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Preliminary data on new drug looks promising.
A 48-week study by Melbourne-based biotechnology company Avexa into its experimental HIV treatment Apricitabine (ATC) showed that it reduced the virus to undetectable levels in more than 90 per cent of patients.
Patients who were initially treated with another drug 3TC (brand name Epivir) but who changed to ATC at week 24 also improved their response after their switch to ATC.
Avexa also reported that the CD4 cell count of ATC-treated patients continued to increase out to 48 weeks. Patients initially treated with 3TC who then switched to ATC doubled their levels of CD4 cell count at week 48 (after 24 weeks of ATC) compared to their CD4 cell count after 24 weeks of 3TC.
“These exciting results indicate that the clinical and immunological benefit of ATC continues to increase with long-term treatment out to 48 weeks,” Avexa CEO Dr Julian Chick said in a statement.
“This is compelling evidence of the improvements that can be obtained when patients switch to ATC from 3TC.
"These 48-week results clearly define ATC as a drug with huge potential both for drug-resistant patients in need of potent and safe new HIV therapies and for patients whose regimen currently con tains 3TC.”
No ATC resistance has been identified after 48 weeks of therapy and no serious adverse side effects related to ATC have occurred to date, according to Avexa.
Around 50 patients from Australia and Argentina took part in the study, which comprised two thirds or more men, according to the company’s head of development Dr Susan Cox.
Cox expressed optimism about the results: “We are currently in the process of starting up phase three studies, which involves larger studies,” she told SX.
“The results are extremely positive so we have to repeat them again with a greater number of patients. Clearly the chances of getting similar positive results are very high.”
If all goes well, approval for the new drug is likely to be in “two to three years”, Cox said.
David Cooper, director of the National Centre in HIV Epidemiology and Clinical Research (NCHECR), is “cautiously optimistic” about the data.
“The results are encouraging,” he told SX.
“It is now reasonable for the company to move to phase three; the drug is worth developing. There are a lot of hurdles the company still has to go through, though.”
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