Does Epclusa (sofosbuvir and velpatasvir) cause side effects?
Epclusa (sofosbuvir and velpatasvir) contains two direct-acting antiviral agents used to treat chronic infection with the hepatitis C virus (HCV), genotype 1,2,3,4, 5, or 6 in adults. It also may be combined with ribavirin (Rebetol) for treatment of adults with decompensated cirrhosis.
Sofosbuvir is converted to an active form in the body before it is effective. The active form of sofosbuvir directly blocks replication of the HVC by interfering with a hepatitis C virus enzyme called NS5B.
Velpatasvir is an inhibitor of another hepatitis C virus enzyme called NS5A, which also is needed for viral replication. Both drugs in Epclusa interfere with enzymes needed by hepatitis C virus to multiply and make new viruses, thus reducing the overall viral load.
Common side effects of Epclusa include
- depressed mood,
- increased blood levels of lipase,
- increased blood levels of creatinine kinase, and
- increased blood levels of indirect bilirubin.
Serious side effects of Epclusa include
- For example, famotidine, and proton pump inhibitors (PPIs) because they may decrease the effectiveness of Epclusa treatment by decreasing blood levels of velpatasvir.
- Co-administration of Epclusa and amiodarone is not recommended because the combination may cause serious heart-related side effects including symptomatic slow heart rate.
- Anti-seizure medications including carbamazepine, phenytoin, phenobarbital, and oxcarbazepine may increase the breakdown of Epclusa, leading to reduced therapeutic effectiveness.
- Taking St. John's wort or rifampin with Epclusa may also reduce the effectiveness of treatment and is not recommended.
- Certain medications used to treat tuberculosis infection may decrease the effectiveness of Epclusa treatment.
- Patients taking rifampin, rifabutin, or rifapentine should consult with their doctor or pharmacist before starting Epclusa.
- Co-administration of Epclusa with rosuvastatin or atorvastatin cholesterol lowering medications may significantly increase the blood concentration of rosuvastatin or atorvastatin and increase the risk of side effects such as serious muscle injury.
- Drug interactions between Epclusa and certain HIV antiretroviral therapies such as efavirenz, tenofovir, tipranavir, and ritonavir have also been reported.
Adequate studies of Epclusa treatment in pregnant women are lacking. Epclusa should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. However, ribavirin which may be combined with Epclusa should not be used by pregnant women or their male partners.
What are the important side effects of Epclusa (sofosbuvir and velpatasvir)?
Common side effects of Epclusa include:
Other side effects of Epclusa include:
Other less common side effects of Epclusa include:
- Increased blood levels of lipase
- Increased blood levels of creatinine kinase
- Increased blood levels of indirect bilirubin
Possible serious side effects include:
Epclusa (sofosbuvir and velpatasvir) side effects list for healthcare professionals
The following serious adverse reactions are described below and elsewhere in labeling:
- Serious Symptomatic Bradycardia When Coadministered with Amiodarone.
Clinical Trials Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- If Epclusa is administered with ribavirin, refer to the prescribing information for ribavirin for a description of ribavirin-associated adverse reactions.
Clinical Trials In Adult Subjects
Adverse Reactions in Subjects without Cirrhosis or with Compensated Cirrhosis
- The adverse reactions data for Epclusa in patients without cirrhosis or with compensated cirrhosis were derived from three Phase 3 clinical trials (ASTRAL-1, ASTRAL-2, and ASTRAL-3) which evaluated a total of 1035 subjects infected with genotype 1, 2, 3, 4, 5, or 6 HCV, without cirrhosis or with compensated cirrhosis, who received Epclusa for 12 weeks. Epclusa was studied in placebo-and active-controlled trials.
- The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2% for subjects who received Epclusa for 12 weeks.
- The most common adverse reactions (adverse events assessed as causally related by the investigator and at least 10%) were headache and fatigue in subjects treated with Epclusa for 12 weeks.
- Adverse reactions, all grades, observed in greater than or equal to 5% of subjects receiving 12 weeks of treatment with Epclusa in ASTRAL-1 include
- Of subjects receiving Epclusa who experienced these adverse reactions, 79% had an adverse reaction of mild severity (Grade 1).
- With the exception of asthenia, each of these adverse reactions occurred at a similar frequency or more frequently in subjects treated with placebo compared to subjects treated with Epclusa (asthenia: 3% versus 5% for the placebo and Epclusa groups, respectively).
