HIV drug trial collapses

HIV drug trial collapses

The collapse of an HIV drug in its final trial phase is unlikely to have an impact on the treatment of HIV patients in Australia, according to the National Association of People Living With HIV/AIDS (NAPWA).

Melbourne-based biotech company Avexa recently announced the closure of Phase III trials of apricitabine.

NAPWA executive director Jo Watson told Southern Star there were question marks over the need for apricitabine in the current HIV drug market.

“The Avexa drug has been a long and slow development process,” she said.

“There was a hope this new drug may offer some resistance benefit in the [nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) drug] class.

“It may have still been useful for those patients who had resistance to other NRTI drugs, but that wasn’t ever really conclusive and data was always slow in coming forward from the three trials anyway.”

Avexa failed to attract a pharmaceutical licensing partner last year for the Phase III trial drug, with company shares taking a hit on the stock market when the trial’s closure was announced in May.

London-based business analyst firm Datamonitor said the demise of apricitabine had not come as a surprise as the HIV drugs market is looking for combination HIV treatments (once-daily cross-class fixed dose combination [FDC] drugs) rather than apricitabine’s twice-daily single dose.

“In the increasingly competitive HIV market, once-daily cross-class FDCs will drive future growth, dwarfing the commercial opportunity for single nucleoside reverse transcriptase inhibitors like apricitabine,”  Datamonitor lead healthcare analyst Hedwig Kresse said.

“The launch of the first once-daily cross-class FDC, Atripla, in 2006 was a major landmark and has significantly raised the bar for HIV pipeline drugs with regards to efficacy and convenience.”

Watson said the focus on FDC products is about offering patients a more convenient treatment regime.

“Combination products are seen to be attractive for patients because they reduce the number of tablets … and they’re theoretically meant to alleviate some of the cost issues because you’ve got a combination of drugs in one script,” she said.

“You hope that the co-formulation is improving things like some of the side effects or toxicity issues often associated when you’re mixing a number of drugs in a combination of single agents.

“Across all of the HIV antiretroviral drug classes, it’s the new generation of drugs we’re all looking forward to because they’re the ones that are hopefully going to pick up on the weaknesses or the vulnerabilities or the toxicities of the earlier generations of those class of drugs.”

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One response to “HIV drug trial collapses”

  1. Avexa announced the closure of their phase III trial of anti-HIV drug apricitabine at the 24-week stage in October last year not May as claimed here. What is news from Avexa, is that on 10 May they announced the closure of their development program for apricitabine after failing to attract a global licensing agreement with a pharmaceutical company that might have bought the drug to the market. I think it is a little unfair to refer to apricitabine demise as “collapse of an HIV drug in its final trial phase” or “HIV drug trial collapses” as that suggests that the drug does not work as an HIV inhibitor. Rather, as the rest of your article explains, the phase III trial was haltered early because apricitabine was not attracting finance in a competitive market for its class.

    Personally it concerns me that the convenience of once a day and one pill instead of few dictates which drugs get to market. I need to take pills twice a day for my mental health anyway. The money saved on 1 script instead of 3 must be small compared to the cost of the drugs’ development. Is our convenience going to make HIV drugs more expensive for us and for developing countries?