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Drug Interactions between metformin 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

metFORMIN sofosbuvir

Applies to: metformin and sofosbuvir / velpatasvir / voxilaprevir

MONITOR: Clearance of hepatitis C virus (HCV) infection with direct acting antiviral agents (DAAs) may lead to changes in hepatic function which may result in altered blood glucose control. Serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies. These cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment.

MANAGEMENT: Blood glucose should be closely monitored during treatment of HCV with DAAs, particularly during the first 3 months, and appropriate changes made to the antidiabetic drug regimen as needed. The patient as well as the healthcare providers in charge of diabetic care should be apprised of the risk of hypoglycemia. Patients should be aware of the potential signs and symptoms of hypoglycemia such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, palpitation, and tachycardia. For antidiabetic medications that are not glucose-dependent, reduction in the dosage should be considered to mitigate the risk of hypoglycemia.

References (12)
  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Sovaldi (sofosbuvir)." Gilead Sciences
  4. (2014) "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences
  5. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC
  6. (2015) "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb
  7. Cerner Multum, Inc (2015) "Malaysia product information."
  8. (2016) "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Co., Inc
  9. (2016) "Product Information. Epclusa (sofosbuvir-velpatasvir)." Gilead Sciences
  10. (2017) "Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir)." Gilead Sciences
  11. (2017) "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical
  12. Drazilova S, Gazda J, Janicko M, Jarcuska P (2018) "Chronic Hepatitis C Association with Diabetes Mellitus and Cardiovascular Risk in the Era of DAA Therapy" Can J Gastroenterol Hepatol, 1, p. 1-11
Moderate

metFORMIN velpatasvir

Applies to: metformin and sofosbuvir / velpatasvir / voxilaprevir

MONITOR: Clearance of hepatitis C virus (HCV) infection with direct acting antiviral agents (DAAs) may lead to changes in hepatic function which may result in altered blood glucose control. Serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies. These cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment.

MANAGEMENT: Blood glucose should be closely monitored during treatment of HCV with DAAs, particularly during the first 3 months, and appropriate changes made to the antidiabetic drug regimen as needed. The patient as well as the healthcare providers in charge of diabetic care should be apprised of the risk of hypoglycemia. Patients should be aware of the potential signs and symptoms of hypoglycemia such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, palpitation, and tachycardia. For antidiabetic medications that are not glucose-dependent, reduction in the dosage should be considered to mitigate the risk of hypoglycemia.

References (12)
  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Sovaldi (sofosbuvir)." Gilead Sciences
  4. (2014) "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences
  5. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC
  6. (2015) "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb
  7. Cerner Multum, Inc (2015) "Malaysia product information."
  8. (2016) "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Co., Inc
  9. (2016) "Product Information. Epclusa (sofosbuvir-velpatasvir)." Gilead Sciences
  10. (2017) "Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir)." Gilead Sciences
  11. (2017) "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical
  12. Drazilova S, Gazda J, Janicko M, Jarcuska P (2018) "Chronic Hepatitis C Association with Diabetes Mellitus and Cardiovascular Risk in the Era of DAA Therapy" Can J Gastroenterol Hepatol, 1, p. 1-11
Moderate

metFORMIN voxilaprevir

Applies to: metformin and sofosbuvir / velpatasvir / voxilaprevir

MONITOR: Clearance of hepatitis C virus (HCV) infection with direct acting antiviral agents (DAAs) may lead to changes in hepatic function which may result in altered blood glucose control. Serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies. These cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment.

MANAGEMENT: Blood glucose should be closely monitored during treatment of HCV with DAAs, particularly during the first 3 months, and appropriate changes made to the antidiabetic drug regimen as needed. The patient as well as the healthcare providers in charge of diabetic care should be apprised of the risk of hypoglycemia. Patients should be aware of the potential signs and symptoms of hypoglycemia such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, palpitation, and tachycardia. For antidiabetic medications that are not glucose-dependent, reduction in the dosage should be considered to mitigate the risk of hypoglycemia.

References (12)
  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Sovaldi (sofosbuvir)." Gilead Sciences
  4. (2014) "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences
  5. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC
  6. (2015) "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb
  7. Cerner Multum, Inc (2015) "Malaysia product information."
  8. (2016) "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Co., Inc
  9. (2016) "Product Information. Epclusa (sofosbuvir-velpatasvir)." Gilead Sciences
  10. (2017) "Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir)." Gilead Sciences
  11. (2017) "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical
  12. Drazilova S, Gazda J, Janicko M, Jarcuska P (2018) "Chronic Hepatitis C Association with Diabetes Mellitus and Cardiovascular Risk in the Era of DAA Therapy" Can J Gastroenterol Hepatol, 1, p. 1-11
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

Major

metFORMIN food

Applies to: metformin

GENERALLY AVOID: Alcohol can potentiate the effect of metformin on lactate metabolism and increase the risk of lactic acidosis. In addition, alcohol may cause hypoglycemia or hyperglycemia in patients with diabetes. Although hypoglycemia rarely occurs during treatment with metformin alone, the risk may increase with acute consumption of alcohol. Even modest amounts can lower blood sugar significantly, especially when the alcohol is ingested on an empty stomach or following exercise. The mechanism involves inhibition of both gluconeogenesis as well as the counter-regulatory response to hypoglycemia. Episodes of hypoglycemia may last for 8 to 12 hours after ethanol ingestion. By contrast, chronic alcohol abuse can cause impaired glucose tolerance and hyperglycemia. Moderate alcohol consumption generally does not affect blood glucose levels in patients with well controlled diabetes.

Food may have varying effects on the absorption of metformin from immediate-release versus extended-release formulations. When a single 850 mg dose of immediate-release metformin was administered with food, mean peak plasma concentration (Cmax) and systemic exposure (AUC) decreased by 40% and 25%, respectively, and time to peak plasma concentration (Tmax) increased by 35 minutes compared to administration under fasting conditions. By contrast, administration of extended-release metformin with food increased AUC by 50% without affecting Cmax or Tmax, and both high- and low-fat meals had the same effect. These data may not be applicable to formulations that contain metformin with other oral antidiabetic agents.

MANAGEMENT: Metformin should be taken with meals, and excessive alcohol intake should be avoided during treatment. Diabetes patients in general should avoid consuming alcohol if their blood glucose is not well controlled, or if they have hypertriglyceridemia, neuropathy, or pancreatitis. Alcohol should not be consumed on an empty stomach or following exercise, as it may increase the risk of hypoglycemia. Patients should contact their physician immediately if they experience potential signs and symptoms of lactic acidosis such as malaise, myalgia, respiratory distress, increasing somnolence, and nonspecific abdominal distress (especially after stabilization of metformin therapy, when gastrointestinal symptoms are uncommon). With more marked acidosis, there may also be associated hypothermia, hypotension, and resistant bradyarrhythmias. Metformin should be withdrawn promptly if lactic acidosis is suspected. Serum electrolytes, ketones, blood glucose, blood pH, lactate levels, and blood metformin levels may be useful in establishing a diagnosis. Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).

References (2)
  1. (2001) "Product Information. Glucophage (metformin)." Bristol-Myers Squibb
  2. (2002) "Position Statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes related complications. American Diabetes Association." Diabetes Care, 25(Suppl 1), S50-S60
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

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

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