Version July 2025
Note: Gene mutation and antiretroviral (ARV) resistance patterns should be evaluated (refer to https://www.iasusa.org/ for more information) when necessary.
HIV-1 infection, treatment: Note: Use in combination with other ARV agents:
Children and Adolescents weighing ≥35 kg: Oral: 100 mg once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function:
Children and Adolescents weighing ≥35 kg:
Mild, moderate, or severe impairment: No dosage adjustment necessary.
End-stage renal disease (ESRD) on hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Children and Adolescents weighing ≥35 kg:
Mild or moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
(For additional information see "Doravirine: Drug information")
HIV-1 infection, treatment: Oral: 100 mg once daily, in combination with other antiretroviral agents
Dosage adjustment for rifabutin coadministration: Increase doravirine to 100 mg twice daily (~12 hours apart) for the duration of rifabutin coadministration.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Mild, moderate, or severe impairment: No dosage adjustment necessary.
ESRD on hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Mild (Child-Pugh class A) or moderate (Child-Pugh class B) impairment: No dosage adjustment necessary.
Severe impairment: (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults. Incidences reflect adverse reactions that occur with combination therapy.
1% to 10%:
Cardiovascular: Increased serum creatine kinase (3% to 5%)
Dermatologic: Skin rash (2%)
Endocrine & metabolic: Increased serum triglycerides (1%)
Gastrointestinal: Abdominal pain (5%), diarrhea (6%), increased serum lipase (3% to 7%), nausea (7%)
Hepatic: Increased serum alanine aminotransferase (2% to 4%), increased serum aspartate aminotransferase (2% to 5%), increased serum bilirubin (≤6%)
Nervous system: Abnormal dreams (1%), dizziness (3%), fatigue (6%), headache (6%), insomnia (1%)
Renal: Increased serum creatinine (4%)
<1%:
Endocrine & metabolic: Increased LDL cholesterol
Hepatic: Increased serum alkaline phosphatase
Concurrent administration of strong CYP3A inducers, including, but not limited to: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St John's wort
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to doravirine or any component of the formulation.
Concerns related to adverse effects:
• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) later in therapy; further evaluation and treatment may be required.
• Skin reactions: Severe skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported. Discontinue doravirine immediately and institute appropriate treatment if a painful rash with mucosal involvement or a progressive severe rash develops.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Pifeltro: 100 mg
No
Tablets (Pifeltro Oral)
100 mg (per each): $73.60
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Pifeltro: 100 mg
Oral: Administer with or without food.
Oral: Administer with or without food
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in the original bottle; protect from moisture. Do not remove desiccant.
Treatment of HIV-1 infection in combination with other antiretroviral agents in patients with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known doravirine resistance-associated substitutions (FDA approved in pediatric patients weighing ≥35 kg and adults); Note: HIV regimens consisting of three antiretroviral agents from at least two classes are strongly recommended.
Doravirine may be confused with Dovato
DOR is an error-prone abbreviation (mistaken as Dovato [dolutegravir and lamiVUDine])
Substrate of CYP3A4 (Major with inducers), CYP3A4 (Minor with inhibitors); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Atidarsagene Autotemcel: Antiretroviral Agents may decrease therapeutic effects of Atidarsagene Autotemcel. Risk X: Avoid
CYP3A4 Inducers (Moderate): May decrease serum concentration of Doravirine. Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Doravirine. Risk X: Avoid
Ergonovine: Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase serum concentration of Ergonovine. Specifically, this would be most likely with delavrdine, while other Non-Nucleoside Reverse Transcriptase Inhibitors may be more likely to decrease the concentration of Ergonovine. Risk X: Avoid
Levomethadone: Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease serum concentration of Levomethadone. Management: Levomethadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. Risk C: Monitor
Methadone: Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase metabolism of Methadone. Management: Methadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. Risk C: Monitor
Orlistat: May decrease serum concentration of Antiretroviral Agents. Risk C: Monitor
OXcarbazepine: May decrease serum concentration of Doravirine. Risk X: Avoid
Phenobarbital-Primidone: May decrease serum concentration of Doravirine. Risk X: Avoid
Reverse Transcriptase Inhibitors (Non-Nucleoside): May increase adverse/toxic effects of Reverse Transcriptase Inhibitors (Non-Nucleoside). Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease serum concentration of Reverse Transcriptase Inhibitors (Non-Nucleoside). Specifically, efavirenz and nevirapine may decrease the serum concentrations of other non-nucleoside reverse transcriptase inhibitors. Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase serum concentration of Reverse Transcriptase Inhibitors (Non-Nucleoside). Specifically, delavirdine may increase the serum concentration of etravirine. Risk X: Avoid
Rifabutin: May decrease serum concentration of Doravirine. Management: Increase doravirine dose to 1 tablet (100 mg) twice daily when combined with rifabutin. If taking the combination product doravirine/lamivudine/tenofovir, an additional tablet of doravirine (100 mg) should be given 12 hours after the combination product. Risk D: Consider Therapy Modification
Rifapentine: May decrease serum concentration of Doravirine. Risk X: Avoid
St John's Wort: May decrease serum concentration of Doravirine. Risk X: Avoid
Contraception is not required to initiate or continue antiretroviral therapy.
