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Drug Interactions between Stribild and telaprevir

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

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Interactions between your drugs

Moderate

tenofovir telaprevir

Applies to: Stribild (cobicistat / elvitegravir / emtricitabine / tenofovir) and telaprevir

MONITOR: Coadministration of tenofovir disoproxil fumarate with telaprevir may increase the plasma concentrations of tenofovir. The mechanism of interaction has not been described. In 16 study subjects, administration of tenofovir DF (300 mg once daily) in combination with telaprevir (750 mg every 8 hours) for 7 days increased the tenofovir peak plasma concentration (Cmax) and systemic exposure (AUC) by an average of 30% and the trough plasma concentration (Cmin) by 41% compared to administration alone. The Cmax, AUC and Cmin of telaprevir did not change significantly. When the same dosage of tenofovir DF was given in combination with both efavirenz (600 mg once daily) and telaprevir (1125 mg every 8 hours) for 7 days to fifteen study subjects, tenofovir Cmax, AUC and Cmin increased by an average of just 22%, 10% and 17%, respectively. Similar results were observed when the telaprevir dosage was changed to 1500 mg every 12 hours and administered with tenofovir DF and efavirenz.

MANAGEMENT: Increased clinical and laboratory monitoring are warranted when tenofovir DF is coadministered with telaprevir. Treatment with tenofovir DF should be discontinued in patients who develop tenofovir-related toxicities such as renal impairment or lactic acidosis and severe hepatomegaly with steatosis.

References

  1. Durant J, Clevenbergh P, Garraffo R, Halfon P, Icard S, DelGiudice P, Montagne N, Schapiro JM, Dellamonica P (2000) "Importance of protease inhibitor plasma levels in HIV-infected patients treated with genotypic-guided therapy: pharmacological data from the Viradapt Study." Aids, 14, p. 1333-9
  2. (2011) "Product Information. Incivek (telaprevir)." Vertex Pharmaceuticals

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Moderate

tenofovir cobicistat

Applies to: Stribild (cobicistat / elvitegravir / emtricitabine / tenofovir) and Stribild (cobicistat / elvitegravir / emtricitabine / tenofovir)

MONITOR: Concomitant use of tenofovir with cobicistat may increase the risk for tenofovir-related renal adverse effects, including renal impairment, renal failure, elevated creatinine, and Fanconi syndrome. The mechanism of this interaction has not been described. Cobicistat may decrease estimated creatinine clearance via inhibition of tubular secretion of creatinine; however, renal glomerular function does not appear to be affected. When given concomitantly with cobicistat, the systemic exposure (AUC) and trough plasma concentrations (Cmin) of tenofovir was also increased by 23% and 55%, respectively. However, data are lacking to determine whether concomitant use of tenofovir with cobicistat-containing regimens is associated with a greater risk of renal complications compared with regimens that do not include cobicistat.

MANAGEMENT: Initiation of cobicistat or cobicistat-containing regimens is not recommended in patients with CrCl less than 70 mL/min if any coadministered medicine requires dose adjustment based on renal function (including tenofovir), or is nephrotoxic. If concomitant therapy is necessary, monitoring of renal function is recommended, particularly in patients with risk factors for renal impairment.

References

  1. (2001) "Product Information. Viread (tenofovir)." Gilead Sciences
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2014) "Product Information. Tybost (cobicistat)." Gilead Sciences
View all 4 references

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Moderate

emtricitabine cobicistat

Applies to: Stribild (cobicistat / elvitegravir / emtricitabine / tenofovir) and Stribild (cobicistat / elvitegravir / emtricitabine / tenofovir)

GENERALLY AVOID: Cobicistat may increase the plasma concentrations of antiretroviral agents. The plasma concentrations of cobicistat may also be increased or reduced in the presence of antiretroviral agents. The proposed mechanism is cobicistat inhibition of the CYP450 3A4 isoenzyme, of which antiretroviral agents may be substrates, and the inhibition or induction of CYP450 3A4 by concomitant antiretroviral medications. Cobicistat is a mechanism-based inhibitor and substrate of CYP450 3A4 with no antiretroviral activity of its own. Rather, it is indicated in its capacity as a pharmacokinetic booster of CYP450 3A4 to increase the systemic exposure of some antiretroviral medications such as atazanavir, darunavir, and elvitegravir, which are substrates of this isoenzyme. Concomitant use of other antiretroviral agents with cobicistat may also increase the plasma levels and risk of side effects associated with these medicines. In contrast, concomitant use of cobicistat-boosted atazanavir or darunavir with CYP450 3A4 inducers nevirapine, etravirine, or efavirenz may reduce the plasma concentrations of cobicistat, darunavir, and atazanavir, leading to a potential loss of therapeutic effect and development of resistance to darunavir and atazanavir. Pharmacokinetic data are not available.

