Important note: Information in this article was accurate in June 2007. The state of the art may have changed since the publication date.
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AIDSWEEKLY Plus; Monday, June 4, 2007
Staff Medical Writers
The Phase IIb trial compared the effectiveness of ATC in reducing the viral load of patients with drug-resistant HIV with the effectiveness of lamivudine (3TC), a leading NRTI in widespread use. A total of 47 patients completed 21 day dosing. Of these 17 patients received 600 mg doses of ATC, 16 received 800 mg doses of ATC and the control group of 14 patients were treated with 3TC.
The results for patients in both ATC cohorts exceeded the Phase IIb trial primary endpoint by a substantial margin. Patients who received ATC achieved on average a reduction of greater than 0.8 log10 (85%) in the level of HIV in the blood after 21 days treatment compared to a reduction of less than 0.03 log10 in patients treated with 3TC. Nine patients achieved a greater than 1.5 log10 (97%) reduction after 21 days, with 3 patients achieving a reduction of over 2.0 log10 (99%). Remarkably, one patient achieved a decrease in the amount of virus of more than 2.5 log10 (99.7%) after 21 days on ATC. Patients with the highest degree of drug resistance still achieved a significant benefit from treatment with ATC. The demonstration of superior activity in this study indicates that ATC will be an effective antiviral drug for the treatment of many drug-resistant patients, including even those most highly resistant.
"This is a fantastic result for Avexa," stated CEO Dr Julian Chick. "The positive result allows us to continue to progress ATC into Phase III trials and towards commercialisation. The team at Avexa has done a great job and these excellent results show that their hard work has paid off."
There were no Serious Adverse Events (SAEs) related to the study drug, and no patients withdrew from the study because of side effects of study drug treatment. ATC continues to be very well tolerated, with some patients having received more than 12 months treatment to date. Currently there are 14 patients in the open label section of the Phase IIb trial and 6 patients have elected to enter into an extension study (where they continue to be treated with ATC), having completed the full 48 weeks of the study.
"These outstanding results clearly position ATC to become the most effective and well tolerated NRTI for treatment of drug-resistant HIV," stated Dr Jonathan Coates, Avexa's CSO, and co-inventor of 3TC, a NRTI marketed by GSK.
The emergence of resistance to antiviral drugs is one of the most important reasons for treatment failure. No evidence of mutation in the virus resulting in resistance to ATC was detected over the course of the treatment. This indicates that antiviral resistance to ATC does not occur quickly and gives ATC a significant competitive advantage over several other drugs which can rapidly select for resistance.
"Overall the results of Avexa's Phase IIb clinical trial demonstrate that ATC is a clinically effective antiviral drug that can significantly reduce the replication of the virus in patients infected with drug-resistant HIV," said CEO Dr Julian Chick. "Moreover, these results demonstrate that ATC is a safe drug not associated with undesirable side effects. There was no evidence of ATC resistant virus emerging over the trial period. These results indicate that ATC has the properties required to position it as the NRTI of choice for the treatment of patients failing their first line or subsequent anti-HIV drug regimens."
Keywords: HIV/AIDS, AIDS, Acquired Immunodeficiency Syndrome, Clinical Trial Research, Drug Development, Drug Resistance, HIV, Human Immunodeficiency Virus, Pharmaceuticals, Therapy, Treatment, Virology, Avexa Limited.
This article was prepared by AIDS Weekly editors from staff and other reports.
2007-06-04
AW070601
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