NEW YORK: Adding a fourth drug to the existing three-drug anti-retroviral treatment for the initial stages of HIV-1 has not shown any benefits, according to a U.S. study that covered some 765 patients for three years.
Researchers from the Medical College of Cornell University said in an article published in the latest issue of the Journal of the American Medical Association that there were no significant differences over three years between the standard 3-drug regimen and a new 4-drug regimen.
Dr Roy Gulick, who led the team, said, "High rates of virologic suppression achieved in this study support current guidelines that recommend two nucleosides plus efavirenz among preferred regimens for the initial treatment of HIV-1 infection.
Adding abacavir as a fourth drug to the standard initial 3-drug regimen did not change toxicity or adherence but provided no additional benefit.
The 3-drug regimen has been found to suppress presence of HIV in blood, increase CD4 immune cells, delay clinical progression and improve survival.
Some researchers had suggested adding more drugs to the regimen in order to improve anti-retroviral activity, but the study has now established it has no advantages. Instead, the researchers found, it could cause virologic failure, adverse events or drug resistance. Besides, it will add to the costs of an already overburdened system.
The study, supported by the National Institutes of Health, was conducted at more than 40 U.S. sites. More than half the patients in the study were black or Hispanic and almost 20 per cent were female. The patients were randomly assigned to one of two regimens: the four-drug cocktail (zidovudine, lamivudine and abacavir and the non-nucleoside drug efavirenz), or a three-drug cocktail (containing zidovudine, lamivudine and efavirenz).
About the same number of patients in both groups (88 per cent of the four-drug group and 85 per cent of the three-drug group) achieved undetectable blood levels of HIV. After a median three-year follow-up, 25 per cent of the four-drug group and 26 per cent of the three-drug group reached virologic failure, meaning the drugs could no longer reduce the levels of virus in the patient's blood.
In the past 25 years, AIDS has caused 25 million deaths worldwide and 40 million people are living with the HIV virus. It has been established that prognosis is much better for people who can get the powerful new drugs. However, current drugs do not cure AIDS or prevent people from spreading it.
