REAL-WORLD EFFECTIVENESS IN THE LARGEST MAVYRET META-ANALYSIS²

Of 12,531 patients treated with MAVYRET (18 studies), 3657 were clearly characterized as TN, NC and treated for 8 weeks according to label (9 studies)²

99^%	CURE RATE
	(n=3657, mITT SVR12) In GT 1-4, TN, NC patients

Cure = sustained virologic response (SVR12); HCV RNA <LLOQ at 12 weeks after the end of treatment.¹

METHODOLOGY²

Real-world studies reporting SVR12 in adults with HCV infection (n ≥20) treated with MAVYRET were identified in journal publications from January 1, 2017, to February 25, 2019, and congress presentations through April 14, 2019. The 18 identified cohorts included 7 studies from Europe (Spanish HepaC Cohort, German Hepatitis-C Registry, Italian MISTRAL, England NHS Registry, Italian NAVIGATORE-Lombardia, Scottish HCV Registry, Austrian Real-life Cohort), 6 in Japan (Japan Registry, Japan Tamori, Japan Uemura, 2 Japan DAA-experienced, Japanese GT2 retreatment), 3 in the United States (VA Registry, TRIO, Kaiser Permanente), and 2 multicountry studies (Global G/P PMOS, TARGET HCV). Of the 12,531 adults with chronic HCV infection included in the 18 studies, patients who were TN, NC, and who received on-label treatment with MAVYRET for 8 weeks (n=3657), mITT; reported in 9 of the 18 studies were included meta-analysis. Random-effects meta-analysis was used to determine SVR12 rates. The mITT population included ITT population (ie, patients treated with MAVYRET who had SVR12 data available, discontinued early, or were lost to follow-up) and excluded those with nonvirologic failure.

LIMITATIONS²

These real-world studies are retrospective, are observational in nature, and are not in the MAVYRET Prescribing Information. Results of these cohorts may differ from those observed in clinical practice, and the included studies may have differed in regard to their study design and patient characteristics. The level of detail reported across the individual studies was inconsistent, particularly with mITT reporting of SVR12 rates. There were insufficient data available to analyze SVR12 rates in patients with HCV GT 5 or GT 6 infection. The reporting of safety information in this analysis varied widely by study design and data availability. Please refer to MAVYRET’s full Prescribing Information for clinical study safety.

HIGH CURE RATES ACROSS A WIDE RANGE OF PATIENTS^1,3

HIGH CURE RATES IN PATIENTS TAKING PPIs³

In Patients Taking Proton Pump Inhibitors (PPIs)

100^%	CURE RATE (n=136/136 mITT SVR12)

Based on an integrated pooled analysis of GT 1-6, TN NC and CC adult patients treated for 8 weeks across 8 clinical trials.³

When coadministered with omeprazole¹:

No clinically significant interactions observed
No dose adjustments required
No restrictions on timing of administration in label

The MAVYRET Prescribing Information does not include data on drug interactions or dose adjustments for PPIs other than omeprazole.¹*

*MAVYRET pharmacokinetic studies were performed with 20 mg and 40 mg omeprazole once daily.

See clinical trial study designs below.

Nearly 1/3 of diagnosed HCV patients aged ≥12 years have been prescribed a PPI.⁴ Some may also be using OTC formulations.

METHODOLOGY⁴

Data from TriNetX Dataworks—a global federated health research network providing access to electronic medical records (diagnoses, procedures, medications, laboratory values, genomic information)—including approximately 57.7 million de-identified patients in 45 large US healthcare organizations, were queried. The estimated number of individuals age 12 years or older with chronic HCV diagnosis (B18.2; n=118,949) with a prescription for omeprazole, esomeprazole, pantoprazole, lansoprazole, dexlansoprazole, or rabeprazole occurring during or after HCV diagnosis in the 3 years prior to 12/17/2020 were counted (n=34,989) and the rate was calculated.

