Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Reuters NewMedia - Thursday, November 21, 2002
Thomas Stark, from the development team of GSK, Europe's biggest drugmaker, told Reuters that the company hoped to launch the drug in the United States in the second half of 2003 and in Europe in the first half of 2004.
Data showing the second-generation protease inhibitor, known as 908, to be both potent and well-tolerated was presented at the Sixth International Congress on Drug Therapy in HIV Infection in Glasgow.
The drug, being developed with Vertex Pharmaceuticals Inc VRTX.O , is designed to be given with Abbott Laboratories Inc's ABT.N Norvir, or ritonavir, and offers the added benefit of once-daily dosing, so that patients only have to take four pills a day.
Results of the key Phase III trial showed 68 percent of 660 previously untreated patients with advanced HIV infection had undetectable levels of virus in their blood after 48 weeks of treatment, compared with 65 percent of those given Pfizer Inc's PFE.N Viracept.
"These results demonstrate the potency, durability and tolerability of 908/ritonavir once-daily in therapy-naive subjects, with the added benefit of a low pill burden," said study investigator Joseph Gathe.
"Currently approved protease inhibitors require at least six pills a day."
Protease inhibitors revolutionised treatment when they were first introduced in 1996 as part of triple-drug cocktails that effectively turned HIV/AIDS into a manageable condition -- rather than a death sentence -- for thousands of patients.
But the drugs are difficult to use and can cause serious side effects, making the development of improved versions a priority for researchers.
GSK has rights to 908 in the United States, Europe and some Asian countries, while Vertex has options to commercialise the drug in Japan and to co-promote it in the United States and Europe.
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