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Interactions between Epclusa and Semaglutide

2 drug interactions and 13 additional warnings found for the following 2 drugs:

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Drug interactions

Moderate drug interactions

Moderate:

sofosbuvir semaglutide

Applies to: Epclusa (sofosbuvir / velpatasvir) and semaglutide
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 semaglutide

Applies to: Epclusa (sofosbuvir / velpatasvir) and semaglutide
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

Food/lifestyle interactions

Moderate food/lifestyle interactions

Moderate:

semaglutide Food/Lifestyle

Applies to: semaglutide
Adjust dosing interval

Taking oral semaglutide with food, beverage, or other oral medications may alter semaglutide absorption and exposure. In a controlled study with healthy volunteers, limited or no measurable semaglutide exposure was observed in subjects that were fed 30 minutes prior to taking oral semaglutide, while all subjects that fasted overnight and 30 minutes after the oral semaglutide dose had measurable semaglutide exposure. Area under the curve (AUC) and semaglutide peak plasma concentration (Cmax) were approximately 40% greater in subjects that fasted compared to those who did not. AUC and Cmax were also increased with a post-dose fasting period greater than 30 minutes.

Management

It is recommended that oral semaglutide be taken 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water to ensure its efficacy. Fasting longer than 30 minutes after the oral semaglutide dose may lead to increased gastrointestinal side effects including nausea, vomiting, or diarrhea.

References (4)
  1. (2024) "Product Information. Rybelsus (semaglutide)." Novo Nordisk Pharmaceuticals Inc
  2. (2024) "Product Information. Rybelsus (semaglutide)." Novo Nordisk Canada Inc
  3. (2024) "Product Information. Rybelsus (semaglutide)." Novo Nordisk Ltd
  4. Baekdal TA, Breitschaft A, Donsmark M, Maarbjerg SJ, Sondergaard FL, Borregaard J (2021) "Effect of various dosing conditions on the pharmacokinetics of oral semaglutide, a human glucagon-like peptide-1 analogue in a tablet formulation" Diabetes Ther, 12, p. 1915-27

Disease interactions

12 potential interactions Applies to: 12 conditions, including Diarrhea, Gastroparesis, Liver Disease, Cirrhosis, and Dehydration.

Cirrhosis

Moderate:

Epclusa

The sofosbuvir in Epclusa has a moderate potential interaction with Cirrhosis.

Sofosbuvir is extensively metabolized in the liver. The safety and efficacy of sofosbuvir as a single agent have not been established in patients with decompensated cirrhosis. No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B or C).

Dehydration

Moderate:

semaglutide

Semaglutide has a moderate potential interaction with Dehydration.

There have been postmarketing reports of acute kidney injury (sometimes requiring hemodialysis) in patients treated with semaglutide. The majority of events occurred in patients with gastrointestinal adverse reactions leading to dehydration (e.g., nausea, vomiting, diarrhea); therefore, semaglutide is not recommended in patients with severe gastroparesis. It is recommended to monitor renal function in patients reporting adverse reactions to semaglutide that may lead to volume depletion, especially when initiating or escalating doses of semaglutide.

Diabetic Retinopathy

Moderate:

semaglutide

Semaglutide has a moderate potential interaction with Diabetic Retinopathy.

Patients with history of diabetic retinopathy should be monitored for progression of diabetic retinopathy during treatment with semaglutide. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy.

Diarrhea

Moderate:

semaglutide

Semaglutide has a moderate potential interaction with Diarrhea.

There have been postmarketing reports of acute kidney injury (sometimes requiring hemodialysis) in patients treated with semaglutide. The majority of events occurred in patients with gastrointestinal adverse reactions leading to dehydration (e.g., nausea, vomiting, diarrhea); therefore, semaglutide is not recommended in patients with severe gastroparesis. It is recommended to monitor renal function in patients reporting adverse reactions to semaglutide that may lead to volume depletion, especially when initiating or escalating doses of semaglutide.

