ype 1-infected subjects treated in Parts 1 and 2, who were either NS5A inhibitor-experienced only (and treated for 16 weeks), or NS3/4A PI-experienced only (and treated for 12 weeks), the median age was 58 years (range: 34 to 70); 40% of the subjects were NS5A-treatment experienced only and 60% were PI experienced only; 24% had cirrhosis; 19% were ≥65 years, 69% were male; 26% were Black; 43% had a body mass index ≥ 30 kg/m2; 67% had baseline HCV RNA levels of at least 1,000,000 IU per mL; 79% had subtype 1a infection, 17% had subtype 1b infection and 5% had non-1a/1b infection.
Due to higher rates of virologic failure and treatment-emergent drug resistance, the data do not support labeling for treatment of HCV genotype 1 infected patients who are both NS3/4A PI and NS5A inhibitor-experienced.
Table 16. MAGELLAN-1: Efficacy in HCV Genotype 1-Infected Adults Who Are NS3/4A PI-Experienced or NS5A Inhibitor-Experienced, Without Cirrhosis or With Compensated Cirrhosis
PI-Experienced1
(NS5A Inhibitor-
naïve) NS5A Inhibitor-
Experienced2
(PI-naïve)
MAVYRET
12 Weeks
(N=25) MAVYRET
16 Weeks
(N=17)
SVR12 92% (23/25) 94% (16/17)
Outcome for Subjects Without SVR
On-treatment Virologic Failure 0/25 6% (1/17)
Relapse 0/25 0/16
Other3 8% (2/25) 0/17
PI= protease inhibitor
1 Includes subjects who were treated with a regimen containing an NS3/4A PI (simeprevir with sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin) and without prior treatment with an NS5A inhibitor.
2 Includes subjects who were treated with a regimen containing an NS5A inhibitor (ledipasvir with sofosbuvir or daclatasvir with pegylated interferon and ribavirin) and without prior treatment with an NS3/4A PI.
3 Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.CLOSE
16 HOW SUPPLIED/STORAGE AND HANDLING
MAVYRET is dispensed in a 4-week (monthly) or an 8-week carton. Each weekly carton contains seven daily dose wallets. Each monthly carton contains four weekly cartons. Each 8-week carton contains 2 monthly cartons. Each child resistant daily dose wallet contains three 100 mg/40 mg glecaprevir/pibrentasvir tablets. MAVYRET tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “NXT” on one side.
The NDC numbers are:
4-Week Carton: 0074-2625-28
8-Week Carton: 0074-2625-56
Store at or below 30°C (86°F).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of hepatitis B virus infection [see Warnings and Precautions (5.1)].
Drug Interactions
Inform patients that MAVYRET may interact with some drugs; therefore, patients should be advised to report to their healthcare provider the use of any prescription, non-prescription medication or herbal products [see Contraindications (4), Warnings and Precautions (5.2) and Drug Interactions (7)].
Administration
Advise patients to take MAVYRET r |
