Drug updated on 9/4/2024
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.
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Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Pifeltro (doravirine) Prescribing Information. | 2023 | 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 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 |
2019 update of the European AIDS Clinical Society guidelines for treatment of people living with HIV version 10.0. | 2020 | HIV Medicine |