Standard DoseSovaldi is almost never prescribed separately, but instead prescribed as part of co-formulated tablets that contain it with an additional DAA: Epclusa, Harvoni, and Vosevi. Sovaldi is taken as one 400 mg tablet once daily with or without food. Sovaldi should never be taken by itself and must be taken in combination with another DAA. Sovaldi is FDA approved for treatment of HCV genotypes 2 and 3 in pediatric patients down to 3 years old and there are recommendations for dosing in children weighing less than 37.4 pounds (17 kg).
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.
Black Box Warning
Before starting treatment with any direct-acting antiviral (DAA), including Sovaldi, patients should take a blood test to check for hepatitis B (HBV) infection. HBV infection could get worse or reactivate during or after DAA treatment, potentially leading to serious liver problems, including liver failure or death. Patients with current or past HBV infection should be monitored during HCV DAA treatment, and some may need to take HBV treatment. See HBV Reactivation for more information and consult your medical provider.
Available co-formulated tablets and their components
Harvoni Ledipasvir + sofosbuvir
Epclusa Velpatasvir + sofosbuvir
Vosevi Velpatasvir + sofosbuvir + voxilaprevir
Notes: Sovaldi may be used as an alternative regimen with Olysio (genotype 1) or Daklinza (genotypes 1, 2, 3). See hcvguidelines.org for more information on current recommendations. For pediatric patients, Sovaldi is still recommended in combination with weight-based ribavirin for treatment of genotypes 2 and 3.
AWPbrand: $33,600 / month
Potential Side Effects and Toxicity
Sofosbuvir is very well tolerated with minimal side effects. It is difficult to determine specific side effects of Sovaldi because it has been previously studied with ribavirin and pegylated interferon and documented side effects are likely due to those medications. When Sovaldi is taken with these medications (no longer recommended), the most common side effects reported are fatigue, headaches, nausea, fever, chills, and arthralgia (joint pain). Pegylated interferon has been associated with depression, anxiety, and, in rare cases, suicidal thoughts. If you have a history of any of these conditions, talk to your provider before starting it. Sovaldi is also present in several co-formulated tablets (Harvoni, Epclusa, and Vosevi). For more information on the side effects of these medications, see their respective drug pages.
Pregnant women or women who are trying to become pregnant should avoid use if the addition of ribavirin is required. Women of childbearing age and their male partners must use two forms of birth control throughout treatment and for six months after treatment with ribavirin. Changes in hematological (blood) values are also common, and routine blood testing to look for anemia, neutropenia, and other blood conditions is recommended.
Potential Drug Interactions
Before starting sofosbuvir, be sure to tell your medical provider or pharmacist about all of the medications, supplements, and herbal products you take, whether they are prescribed, over-the-counter, or illicit. It is also important to inform them of any changes as they happen during treatment. No sofosbuvir-based HCV regimens are to be used with amiodarone due to possible symptomatic bradycardia. Signs of bradycardia (slow heart rate) include fainting, dizziness, lightheadedness, weakness, excessive fatigue, shortness of breath, chest pains, and confusion or memory problems. Consult a medical provider should any of these occur. Sovaldi cannot be taken with the HIV medication tipranavir/ritonavir but is safe to take with other HIV medications. Do not take Sovaldi with St. John’s wort, and in general, herbal products should be avoided due to lack of information regarding potential for interaction. Sovaldi should not be taken with rifamycin antimicrobials, such as rifampin, rifabutin, rifapentine, or certain anticonvulsants, such as phenobarbital, carbamazepine, phenytoin, and oxcarbazepine, as they reduce the concentrations and its effectiveness.
Sovaldi is almost never prescribed. It is contained, however, in the co-formulated medications Epclusa, Harvoni, or Vosevi, which are very commonly used today. Approved in 2013, the original sofosbuvir dosage and duration is already pretty much obsolete when compared to other HCV treatments. Sovaldi is a drug with a lot of “firsts”—first drug of its class, first drug to receive FDA approval for use without interferon, and the first DAA to receive FDA approval for use in HIV/HCV co-infected patients.