CLINICAL TRIAL STUDY DESIGNS

Integrated, pooled analysis of GT 1-6, TN adult subjects from 8 phase 2/3, open-label clinical trials. The primary endpoint of each study was SVR12.³

ENDURANCE-1^1,5
GT 1, TN or PRS-TE, NC subjects (± HIV-1 coinfection) were randomized to receive MAVYRET for 8 (n=351) or 12 (n=352) weeks.

ENDURANCE-3^1,5
GT 3, TN, NC subjects were randomized (2:1) to receive MAVYRET (n=233) or SOF + DCV (n=115) for 12 weeks; additional subjects (n=157) were subsequently enrolled and nonrandomly assigned to receive MAVYRET for 8 weeks.

ENDURANCE-5,6^1,6
GT 5-6, TN or PRS-TE, NC or CC subjects (n=84) received MAVYRET for 8 (n=75) or 12 (n=9) weeks.

EXPEDITION-2^1,7
GT 1-6, TN or PRS-TE, NC or CC subjects with HIV-1 and ART naïve or on a stable ART regimen received MAVYRET for 8 (n=137) or 12 (n=16) weeks. Treatment-experienced GT 3–infected subjects were excluded.

EXPEDITION-5⁸
GT 1-6, TN or PRS-TE, NC or CC subjects with CKD stage 3b, 4, or 5 received MAVYRET for 8 (n=84), 12 (n=13), or 16 (n=4) weeks.

EXPEDITION-8^1,9
GT 1-6, TN, CC subjects (n=343) received MAVYRET for 8 weeks.

SURVEYOR-1, PART 2 (PHASE 2)^10,11
GT 1, 4-6, TN or PRS-TE, NC or CC subjects received MAVYRET for 8 (n=117) or 12 (n=332) weeks.

SURVEYOR-2, PARTS 2 AND 4 (PHASE 2)^1,12-14
GT 2-6, TN or PRS-TE, NC or CC subjects were randomized to receive MAVYRET for 8 (n=286), 12 (n=48), or 16 (n=4) weeks.

HIGH CURE RATES IN COMPENSATED CIRRHOTICS^1,9

98^%	CURE RATE (n=335/343, ITT SVR12)

In GT 1-6 TN CC adult patients treated for 8 weeks in the EXPEDITION-8 clinical trial.

0% on-treatment virologic failure (n=0/343)

0.3% relapse (n=1/336)

The adverse reactions observed in CC patients were generally consistent with those observed in NC patients

The adverse reactions reported in ≥5% of CC subjects (n=343) were fatigue (8%), pruritus (7%), and headache (6%)
Most adverse events were mild in severity
No subjects discontinued due to an adverse reaction

Baseline characteristics (n=343)

27.2 median body mass index (kg/m²)
20.2 median FibroScan^® score (kPa) (n=295)
18% platelets <100x10⁹ cells/L
27% injection drug use
67% GT 1
83% white

Treatment-Naïve, Compensated Cirrhotic 8-Week Efficacy Per Protocol Results^1,7

MAVYRET for 8 weeks in GT 1-6 in treatment-naïve patients with compensated cirrhosis.

PP: Per protocol excludes subjects from the ITT population with virologic breakthrough or discontinuation prior to week 8, and those missing data in the SVR12 window.

The efficacy of MAVYRET in subjects with GT 3b infection was evaluated in 2 trials conducted in China, Singapore, and South Korea. Across both trials. Subjects with GT 3b infection has a numerically lower SVR12 rate. GT 3b is uncommon in the US (<1% of HCV GT 3 infections).

Compensated cirrhosis was defined by one of the following methods:

Liver biopsy with METAVIR fibrosis score of 4 (or equivalent), FibroScan^® ≥ 14.6 kPa, or FibroTest^™ ≥ 0.75 and APRI > 2 at screening.

FibroScan^® is a registered trademark of Echosens^™ North America.

FibroTest^™ is a trademark of BioPredictive S.A.S.

