricians, on the other hand, are excited about generic AZT.
AZT remains the backbone of the prevention of mother-to-child transmission, said Dr. Katherine F. Luzuriaga, director of the division of pediatric immunology, infectious disease and rheumatology at the University of Massachusetts Medical School.
Depending on the case, AZT can be administered to the mother and child alone for a short period of time or in combination with other drugs. A complete course of treatment, formula feeding and other interventions can reduce transmission odds to two percent, Luzuriaga said.
In addition to the benefits for pediatric AIDS patients, the greater availability of AZT has an impact in communities where there is a waiting list for HIV treatment, Gallagher said. Patients who couldn’t afford treatment before generic AZT may benefit, she said, but they would still have to take several other pills at full cost.
However, in Massachusetts where about 14,200 people are known to be living with HIV/AIDS, according to 2004 Massachusetts Department of Public Health figures, patients have an easier time getting treatment than in other parts of the country because of drug assistance programs, Gallagher said.
Nevertheless, AIDS funding in the state has been declining. The $35.6 million budget for state AIDS prevention and treatment programs for the current fiscal year is 38 percent less than it was five years ago when adjusted for inflation, according to the Massachusetts Budget and Policy Center, an economic think tank in Boston.
In March, Boston’s Mayor Thomas M. Menino announced that the city would receive $1.1 million less this year for funding from the Ryan White CARE Act, a federal measure that pays for services for HIV/AIDS patients in eligible communities.
Yet while funding is decreasing, the number of people living with HIV/AIDS in the state grows annually. In 2003, the year with the most recently available statistics, the number of people with the virus was 20 percent higher than it was five years before.
Provincetown, Boston, Holyoke and Springfield have the highest rates of HIV diagnosis.
The safety and quality of generic drugs isn’t at question, said David Scondras, president and founder of Cambridge-based Search For A Cure, a non-profit treatment advocacy program.
“People shouldn’t feel nervous about using generic drugs,” he said. “Just the opposite-they are tested more.”
But with medical advances in treating HIV/AIDS, doctors don’t prescribe the older drugs by themselves, he said.
“The overall impact of generic drugs is a good one,” said Scondras. “But modern drugs won’t be off label for another 15 years.”
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