What is Sovaldi (sofosbuvir)?
After administration, Sovaldi is first converted to an active form which interferes with multiplication of the ribonucleic acid (RNA) of HCV leading to decreased numbers of hepatitis C virus in the body. Sovaldi is effective for treating infection with HCV genotype 1, 2, 3, or 4, and in clinical trials, 50% to 90% of individuals treated with the drug cleared the hepatitis C virus from their blood.
Common side effects of Sovaldi include:
Other side effects of Sovaldi include:
Serious side effects of Sovaldi include:
- St. John’s wort,
- oxcarbazepine, and
Sovaldi and amiodarone should not be combined with another direct-acting antiviral agent because combining them may significantly reduce heart rate, especially in people who are taking beta-blockers or have underlying heart problems.
There hasn’t been enough research and evaluation of Sovaldi in pregnant women. However, ribavirin, which is combined with Sovaldi, should not be used in pregnant women. Male partners of females of reproductive potential shouldn't use it either.
What are the important side effects of Sovaldi (sofosbuvir)?
The most common side effects reported by patients include:
Other side effects include:
Sovaldi (sofosbuvir) side effects list for healthcare professionals
The following serious adverse reactions are described below and elsewhere in the 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.
When Sovaldi is administered with ribavirin or peginterferon alfa/ribavirin, refer to the respective prescribing information for a description of adverse reactions associated with their use.
Adverse Reactions In Adult Subjects
The safety assessment of Sovaldi was based on pooled Phase 3 clinical trial data (both controlled and uncontrolled) including:
- 650 subjects who received Sovaldi + ribavirin (RBV) combination therapy for 12 weeks,
- 98 subjects who received Sovaldi + ribavirin combination therapy for 16 weeks,
- 250 subjects who received Sovaldi + ribavirin combination therapy for 24 weeks,
- 327 subjects who received Sovaldi + peginterferon (Peg-IFN) alfa + ribavirin combination therapy for 12 weeks,
- 243 subjects who received peginterferon alfa + ribavirin for 24 weeks, and
- 71 subjects who received placebo (PBO) for 12 weeks.
The proportion of subjects who permanently discontinued treatment due to adverse events was 4% for subjects receiving placebo, 1% for subjects receiving Sovaldi + ribavirin for 12 weeks, less than 1% for subjects receiving Sovaldi + ribavirin for 24 weeks, 11% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2% for subjects receiving Sovaldi + peginterferon alfa + ribavirin for 12 weeks.
Adverse events observed in at least 15% of subjects in the Phase 3 clinical trials outlined above are provided in Table 5. A side-by-side tabulation is displayed to simplify presentation; direct comparison across trials should not be made due to differing trial designs.
The most common adverse events (at least 20%) for Sovaldi + ribavirin combination therapy were fatigue and headache. The most common adverse events (at least 20%) for Sovaldi + peginterferon alfa + ribavirin combination therapy were:
Table 5 : Adverse Events (All Grades and without Regard to Causality) Reported in ≥15% of Subjects with HCV in Any Treatment Arm
|Interferon-free Regimens||Interferon-containing Regimens|
|PBO 12 weeks||Sovaldi + RBVa 12 weeks||Sovaldi + RBVa 24 weeks||Peg-IFN alfa + RBVb 24 weeks||Sovaldi + Peg-IFN alfa + RBVa 12 weeks|
|Influenza Like Illness||3%||3%||6%||18%||16%|
|aSubjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing ≥75 kg).|
bSubjects received 800 mg ribavirin per day regardless of weight.
With the exception of anemia and neutropenia, the majority of events presented in Table 5 occurred at severity of grade 1 in Sovaldi-containing regimens.
Less Common Adverse Reactions Reported In Clinical Trials (Less Than 1%)
The following adverse reactions occurred in less than 1% of subjects receiving Sovaldi in a combination regimen in any one trial. These events have been included because of their seriousness or assessment of potential causal relationship.
pancytopenia (particularly in subjects receiving concomitant pegylated interferon).
Changes in selected hematological parameters are described in Table 6. A side-by-side tabulation is displayed to simplify presentation; direct comparison across trials should not be made due to differing trial designs.