EXPEDITION-8 STUDY DESIGN

Single-arm, open-label, phase 3b study in GT 1-6 TN adult subjects (n=343) with compensated cirrhosis (Child-Pugh A) who received MAVYRET for 8 weeks.

PWID PWID

MAT MAT

ALCOHOL ALCOHOL

Real-World Real-World

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE^1,15

PEOPLE WHO INJECT DRUGS (PWID)

98^%	CURE RATE (n=55/56, mITT SVR12)

89^%	CURE RATE (n=55/62, ITT SVR12)

2% virologic failure rate (n=1/62)^1,15

62 subjects identified as current/recent PWID among 4655 chronic HCV GT 1-6 adolescents and adults who received MAVYRET for 8, 12, or 16 weeks in phase 2 and phase 3 trials^1,15†

Most common adverse reactions ≥5% were fatigue (16%), headache (13%), diarrhea (6%), and nausea (6%)¹
2% (n=1/62) treatment discontinuation rate due to serious adverse reactions and/or adverse reactions¹

^†Current/recent PWID defined as self-reported injection drug use within the last 12 months prior to starting MAVYRET.

~70% of new HCV cases occurred in people who inject drugs¹⁶

STUDY DESIGNS¹

Among 4655 chronic HCV GT 1-6–infected adolescents and adults in phase 2 and 3 trials who received MAVYRET 8, 12, or 16 weeks and specified whether or not they had a history of injection-drug use, 1373 subjects were identified as PWID based on self-reported history of injection-drug use at trial enrollment. Of the PWID population, 62 subjects were considered current/recent PWID (defined as self-reported injection-drug use within the last 12 months prior to starting MAVYRET), 959 subjects were considered former PWID (defined as self-reported injection-drug use more than 12 months prior to starting MAVYRET), and 352 subjects did not specify current/recent PWID versus former PWID and were not included in the analysis.

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE^1,15

MEDICATION-ASSISTED TREATMENT (MAT)

99^%	CURE RATE (n=215/216, mITT SVR12)

96^%	CURE RATE (n=215/225, ITT SVR12)

0.4% virologic failure rate (n=1/225)^1,15

225 subjects reported concomitant use of MAT for opioid use disorder among 4655 chronic HCV GT 1-6 adolescents and adults in subjects who received MAVYRET for 8, 12, or 16 weeks in phase 2 and 3 trials^1,15

No buprenorphine/naloxone or methadone dosage adjustment is required when used concomitantly with MAVYRET. There is insufficient information to make a recommendation regarding concomitant use with naltrexone¹
Most common adverse reactions ≥5% were headache (15%), fatigue (12%), nausea (11%), and diarrhea (6%)¹
No treatment discontinuations due to adverse reactions were observed¹

~70% of new HCV cases occurred in people who inject drugs¹⁶

STUDY DESIGNS¹

Among 4655 chronic HCV GT 1-6–infected adolescents and adults in phase 2 and 3 trials who received MAVYRET and specified whether or not they had a history of injection-drug use, 225 subjects reported concomitant use of MAT for opioid use disorder and 4098 subjects reported no use of MAT (332 subjects were not included in the analysis due to missing assessment of MAT).

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE³
ALCOHOL USE

99^%	CURE RATE (n=409/412, mITT SVR12)^‡

Based on an integrated pooled analysis of GT 1-6, TN NC and CC adult patients treated for 8 weeks across 8 clinical trials³

AASLD/IDSA guidelines recommend abstinence from alcohol and, when appropriate, interventions to facilitate cessation of alcohol consumption should be advised for all persons with HCV infection.¹⁷

^‡Alcohol use was self-reported at the time of screening. Patients were categorized as drinker, ex-drinker, or nondrinker. Recent (within 6 months prior to study drug administration) history of alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator was excluded.³

CLINICAL TRIAL STUDY DESIGNS

Integrated, pooled analysis of GT 1-6, TN adult subjects from 8 phase 2/3, open-label clinical trials. The primary endpoint of each study was SVR12.³

ENDURANCE-1^1,5
GT 1, TN or PRS-TE, NC subjects (± HIV-1 coinfection) were randomized to receive MAVYRET for 8 (n=351) or 12 (n=352) weeks.

