Three of the biggest anti-HIV drug manufacturers have announced that they have commenced “early discussions” on developing the first licensed fixed-dose combination therapyHighly Active AntiRetroviral Therapy ??? aggressive treatment of HIV infection using several different drugs together. incorporating drugs from more than one manufacturer.
The proposal opens up the prospect of the first single pill, once-daily treatment incorporating multiple classes of drugs. The proposed treatment would combine two Gilead Sciences drugs — tenofovir and emtricitabine — with efavirenz, marketed by Bristol-Myers Squibb in Australia and the UK, and by Merck & Co. in the United States.
The talks follow an announcement by the US health secretary, Tommy Thompson, of new expedited approval processes for fixed-dose HIV treatments. Instead of taking months to consider applications for new formulations, the US Food and Drug AdministrationThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA). would be able to approve new combinations of already-licensed drugs in a matter of weeks.
The World Health Organisation has said that development of effective fixed-dose combination therapies is a key part of its ‘3 by 5’ program to roll out antiretroviralA medication or other substance which is active against retroviruses such as HIV. treatments in the developing world, where low literacy and poverty mean that simplified treatment regimes are desperately needed.
In order to be effective, any fixed-dose combination treatment would need to incorporate drugs from at least two classes. But no single drug company currently has a viable combination of drugs, a problem which a possible alliance between Gilead, BMS and Merck would address.
Emtricitabine is not yet licensed in Australia, and tenofovir is available only under limited circumstances, meaning that even if the talks between the drug companies are successful, any combined treatment would be unavailable in Australia in the short term.
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