OVERALL CURE RATES

Acute HCV1,2

100

%

CURE RATE(n=275/275, mITT SVR12)

Single-arm, open-label study of GT 1-4, TN, NC and CC adult participants with acute HCV treated for 8 weeks.

0% on-treatment virologic failure (n=0/286)
0% relapse (n=0/286)

Chronic HCV3

99

%

CURE RATE(n=1218/1226, mITT SVR12)

Integrated, pooled analysis of GT 1-6, TN, NC and CC adult participants with chronic HCV treated for 8 weeks from 8 clinical trials.

0.1% on-treatment virologic failure (n=1/1248)
0.6% relapse (n=7/1226)

Contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation.1

*Liver or kidney transplant recipients are not eligible for an 8-week regimen.

mITT population excludes participants who did not achieve SVR12 for reasons other than virologic failure.

Relapse = HCV RNA ≥LLOQ after end-of-treatment response among participants who completed treatment.1

Cure = SVR12 (HCV RNA <LLOQ 12 weeks after the end of treatment)

AASLD and IDSA have not endorsed, and are not sponsors of, or otherwise affiliated with, MAVYRET or AbbVie Inc.

Viral Suppression Across 8 Weeks1,16

In non-cirrhotic patients with chronic HCV completing 8 weeks of MAVYRET

Overall Overall
All Genotypes All Genotypes
Baseline Viral Load Baseline Viral Load

96%

OF PATIENTS WERE VIRALLY SUPPRESSED AT TREATMENT WEEK 4 (n=906/942)

Viral suppression overall chart

Treatment Week

Viral suppression at treatment week 4 is not a clinical endpoint for cure.

Due to assay difference across studies, LLOQ was 25 IU/mL (Roche COBAS TaqMan® RT-PCR assay v.2.0) or 15 IU/mL (Roche COBAS Ampliprep/TaqMan® RT-PCR assay v.2.0).

METHODOLOGY16

Post hoc exploratory pooled analysis from 5 phase 2/3 clinical trials of chronic HCV GT 1-6, TN or PRS-TE, NC adult patients (N=950) treated with MAVYRET for 8 weeks. HCV RNA was measured at baseline, treatment weeks 1, 2, 4, 5, and at the end of treatment. After excluding patients lost to follow up or missing SVR12 data (n=13) or with on-treatment virologic failure (n=2), 942 had data on viral suppression (defined as HCV RNA <LLOQ).

LIMITATIONS1,16

Product labeling for treatment duration should be followed regardless of HCV RNA levels at treatment week 4. The included clinical studies were not powered to assess the impact of on-treatment viral suppression on SVR12. No conclusions should be made from this exploratory analysis.

96%

OF PATIENTS WERE VIRALLY SUPPRESSED AT TREATMENT WEEK 4 (n=906/942)

Viral suppression all genotypes chart

Treatment Week

Viral suppression at treatment week 4 is not a clinical endpoint for cure.

Due to assay difference across studies, LLOQ was 25 IU/mL (Roche COBAS TaqMan® RT-PCR assay v. 2.0) or 15 IU/mL (Roche COBAS Ampliprep/TaqMan® RT-PCR assay v. 2.0).

METHODOLOGY16

Post hoc exploratory pooled analysis from 5 phase 2/3 clinical trials of chronic HCV GT 1-6, TN or PRS-TE, NC adult patients (N=950) treated with MAVYRET for 8 weeks. HCV RNA was measured at baseline, treatment weeks 1, 2, 4, 5, and at the end of treatment. After excluding patients lost to follow up or missing SVR12 data (n=13) or with on-treatment virologic failure (n=2), 942 had data on viral suppression (defined as HCV RNA <LLOQ).

LIMITATIONS1,16

Product labeling for treatment duration should be followed regardless of HCV RNA levels at treatment week 4. The included clinical studies were not powered to assess the impact of on-treatment viral suppression on SVR12. No conclusions should be made from this exploratory analysis.

96%

OF PATIENTS WERE VIRALLY SUPPRESSED AT TREATMENT WEEK 4 (n=906/942)

Viral suppression baseline viral load chart

Treatment Week

Viral suppression at treatment week 4 is not a clinical endpoint for cure.

