Doravirine

(Pifeltro®)

Doravirine

Drug updated on 9/4/2024

Dosage FormTablet (oral: 100 mg)
Drug ClassNon-nucleoside reverse transcriptase inhibitors
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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  • Pifeltro (doravirine) is 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. It is also used 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.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Doravirine (DOR) 100 mg showed the highest efficacy (P score = 0.786) in treating HIV-1 among the doses analyzed, with superior virological suppression compared to some efavirenz, nevirapine, atazanavir, or lopinavir-based regimens in treatment-naïve HIV-1-positive adults.
  • The safety profile of DOR + TDF + 3TC/FTC was favorable, performing better in terms of severe adverse events and drug-related adverse events when compared to other antiretroviral regimens, with DOR 100 mg ranking second in drug-related adverse events safety (P score = 0.720) after placebo.
  • The performance of DOR + TDF + 3TC/FTC was similar to all other analyzed regimens regarding general adverse events, but it performed better concerning severe adverse events and drug-related adverse events.
  • In the P-score rankings for drug-related adverse events, DOR 100 mg had a favorable safety profile (P score = 0.720), second only to placebo (P score = 0.927), with no significant difference in drug-related adverse events between DOR 100 mg and other treatment groups.
  • There is no population types or subgroups information available in the reviewed studies.