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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."
Global HIV market
It is estimated that over 40 million people are currently
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