FDA grants tentative approval to first DTG/FTC/TAF FDC
23 February 2018. Related: Antiretrovirals, Treatment access.
Polly Clayden, HIV i-Base
On 9 February 2018, the FDA’s PEPFAR programme granted Mylan tentative approval for the first fixed-dose combination (FDC) of dolutegravir, emtricitabine, and tenofovir alafenamide (DTG/FTC/TAF). [1]
DTG/FTC/TAF 50/200/25 mg will be the first TAF-based fixed-dose combination available in low- and middle-income countries (LMICs) for first-line ART.
Mylan manufactures this generic product under licenses from the Medicines Patent Pool and Gilead Sciences (for DTG and FTC/TAF, respectively).
According to Mylan’s press release, the tablet will be the smallest single-tablet regimen available for people in LMICs. It will be offered in both a 30-day and 90-day package.
comment
This FDC has been highlighted as a potential optimised first-line ART regimen for some time – so this is good news. But, although this combination of antiretrovirals is currently recommended in the US and Europe, TAF is not yet recommended (or even mentioned) in WHO guidelines.
Several data gaps remain before it is likely to be recommended, particularly on safety in pregnant women and TB co-treatment.
More data on TAF and rifampicin will be presented at CROI 2018 but data in pregnancy are scant. We look at this in more detail in the March update of the i-Base Fit for Purpose report.
References
- FDA tentative approval letter dolutegravir, emtricitabine, and tenofovir alafenamide. 9 February 2018.
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210237Orig1s000TAltr.pdf (PDF) - Mylan press release. Mylan receives tentative approval for combination HIV treatment DTG/FTC/TAF under FDA’s PEPFAR program. (20 February 2018).
http://investor.mylan.com/news-releases/news-release-details/mylan-receives-tentative-approval-combination-hiv-treatment