- The adverse reactions observed in subjects treated with Epclusa in ASTRAL-2 and ASTRAL-3 were consistent with those observed in ASTRAL-1.
- Irritability was also observed in greater than or equal to 5% of subjects treated with Epclusa in ASTRAL-3.
Adverse Reactions In Subjects Coinfected With HCV And HIV-1
- The safety assessment of Epclusa in subjects with HCV/HIV-1 coinfection was based on an open-label clinical trial (ASTRAL-5) in 106 subjects who were on stable antiretroviral therapy.
- The safety profile in HCV/HIV-1 coinfected subjects was similar to that observed in HCV mono-infected subjects.
- The most common adverse reactions occurring in at least 10% of subjects were
Adverse Reactions In Subjects With Decompensated Cirrhosis
- The safety assessment of Epclusa in subjects infected with genotype 1, 2, 3, 4, or 6 HCV with decompensated cirrhosis was based on one Phase 3 trial (ASTRAL-4) including 87 subjects who received Epclusa with ribavirin for 12 weeks.
- All 87 subjects had Child-Pugh B cirrhosis at screening.
- On the first day of treatment with Epclusa with ribavirin, 6 subjects and 4 subjects were assessed to have Child-Pugh A and Child-Pugh C cirrhosis, respectively.
- The most common adverse reactions (adverse events assessed as causally related by the investigator, all grades with frequency of 10% or greater) in the 87 subjects who received Epclusa with ribavirin for 12 weeks were
- Of subjects who experienced these adverse reactions, 98% had adverse reactions of mild to moderate severity.
- A total of 4 (5%) subjects permanently discontinued Epclusa with ribavirin due to an adverse event; there was no adverse event leading to discontinuation that occurred in more than 1 subject.
- Decreases in hemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were observed in 23% and 7% of subjects treated with Epclusa with ribavirin for 12 weeks, respectively.
- Ribavirin was permanently discontinued in 17% of subjects treated with Epclusa with ribavirin for 12 weeks, due to adverse reactions.
Less Common Adverse Reactions Reported In Clinical Trials
- The following adverse reactions occurred in less than 5% of subjects without cirrhosis or with compensated cirrhosis treated with Epclusa for 12 weeks and are included because of a potential causal relationship.
- In the ASTRAL-1 study, rash occurred in 2% of subjects treated with Epclusa and in 1% of subjects treated with placebo. No serious adverse reactions of rash occurred, and all rashes were mild or moderate in severity.
- In the ASTRAL-1 study, depressed mood occurred in 1% of subjects treated with Epclusa and was not reported by any subject taking placebo.
- No serious adverse reactions of depressed mood occurred, and all events were mild or moderate in severity.
- The following adverse reactions occurred in less than 10% of subjects with decompensated cirrhosis (ASTRAL-4) treated with Epclusa with ribavirin for 12 weeks and are included because of a potential causal relationship.
- Rash occurred in 5% of subjects treated with Epclusa with ribavirin.
- No serious adverse reactions of rash occurred, and all rashes were mild or moderate in severity.
- In ASTRAL-1, isolated, asymptomatic lipase elevations of greater than 3xULN were observed in 3% and 1% of subjects treated with Epclusa and placebo for 12 weeks, respectively; and in 6% and 3% of subjects treated with Epclusa in ASTRAL-2 and ASTRAL-3, respectively.
- In the Phase 3 trial of subjects with decompensated cirrhosis (ASTRAL-4), lipase was assessed when amylase values were greater than or equal to 1.5xULN.
- Isolated, asymptomatic lipase elevations of greater than 3xULN were observed in 2% of subjects treated with Epclusa with ribavirin for 12 weeks.
- In ASTRAL-1, isolated, asymptomatic creatine kinase elevations greater than or equal to 10xULN were reported in 1% and 0% of subjects treated with Epclusa and placebo for 12 weeks, respectively; and in 2% and 1% of subjects treated with Epclusa in ASTRAL-2 and ASTRAL-3, respectively.
- In the Phase 3 trial with decompensated cirrhosis (ASTRAL-4), isolated, asymptomatic creatine kinase elevations greater than or equal to 10xULN were reported in 1% of subjects treated with Epclusa with ribavirin for 12 weeks.
