One famous HIV clinician/clinical researcher likens co-formulated TDF/FTC/EFV (Atripla) to a "Godzilla," so dominant has the treatment become as initial therapy for HIV. He bases his comments on this study done at his institution, showing that in 2007, fully 85% of patients starting treatment in their clinic began TDF/FTC/EFV.
Does this big lizard of a regimen now have a competitor? Maybe:
On August 10, 2011, FDA approved Complera, a fixed dose combination (FDC) drug product containing emtricitabine/rilpivirine/tenofovir DF (FTC/RPV/TDF) for the treatment of HIV. The recommended dose of CompleraTM is one tablet, containing 200mg/25mg/300mg of FTC/RPV/TDF, once daily, taken orally with a meal.
A couple of quick thoughts as I get used to the name:
- As I've written before, the data suggest that using TDF/FTC/RPV involves a trade-off between safety/tolerability (favoring RPV) and efficacy (favoring EFV). Will this efficacy difference be reduced now that the single-pill treatment is available? This study is testing that very question. For now, probably best to limit use to those with HIV viral load < 100,000.
- Are people going to be using TDF/FTC/RPV as a switch strategy from virologically suppressed patients? The answer to that is undoubtedly yes, though of course this will be an off-label use, and clinicians might get push-back from payors. (I did already when trying to prescribe TDF/FTC + RPV separately to a treatment-experienced patient.) Again, ongoing studies are testing this switch strategy, both from boosted PI-based regimens and from EFV -- the latter particularly important since EFV induces metabolism of RPV, lowering levels for a least a few weeks.
- Rilpivirine must be taken with a meal -- not just food, but a meal -- and it's not clear yet whether this will be something that all patients can reliably do in clinical practice.
- One area where I'm sure the treatment will get some traction is in women of childbearing potential, as some clinicians are leery of prescribing EFV. One caveat of course is that there are no actual pregnancy data yet on this new drug, but at least at the outset RPV is a Category B drug (EFV is category D).
- We should expect the usual delay between this approval and the appearance of the regimen on ADAP, other government, and private insurance formularies.
Isn't it odd that pronunciation of these new drugs is often a mystery? I'm still not sure whether it's etra-VIR-ine or e-TRA-virine, IN-telence or In-TEL-ence, and is "Edurant" pronounced EE-durant or EH-durant or ee-DUR-ant?
As for Complera, I'll assume the accent is on the second syllable until I hear otherwise.
Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.
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