Table 6 : Percentage of Subjects Reporting Selected Hematological Parameters
|Hematological Parameters||Interferon-free Regimens||Interferon-containing Regimens|
|PBO 12 weeks||Sovaldi + RBVa 12 weeks||Sovaldi + RBVa 24 weeks||Peg-IFN + RBVb 24 weeks||Sovaldi + Peg-IFN + RBVa 12 weeks|
|≥0.5 - <0.75||1%||<1%||0||12%||15%|
|≥25 - <50||3%||<1%||1%||7%||<1%|
|aSubjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing ≥75 kg).|
bSubjects received 800 mg ribavirin per day regardless of weight.
Total bilirubin elevation of more than 2.5xULN was observed in none of the subjects in the Sovaldi + peginterferon alfa + ribavirin 12 weeks group and in 1%, 3% and 3% of subjects in the peginterferon alfa + ribavirin 24 weeks, Sovaldi + ribavirin 12 weeks and Sovaldi + ribavirin 24 weeks groups, respectively. Bilirubin levels peaked during the first 1 to 2 weeks of treatment and subsequently decreased and returned to baseline levels by post-treatment Week 4. These bilirubin elevations were not associated with transaminase elevations.
Creatine Kinase Elevations
Creatine kinase was assessed in the FISSION and NEUTRINO trials. Isolated, asymptomatic creatine kinase elevation of greater than or equal to 10xULN was observed in less than 1%, 1% and 2% of subjects in the peginterferon alfa + ribavirin 24 weeks, Sovaldi + peginterferon alfa + ribavirin 12 weeks and Sovaldi + ribavirin 12 weeks groups, respectively.
Isolated, asymptomatic lipase elevation of greater than 3xULN was observed in less than 1%, 2%, 2%, and 2% of subjects in the Sovaldi + peginterferon alfa + ribavirin 12 weeks, Sovaldi + ribavirin 12 weeks, Sovaldi + ribavirin 24 weeks and peginterferon alfa + ribavirin 24 weeks groups, respectively.
Patients With HCV/HIV-1 Coinfection
Sovaldi used in combination with ribavirin was assessed in 223 HCV/HIV-1 coinfected subjects. The safety profile in HCV/HIV-1 coinfected subjects was similar to that observed in HCV mono-infected subjects. Elevated total bilirubin (grade 3 or 4) was observed in 30/32 (94%) subjects receiving atazanavir as part of the antiretroviral regimen. None of the subjects had concomitant transaminase increases. Among subjects not taking atazanavir, grade 3 or 4 elevated total bilirubin was observed in 2 (1.5%) subjects, similar to the rate observed with HCV mono-infected subjects receiving Sovaldi + ribavirin in Phase 3 trials.
Adverse Reactions In Pediatric Subjects 3 Years Of Age And Older
The safety assessment of Sovaldi in pediatric subjects 3 years of age and older is based on data from 106 subjects who were treated with Sovaldi plus ribavirin for 12 weeks (genotype 2 subjects) or 24 weeks (genotype 3 subjects) in a Phase 2, open-label clinical trial. The adverse reactions observed were consistent with those observed in clinical studies of Sovaldi plus ribavirin in adults. Among pediatric subjects 3 years to < 12 years of age taking Sovaldi in combination with ribavirin oral solution, decreased appetite was observed in 13% (7/54) subjects.
The following adverse reactions have been identified during post approval use of Sovaldi. 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 Sovaldi (sofosbuvir)?
Potentially Significant Drug Interactions
Sofosbuvir is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) while the predominant circulating metabolite GS-331007 is not. Drugs that are P-gp inducers in the intestine (e.g., rifampin or St. John's wort) may decrease sofosbuvir plasma concentration, leading to reduced therapeutic effect of Sovaldi, and thus concomitant use with Sovaldi is not recommended.
Information on potential drug interactions with Sovaldi is summarized in Table 7. The table is not all-inclusive.
Fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment, including treatment with Sovaldi. Frequent monitoring of INR values is recommended during treatment and post-treatment follow-up.
