Version July 2025
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).
Refer to adult dosing.
(For additional information see "Doravirine: Pediatric drug information")
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).
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.
HIV-1 infection, treatment: Treatment of HIV-1 infection in combination with other antiretroviral agents in pediatric patients ≥35 kg and adults with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.
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.
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).
It is not known if doravirine is present in breast milk.
Provide patient-centered evidence-based counseling for infant feeding options as early as possible in pregnancy.
• Using properly prepared formula or pasteurized banked donor milk eliminates the risk of postnatal HIV transmission via breastfeeding.
• Counsel patients on antiretroviral therapy (ART) who achieve and maintain a consistently undetectable plasma viral load during pregnancy and postnatally about feeding options, including breastfeeding, formula feeding, or banked donor milk. Maintaining maximum viral suppression decreases but does not eliminate the risk of HIV transmission via breast milk. Temporary discontinuation of breastfeeding and use of replacement feeding may be required if maternal viral load becomes detectable or if mastitis or bleeding nipples develop. Permanent discontinuation of breastfeeding is recommended if the maternal HIV RNA is ≥200 copies/mL.
• Formula feeding or banked donor milk is recommended for persons with HIV who are not on ART and/or do not have sustained viral suppression. Provide the infant presumptive ART throughout breastfeeding and for up to 6 weeks after the last exposure to breast milk if the breastfeeding parent does not have sustained viral suppression but breastfeeding is continued; conduct infant virologic diagnostic testing at specified intervals.
• When the HIV status at delivery is not known, breast milk may be expressed and stored until a negative test is available.
• Discontinue breastfeeding immediately if HIV infection is diagnosed after breastfeeding has been initiated.
• Evaluate and provide support for maternal conditions that would make adherence to postpartum ART difficult.
Information is available for counseling and managing patients with HIV who are considering breastfeeding (1-888-448-8765). 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 (HHS [perinatal] 2024).
Viral load, CD4 count; signs and symptoms of severe skin reactions.
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.