Gastroparesis

Moderate:

semaglutide

Semaglutide has a moderate potential interaction with Gastroparesis.

There have been postmarketing reports of acute kidney injury (sometimes requiring hemodialysis) in patients treated with semaglutide. The majority of events occurred in patients with gastrointestinal adverse reactions leading to dehydration (e.g., nausea, vomiting, diarrhea); therefore, semaglutide is not recommended in patients with severe gastroparesis. It is recommended to monitor renal function in patients reporting adverse reactions to semaglutide that may lead to volume depletion, especially when initiating or escalating doses of semaglutide.

Immunodeficiency

Major:

Epclusa

The sofosbuvir in Epclusa has a major potential interaction with Immunodeficiency.

HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in hepatitis B surface antigen (HBsAg)-positive patients and patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and hepatitis B core antibody [anti-HBc] positive). HBV reactivation has also been reported in patients using certain immunosuppressant or chemotherapeutic agents; risk of HBV reactivation associated with HCV direct-acting antiviral therapy may be increased in these patients. All patients should be tested for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before starting HCV direct-acting antiviral therapy. Patients with serologic evidence of current or prior HBV infection should be monitored for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

Infectious Hepatitis

Major:

Epclusa

The sofosbuvir in Epclusa has a major potential interaction with Infectious Hepatitis.

HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in hepatitis B surface antigen (HBsAg)-positive patients and patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and hepatitis B core antibody [anti-HBc] positive). HBV reactivation has also been reported in patients using certain immunosuppressant or chemotherapeutic agents; risk of HBV reactivation associated with HCV direct-acting antiviral therapy may be increased in these patients. All patients should be tested for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before starting HCV direct-acting antiviral therapy. Patients with serologic evidence of current or prior HBV infection should be monitored for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

Liver Disease

Moderate:

Epclusa

The sofosbuvir in Epclusa has a moderate potential interaction with Liver Disease.

Sofosbuvir is extensively metabolized in the liver. The safety and efficacy of sofosbuvir as a single agent have not been established in patients with decompensated cirrhosis. No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B or C).

Multiple Endocrine Neoplasia Type II

Major:

semaglutide

Semaglutide has a major potential interaction with Multiple Endocrine Neoplasia Type II.

The use semaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Patients with elevated serum calcitonin or thyroid nodules noted on physical examination or neck imaging should be further evaluated. It is recommended to counsel patients regarding the potential risk for MTC with the use of semaglutide and inform them of symptoms of thyroid tumors.

Renal Dysfunction

Moderate:

Epclusa

The sofosbuvir in Epclusa has a moderate potential interaction with Renal Dysfunction.

The safety and efficacy of sofosbuvir as a single agent have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73m2) or ESRD requiring hemodialysis. No dosage recommendation can be given for patients with severe renal impairment or ESRD. No dosage adjustment is necessary for patients with mild or moderate renal impairment.

Thyroid Tumor

Major:

semaglutide

Semaglutide has a major potential interaction with Thyroid Tumor.

The use semaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Patients with elevated serum calcitonin or thyroid nodules noted on physical examination or neck imaging should be further evaluated. It is recommended to counsel patients regarding the potential risk for MTC with the use of semaglutide and inform them of symptoms of thyroid tumors.

Vomiting

Moderate:

semaglutide

Semaglutide has a moderate potential interaction with Vomiting.

There have been postmarketing reports of acute kidney injury (sometimes requiring hemodialysis) in patients treated with semaglutide. The majority of events occurred in patients with gastrointestinal adverse reactions leading to dehydration (e.g., nausea, vomiting, diarrhea); therefore, semaglutide is not recommended in patients with severe gastroparesis. It is recommended to monitor renal function in patients reporting adverse reactions to semaglutide that may lead to volume depletion, especially when initiating or escalating doses of semaglutide.

More resources

Epclusa

A total of 219 drugs are known to interact with Epclusa.

semaglutide

A total of 404 drugs are known to interact with semaglutide.

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.