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Juluca approval
Nov 22, 2017

Hi dr young, a new single pill drug called juluca has just been approved. It consists of doluegravir and rilpivirine.

Any idea how this is more superior than doluegravir and truvada in terms of toxicity? Thank you.

Response from Dr. Young

Hello and thanks for posting your timely and interesting question.

The fixed-dose combination pill of the NNRTI rilpivirine and the integrase inhibitor dolutegravir (sold under the brand name Juluca) was approved by the US Food and Drug Administration yesterday for maintenance/simplification for virologically suppressed patients, based on the results of the tandem SWORD 1 and 2 clinical trials.

The relative merits and limitations of today's excellent three drug regimens (like the Truvada (tenofovir DF/FTC) and Tivicay (dolutegravir) you mention; and tenofovir AF(TAF)/FTC-based 3 and 4 drug combinations, Odefsey and Genvoya) versus the emerging 2-drug regimens (including Juluca, the experimental long-acting (LA) monthly (or every other monthly) injectable regimen of LA rilpivirine and cabotegravir (an investigational integrase inhibitor) and an oral combo of lamivudine (3TC) and dolutegravir) have been reviewed in detail at TheBodyPro by Dr. Josep Llibre; I'd suggest looking over this article. One of the key limitations of Genvoya, namely the requirement for the pharmacokinetic boosting drug cobicistat (and its raft of drug-drug interactions) will be addressed with the (likely to soon be FDA-approved) unboosted integrase inhibitor bictegravir (being developed as a single tablet regimen with TAF and FTC).

Two drug regimens have the potential to reduce risk of drug toxicity (another prominent Spanish HIV doctor, Santiago Moreno summed this up by saying "the best drug is the drug you don't prescribe), or lowering costs. In the case of Juluca, this maintenance regimen avoids the use of all nucleoside RT inhibitors (nukes), thereby circumventing the safety debate between the drug makers Gilead (tenofovir) and ViiV (abacavir) that has dominated research and commercial dialog for a decade. We cant' say that the combination is superior to Truvada+Tivicay (or Descovy+Tivicay or Genvoya), since this has not been studied in any head-to-head clinical trials; yet there attributes that are different between the regimens, that include lack of data (and recommendations) to use Juluca for patients who aren't already virologically suppressed or longer term data (the current data was through 48 weeks and the studies will continue through 96 weeks), and the the discomfort that some (or many) may have with a shift from the very successful standard bearer 3-drug paradigm to anything with fewer drugs (remember that older 2-drug initial or simplification studies were unsuccessful). Some will argue if it ain't broke, don't fix, and other will say (like Drs. Llibre and Moreno) that fewer drugs, if equally effective in suppressing the virus and restoring immune health should be better. If one has intolerance or toxicity to tenofovir (kidney and/or bone; though markedly reduced with the new TAF formulation) or abacavir (allergy and perhaps cardiac), an effective, well-studied (if only 48 week data) regimen is very welcomed. Yet compared to Truvada, rilpivirine should be taken with food and adds some drug-drug interactions. That said, there are number of large ongoing clinical trials using this and other 2 drug regimens, and the results of some of these studies (presentations anticipated in the 2018) should answer important remaining questions.

I hope that's helpful, BY


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