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Drug Interactions between atidarsagene autotemcel and Viekira Pak

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

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Interactions between your drugs

Major

ritonavir atidarsagene autotemcel

Applies to: Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir) and atidarsagene autotemcel

ADJUST DOSING INTERVAL: Antiretroviral medications may interfere with the manufacturing of apheresed cells used for autologous gene therapy that undergo transduction by a lentiviral vector (LVV) (e.g., atidarsagene autotemcel, betibeglogene autotemcel, elivaldogene autotemcel, lovotibeglogene autotemcel). Following hematopoietic stem cell (HSC) mobilization and apheresis, CD34+ cells are genetically modified with a replication-incompetent, self-inactivating LVV carrying functional copies of deoxyribonucleic acid (DNA). Lentiviruses are retroviruses which possess short spans of genetic information identical to that of the human immunodeficiency virus (HIV) and may therefore be susceptible to inactivation by antiretroviral medications. Clinical data examining the use of antiretroviral medication(s) during the mobilization and apheresis process are not available.

MANAGEMENT: Antiretroviral medications should be avoided for at least one month, or the expected duration of elimination of the antiretroviral medication, prior to HSC mobilization and until all cycles of apheresis have been completed. Some manufacturers of atidarsagene autotemcel suggest continuing to avoid antiretroviral medications for at least 7 days after its infusion. If antiretroviral therapy is being considered for HIV or human T-lymphotropic virus (HTLV) prophylaxis, serology testing should be conducted to rule out infection before initiating mobilization and apheresis. Delaying gene therapy treatment until an HIV/HTLV western blot and viral load assay have been performed at 6-months postexposure may be appropriate. In addition, after the administration of autologous gene therapies that undergo the LVV transduction process, use of non-polymerase chain reaction (PCR)-based assays are recommended when screening for HIV, due to the risk of a false positive result with PCR-based assays.

References

  1. (2022) "Product Information. Zynteglo (betibeglogene autotemcel)." bluebird bio
  2. (2022) "Product Information. Skysona (elivaldogene autotemcel)." bluebird bio
  3. (2023) "Product Information. Lyfgenia (lovotibeglogene autotemcel)." bluebird bio
  4. (2024) "Product Information. Lenmeldy (atidarsagene autotemcel)." Orchard Therapeutics
View all 4 references

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Drug and food interactions

Moderate

ritonavir food

Applies to: Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir)

ADJUST DOSING INTERVAL: Administration with food may modestly affect the bioavailability of ritonavir from the various available formulations. When the oral solution was given under nonfasting conditions, peak ritonavir concentrations decreased 23% and the extent of absorption decreased 7% relative to fasting conditions. Dilution of the oral solution (within one hour of dosing) with 240 mL of chocolate milk or a nutritional supplement (Advera or Ensure) did not significantly affect the extent and rate of ritonavir absorption. When a single 100 mg dose of the tablet was administered with a high-fat meal (907 kcal; 52% fat, 15% protein, 33% carbohydrates), approximately 20% decreases in mean peak concentration (Cmax) and systemic exposure (AUC) were observed relative to administration after fasting. Similar decreases in Cmax and AUC were reported when the tablet was administered with a moderate-fat meal. In contrast, the extent of absorption of ritonavir from the soft gelatin capsule formulation was 13% higher when administered with a meal (615 KCal; 14.5% fat, 9% protein, and 76% carbohydrate) relative to fasting.

MANAGEMENT: Ritonavir should be taken with meals to enhance gastrointestinal tolerability.

References

  1. (2001) "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical

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Moderate

paritaprevir food

Applies to: Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir)

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of ombitasvir, paritaprevir, ritonavir, and dasabuvir. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a moderate-fat meal (approximately 600 Kcal; 20% to 30% calories from fat) increased the mean systemic exposure (AUC) by 82%, 211%, 49%, and 30%, respectively. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a high-fat meal (approximately 900 Kcal; with 60% calories from fat) increased the mean AUC by 76%, 180%, 44%, and 22%, respectively.

MANAGEMENT: Ombitasvir/paritaprevir/ritonavir plus dasabuvir should always be administered with a meal. The fat or calorie content does not matter.

References

  1. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC

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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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