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Novel NNRTI Doravirine
How New Data From CROI 2017 May Renew Interest in NNRTIs

Released: April 21, 2017

Expiration: April 20, 2018

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In this HIV commentary series, we highlight the critical decision making that goes into selecting optimal patient management strategies with current therapies and evolving treatment options for HIV treatment. Data recently presented at CROI 2017 suggest there may be renewed interest in a new NNRTI, an ART class that has generally fallen out of favor among US prescribers in recent years.

New Drugs Under Investigation
Currently available antiretroviral treatment (ART) regimens for HIV-infected patients are, for the most part, outstanding, although none are without flaws of some kind. Given the overall favorable excellence of currently available ART options, it came as something of a pleasant surprise to see how many new HIV treatment options are in development. Data presented at CROI 2017 described a variety of ART drugs in varying stages of development. The drug that is most advanced in its development cycle is doravirine, a novel NNRTI that features significant antiviral activity against many NNRTI-resistant variants, a low potential for drug–drug interactions (including proton pump inhibitors), and an absence of food requirements or restrictions

New Data From CROI 2017
Results from the multicenter, randomized, double-blind phase III DRIVE study of treatment-naive patients showed that doravirine compares favorably as a potential first-line ART option when compared with currently recommended PI-based ART. In this study, once daily doravirine 100 mg was compared with darunavir/ritonavir (DRV/RTV) once daily, each paired with 2 NRTIs.

At Week 48, compared to patients receiving DRV/RTV, patients treated with doravirine had:

  • Noninferior virologic efficacy (HIV-1 RNA < 50 copies/mL) across a range of HIV-1 RNA and CD4+ cell count strata
  • Equivalent overall rates of adverse events
  • Improvements in fasting lipid parameters, including significant decreases in LDL and non-HDL cholesterol fractions
  • No emergence of drug resistance in patients with protocol-defined virologic failure

Future Studies Underway
Comparisons across different studies are not recommended, but it is worth noting that doravirine was not compared to an INSTI-based ART regimen, the most commonly prescribed treatment option in contemporary HIV management. Although it is a once daily option, the doravirine combination currently requires taking multiple tablets rather than the increasingly popular single-tablet combinations. Additional ongoing phase III studies involve a coformulated combination that includes doravirine, lamivudine, and tenofovir disoproxil fumarate to evaluate efficacy and safety in treatment-naive and virologically suppressed patient populations. The role of doravirine in future ART treatment options will be interesting to follow.

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In the future, how likely are you to incorporate novel NNRTIs in your clinical practice?
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