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Doravirine

(Pifeltro®)

Pifeltro®

Drug updated on 10/29/2024

Dosage FormTablet (oral; 100 mg)
Drug ClassHIV-1 non-nucleoside reverse transcriptase inhibitors (NNRTI)
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no prior antiretroviral treatment history, or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • At week 48, the combination of Doravirine (DOR) + Tenofovir Dipivoxil Fumarate (TDF) + Lamivudine (3TC) or Emtritabine (FTC) achieved superior virological suppression compared to certain regimens, with an odds ratio (OR) of 0.52 (95% credible interval [CrI] = 0.35-0.77).
  • The DOR 100 mg treatment strategy had the highest efficacy with a P score of 0.786, outperforming DOR 25 mg (P score = 0.684) and Efavirenz 600 mg (P score = 0.574) in meta-analysis findings.
  • DOR + TDF + 3TC/FTC demonstrated superiority over Nevirapine, Atazanavir, and Lopinavir-based regimens, while DOR 100 mg ranked higher in efficacy compared to Ritonavir plus Darunavir and other DOR doses.
  • The performance of Doravirine (DOR) + Tenofovir Dipivoxil Fumarate (TDF) + Lamivudine (3TC) or Emtritabine (FTC) was relatively similar to all other analyzed regimens in terms of general adverse events, while it showed better performance regarding severe adverse events and drug-related adverse events compared to other regimens.
  • One study found the placebo had the highest safety profile with a P score of 0.927, followed by DOR 100 mg with a P score of 0.720, showing no significant difference in adverse events when compared to Ritonavir plus Darunavir, other DOR doses, or Efavirenz.
  • There is no population types or subgroups information available in the reviewed studies.