Medical researchers on Sunday unveiled clinical trials of new anti-Aids drug that better controls the spread of the deadly syndrome among previously untreated patients.
Developed by US pharmaceutical giant Merck, Isentress is the first of a new type of anti-Aids medication called HIV integrase inhibitor, based on the enzyme that controls HIV virus reproduction.
The study’s Phase III clinical trials — the last step before an approval request can be submitted to the Food and Drug Administration (FDA) — showed Isentress reduced HIV viral load to undetectable levels in 86% of patients, against 82% treated with efavirenz, an older anti-HIV medication also developed by Merck.
Drug-related adverse effects were also significantly fewer in patients treated with Isentress (44%) than with efavirenz (77%), the researchers told the 48th annual Interscience Conference on Antimicrobial Agents held this weekend in Washington.
Patients taking part in the clinical trial also took tenofovir and emtricitabine in combination with Isentress and efavirenz, Merck said in a statement.
On October 12 2007, the FDA granted Isentress accelerated approval for use with patients that showed initial signs of resistance to existing antiretroviral treatment, a common problem among HIV/Aids patients.
Merck estimates that among about 500 000 US patients treated with anti-HIV cocktails, up to 40% have developed resistance to treatment.
Industry analysts said treatment with Isentress pills twice a day could bring Merck $1-billion in sales over the next three years, competing directly with rival Gilead Sciences’ elvitegravir, also undergoing clinical trials.
A separate study presented at the ICAAC conference showed antiretroviral treatment was more effective if begun earlier: patients treated when CD4 cell count was at 500 had a 71% greater risk of dying than those treated when CD4 levels reached 350.
According to the World Health Organisation, 33-million people around the world are infected with the HIV/Aids, mostly in sub-Saharan Africa. One million HIV-infected people live in the United States.
About two million people died worlwide of HIV/Aids in 2007. – AFP
