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Bevirimat Antiviral Activity & Safety, 14-Day Monotherapy Study
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Reported by Jules Levin
ICAAC Sept 14 2009 San Francisco
From Jules: at the oral Late-Breaker session on Monday results were reported from this 14-day monotherapy study looking at 2 doses of Bevirimat, now called MPC-4326 since Myriad took over the drug. 32 patients received one of 2 doses of bevirimat. For patients who they predicted would respond based on their current genotypic algorithm the viral load reduction at day 15 with the highest dose looked at, 300 mg bid, was -1.38 log. Their mean baseline viral load was 4.21 logs This compared to the viral load reduction for predicted non-responders of -0.17 log. For predicted responded receiving 200 mg bid their viral load response was -0.89 log. Responders were defined post hoc as : 0.8 or greater log viral load decline. There were 48 responders & 52 non-responders. A model was built to identify the reltionship of all the 501 Gag amino acids to viral load reduction and to identify the most important residues. 5 key Gag residues emerged as important determinants of viral load decline. Based on stepwise linear regression and subsequent Linear Discriminant Analysis: 43 responders correctly predicted out of 54 total predicted (80%); 41 non-responders correctly predicted out of 46 total predicted (89%).
After the talk I went to the microphone and raised concern that since so many patients could not have their response predicted, this creates a dilemna in trying to make decisions about using the drug. The response from the investigator was the company is trying to improve the algorithm and they expect to be able to improve it, and my guess is they will be able to improve it. But when making a treatment decision on whether or not to include a drug in one's regimen it is difficult if you are unsure if the drug will provide benefit.
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