FDA may fast track drugs to fight HIV

Patients could get new options

WASHINGTON — Harold Fuller has run out of options to keep his HIV at bay.

Fuller, 56, of Brooklyn, has lived with the virus for 20 years. Earlier in his illness, he stayed ahead of HIV’s ability to mutate by changing medicines every two years. For the past five years, though, Fuller has had to take the same pills because of a lack of new treatments.

‘‘I’ve been on medication since 1995, and after a while everything stops working,’’ Fuller said. His doctor, he said, ‘‘has no clue what to do.’’


With most HIV research focused on prevention and on developing drugs for the newly infected, a growing number of long-term patients such as Fuller found themselves caught in a medical no-man’s land with diminishing options to fight off the life-threatening virus. That may be about to change.

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In an effort to give long-term sufferers more treatment options, the Food and Drug Administration is seeking to make it easier to develop HIV drugs. New guidelines close to approval are designed to cut research time for regulatory clearance by eliminating previously mandated follow-up studies that can take almost a year to complete and cost millions of dollars.

The goal is to ‘‘open up the pipeline,’’ said Jeffrey Murray, deputy director of the FDA’s antiviral products division.

Many pharmaceutical firms have refocused their infectious-disease research budgets away from the mature $17 billion global HIV market in favor of investments to tap the smaller yet faster growing market for hepatitis C drugs.

The updated guidelines make the market for new treatments for long-time HIV sufferers more appealing.


Margo Heath-Chiozzi, vice president for global regulatory strategy in virology at Bristol-Myers Squibb Co., said the changes make sense.

‘‘It so streamlines the process,’’ she said. ‘‘I think it does encourage development of therapy for patients with the greatest need.’’

The proposed guidelines, unveiled in June, eliminate an almost yearlong follow-up study of therapies for HIV sufferers who have developed resistance to existing treatments.

That’s an incentive for companies such as Bristol-Myers to invest in new drugs. Bristol-Myers is currently developing three new HIV drugs, two of which may help people resistant to existing drugs.