ENDURANCE-5,6^1,6
GT 5-6, TN or PRS-TE, NC or CC subjects (n=84) received MAVYRET for 8 (n=75) or 12 (n=9) weeks.

EXPEDITION-5⁸
GT 1-6, TN or PRS-TE, NC or CC subjects with CKD stage 3b, 4, or 5 received MAVYRET for 8 (n=84), 12 (n=13), or 16 (n=4) weeks.

EXPEDITION-8^1,9
GT 1-6, TN, CC subjects (n=343) received MAVYRET for 8 weeks.

SURVEYOR-1, PART 2 (PHASE 2)^10,11
GT 1, 4-6, TN or PRS-TE, NC or CC subjects received MAVYRET for 8 (n=117) or 12 (n=332) weeks.

SURVEYOR-2, PARTS 2 AND 4 (PHASE 2)^1,12-14
GT 2-6, TN or PRS-TE, NC or CC subjects were randomized to receive MAVYRET for 8 (n=286), 12 (n=48), or 16 (n=4) weeks.

REAL-WORLD EFFECTIVENESS IN PATIENTS WITH
SUBSTANCE USE OR PSYCHIATRIC DISORDERS¹⁸

Real-world data pooled from 9 studies with adult patients taking 8, 12, or 16 weeks of MAVYRET

Real-world effectiveness in patients with substance use or psychiatric disorders chart

The MAVYRET Prescribing Information does not contain efficacy, safety, or drug interaction information when MAVYRET is coadministered with specific illicit drugs. Potential drug-drug interactions with these illicit drugs have not been studied.

People who use drugs (PWUD) were defined as any patient who self-reported illicit drug use, including heroin, cocaine, marijuana, hashish, or opioids. Alcohol users were defined as those who consumed more than 2 alcoholic drinks/day. Patients with psychiatric disorders were defined as those with a history of depression or bipolar disease, depression and suicide/self-injury, and anxiety.¹⁸

METHODOLOGY¹⁸

Interim analysis of data pooled from AbbVie-sponsored postmarketing observational studies across 9 countries from November 13, 2017, to January 31, 2020. Patients were ≥18 years old with HCV GT 1-6 infection and received MAVYRET at the treating physician’s discretion according to local label, national or international recommendations, and/or local clinical practice. Patients were treatment-naïve or had been previously treated with interferon, ribavirin, sofosbuvir, or DAA; the patient population included those without cirrhosis or with compensated cirrhosis. Effectiveness was assessed through the percentage of patients who achieved SVR12 in the core population with sufficient follow-up (CPSFU). The CPSFU (n=1684) was defined as the total population (n=2036) excluding DAA-experienced patients, and those lost to follow-up, with the premature discontinuation or missing SVR12 data due to ongoing data collection.

LIMITATIONS¹⁸

These real-world studies are retrospective, are observational in nature, and may differ from Prescribing Information. Results of these cohorts may differ from those observed in clinical practice and may have differed from MAVYRET clinical trials in regard to their study design, patient characteristics, and definitions of PWUD, alcohol use, or psychiatric disorders. The reporting of safety information in this analysis varied widely by study design and data availability. Please refer to MAVYRET’s full Prescribing Information for clinical study safety.

SELECT PATIENT CHARACTERISTICS AT BASELINE¹⁸

83.5% (1701/2036) received MAVYRET for 8 weeks

9.8% (200/2036) had psychiatric disorders

22.5% (451/2036) had a history of heroin use

18.5% (322/2036) had a history of alcohol use

7.9% (158/2036) had a history of cocaine use

3.8% (77/2036) had a history of marijuana use

2.9% (58/2036) had a history of hashish use

1.3% (27/2036) had a history of opioid use

35% of patients (697/2008) reported recreational drug use^§

11% (219/1990) were on stable opioid substitution therapy^§

^§Percentages calculated from non-missing values.

