Drug Trials Snapshots: VOSEVI
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the VOSEVI Prescribing Information for complete information.
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the VOSEVI Prescribing Information for complete information.
VOSEVI (sofosbuvir, velpatasvir and voxilaprevir)
Vo-SEV-ee
Gilead Sciences
Approval date: July 18, 2017
Vo-SEV-ee
Gilead Sciences
Approval date: July 18, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
VOSEVI is a drug for the treatment of adults who have a specific type of hepatitis C virus (HCV) infection, called chronic hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to decreased liver function, cirrhosis, liver failure, liver cancer or death.
VOSEVI is a combination of three anti-viral drugs: sofosbuvir and velpatasvir (previously approved drugs for HCV infection) and voxilaprevir (new drug for HCV infection). It is intended to be used in patients who were not successfully treated with other HCV drugs in the past and who do not have cirrhosis or who have early stage cirrhosis.
How is this drug used?
VOSEVI is a tablet that is taken once a day for 12 weeks.
What are the benefits of this drug?
VOSEVI may clear the body of the hepatitis C virus as measured by a blood test 12 weeks after finishing treatment.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: VOSEVI worked similarly in men and women.
- Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in response among races could not be determined.
- Age: VOSEVI worked similarly in patients below and above 65 years of age.
What are the possible side effects?
VOSEVI may cause serious liver problems including liver failure and death in patients who had hepatitis B virus infection. This is because the hepatitis B virus could become active again (called reactivation) during or after treatment of hepatitis C virus with VOSEVI.
VOSEVI may cause serious slowing of the heart rate in patients who are taking medication amiodarone.
The most common side effects of VOSEVI are headache, tiredness, diarrhea and nausea.
Were there any differences in side effects among sex, race and age?
- Sex: The risk of side effects was similar in men and women.
- Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in side effects among races could not be determined.
- Age: The risk of side effects was similar in patients younger and older than 65 years of age.
VOSEVI Prescribing Information
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved VOSEVI based on evidence from two clinical trials of 748 patients with chronic hepatitis C virus infection. In these trials, enrolled patients had previously failed treatment with another hepatitis drug. Some patients had cirrhosis and some did not. The trials were conducted in the United States, Canada, Europe, Australia, and New Zealand.
The figure below summarizes how many men and women were in the clinical trials.
Figure 1. Baseline Demographics by Sex 
Figure 2 and Table 1 summarize the percentage of patients in the clinical trials
FDA review
Figure 2. Baseline Demographics by Race
FDA review
Table 1. Demographics of Trials by Race
Race | Number of Patients | Percentage |
|---|---|---|
White | 626 | 84 |
Black or African American | 89 | 12 |
Asian | 20 | 2 |
American Indian or Alaska Native | 5 | 1 |
Native Hawaiian or Pacific Islander | 3 | less than 1 |
Other | 4 | 1 |
Not reported | 1 | Less than 1 |
Figure 3 summarizes the percentage of patients by age in the clinical trials.
Figure 3. Baseline Demographics by Age4
FDA review
How were the trials designed?
The benefits and side effects of VOSEVI were evaluated in two clinical trials. Patients in both trials had previously failed treatment with direct-acting antiviral (DAA) drugs for hepatitis C. Some patients had cirrhosis and some did not.Each trial was designed differently.
In Trial 1, patients with genotypes 1, 2, 3, 4, 5 or 6 randomly received either VOSEVI or placebo pill once a day for 12 weeks. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.
In Trial 2, patients with genotypes 1, 2 or 3 randomly received either VOSEVI for 12 weeks or the combination of previously approved drugs called sofosbuvir and velpatasvir for 12 weeks. In this trial, both patients and health care providers knew which treatment was given.
Both trials measured the blood level of hepatitis virus C before and after treatment.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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