MANAGEMENT: Cobicistat is not intended for use with more than one antiretroviral medication that requires pharmacokinetic enhancement, such as two protease inhibitors or elvitegravir in combination with a protease inhibitor. In addition, cobicistat should not be used concomitantly with ritonavir due to their similar effects on CYP450 3A4. According to some authorities, use of the antiretroviral combinations of atazanavir-cobicistat or darunavir-cobicistat concomitantly with the CYP450 3A4 inducers efavirenz, etravirine, or nevirapine is also not recommended. Other authorities consider the administration of atazanavir-cobicistat with efavirenz or nevirapine to be contraindicated. Since dosing recommendations have only been established for a number of antiretroviral medications, product labeling and current antiretroviral treatment guidelines should be consulted.

References

  1. (2001) "Product Information. Viramune (nevirapine)." Boehringer-Ingelheim
  2. (2001) "Product Information. Sustiva (efavirenz)." DuPont Pharmaceuticals
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. (2006) "Product Information. Prezista (darunavir)." Ortho Biotech Inc
  5. (2008) "Product Information. Intelence (etravirine)." Ortho Biotech Inc
  6. Cerner Multum, Inc. "Australian Product Information."
  7. (2012) "Product Information. Stribild (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences
  8. (2014) "Product Information. Tybost (cobicistat)." Gilead Sciences
  9. (2014) "Product Information. Prezcobix (cobicistat-darunavir)." Janssen Pharmaceuticals
  10. (2015) "Product Information. Evotaz (atazanavir-cobicistat)." Bristol-Myers Squibb
View all 10 references

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Drug and food interactions

Moderate

telaprevir food

Applies to: telaprevir

ADJUST DOSING INTERVAL: Food significantly enhances the oral bioavailability of telaprevir. When given with a meal containing 533 kcal and 21 g fat, telaprevir systemic exposure (AUC) increased by 237% compared to administration under fasting conditions. The type of meal also affects the exposure to telaprevir. Relative to fasting, telaprevir AUC increased by approximately 117% with a low-fat meal (249 kcal; 3.6 g fat) and 330% with a high-fat meal (928 kcal; 56 g fat). In Phase 3 clinical trials, telaprevir doses were administered within 30 minutes of completing a meal or snack containing approximately 20 grams of fat.

MANAGEMENT: Telaprevir should be administered with food containing approximately 20 grams of fat. Patients should be advised that the fat content of the meal or snack is critical to the absorption of telaprevir. Food taken with telaprevir should be ingested within 30 minutes prior to each dose. Examples of some foods that could be taken with telaprevir include: bagel with cream cheese; half cup of nuts; 3 tablespoons of peanut butter; 1 cup of ice cream; 2 ounces of American or cheddar cheese; 2 ounces of potato chips; or half cup of trail mix.

References

  1. (2011) "Product Information. Incivek (telaprevir)." Vertex Pharmaceuticals

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Moderate

elvitegravir food

Applies to: Stribild (cobicistat / elvitegravir / emtricitabine / tenofovir)

ADJUST DOSING INTERVAL: Food enhances the oral bioavailabilities of both elvitegravir and tenofovir. When a single dose of cobicistat/elvitegravir/emtricitabine/tenofovir (trade name Stribild) was given with a light meal (approximately 373 kcal; 20% fat), mean elvitegravir and tenofovir systemic exposures (AUCs) increased by 34% and 24%, respectively, relative to fasting conditions. When administered with a high-fat meal (approximately 800 kcal; 50% fat), the mean AUC of elvitegravir and tenofovir increased by 87% and 23%, respectively, relative to fasting conditions. The alterations in mean AUCs of cobicistat and emtricitabine were not clinically significant with either the light or high-fat meal.

MANAGEMENT: Cobicistat/elvitegravir/emtricitabine/tenofovir as a fixed-dose preparation should be administered once daily with food. Elvitegravir as a single-ingredient preparation should also be administered once daily with food.

References

  1. (2012) "Product Information. Stribild (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences
  2. (2014) "Product Information. Vitekta (elvitegravir)." Gilead Sciences

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Minor

tenofovir food

Applies to: Stribild (cobicistat / elvitegravir / emtricitabine / tenofovir)

Food enhances the oral absorption and bioavailability of tenofovir, the active entity of tenofovir disoproxil fumarate. According to the product labeling, administration of the drug following a high-fat meal increased the mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of tenofovir by approximately 14% and 40%, respectively, compared to administration in the fasting state. However, administration with a light meal did not significantly affect the pharmacokinetics of tenofovir compared to administration in the fasting state. Food delays the time to reach tenofovir Cmax by approximately 1 hour. Tenofovir disoproxil fumarate may be administered without regard to meals.

References

  1. (2001) "Product Information. Viread (tenofovir)." Gilead Sciences

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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.


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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.