Table 7 : Potentially Significant Drug Interactions: Alteration in Dosage or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interactiona
|Concomitant Drug Class: Drug Name||Effect on Concentrationb||Clinical Comment|
|Antiarrhythmics: amiodarone||Effect on amiodarone and sofosbuvir concentrations unknown||Coadministration of amiodarone with a sofosbuvir-containing regimen may result in serious symptomatic bradycardia. The mechanism of this effect is unknown. Coadministration of amiodarone with Sovaldi is not recommended; if coadministration is required, cardiac monitoring is recommended.|
|Coadministration of Sovaldi with carbamazepine, phenytoin, phenobarbital or oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi. Coadministration is not recommended.|
|Coadministration of Sovaldi with rifabutin or rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi. Coadministration is not recommended. Coadministration of Sovaldi with rifampin, an intestinal P-gp inducer, is not recommended.|
|Herbal Supplements: St. John’s wort (Hypericum perforatum)||↓ sofosbuvir|
|Coadministration of Sovaldi with St. John’s wort, an intestinal P-gp inducer, is not recommended.|
|HIV Protease Inhibitors: tipranavir/ritonavir||↓ sofosbuvir|
|Coadministration of Sovaldi with tipranavir/ritonavir is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi. Coadministration is not recommended.|
|aThis table is not all-inclusive.|
Drugs Without Clinically Significant Interactions With Sovaldi
Based on drug interaction studies conducted with Sovaldi, no clinically significant drug interactions have been either observed or are expected when Sovaldi is combined with the following drugs:
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Related Disease Conditions
Hepatitis (Viral Hepatitis A, B, C, D, E, G)
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.
Hepatitis C (HCV, Hep C)
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)
Hepatitis means inflammation of the liver. Hepatitis A (HAV, Hep A) is one type of liver disease caused by a virus. Since hepatitis A is a virus, it can pass from person to person from eating or drinking contaminated food or coming into contact with contaminated materials containing the virus. Symptoms of hepatitis A include stomach pain, diarrhea, dark yellow urine, jaundice, and more. There is a vaccine to prevent contracting hepatitis A.
Hepatitis B (HBV, Hep B)
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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Hepatitis A and hepatitis B are the two most commnon viruses that infect the liver. Hepatitis A and Hepatitis B can be prevented and treated with immunizations (vaccinations) such as Havrix, Vaqta, Twinrix, Comvax, Pediarix, and hepatitis b immune globulin (HBIG).
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Is Hepatitis C Contagious?
Hepatitis C or hep C causes acute and chronic liver disease. Hep C is a form of liver disease with symptoms like fatigue, jaundice, nausea and vomiting, anorexia, and abdominal discomfort. Hepatitis C is a contagious viral infection caused by persons sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
Is Hepatitis B Contagious?
Hepatitis B is a type of liver infection. Hepatitis B is spread through person-to-person contact or through personal items like razors, toothbrushes, etc. Symptoms of hepatitis B include fever, yellowish skin (jaundice), dark urine, fatigue, nausea, and vomiting. There is no drug to cure hepatitis B; however, there is a hepatitis B vaccine available.
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Hepatitis E (hep E) is a type of hepatitis viral infection that includes hepatitis A, B, C, D, F, which is caused by the hepatitis E virus. Usually, you get (transmitted) hepatitis E from eating or drinking dirty or contaminated water. Hepatitis E can be very serious, especially if a woman is pregnant. Up to ¼ of women who are pregnant with the hep E virus can die from the infection. The signs and symptoms of hepatitis E infection are nausea and vomiting, brown or dark urine, stool changes jaundice (yellow eyes and skin), pain in the right side of the abdomen, dark or brown urine, and light-colored stool. Some people with hep E don’t have any symptoms so they don’t know that they are contagious. It takes about 6 weeks to recover from hep E. A person who has any type of hepatitis, including hepatitis E, should not drink any alcohol. Hep E complications are rare, but when they do occur they include severe (“fulminant”) hepatitis, liver failure, and death. Currently, no specific drugs or treatments are available for hepatitis E. Moreover, the only hepatitis E vaccine currently is available in China. Avoid alcohol, keep hydrated, and getting rest are home remedies for hepatitis E. Talk to your doctor before taking any over-the-counter (medications), especially those containing acetaminophen (Tylenol and others). Usually, the prognosis and life expectancy for hepatitis E after recovery is good. Most people do not have long term liver problems from the infection.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.