sábado, 19 de agosto de 2017

Drug Approvals and Databases > MAVYRET Drug Trials Snapshot

Drug Approvals and Databases > MAVYRET Drug Trials Snapshot



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A new DRUG TRIALS SNAPSHOT is now available.
MAVYRET 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.
MAVYRET is a combination of two anti-viral drugs: glecaprevir and pibrentasvir. It is intended to be used in patients who do not have cirrhosis or who have early stage cirrhosis.
See more Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov

MAVYRET Drug Trials Snapshot

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.
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 MAVYRET Prescribing Information for complete information.
MAVYRET (glecaprevir and pibrentasvir) 
MAV-ih-reht
AbbVie Inc.
Approval date: August 3, 2017

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

MAVYRET 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.
MAVYRET is a combination of two anti-viral drugs: glecaprevir and pibrentasvir. It is intended to be used in patients who do not have cirrhosis or who have early stage cirrhosis.

How is this drug used?

MAVYRET is a tablet. Three tablets are taken once a day. Treatment duration is different depending on viral genotype, prior treatment history and cirrhosis status.

What are the benefits of this drug?

MAVYRET may clear the body of the hepatitis C virus as measured by a blood test after finishing treatment.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: MAVYRET worked similarly in men and women.
  • Race: MAVYRET worked similarly in patients of White, Asian and Black or African American race.
  • Age: MAVYRET worked similarly in patients below and above 65 years of age.

What are the possible side effects?

MAVYRET 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 MAVYRET.
The most common side effects of MAVYRET are headache and tiredness.

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 risk of side effects was similar in patents of White, Asian and Black or African American race.
  • Age: The risk of side effects was similar in patients younger and older than 65 years of age.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved MAVYRET based on evidence from nine clinical trials of 2369 patients with chronic hepatitis C virus infection. In these trials some patients were previously treated for hepatitis C and some were never treated before. 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
Pie chart summarizing how many men and women were in the clinical trials. In total, 1318 men (56%) and 1051 women (44%) participated in the clinical trials.
Clinical trial report
Figure 2 and Table 1 summarize the percentage of patients in the clinical trials.
Figure 2. Baseline Demographics by Race
Pie chart summarizing the percentage of patients by race in the clinical trials. In total, 1898 Whites (80%), 272 Asians (12%), 149 Black or African Americans (6%),  and 50 all Others combined (2%) participated in the clinical trials.
Clinical trial report
Table 1. Demographics of Trials by Race
Race
Number of Patients
Percentage
  White
1898
80
  Asian
272
12
  Black or African American
149
6
 Native Hawaiian or Pacific Islander
17
1
 Multiple
17
1
 American Indian or Alaska Native
13
1
 Not reported
3
less than 1
Clinical trial report
Figure 3 summarizes the percentage of patients by age in the clinical trials.
Figure 3. Baseline Demographics by Age
Pie chart summarizing how many individuals of certain age groups were in the clinical trials.  In total, 2041 patients were less than 65 years old (86%) and 328 were 65 and older (14%).
Clinical trial report

How were the trials designed?

FDA approved MAVYRET based on evidence from nine clinical trials of 2369 patients with chronic hepatitis C virus infection genotypes 1-6.
Across the trials some patients were previously treated for hepatitis C and some were never treated before. Some patients had cirrhosis and some did not. One trial included patients who also had HIV infection and one trial included patients who had advanced kidney disease, including some patients who required dialysis.
Each trial was designed differently. Patients received MAVYRET for 8, 12 or 16 weeks Seven trials included treatment with MAVYRET only, and two trials compared MAVYRET treatment to either placebo or an approved daclatasvir + sofosbuvir HCV regimen.
All trials measured the blood level of hepatitis virus C before, during, 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.

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