Intriguing 'Drug Holidays' From HIV Treatment
"Resistance is one of the big risks involved in this type of study," Dybul said. "So far we haven't seen emergence of any drug resistant genes in these patients who have had instances of viral rebound."
Dybul said the goal of the study is to determine if the patients taking the drug holidays have the same outcomes as a similar group of patients who take their medications continuously.
Dybul also reported another study in which patients are receiving treatment for seven days and then are off for seven days -- in essence reducing drug intake by 50%. He has enrolled five patients in this study. He demonstrated that one patient -- on treatment for more than three months -- had no rebound of the virus. The study design calls for following these patients for six months to see if their virus can be continually suppressed with the drug interruptions.
"But this is just five patients," Dybul said, "and you really can't say anything about five patients."
"If you say you can't say anything about five patients, why are you presenting this data?" asked Brian Gazzard, MD, chief of AIDS treatment at Chelsea and Westminster Hospitals in London. Gazzard said he was concerned that others would try to repeat the trials on their own.
Jules Levin, an AIDS activist and editor in New York, also criticized reporting the sketchy data, said, "By discussing these things in public, you may be encouraging people to try these things. People will hear about this and say, 'It must be okay to do these things.'"
"I share your concern," Dybul said. "We are emphasizing that this is just a research tool and that no one -- patients or doctors -- should try these treatments outside a clinical trial. We think these interesting data ought to be exchanged."
In another study, Eron said he found out that adding even more pills did not improve a patient's response to treatment. He reported on a trial in which patients were put on a four-drug combination of treatment and were compared to patients on a standard three-drug regimen.