Vosevi

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/2/2021
Vosevi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Vosevi?

Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) tablets are a fixed-dose combination of a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, an HCV NS5A inhibitor, and an HCV NS3/4A protease inhibitor, indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor; or genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

What Are Side Effects of Vosevi?

Common side effects of Vosevi include:

  • headache,
  • fatigue,
  • diarrhea,
  • nausea,
  • weakness or lack of energy,
  • insomnia,
  • rash, or
  • depression.

Dosage for Vosevi

All patients should be tested for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with Vosevi. The recommended dosage of Vosevi is one tablet (400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir) taken orally once daily with food.

What Drugs, Substances, or Supplements Interact with Vosevi?

Vosevi may interact with St. John's wort, carbamazepine, antacids, H2-receptor antgonists, proton pump inhibitors (PPIs), methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan, amiodarone, digoxin, dabigatran, phenytoin, phenobarbital, oxcarbazepine, rifampin, rifabutin, rifapentine, antiretrovirals, HMG-CoA reductase inhibitors, and cyclosporine. Tell your doctor all medications and supplements you use.

Vosevi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Vosevi; it is unknown how it may affect a fetus. It is unknown if Vosevi passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Hepatitis: How Do You Get Hepatitis A, B, and C? See Slideshow
Vosevi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Vosevi may cause serious liver injury. Call your doctor right away if you have symptoms such:

  • right-sided upper stomach pain;
  • nausea, vomiting, loss of appetite;
  • confusion, tiredness, feeling light-headed;
  • easy bruising or bleeding, vomiting blood;
  • diarrhea, black or bloody stools;
  • dark urine; or
  • yellowing of your skin or eyes.

If you also take a heart rhythm medicine called amiodarone: Taking amiodarone with Vosevi can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

  • very slow heartbeats, chest pain, shortness of breath;
  • confusion, memory problems; or
  • weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common side effects may include:

  • headache;
  • feeling tired; or
  • nausea, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vosevi (Sofosbuvir)

QUESTION

Hepatitis C virus causes an infection of the ______________. See Answer
Vosevi Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

  • Serious Symptomatic Bradycardia When Coadministered with Amiodarone [see WARNINGS AND PRECAUTIONS].

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.

Adverse Reactions In HCV-Infected Subjects Without Cirrhosis Or With Compensated Cirrhosis

The adverse reactions data for VOSEVI were derived from two Phase 3 clinical trials (POLARIS-1 and POLARIS-4) that evaluated a total of 445 subjects infected with genotype 1, 2, 3, 4, 5, or 6 HCV, without cirrhosis or with compensated cirrhosis (Child-Pugh A), who received VOSEVI for 12 weeks. VOSEVI was studied in placebo-and active-controlled (sofosbuvir/velpatasvir) trials [see Clinical Studies].

The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2% for subjects who received VOSEVI for 12 weeks.

The most common adverse reactions (adverse events assessed as causally related by the investigator and at least 10%) were headache, fatigue, diarrhea, and nausea in subjects treated with VOSEVI for 12 weeks.

Table 2 lists adverse reactions (adverse events assessed as causally related by the investigator, all grades) observed in at least 5% of subjects receiving 12 weeks of treatment with VOSEVI in the Phase 3 clinical trials. The side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs.

Table 2 : Adverse Reactions (All Grades) Reported in ≥5% of Subjects With HCV Without Cirrhosis or With Compensated Cirrhosis Receiving VOSEVI in POLARIS-1 and POLARIS-4

  POLARIS-1 POLAR MS-4
VOSEVI 12 weeks
(N=263)
Placebo 12 weeks
(N=152)
VOSEVI 12 weeks
(N=182)
SOF/VEL 12 weeks
(N=151)
Headache 21% 14% 23% 23%
Fatigue 17% 15% 19% 23%
Diarrhea 13% 9% 14% 3%
Nausea 13% 7% 10% 3%
Asthenia 6% 4% 4% 6%
Insomnia 6% 3% 3% 1%

In POLARIS-1, of the subjects receiving VOSEVI who experienced adverse reactions, 99% were mild or moderate (Grade 1 or 2) in severity. In POLARIS-4, of the subjects receiving VOSEVI who experienced adverse reactions, all the reported adverse reactions were mild or moderate (Grade 1 or 2) in severity.

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 VOSEVI for 12 weeks and are included because of a potential causal relationship.

Rash

In the POLARIS-1 and POLARIS-4 trials, rash occurred in less than 1% and 2% of subjects treated with VOSEVI, respectively. Rash was reported in 1% of subjects treated with placebo in POLARIS-1 and was not reported by any subject taking sofosbuvir/velpatasvir in POLARIS-4. No serious adverse reactions of rash occurred, and all rashes were mild or moderate in severity.

Depression

In the POLARIS-1 and POLARIS-4 trials, depressed mood occurred in less than 1% and 1% of subjects treated with VOSEVI, respectively. Depressed mood was not reported by any subject taking placebo in POLARIS-1 and was reported in 1% of subjects treated with sofosbuvir/velpatasvir in POLARIS-4. No serious adverse reactions of depressed mood occurred and all events were mild or moderate in severity.

Laboratory Abnormalities

Lipase Elevations

Isolated, asymptomatic lipase elevations of greater than 3xULN were observed in POLARIS-1 in 2% of subjects treated with VOSEVI and 3% of subjects treated with placebo, and in POLARIS-4 in 2% of subjects treated with VOSEVI and less than 1% of subjects treated with sofosbuvir/velpatasvir.

Creatine Kinase

Isolated, asymptomatic creatine kinase elevations greater than or equal to 10xULN were reported in POLARIS-1 in 1% of subjects treated with VOSEVI and 1% of subjects treated with placebo, and in POLARIS-4 in less than 1% of subjects treated with VOSEVI and no subjects treated with sofosbuvir/velpatasvir.

Total Bilirubin

Increases in total bilirubin less than or equal to 1.5xULN were observed in subjects treated with VOSEVI due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir: 4% and 6% of subjects without cirrhosis in POLARIS-1 and POLARIS-4, respectively; and 7% and 13% of subjects with compensated cirrhosis in POLARIS-1 and POLARIS-4, respectively. No subjects experienced jaundice and total bilirubin levels decreased after completing VOSEVI treatment.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of sofosbuvir-containing regimens. 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.

Hepatobiliary Disorders

Hepatic decompensation, hepatic failure with NS3/4A protease inhibitor-containing regimens [see WARNINGS AND PRECAUTIONS].

Cardiac Disorders

Serious symptomatic bradycardia has been reported in patients taking amiodarone who initiated treatment with a sofosbuvir-containing regimen [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Skin And Subcutaneous Tissue Disorders

Skin rashes, sometimes with blisters or angioedema-like swelling Angioedema

Read the entire FDA prescribing information for Vosevi (Sofosbuvir)

© Vosevi Patient Information is supplied by Cerner Multum, Inc. and Vosevi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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