Harold Fuller has run out of options to keep his HIV at bay.
Fuller, 56, of Brooklyn, New York, 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 in an interview. 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 like Fuller have 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.
In a bid to give long-term sufferers more treatment options, the U.S. Food and Drug Administration is making it easier to develop new HIV drugs. New FDA guidelines close to approval are designed to cut the research time needed 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,” Jeffrey Murray, deputy director of the FDA’s antiviral products division, said in an interview.
Many pharmaceutical companies 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. Now, the updated guidelines are making the market for new treatments for long-time HIV sufferers more appealing.
Margo Heath-Chiozzi, vice president for global regulatory strategy in virology at New York-based Bristol-Myers Squibb Co., said the changes makes sense.
“It so streamlines the process. It basically was double work for both the companies and the agency,” said Heath-Chiozzi. “I think it does encourage development of therapy for patients with the greatest need.”
The revised 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.
Gilead Sciences Inc., the world’s biggest maker of AIDS drugs, received FDA approval last year for Stribild, a pill that combines four drugs in one. That drug is approved only for patients who have never been treated before. The last major treatment specifically for patients with a resistance to other drugs, Johnson & Johnson’s Intelence, was cleared by the FDA in 2008.
Cancer is one of the few other diseases for which such accelerated approvals have been allowed by FDA.
HIV, the human immunodeficiency virus that causes AIDS, infects about 1.1 million Americans, according to the U.S. Centers for Disease Control and Prevention. By 2015, about half that number is expected to be ages 50 or older, and many of those -- like Fuller -- have stayed alive over the years by mixing and matching about 30 approved HIV drugs that, for the most part, came on the market before 2004.
“They have had HIV for a long time and are resistant, or can’t take most things,” said Daniel Tietz, executive director of the New York-based AIDS Community Research Initiative of America. “They live in fear that one day this all goes to hell, their viral load spikes and they get sick and die.”
Since 1996, the virus has largely been controlled through the use of drug cocktails made up of three or more types of medicines taken together. While these combination therapies limit the number of paths used by the virus to invade human cells, they don’t end its ability to mutate in ways that allow it to overcome the therapies, often within three to four years.
For HIV sufferers like Fuller, a wave of new drugs can’t come soon enough. He said his disease has begun to develop resistance to his current drug regimen. Without a new medicine soon, his life is increasingly in danger.
“My church keeps me going. I have family I call, I have friends I call,” Fuller said. “They keep me up.”