February 15, 2018
On Feb. 7, 2018, the U.S. FDA approved a new generic fixed dose combination (FDC) that uses a lower dose of efavirenz (400 mg rather than 600 mg) together with lamivudine and tenofovir DF.1
Approval is primarily based on results from the randomised double-blind ENCORE1 study in 630 treatment-naive individuals that reported results three years ago. ENCORE1 reported similar efficacy with slightly fewer side effects in the 400 mg vs 600 mg efavirenz group.2
The most common psychiatric side effects were: abnormal dreams (8.7% vs 11.3%), insomnia (6.2% vs 6.5%), somnolence (3.1% vs 3.9%), depression (3.1% vs 1.6%), nightmare (1.9% vs 2.6%), sleep disorder (2.2% vs 1.3%), and anxiety (1.2% vs 1.3%), in the 400 mg vs 600 mg groups respectively.
Approval is for adults and children weighing >35 kg.
The FDC is manufactured by Mylan and will be marketed with the brand name Simfi Lo.
For full details see the produced information for the FDC and for the individual drug components.3
The option to use this new reduced dose efavirenz-based FDC is welcome -- and reducing the dose of a drug that was still under patent protection is an achievement -- but results from ENCORE1 were first presented almost five years ago.4
Although this new formulation might improve quality of life for some people, the reduction in side effects with the 400 mg dose was modest. For this reason, efavirenz is no-longer recommended as a preferred first-line combination in UK guidelines.
Earlier this month Mylan also announced approval in the U.S. and EU of their generic 600 mg efavirenz, that comes with 180 days marketing exclusivity.5
The Mylan low dose efavirenz FDC was granted FDA tentative approval (for use outside the U.S., in association with PEPFAR, even where there is still patent or exclusivity market protection for the product in the U.S.) in March 2017.6
[Note from TheBodyPRO: This article was originally published by HIV i-Base on Feb. 12, 2018. We have cross-posted it with their permission.]
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