HIGH CURE RATES IN PATIENTS WITH A HISTORY OF DEPRESSION OR BIPOLAR DISORDER³

100^%	CURE RATE (n=212/212, mITT SVR12)

Based on an integrated pooled analysis of GT 1-6, TN NC and CC adult patients treated for 8 weeks across 8 clinical trials.

CLINICAL TRIAL STUDY DESIGNS

Integrated, pooled analysis of GT 1-6, TN adult subjects from 8 phase 2/3, open-label clinical trials. The primary endpoint of each study was SVR12.³

ENDURANCE-1^1,5
GT 1, TN or PRS-TE, NC subjects (± HIV-1 coinfection) were randomized to receive MAVYRET for 8 (n=351) or 12 (n=352) weeks.

ENDURANCE-5,6^1,6
GT 5-6, TN or PRS-TE, NC or CC subjects (n=84) received MAVYRET for 8 (n=75) or 12 (n=9) weeks.

EXPEDITION-5⁸
GT 1-6, TN or PRS-TE, NC or CC subjects with CKD stage 3b, 4, or 5 received MAVYRET for 8 (n=84), 12 (n=13), or 16 (n=4) weeks.

EXPEDITION-8^1,9
GT 1-6, TN, CC subjects (n=343) received MAVYRET for 8 weeks.

SURVEYOR-1, PART 2 (PHASE 2)^10,11
GT 1, 4-6, TN or PRS-TE, NC or CC subjects received MAVYRET for 8 (n=117) or 12 (n=332) weeks.

SURVEYOR-2, PARTS 2 AND 4 (PHASE 2)^1,12-14
GT 2-6, TN or PRS-TE, NC or CC subjects were randomized to receive MAVYRET for 8 (n=286), 12 (n=48), or 16 (n=4) weeks.

HIGH CURE RATES IN HIV-COINFECTED PATIENTS³

100^%	CURE RATE (n=120/120, mITT SVR12)

Based on an integrated pooled analysis of GT 1-6, TN NC and CC adult patients treated for 8 weeks across 8 clinical trials. MAVYRET for 8 weeks was not studied in HIV-coinfected TN patients with compensated cirrhosis.^1,3

MAVYRET is contraindicated with atazanavir and not recommended with darunavir, lopinavir, ritonavir, or efavirenz¹
No clinically significant interactions observed with abacavir, dolutegravir, elvitegravir/cobicistat, emtricitabine, lamivudine, raltegravir, rilpivirine, tenofovir alafenamide, and tenofovir disoproxil fumarate¹
The overall safety profile in HCV/HIV-1–coinfected subjects (ENDURANCE-1 and EXPEDITION-2) was similar to that observed in HCV-monoinfected subjects¹

CLINICAL TRIAL STUDY DESIGNS

Integrated, pooled analysis of GT 1-6, TN adult subjects from 8 phase 2/3, open-label clinical trials. The primary endpoint of each study was SVR12.³

ENDURANCE-1^1,5
GT 1, TN or PRS-TE, NC subjects (± HIV-1 coinfection) were randomized to receive MAVYRET for 8 (n=351) or 12 (n=352) weeks.

ENDURANCE-5,6^1,6
GT 5-6, TN or PRS-TE, NC or CC subjects (n=84) received MAVYRET for 8 (n=75) or 12 (n=9) weeks.

EXPEDITION-5⁸
GT 1-6, TN or PRS-TE, NC or CC subjects with CKD stage 3b, 4, or 5 received MAVYRET for 8 (n=84), 12 (n=13), or 16 (n=4) weeks.

EXPEDITION-8^1,9
GT 1-6, TN, CC subjects (n=343) received MAVYRET for 8 weeks.

