People with HIV infection who take breaks in antiretroviral (ARV) drug treatment face greater risk of infection and heart disease compared to those who take their medicine regularly, according to a new study in the New England Journal of Medicine.
Striving to end a long debate on the value of 'drug holidays', an approach otherwise known as standardised treatment interruption (STI) and a popular strategy in the war against HIV and AIDS over the past five years, the study warns of 2.6 times greater risk.
STI was initially designed to mitigate the serious side effects of HIV medications in patients, including changes in body fat, liver problems and heart disease.
Patients following STI would take a break when their immune systems were strong and start taking the drugs again when their bodies' natural defenses were down.
"This is a very important study," says Paul Skolnik, director of the Centre for HIV/AIDS Care and Research at Boston University Medical Centre in Boston, Massachusetts.
"It was controversial at the time it was designed, because there were many who fervently believed, despite the lack of data, that drug interruption was the correct way to go."
The Strategies for Management of Antiretroviral Therapy (SMART) study, which looked at nearly 6,000 patients in 33 countries, revealed that patients who stopped and started their drug regimens experienced a 2.6 times greater risk of infectious disease or death.
"Much of HIV treatment over the years has, unfortunately, been based on anecdotal or limited evidence," Skolnik says. "We have learned time and time again that these kinds of decisions can only be wisely made through adequately controlled and designed studies."
"It was surprising that death rates and cardiac disease tended to be higher in the interruption group," says Jeffrey Lennox, professor of medicine and principal investigator for the Emory AIDS Clinical Trials Unit, in Atlanta.
Though the findings may be a disappointment to many doctors and patients who held high hopes for STI, experts say the study is an important step in ensuring the best treatment strategy possible for HIV and AIDS patients.
The study is expected to reassure many patients who are worried about the toxicity of their HIV treatments.
"The SMART study shows that stopping or interrupting therapy is not smart," says Carlos del Rio, director for Clinical Sciences and International Research, Emory Centre for AIDS Research in Atlanta.