Doravirine

(Pifeltro®)

Doravirine

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Drug updated on 6/10/2024

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.

Summary
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  • Doravirine (Pifeltro) 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. It is suitable for use by individuals with no prior antiretroviral treatment history or for those looking to replace their current regimen in circumstances where there is virological suppression on a stable regimen without any known resistance to doravirine.
  • Three studies were analyzed, focusing on the efficacy, safety, and pharmacokinetics of Pifeltro among different population groups.
  • The exposure to Doravirine appears unaffected by aging, suggesting its pharmacokinetics remain stable across different age groups. This stands in contrast to Darunavir, where exposure increases modestly with age.
  • Regarding efficacy and safety among treatment-naïve HIV-positive adults, Pifeltro, combined with TDF and 3TC/FTC, exhibited superiority over older regimens based on efavirenz, nevirapine, atazanavir, or lopinavir. It also demonstrated an overall good safety profile with regard to severe adverse events and drug-related adverse events.
  • A comprehensive study found that Pifeltro had high efficacy when compared to various dosages of itself as well as other regimens, including efavirenz and ritonavir-boosted darunavir regimen. Its safety profile was favorable, ranking just after the placebo group, showing no significant difference in adverse events compared to other treatments assessed.
  • For specific subgroups, such as aging populations living with HIV who do not require dose adjustments based solely on age alone, it is suitable due to its stability across ages. For newly diagnosed individuals starting their first-line therapy, it stands out because of its superior effectiveness coupled with a strong safety record.