Drug updated on 3/28/2024
| Dosage Form | Tablet (oral: 100 mg) |
| Drug Class | Non-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
- 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.
- Three systematic reviews/meta-analyses were reviewed, providing insights into the safety and efficacy of doravirine (Pifeltro).
- One study found that exposure to doravirine does not appear to be affected by age, suggesting it could be a suitable option for older individuals living with HIV who may have altered drug pharmacokinetics due to aging.
- A Bayesian network meta-analysis compared doravirine combined with tenofovir dipivoxil fumarate and lamivudine/emtritabine against traditional triple therapies, finding that this regimen exhibited superior virological suppression relative to some efavirenz-, nevirapine-, atazanavir-, or lopinavir-based regimens.
- The same analysis also showed similar performance between the doravirinetenofovir-lamivudinemtricitabinee regimen and all other analyzed regimens regarding adverse events but performed better concerning severe adverse events and drug-related adverse events after 48 weeks of treatment.
- Another research concluded that Doravinre could be considered an efficacious, safe, well-tolerated initial therapy option preferable over certain other treatments for individuals infected with HIV-1 based on its high efficacy score from direct/indirect estimates as well as lower rates of associated adverse effects when compared across different doses used in various studies included in their meta-analysis review.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pifeltro (doravirine) Prescribing Information. | 2022 | Merck Sharp & Dohme LLC, Rahway, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV: A Systematic Review. | 2023 | Clinical Pharmacokinetics |
| Comparison of the Efficacy and Safety of a Doravirine-Based, Three-Drug Regimen in Treatment-Naïve HIV-1 Positive Adults: A Bayesian Network Meta-Analysis. | 2022 | Frontiers ion Pharmacology |
| Efficacy and safety of doravirine in treatment-naive HIV-1-infected adults: a systematic review and meta-analysis. | 2021 | Environmental Science and Pollution Research |
| Clinical review report: doravirine (Pifeltro). | 2019 | CADTH |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. | 2023 | NIH |
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2022 | NIH |
| Therapeutic guidelines for antiretroviral treatment of adult HIV infection. | 2020 | British Columbia Centre for Excellence in HIV/AIDS |
| 2019 update of the European AIDS Clinical Society guidelines for treatment of people living with HIV version 10.0. | 2020 | HIV Medicine |