Sovaldi: 7 things you should know
Medically reviewed by Carmen Fookes, BPharm. Last updated on Dec 17, 2020.
1. How it works
- Sovaldi is a brand (trade) name for sofosbuvir. It may be used to treat certain genotypes of the hepatitis C virus in adults and children over the age of three.
- Sovaldi (sofosbuvir) interferes with the reproduction of genetic material of the hepatitis C virus, by inhibiting an RNA-dependent polymerase called HCV NS5B, which is also needed by the virus to replicate itself. Sovaldi initially greatly reduces and then completely stops the production of new copies of the hepatitis C virus.
- Sovaldi belongs to the class of medicines known as hepatitis C antivirals.
- Sovaldi may be used to treat genotype 2 or 3 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis in adults or children over the age of 3 years in combination with ribavirin.
- Sovaldi may also be used to treat genotype 1 or 4 HCV infection without cirrhosis or with compensated cirrhosis in adults in combination with pegylated interferon and ribavirin
- The usual dosage of Solvaldi is one 400mg tablet, taken once daily for 12 weeks (genotypes 1,2, or 4) or 24 weeks (genotype 3) in combination with other antiviral agents.
- Available as tablets or oral pellets which are taken by mouth. Tablets come in two strengths (400mg and 200mg) and pellets come in two strengths (200mg and 150mg).
- May be taken with or without food.
- Usually, the side effects that occur with Sovaldi are mild.
- The dosage of Sovaldi does not need to be modified in those with liver disease or kidney disease, including those with end-stage renal disease (ESRD) on dialysis.
- Gilead, the manufacturer of Sovaldi has a special patient assistance program called Support Path™ that may assist with co-pay insurance coupons or make Sovaldi available at no charge for eligible and qualified uninsured patients.
- Sovaldi is also available as a cost-saving generic under the name of sofosbuvir.
If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:
- Most side effects that occur with Sovaldi are mild but the most common ones reported were headache, fatigue, itching, asthenia (lack of energy), and nausea.
- Weight gain has not been reported in clinical trials as a side effect of Sovaldi.
- Reactivation of hepatitis B has been reported. All patients should be tested for current or prior hepatitis B virus (HBV) infection before initiating treatment with Sovaldi.
- Sovaldi is expensive. The wholesale cost of Sovaldi is $1000 per 400mg tablet and a 12-week treatment course would cost around $84,000 and a 24-week course, $168,000. However, this does not take into account the cost of the other treatment needed to be given with Sovaldi. However, most insurance companies and Medicare cover Sovaldi if you meet certain criteria but there may be a co-pay.
- Sovaldi is usually taken for 12 weeks but needs to be taken for 24 weeks in people with genotype 3 HCV.
- Sovaldi may cause elevations in laboratory levels of bilirubin, lipase, and creatinine kinase.
- Sovaldi is ALWAYS given in combination with other hepatitis C treatments. It should NOT be given alone. If other medications used in combination with Sovaldi are discontinued, it should also be discontinued.
Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects
- Before you start taking Sovaldi your doctor will test you for hepatitis B virus (HBV) infection. This because treating HCV may reactivate an underlying hepatitis B infection (HBV). Any underlying HBV infection should be treated before Sovaldi is started.
- Sovaldi pellets may be used to treat HCV in children or in those who have difficulty swallowing. Sovaldi pellets should not be chewed. Do not open the packet until ready to use. Sovaldi pellets may be taken right in the mouth without chewing or sprinkled on top of non-acidic soft foods such as pudding, chocolate syrup, mashed potato, or ice cream that is at or below room temperature. The mixture of foods and pellets should be swallowed whole within 30 minutes of mixing to avoid a bitter aftertaste. Do not store any leftover mixture.
- Sovaldi is best taken at the same time every day. Follow your physician's advice with regards to the dosage of Sovaldi and do not miss or skip doses. Take Sovaldi for the duration that is recommended by your physician.
- Tell your doctor if you take any other medications or supplements, including those purchased from a supermarket or health store. Some medications, such as amiodarone, should not be taken with Sovaldi.
- Seek urgent medical attention if you develop a very slow heartbeat, feel faint or unwell, or experience symptoms such as dizziness or lightheadedness, weakness, excessive tiredness, shortness of breath, chest pains, confusion, or memory problems.
- There is limited data as to the effects of Sovaldi on a developing fetus. Because Sovaldi is usually always taken with ribavirin, you should use adequate contraception to ensure you do not become pregnant. If you do become pregnant while taking Sovaldi, see your doctor immediately. Men whose female partners are pregnant should not be given Sovaldi in combination with ribavirin or peginterferon alfa. The effects of Sovaldi on a breastfeeding infant are also not known.
- While you are taking Sovaldi to treat hepatitis C, you should take steps to ensure you do not pass HCV to others. This includes not sharing needles and practicing safe sex.
6. Response and Effectiveness
- The sustained virologic response (SVR) at 12 weeks (SVR12) for Sovaldi in combination with ribavirin for treatment-naive genotype 2 HCV patients was 95% and 5% relapsed. The SVR24 for Sovaldi in combination with ribavirin for treatment-naive genotype 3 HCV patients was 93%.
- The SVR12 for Sovaldi in combination with pegylated interferon and ribavirin for genotype 1 or 4 HCV was 90% in those with genotype 1, 92% with genotype 1a, 83% with genotype 1b, and 96% with genotype 4. The overall SVR12 was 90% and 9% relapsed. This means that 90% of people given Sovaldi who had HCV genotype 1 were cured and 96% of people given Solvadi who had genotype 4 were cured.
- Cure rates were higher in nonblacks (91%) compared with blacks (87%). Cure rates were also higher in people with genotype 1 or 4 hepatitis C and baseline IL28B C/C alleles (alleles are alternative forms of a gene that arise by mutation) being 99% compared to 87% in those with non-C/C alleles.
- Sovaldi works directly on viral RNA and does not inhibit human DNA or RNA.
Medicines that interact with Sovaldi may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Sovaldi. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.
Common medications that may interact with Sovaldi include:
- amiodarone (not recommended because symptomatic bradycardia, fatal cardiac arrest, and pacemaker intervention have occurred)
- anticancer treatments such as lorlatinib or tucatinib
- anticonvulsants, such as carbamazepine, phenytoin or phenobarbital
- antimicrobials, such as rifabutin or rifampin
- inducers of P-glycoprotein such as carbamazepine, dexamethasone, doxorubicin, nefazodone, phenobarbital, phenytoin, prazosin, rifampicin, St. John's wort, tenofovir, tipranavir, trazodone, and vinblastine
- prostate cancer treatments such as apalutamide or enzalutamide
Sovaldi is usually given in combination with ribavirin. All the medications that interact with ribavirin will also interact with the combination of Sovaldi and ribavirin. In addition, women taking ribavirin should not become pregnant while taking ribavirin.
Sovaldi is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) and medications that are P-gp inducers in the intestine such as rifampin or St. John's wort may decrease Sovaldi plasma concentrations, leading to a reduced therapeutic effect of Sovaldi. Avoid concomitant use.
Note that this list is not all-inclusive and includes only common medications that may interact with Sovaldi. You should refer to the prescribing information for Sovaldi for a complete list of interactions.
Sovaldi (sofosbuvir) [Package insert]. Updated 03/2020. Gilead Sciences, Inc. https://www.drugs.com/pro/sovaldi.html
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Sovaldi only for the indication prescribed.
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