SURVEYOR-1, PART 2 (PHASE 2)^10,11
GT 1, 4-6, TN or PRS-TE, NC or CC subjects received MAVYRET for 8 (n=117) or 12 (n=332) weeks.

SURVEYOR-2, PARTS 2 AND 4 (PHASE 2)^1,12-14
GT 2-6, TN or PRS-TE, NC or CC subjects were randomized to receive MAVYRET for 8 (n=286), 12 (n=48), or 16 (n=4) weeks.

HIGH CURE RATES IN PATIENTS WITH SEVERE RENAL IMPAIRMENT^1,3

100^%	CURE RATE (n=65/65, mITT SVR12)³

Based on an integrated pooled analysis of GT 1-6, TN NC and CC adult patients treated for 8 weeks across 8 clinical trials. MAVYRET for 8 weeks was not studied in patients with severe renal impairment with CC.^1,3

Per Prescribing Information¹:

No dose adjustment is required in patients with mild, moderate, or severe renal impairment, including those on dialysis
Most common adverse reactions ≥5% in HCV-infected adults with severe renal impairment receiving 12 weeks of MAVYRET were pruritus (17%), fatigue (12%), nausea (9%), asthenia (7%), and headache (6%)
2% discontinuation rate due to adverse reactions

CLINICAL TRIAL STUDY DESIGNS

Integrated, pooled analysis of GT 1-6, TN adult subjects from 8 phase 2/3, open-label clinical trials. The primary endpoint of each study was SVR12.³

ENDURANCE-1^1,5
GT 1, TN or PRS-TE, NC subjects (± HIV-1 coinfection) were randomized to receive MAVYRET for 8 (n=351) or 12 (n=352) weeks.

ENDURANCE-3^1,5GT 3, TN, NC subjects were randomized (2:1) to receive MAVYRET (n=233) or SOF + DCV (n=115) for 12 weeks; additional subjects (n=157) were subsequently enrolled and nonrandomly assigned to receive MAVYRET for 8 weeks.

ENDURANCE-5,6^1,6GT 5-6, TN or PRS-TE, NC or CC subjects (n=84) received MAVYRET for 8 (n=75) or 12 (n=9) weeks.

EXPEDITION-5⁸
GT 1-6, TN or PRS-TE, NC or CC subjects with CKD stage 3b, 4, or 5 received MAVYRET for 8 (n=84), 12 (n=13), or 16 (n=4) weeks.

EXPEDITION-8^1,9
GT 1-6, TN, CC subjects (n=343) received MAVYRET for 8 weeks.

SURVEYOR-1, PART 2 (PHASE 2)^10,11
GT 1, 4-6, TN or PRS-TE, NC or CC subjects received MAVYRET for 8 (n=117) or 12 (n=332) weeks.

SURVEYOR-2, PARTS 2 AND 4 (PHASE 2)^1,12-14
GT 2-6, TN or PRS-TE, NC or CC subjects were randomized to receive MAVYRET for 8 (n=286), 12 (n=48), or 16 (n=4) weeks.

HIGH CURE RATES IN KIDNEY OR LIVER TRANSPLANT PATIENTS WITHOUT CIRRHOSIS^1,19

98^%	12-WEEK CURE RATE^1,19 (n=98/100, ITT SVR12)

In GT 1-4, 6 TN and GT 1, 2, 4, 6 PRS-TE, NC adult liver (n=80) or kidney (n=20) transplant recipients treated for 12 weeks in the MAGELLAN-2 clinical trial.^1,19

0 on-treatment virologic failures (n=0/100)¹⁹

1 relapse (n=1/100)¹⁹

The overall safety profile in transplant recipients was similar to that observed in subjects in phase 2 and 3 studies, without a history of transplantation¹
Most common adverse reactions ≥5% were headache (17%), fatigue (16%), nausea (8%), and pruritus (7%)¹
No observed clinically significant interaction with tacrolimus¹
MAVYRET is not recommended for use in patients requiring stable cyclosporine doses >100 mg per day¹
2% of subjects experienced a serious adverse reaction, and no subjects permanently discontinued treatment due to adverse reactions¹