Due to assay difference across studies, LLOQ was 25 IU/mL (Roche COBAS TaqMan® RT-PCR assay v. 2.0) or 15 IU/mL (Roche COBAS Ampliprep/TaqMan® RT-PCR assay v. 2.0).

METHODOLOGY16

Post hoc exploratory pooled analysis from 5 phase 2/3 clinical trials of chronic HCV GT 1-6, TN or PRS-TE, NC adult patients (N=950) treated with MAVYRET for 8 weeks. HCV RNA was measured at baseline, treatment weeks 1, 2, 4, 5, and at the end of treatment. After excluding patients lost to follow up or missing SVR12 data (n=13) or with on-treatment virologic failure (n=2), 942 had data on viral suppression (defined as HCV RNA <LLOQ).

LIMITATIONS1,16

Product labeling for treatment duration should be followed regardless of HCV RNA levels at treatment week 4. The included clinical studies were not powered to assess the impact of on-treatment viral suppression on SVR12. No conclusions should be made from this exploratory analysis.

CURE RATES IN PATIENTS WITH VARIED ADHERENCE17

Based on a retrospective, exploratory analysis of TN, NC or CC patients from 10 phase 3 clinical trials

Cure Rates Cure Rates
Adherence Over Time Adherence Over Time

100%

CURE RATE WITH <90% ADHERENCE

(mITT SVR12)

During weeks 0-4 (n=21/21) and weeks 5-8 (n=76/76)

99%

CURE RATE WITH ≥90% ADHERENCE

(mITT SVR12)

During weeks 0-4 (n=1155/1162) and weeks 5-8 (n=1136/1143)

TELL YOUR PATIENTS THAT IT IS IMPORTANT NOT TO MISS OR SKIP DOSES OF MAVYRET DURING TREATMENT.

METHODOLOGY17

Post hoc, exploratory pooled analysis from 10 phase 3 clinical trials evaluating 8-week treatment with MAVYRET in chronic HCV GT 1-6, TN, NC and CC adult patients. Endpoints include SVR12 and adherence, calculated as the percentage of pills taken relative to the total number expected to be taken during each dispensation interval (weeks 0-4 and weeks 5-8), excluding patients with missing pill count data for that interval.

LIMITATIONS17

The included clinical studies were not powered to assess differences between groups or the impact of adherence on SVR12; therefore, conclusions from this exploratory analysis should be drawn with caution. Patients with stage 4 or 5 chronic kidney disease, or with prior HCV treatment, were excluded. Patients with missing pill-count data were excluded for each interval.

SELECT BASELINE CHARACTERISTICS17

  • 9% (n=111/1304) on stable opioid substitution therapy
  • 27% (n=349/1304) with history of psychiatric disorder
  • 27% (n=351/1304) on ≥5 concomitant medications
  • 33% (n=435/1304) currently using alcohol
  • 39% (n=510/1304) with history of injection drug use

Patients with a history of psychiatric disorders were self-reported or defined as those with reported concomitant psychiatric medications. Patients using alcohol or with any history of injection drug use were self-reported.

Patient subgroups were not mutually exclusive.

PERCENT OF PATIENTS WITH ≥90% ADHERENCE

Cure rates in patients with varied adherence chart

TELL YOUR PATIENTS THAT IT IS IMPORTANT NOT TO MISS OR SKIP DOSES OF MAVYRET DURING TREATMENT.

METHODOLOGY17

Post hoc, exploratory pooled analysis from 10 phase 3 clinical trials evaluating 8-week treatment with MAVYRET in chronic HCV GT 1-6, TN, NC and CC adult patients. Endpoints include SVR12 and adherence, calculated as the percentage of pills taken relative to the total number expected to be taken during each dispensation interval [weeks 0-4 and weeks 5-8], excluding patients with missing pill count data for that interval.

SELECT BASELINE CHARACTERISTICS17

  • 9% (n=111/1304) on stable opioid substitution therapy
  • 27% (n=349/1304) with history of psychiatric disorder
  • 27% (n=351/1304) on ≥5 concomitant medications
  • 33% (n=435/1304) currently using alcohol
  • 39% (n=510/1304) with history of injection drug use

Patients with a history of psychiatric disorders were self-reported or defined as those with reported concomitant psychiatric medications. Patients using alcohol or with any history of injection drug use were self-reported.

Patient subgroups were not mutually exclusive.

See MAVYRET's effectiveness in a wide range of patients