Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 100 mg) |
| Drug Class | HIV-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.
Latest News
Summary
- 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 DOR + TDF + 3TC or 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.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pifeltro (doravirine) Prescribing Information. | 2023 | Merck & Co., Inc., Rahway, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparison of the Efficacy and Safety of a Doravirine-Based, Three-Drug Regimen in Treatment-Naive HIV-1 Positive Adults: A Bayesian Network Meta-Analysis | 2022 | Frontiers in 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 Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Therapeutic guidelines for antiretroviral treatment of adult HIV infection. | 2023 | British Columbia Centre for Excellence in HIV/AIDS |
| Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. | 2023 | National Institutes of Health |
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2022 | National Institutes of Health |
| European AIDS Clinical Society guidelines 2019 version 10.0. | 2020 | European AIDS Clinical Society |