CLINICAL TRIAL STUDY DESIGN^1,19

A phase 3, single-arm, open-label study: in adult patients (n=100) with liver or kidney transplant who were TN (HCV GT 1-6) or PRS-TE (HCV GT 1, 2, 4, 6) without cirrhosis were eligible to enroll. PRS-TE, GT 3–infected patients were excluded. Patients received MAVYRET for 12 weeks. Patients had to have received a deceased or living donor liver or kidney transplant ≥3 months prior to screening and been maintained on a stable immunosuppression regimen and/or low-dose steroids.

Immunosuppressants allowed for coadministration were cyclosporine ≤100 mg, tacrolimus, sirolimus, everolimus, azathioprine, mycophenolic acid, prednisone, and prednisolone.

DORA PART 1 DORA PART 1

DORA PART 2 DORA PART 2

EFFICACY AND SAFETY
IN CHILDREN ≥3 YEARS^1,20,21

In adolescents aged 12 to <18 years^1,20

100^%	CURE RATE (n=47/47, ITT SVR12)

In GT 1-4, TN/TE^||, NC patients treated with MAVYRET tablets for 8 or 16 weeks (n=47, ITT); 79% had GT 1, and 77% were HCV TN.

0% virologic failures (n=0/47)^1,20

0	PATIENTS DISCONTINUED DUE TO AN ADVERSE REACTION

The only adverse reaction observed in ≥5% of subjects was fatigue (6%)
No subjects discontinued or interrupted treatment with MAVYRET due to an adverse reaction

^||Treatment experienced to interferon and ribavirin.

CLINICAL TRIAL STUDY DESIGNS^1,20,21

Nonrandomized, open-label phase 2/3 study (DORA) in subjects with chronic HCV aged 3 to <12 years (Part 2) and 12 to <18 years (Part 1); those with GT 1-6 (TN or PRS-TE, NC or CC, ± HIV-1) were eligible to enroll. Subjects in Part 1 (n=47) received the adult dose (300 mg glecaprevir/120 mg pibrentasvir) of MAVYRET tablets and in Part 2 (n=80) received weight-based dosing of MAVYRET oral pellets taken once daily with food for 8, 12, or 16 weeks. Treatment duration was chosen to match approved adult durations based on HCV GT and prior treatment experience. The primary efficacy endpoint was SVR12.

EFFICACY AND SAFETY IN CHILDREN ≥3 YEARS^1,20,21

In children aged 3 to <12 years^1,21

98^%	CURE RATE (n=61/62, ITT SVR12)^¶

In GT 1-4, TN/TE^#, NC patients treated with MAVYRET weight-based oral pellets in packets for 8 or 16 weeks (n=80, ITT); 73% had GT 1, and 97.5% were HCV TN.

0% virologic failures (n=0/62)

1	PATIENT DISCONTINUED DUE TO AN ADVERSE REACTION

1 subject discontinued due to an adverse reaction of erythematous rash (Grade 3)
The most common adverse reactions ≥5% were vomiting, fatigue, and headache (8% each)

^¶18 patients received doses lower than the recommended weight-based dosage and were not included in the efficacy analysis. Please see Full Instructions for Use for oral pellet administration information.

^#Treatment experienced to interferon ribavirin.

CLINICAL TRIAL STUDY DESIGNS^1,20,21

HIGH CURE RATES IN 8 WEEKS FOR ALL
GENOTYPES^1,3

The efficacy of MAVYRET in adult subjects with GT 3b infection was evaluated in 2 trials conducted in China, Singapore, and South Korea. Across both trials, subjects with GT 3b infection had a numerically lower SVR12 rate. GT 3b is uncommon in the US (<1% of HCV GT 3 infections).¹

Integrated, pooled analysis of GT 1-6, TN adult subjects from 8 phase 2/3, open-label clinical trials. The primary endpoint of each study was SVR12.³

ENDURANCE-1^1,5
GT 1, TN or PRS-TE, NC subjects (± HIV-1 coinfection) were randomized to receive MAVYRET for 8 (n=351) or 12 (n=352) weeks.

