DDIs
Doravirine▼ safety: drug-drug interactions (DDIs)
DELSTRIGO®▼ (doravirine/3TC/TDF)
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
PIFELTRO®▼ (doravirine)
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
Doravirine/3TC/TDF = DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate).
Licensed indications
PIFELTRO®▼ (doravirine) 100 mg film-coated tablet is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older, weighing at least 35 kg, infected with HIV-1, without past or present evidence of resistance to the NNRTI class.
DELSTRIGO®▼ (100 mg doravirine/300 mg lamivudine/300 mg tenofovir disoproxil fumarate, equivalent to 245 mg tenofovir disoproxil) is indicated for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir.
DELSTRIGO®▼ is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg, who are infected with HIV-1, without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Doravirine can be used with a variety of non-HIV medications
- Doravirine is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A are expected to affect the clearance of doravirine. Doravirine or doravirine/lamivudine/tenofovir disoproxil should not be co-administered with medicinal products that are strong CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of doravirine or doravirine/lamivudine/tenofovir disoproxil1,2
- Doravirine can be co administered with acid reducing agents without dosing restrictions1,2,3
- Doravirine can also be co-administered with drugs used to treat common co-morbidities such as anti-diabetics and cardiovascular medications including statins1,2,4,5
Selected interactions
Absence of interaction citation below does not imply that interaction information is not included in the SmPC and co-administration may still be contraindicated. Please refer to relevant SmPCs for full information on potential interactions and contraindications before prescribing.
No clinically significant interaction expected
These drugs should not be co-administered
| Medicinal product by therapeutic area | Recommendation concerning co-administration with doravirine/lamivudine/tenofovir disoproxil (Delstrigo) | Recommendation concerning co-administration with doravirine (Pifeltro) |
| Acid-reducing agents Antacid (aluminium and magnesium hydroxide oral suspension) (20mL SD, doravirine 100mg SD), pantoprazole (40 mg QD, doravirine 100mg SD) and omeprazole | | |
| Cardiovascular medications Angiotensin Converting Enzyme Inhibitors Lisinopril | | |
| Calcium Channel Blockers Diltiazem and verapamil | | |
| Statins Atorvastatin (20mg SD, doravirine 100mg QD), rosuvastatin and simvastatin | | |
| Central Nervous System medications Anticonvulsants Carbamazepine, oxcarbazepine, phenobarbital and phenytoin | | |
| Antipsychotics Thioridazine | Co-administration should be avoided. If co-administration cannot be avoided, a 100 mg dose of doravirine should be taken daily, approximately 12 hours after the dose of doravirine/lamivudine/tenofovir disoproxil. | Co-administration should be avoided. If co-administration cannot be avoided, one tablet of doravirine should be taken twice daily (approximately 12 hours apart). |
| Sedatives/Hypnotics Midazolam (2mg SD, doravirine 120mg QD) | | |
| Antidiabetics Metformin (1000mg SD, doravirine 100mg QD), canagliflozin, liraglutide and sitagliptin | | |
| Antimycobacterials Single dose rifampicin (600mg SD, doravirine 100mg SD) Multiple dose rifampicin (600mg QD, doravirine 100mg SD) rifapentine | | |
| Rifabutin (300 mg QD, doravirine 100 mg SD) | If doravirine/lamivudine/tenofovir disoproxil is co-administered with rifabutin, a 100mg dose of doravirine should be taken daily, approximately 12 hours after dose of doravirine/lamivudine/tenofovir disoproxil. | If doravirine is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily (approximately 12 hours apart). |
| Azole Antifungal Agents Ketoconazole (400mg QD, doravirine 100mg SD), fluconazole, itraconazole, posaconazole and voriconazole | | |
| Hepatitis C Antiviral Agents Elbasvir + grazoprevir (50 mg elbasvir QD + 200 mg grazoprevir QD, doravirine 100 mg QD), sofosbuvir, daclatasvir, ombitasvir/paritaprevir/ritonavir and dasabuvir +/- ritonavir, dasabuvir, glecaprevir, pibrentasvir and ribavirin | | |
| Ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirine 100 mg SD) | Patients receiving doravirine/lamivudine/tenofovir disoproxil concomitantly with ledipasvir/sofosbuvir should be monitored for adverse reactions associated with tenofovir disoproxil. | |
| Sofosbuvir/velpatasvir | Patients receiving doravirine/lamivudine/tenofovir disoproxil concomitantly with sofosbuvir/velpatasvir should be monitored for adverse reactions associated with tenofovir disoproxil. | |
| Herbal Supplements St. John’s wort (Hypericum perforatum) | | |
| Immunosuppressants Tacrolimus and sirolimus | Monitor blood concentrations of tacrolimus and sirolimus as the dose of these agents may need to be adjusted. | Monitor blood concentrations of tacrolimus and sirolimus as the dose of these agents may need to be adjusted. |
| Opioid Analgesics Methadone (20-200mg QD individualised dose, doravirine 100mg QD), buprenorphine and naloxone | | |
| Oral Contraceptives 0.03mg ethinyl oestradiol/0.15mg levonorgestrel SD, doravirine 100mg QD, norgestimate/ethinyl oestradiol | | |
SD=single dose, QD=once daily
References
- DELSTRIGO Summary of Product Characteristics.
- PIFELTRO Summary of Product Characteristics.
- Khalilieh SG, Yee KL, Sanchez RI, et al. A Study to Evaluate Doravirine Pharmacokinetics When Coadministered With Acid-Reducing Agents. J Clin Pharmacol. 2019;59(8):1093-1098.
- Livio F, Marzolini C. Prescribing issues in older adults living with HIV: thinking beyond drug-drug interactions with antiretroviral drugs. Ther Adv Drug Saf. 2019;10:2042098619880122.
- HIV Drug Interactions, University of Liverpool: https://www.hiv-druginteractions.org/
Supporting documentation
DELSTRIGO®▼ Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
PIFELTRO®▼ Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website
Doravirine/3TC/TDF = DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate).