- Increases in indirect bilirubin up to 3 mg/dL above baseline were noted among HIV-1/HCV coinfected subjects treated with Epclusa and an atazanavir/ritonavir-based antiretroviral regimen.
- The elevated indirect bilirubin values were not associated with clinical adverse events, and all subjects completed 12 weeks of Epclusa without dose adjustment or treatment interruption of either Epclusa or HIV antiretroviral agents.
Adverse Reactions In Adult Liver Transplant Recipients
The safety assessment of Epclusa in liver transplant recipients was based on an open-label clinical trial (Trial 2104) in 79 adults without cirrhosis or with compensated cirrhosis who received Epclusa for 12 weeks. One subject discontinued treatment due to an adverse event on Day 7. The adverse reactions observed were consistent with the known safety profile of Epclusa.
Adverse reactions occurring in at least 5% of subjects were
- headache (18%),
- fatigue (15%),
- nausea (8%),
- diarrhea (6%), and
- asthenia (5%).
Adverse Reactions In Adults With Severe Renal Impairment Requiring Dialysis
- In an open-label trial (Trial 4062), in which a total of 59 adults with HCV with compensated liver disease (with or without cirrhosis) and ESRD requiring dialysis received Epclusa for 12 weeks, the most common adverse reaction was nausea (7%).
Adverse Reactions In Pediatric Subjects 6 Years Of Age And Older
- The safety assessment of Epclusa in pediatric subjects 6 years of age and older or weighing at least 17 kg is based on data from a Phase 2, open-label clinical trial (Study 1143) that enrolled 175 subjects who were treated with Epclusa for 12 weeks.
- The adverse reactions observed were consistent with those observed in clinical trials of Epclusa in adults.
The following adverse reactions have been identified during post approval use of sofosbuvir. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Serious symptomatic bradycardia has been reported in patients taking amiodarone who initiate treatment with a sofosbuvir-containing regimen.
Skin And Subcutaneous Tissue Disorders
What drugs interact with Epclusa (sofosbuvir and velpatasvir)?
Potential For Other Drugs To Affect Epclusa
- Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP while GS-331007 (the predominant circulating metabolite of sofosbuvir) is not. In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8, and CYP3A4 was observed.
- Drugs that are inducers of P-gp and/or moderate to strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g., rifampin, St. John's wort, carbamazepine) may decrease plasma concentrations of sofosbuvir and/or velpatasvir, leading to reduced therapeutic effect of Epclusa.
- The use of these agents with Epclusa is not recommended. Epclusa may be coadministered with P-gp, BCRP, and CYP inhibitors.
Potential For Epclusa To Affect Other Drugs
- Velpatasvir is an inhibitor of drug transporters P-gp, breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, and OATP2B1.
- Coadministration of Epclusa with drugs that are substrates of these transporters may increase the exposure of such drugs.
Established And Potentially Significant Drug Interactions
- Clearance of HCV infection with direct acting antivirals may lead to changes in hepatic function, which may impact the safe and effective use of concomitant medications.
- For example, altered blood glucose control resulting in serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies.
- Management of hypoglycemia in these cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment.
- Frequent monitoring of relevant laboratory parameters (e.g., International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of concomitant medications such as cytochrome P450 substrates with a narrow therapeutic index (e.g., certain immunosuppressants) is recommended to ensure safe and effective use. Dose adjustments of concomitant medications may be necessary.
- Table 4 provides a listing of established or potentially clinically significant drug interactions.
- The drug interactions described are based on studies conducted with either Epclusa, the components of Epclusa (sofosbuvir and velpatasvir) as individual agents, or are predicted drug interactions that may occur with Epclusa.
