US stops trial of interrupted HIV treatment

WASHINGTON (Reuters) – The U.S. government stopped a trial
of AIDS drugs on Wednesday aimed at finding out whether
patients could take breaks from treatment, saying people were
much more likely to become ill or die if they took breaks.

The trial quickly showed that patients do better when they
continuously take the drugs, said the National Institute of
Allergy and Infectious Diseases (NIAID).

Some smaller studies had suggested that patients could
safely take carefully monitored breaks from the strict regimens
of drug cocktails that keep AIDS at bay.

But the larger, international trial showed that patients
had twice the risk of dying or developing clinical AIDS if they
took breaks from the drug cocktails, called highly active
antiretroviral therapy, or HAART.

“Furthermore, there was an increase in major complications
such as cardiovascular, kidney and liver diseases in the
participants on the drug conservation arm,” the NIAID said in a
statement.

“These complications have been associated with (HAART), and
it was hoped that they would be seen less frequently in those
patients receiving less drug,” it added.

The drug cocktails also cause nausea, diarrhea and other
discomforts, and patients can build up resistance to the drugs,
meaning the virus evolves and the drugs work less effectively
over time.

The hope was the breaks would minimize these effects.

“We were surprised to learn that in the short term,
episodic antiretroviral therapy carries such an increased risk
without evidence of sparing patients the known side effects
associated with ART (antiretroviral therapy),” said Dr. Wafaa
El-Sadr of the Harlem Hospital Center and Columbia University
in New York, who was working on the trial.

During the study, known as Strategies for Management of
Anti-Retroviral Therapy, or SMART, patients either continuously
took their drug treatments, or started only when numbers of key
immune cells, called CD4 T-cells, dropped below a certain
level.

When the trial was stopped, it was running in 33 countries
with more than 5,000 patients taking part.

AIDS advocates welcomed the findings.

“It is important to emphasize that the cessation of SMART
does not necessarily mean that all treatment strategies
involving interruptions of antiretroviral therapy are
dangerous, just that the specific approach employed by the
SMART study design was less successful at preventing clinical
events than continuous treatment,” The Treatment Action Group
said in a statement.

“There is a large body of data suggesting that individuals
who initiate therapy with relatively high CD4 counts can safely
interrupt therapy.”

In a second study on HIV therapy published on Wednesday,
researchers said they had shown one combination was clearly
better than another for patients just starting out on HAART.

The report, published in the New England Journal of
Medicine, showed that taking the three drugs Viread, known
generically as tenofovir, Emtriva, known generically as
emtricitabine, and Sustiva or efavirenz suppressed the virus
better with fewer side effects, than the older combination of
AZT and 3TC (sold as a one-pill combination called Combivir),
plus Sustiva.

“The implications are quite clear for patients with HIV who
are about to start therapy: The simple combination of tenofovir
and emtricitabine, plus efavirenz, is likely to be highly
potent with minimal side effects or long term toxicity,” said
Dr. Joel Gallant of Johns Hopkins University in Baltimore, who
led the study.