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Drug Interactions between pretomanid and sofosbuvir / velpatasvir / voxilaprevir

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

sofosbuvir pretomanid

Applies to: sofosbuvir / velpatasvir / voxilaprevir and pretomanid

MONITOR: Coadministration with pretomanid may increase the plasma concentrations and the risk of adverse effects of drugs that are substrates of breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP1B3), and/or P-glycoprotein (P-gp). The proposed mechanism, based on in vitro data, is decreased clearance due to pretomanid-mediated inhibition of BCRP, OATP1B3, and/or P-gp. The clinical significance is unknown as data are limited and conflicting.

MANAGEMENT: Until more information is available, the manufacturers of pretomanid recommend that clinicians should be aware of the potential for enhanced pharmacologic effects with drugs that are substrates of BCRP, OATP1B3, and/or Pg-p, particularly those with a narrow therapeutic range, when pretomanid is coadministered. Dosage adjustments as well as clinical and laboratory monitoring of the BCRP, OATP1B3, and/or P-gp substrate drug should be considered whenever pretomanid is added to or withdrawn from therapy with these drugs. Patients should be monitored for the development of adverse effects.

References (3)
  1. (2019) "Product Information. Pretomanid (pretomanid)." The Global Alliance for TB Drug Development
  2. (2024) "Product Information. Dovprela (pretomanid)." Imported (Italy)
  3. Center for Drug Evaluation and Research (2025) Center for drug evaluation and research. Application number: 212862Orig1s000. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212862Orig1s000MultidisciplineR.pdf
Moderate

velpatasvir voxilaprevir

Applies to: sofosbuvir / velpatasvir / voxilaprevir and sofosbuvir / velpatasvir / voxilaprevir

MONITOR: Coadministration with inhibitors of organic anion transporting polypeptides (OATP) 1B1 and/or 1B3 may increase the plasma concentrations of voxilaprevir, which is a substrate of the hepatic uptake transporters. When a single 100 mg dose of voxilaprevir was administered with a single 600 mg dose of the potent OATP 1B1/1B3 inhibitor cyclosporine (n=24), mean voxilaprevir peak plasma concentration (Cmax) and systemic exposure (AUC) increased by approximately 19.0- and 9.4-fold, respectively. Inhibition of P-glycoprotein (P-gp)- and breast cancer resistance protein (BCRP)-mediated intestinal transport and CYP450 3A4-mediated metabolism of voxilaprevir may also contribute to the overall interaction with cyclosporine. The safety of such high levels of voxilaprevir has not been established.

MANAGEMENT: Caution and monitoring are advised when voxilaprevir is used with OATP 1B1 or 1B3 inhibitors.

References (1)
  1. (2017) "Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir)." Gilead Sciences

Drug and food interactions

Moderate

voxilaprevir food

Applies to: sofosbuvir / velpatasvir / voxilaprevir

ADJUST DOSING INTERVAL: Administration with food enhances the oral bioavailability of sofosbuvir, velpatasvir, and voxilaprevir. Relative to fasting conditions, mean sofosbuvir systemic exposure (AUC) increased by 64% to 144%, mean velpatasvir AUC increased by 40% to 166%, and mean voxilaprevir AUC increased by 112% to 435% when the combined sofosbuvir/velpatasvir/voxilaprevir formulation is administered with food.

MANAGEMENT: Sofosbuvir/velpatasvir/voxilaprevir should be administered with food.

References (1)
  1. (2017) "Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir)." Gilead Sciences
Moderate

pretomanid food

Applies to: pretomanid

GENERALLY AVOID: Coadministration with alcohol may increase the risk of hepatotoxicity associated with the use of combination drug regimens that include pretomanid.

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of pretomanid. The mechanism has not been reported. Compared with the fasted state, oral administration of pretomanid with a high-fat, high-calorie meal (approximately 150, 250, and 500 to 600 calories from protein, carbohydrate, and fat, respectively) increased mean systemic exposure (AUC) and peak plasma concentration (Cmax) of pretomanid by 88% and 76%, respectively.

MANAGEMENT: Patients should avoid alcohol use during treatment with pretomanid. In addition, to ensure maximal oral absorption, pretomanid should be administered with food. Tablets should be swallowed whole.

References (1)
  1. (2019) "Product Information. Pretomanid (pretomanid)." The Global Alliance for TB Drug Development

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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