From the Guidelines
Velasof and Sovihep V (containing sofosbuvir/velpatasvir) should be used with caution due to several important drug interactions that can affect their efficacy and safety, as outlined in the most recent guidelines 1.
Important Interactions to Consider
- Sofosbuvir/velpatasvir may be given with most antiretroviral drugs, except for inducing drugs like efavirenz, etravirine, and nevirapine, which can decrease velpatasvir exposure 1.
- Concomitant use with medicinal products that are strong P-gp and/or strong CYP inducers, such as rifampicin, rifabutin, St John’s wort, carbamazepine, phenobarbital, or phenytoin, is contraindicated due to the decrease in sofosbuvir, velpatasvir, and/or voxilaprevir exposure 1.
- Patients on a regimen containing tenofovir disoproxil fumarate (TDF) require monitoring of renal function due to increased tenofovir exposure caused by P-gp inhibition by sofosbuvir/velpatasvir 1.
- Rosuvastatin is contraindicated due to a 19-fold increase in plasma exposure of the statin, and other BCRP substrates like methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, sulfasalazine, and topotecan are not recommended 1.
- Dabigatran is contraindicated due to a near 3-fold increase in AUC caused by P-gp inhibition by both velpatasvir and voxilaprevir 1.
Recommendations for Use
- Sofosbuvir/velpatasvir should be taken with food and 4 hours before proton pump inhibitors (if necessary) to minimize interactions 1.
- Progestogen-containing contraception is allowed, but concomitant use with ethinylestradiol-containing contraception is contraindicated due to the risk of ALT elevations 1.
- Patients should be monitored for renal adverse events when taking sofosbuvir/velpatasvir with tenofovir disoproxil fumarate 1.
- Dose adjustment or additional monitoring is required when co-administering sofosbuvir, velpatasvir, and voxilaprevir with medicinal products that are substrates of P-gp, BCRP, OATP1B1, and OATP1B3 1.
From the FDA Drug Label
7 DRUG INTERACTIONS 7.1 Potential for Other Drugs to Affect Sofosbuvir and Velpatasvir 7.2 Potential for Sofosbuvir and Velpatasvir to Affect Other Drugs 7.3 Established and Potentially Significant Drug Interactions 7.4 Drugs without Clinically Significant Interactions with Sofosbuvir and Velpatasvir 5.2 Serious Symptomatic Bradycardia When Coadministered with Amiodarone 5.3 Risk of Reduced Therapeutic Effect Due to Concomitant Use of Sofosbuvir and Velpatasvir with Inducers of P-gp and/or Moderate to Strong Inducers of CYP
Drug Interactions: The drug label indicates that VELASOF/SOVIHEP V (sofosbuvir and velpatasvir) has established and potentially significant drug interactions.
- Serious Symptomatic Bradycardia: can occur when coadministered with Amiodarone.
- Reduced Therapeutic Effect: can occur due to concomitant use with inducers of P-gp and/or moderate to strong inducers of CYP. 2
From the Research
Drug Interaction with VELASOF/SOVIHEP V
- VELASOF/SOVIHEP V, a combination of sofosbuvir and velpatasvir, is used to treat hepatitis C virus (HCV) infection.
- Drug-drug interactions (DDIs) can occur when one drug affects the absorption, distribution, metabolism, or excretion of another drug, or when one drug adds to or diminishes the effect of another drug 3.
- Common DDIs result from alterations in drug metabolism through interactions with cytochrome P450 enzymes and absorption through interactions with P-glycoproteins 3.
- The efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) have been reported in patients with chronic HCV infection who have previously experienced a direct-acting antiviral (DAA) containing regimen 4.
- However, there is limited information on the specific drug interactions with VELASOF/SOVIHEP V.
- A meta-analysis of the safety and efficacy of sofosbuvir-velpatasvir found that the 12-week regimen was highly effective in HCV patients, but did not provide information on specific drug interactions 5.
- It is essential to use drug interaction software and collaborate with pharmacists to prevent clinically significant DDIs and optimize drug safety 3, 6.
Factors Affecting Drug Interactions
- Patient-specific factors, such as age, health conditions, and concomitant medications, can affect the risk of drug interactions 6.
- The presence of NS5A RAS mutation, HIV infection, and cirrhosis did not affect the efficacy of SOF/VEL/VOX in patients with chronic HCV infection 4.
- Compensated cirrhosis was associated with a increased risk of not achieving sustained virological response (SVR12/24) in patients treated with sofosbuvir/velpatasvir 7.