Table 4 Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studiesor Predicted Interactiona
|Concomitant Drug Class: Drug Name||Effect on Concentrationb||Clinical Effect/Recommendation|
|Acid Reducing Agents:||↓ velpatasvir||Velpatasvir solubility decreases as pH increases. Drugs that increase gastric pH are expected to decrease concentration of velpatasvir.|
|Antacids (e.g., aluminum and magnesium hydroxide)||Separate antacid and Epclusa administration by 4 hours.|
|H2-receptor antagonistsc (e.g., famotidine)||H2-receptor antagonists may be administered simultaneously with or 12 hours apart from Epclusa at a dose that does not exceed doses comparable to famotidine 40 mg twice daily.|
|Proton-pump inhibitorsc (e.g., omeprazole)||Coadministration of omeprazole or other proton-pump inhibitors is not recommended. If it is considered medically necessary to coadminister, Epclusa should be administered with food and taken 4 hours before omeprazole 20 mg. Use with other proton-pump inhibitors has not been studied.|
|Effect on amiodarone, sofosbuvir, and velpatasvir concentrations unknown||Coadministration of amiodarone with a sofosbuvircontaining regimen may result in serious symptomatic bradycardia. The mechanism of this effect is unknown. Coadministration of amiodarone with Epclusa is not recommended; if coadministration is required, cardiac monitoring is recommended.|
|digoxinc||↑ digoxin||Therapeutic concentration monitoring of digoxin is recommended when coadministered with Epclusa. Refer to digoxin prescribing information for monitoring and dose modification recommendations for concentration increases of less than 50%.|
|↑ topotecan||Coadministration is not recommended.|
|Coadministration is not recommended.|
|Coadministration is not recommended.|
|↓ velpatasvir||Coadministration of Epclusa with efavirenz-containing regimens is not recommended.|
|Regimens containing tenofovir DF||↑ tenofovir||Monitor for tenofovir-associated adverse reactions in patients receiving Epclusa concomitantly with a regimen containing tenofovir DF. Refer to the prescribing information of the tenofovir DF-containing product for recommendations on renal monitoring.|
|Coadministration is not recommended.|
St. John’s wort (Hypericum perforatum)
|Coadministration is not recommended.|
|HMG-CoA Reductase Inhibitors:|
|↑ rosuvastatin||Coadministration of Epclusa with rosuvastatin may significantly increase the concentration of rosuvastatin, which is associated with increased risk of myopathy, including rhabdomyolysis. Rosuvastatin may be administered with Epclusa at a dose that does not exceed 10 mg.|
|atorvastatinc||↑ atorvastatin||Coadministration of Epclusa with atorvastatin may be associated with increased risk of myopathy, including rhabdomyolysis. Monitor closely for HMG-CoA reductase inhibitor-associated adverse reactions, such as myopathy and rhabdomyolysis.|
|DF = disoproxil fumarate.|
a. This table is not all inclusive.
b. ↓ = decrease, ↑ = increase.
c. These interactions have been studied in healthy adults.
Drugs Without Clinically Significant Interactions With Epclusa
Based on drug interaction studies conducted with the components of Epclusa (sofosbuvir or velpatasvir) or Epclusa, no clinically significant drug interactions have been observed with the following drugs:
- Epclusa: atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, raltegravir, or rilpivirine.
- Sofosbuvir: ethinyl estradiol/norgestimate, methadone, or tacrolimus.
- Velpatasvir: ethinyl estradiol/norgestimate, ketoconazole, or pravastatin.
See Table 4 for use of Epclusa with certain HIV antiretroviral regimens.
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Hepatitis is most often viral, due to infection with one of the hepatitis viruses (A, B, C, D, E, F (not confirmed), and G) or another virus (such as those that cause infectious mononucleosis, cytomegalovirus disease). The main nonviral causes of hepatitis are alcohol and drugs. Many patients infected with hepatitis A, B, and C have few or no symptoms of illness. For those who do develop symptoms of viral hepatitis, the most common are flu-like symptoms including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, and aching in the abdomen. Treatment of viral hepatitis is dependent on the type of hepatitis.
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Hepatitis C is an inflammation of the liver due to the hepatitis C virus (HCV), which is usually spread by blood transfusion, hemodialysis, and needle sticks, especially with intravenous drug abuse. Symptoms of chronic hepatitis include fatigue, fever, muscle aches, loss of appetite, and fever. Chronic hepatitis C may be cured in most individuals with drugs that target specific genomes of hepatitis C.
Hepatitis A (HAV, Hep A)
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The hepatitis B virus (HBV, hep B) is a unique, coated DNA virus belonging to the Hepadnaviridae family of viruses. The course of the virus is determined primarily by the age at which the infection is acquired and the interaction between the virus and the body's immune system. Successful treatment is associated with a reduction in liver injury and fibrosis (scarring), a decreased likelihood of developing cirrhosis and its complications, including liver cancer, and a prolonged survival.
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