Data are insufficient to recommend doravirine for patients with HIV who are not yet pregnant but are trying to conceive.
Maximum viral suppression sustained below the limits of detection prior to conception is recommended for all persons with HIV who are planning a pregnancy. Prior to pregnancy, select or make changes to a specific antiretroviral regimen as part of a shared decision-making process. In most cases, recommendations based on data obtained from cisgender women can be applied to transgender and gender diverse people assigned female sex at birth.
Health care providers caring for couples planning a pregnancy when one or both partners are diagnosed with HIV may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2024).
Based on a placental perfusion study, doravirine crosses the placenta.
Data collected by the antiretroviral registry related to the use of doravirine in pregnancy are insufficient to evaluate teratogenicity.
Maternal antiretroviral therapy (ART) may be associated with adverse pregnancy outcomes including preterm birth, low birth weight, and small for GA infants. High viral loads are also associated with adverse outcomes, including preterm birth and pregnancy loss. Treatment improves the health of the pregnant patient and reduces the risk of perinatal transmission. Do not withhold appropriate maternal ART due to concerns for adverse neonatal outcomes. Closely monitor for pregnancy complications. Document in utero ART exposure in the long-term medical record of a child born without HIV; evaluate for potential metabolic dysfunction if significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) develop.
Data are insufficient to recommend doravirine for pregnant patients with HIV who are antiretroviral naive, who have had ART therapy in the past but are restarting, or who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). Patients who become pregnant while taking doravirine may continue with frequent monitoring if viral suppression is effective and the regimen is well tolerated or consider changing to a preferred or alternate regimen due to insufficient data for doravirine. Frequent viral load monitoring (every 1 to 2 months) is recommended if continued in patients who are virologically suppressed.
Pharmacokinetic studies of doravirine are not available to make dosing recommendations for patients who are pregnant.
ART is recommended for all pregnant people with HIV to maximize their health, maintain the viral load below the limit of an ultrasensitive assay detection, and reduce the risk of perinatal transmission. Start ART prior to conception or as soon as possible during pregnancy. During pregnancy, select or make changes to a specific antiretroviral regimen as part of a shared decision-making process. Patients on fully suppressive regimens prior to pregnancy generally may continue the same regimen considering known pregnancy outcomes and pharmacokinetic data. Monitor pregnant patients more frequently than nonpregnant patients. ART initiated during pregnancy can be modified after delivery. In most cases, recommendations based on data obtained from cisgender women can be applied to transgender and gender diverse people assigned female sex at birth.
Data collection to monitor pregnancy and infant outcomes following exposure to ART is ongoing. Enroll all patients exposed to antiretroviral medications as early in pregnancy as possible in the Antiretroviral Pregnancy Registry (1-800-258-4263).
Health care providers caring for pregnant patients with HIV infection and their infants may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2024).
HIV: General recommendations: Management of HIV infection requires extensive monitoring; refer to current guidelines (https://clinicalinfo.hiv.gov/en/guidelines) for additional guidance. Antiretroviral drug-resistance testing is recommended before initiation of therapy in treatment-naive patients. After initiation of or change in antiretroviral therapy regimen, pediatric patients should be evaluated for clinical adverse effects and treatment adherence at 1 to 2 weeks, and laboratory testing for drug toxicity should occur at 2 to 4 weeks; monitor for therapy adherence, effectiveness, and toxicities every 3 to 4 months.
Drug-specific monitoring: Frequency may vary based on several factors including age, concomitant therapy, and clinical response; refer to current guidelines for additional information.
Monitor for nausea, diarrhea, rash/skin reactions, and abnormal dreams.
Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor that inhibits HIV-1 replication by noncompetitive inhibition of HIV-1 reverse transcriptase.
Distribution: Vdss: 60.5 L
Protein binding: 76%
Metabolism: Primarily metabolized by CYP3A
Bioavailability: 64%
Half-life elimination: 15 hours
Time to peak: 2 hours
Excretion: Urine (6% [unchanged drug]); feces (minor [unchanged drug])
Pediatric: Overall, exposure in pediatric patients 12 to 18 years of age weighing ≥35 kg was similar to in adults. In the proportion of this population weighing ≥35 to <45 kg, AUC24 was 25% higher and Cmax was 36% higher than adult values; these differences are not considered clinically significant.