ENDURANCE-3^1,5
GT 3, TN, NC subjects were randomized (2:1) to receive MAVYRET (n=233) or SOF + DCV (n=115) for 12 weeks; additional subjects (n=157) were subsequently enrolled and nonrandomly assigned to receive MAVYRET for 8 weeks.

ENDURANCE-5,6^1,6
GT 5-6, TN or PRS-TE, NC or CC subjects (n=84) received MAVYRET for 8 (n=75) or 12 (n=9) weeks.

EXPEDITION-2^1,7
GT 1-6, TN or PRS-TE, NC or CC subjects with HIV-1 and ART naïve or on a stable ART regimen received MAVYRET for 8 (n=137) or 12 (n=16) weeks. Treatment-experienced GT 3–infected subjects were excluded.

EXPEDITION-5⁸
GT 1-6, TN or PRS-TE, NC or CC subjects with CKD stage 3b, 4, or 5 received MAVYRET for 8 (n=84), 12 (n=13), or 16 (n=4) weeks.

EXPEDITION-8^1,9
GT 1-6, TN, CC subjects (n=343) received MAVYRET for 8 weeks.

SURVEYOR-1, PART 2 (PHASE 2)^10,11
GT 1, 4-6, TN or PRS-TE, NC or CC subjects received MAVYRET for 8 (n=117) or 12 (n=332) weeks.

SURVEYOR-2, PARTS 2 AND 4 (PHASE 2)^{1, 12-14}
GT 2-6, TN or PRS-TE, NC or CC subjects were randomized to receive MAVYRET for 8 (n=286), 12 (n=48), or 16 (n=4) weeks.

Learn about the safety profile of MAVYRET

REAL-WORLD EFFECTIVENESS IN THE LARGEST MAVYRET META-ANALYSIS²

Of 12,531 patients treated with MAVYRET (18 studies), 3657 were clearly characterized as TN, NC and treated for 8 weeks according to label (9 studies)²

METHODOLOGY²

LIMITATIONS²

HIGH CURE RATES ACROSS A WIDE RANGE OF PATIENTS^1,3

HIGH CURE RATES IN PATIENTS TAKING PPIs³

Nearly 1/3 of diagnosed HCV patients aged ≥12 years have been prescribed a PPI.⁴ Some may also be using OTC formulations.

HIGH CURE RATES IN COMPENSATED CIRRHOTICS^1,9

Treatment-Naïve, Compensated Cirrhotic 8-Week Efficacy Per Protocol Results^1,7

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE^1,15

PEOPLE WHO INJECT DRUGS (PWID)

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE^1,15

MEDICATION-ASSISTED TREATMENT (MAT)

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE³
ALCOHOL USE

REAL-WORLD EFFECTIVENESS IN PATIENTS WITH
SUBSTANCE USE OR PSYCHIATRIC DISORDERS¹⁸

HIGH CURE RATES IN PATIENTS WITH A HISTORY OF DEPRESSION OR BIPOLAR DISORDER³

HIGH CURE RATES IN HIV-COINFECTED PATIENTS³

HIGH CURE RATES IN PATIENTS WITH SEVERE RENAL IMPAIRMENT^1,3

HIGH CURE RATES IN KIDNEY OR LIVER TRANSPLANT PATIENTS WITHOUT CIRRHOSIS^1,19

EFFICACY AND SAFETY
IN CHILDREN ≥3 YEARS^1,20,21

EFFICACY AND SAFETY IN CHILDREN ≥3 YEARS^1,20,21

HIGH CURE RATES IN 8 WEEKS FOR ALL
GENOTYPES^1,3

INDICATION¹

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

REAL-WORLD EFFECTIVENESS IN THE LARGEST MAVYRET META-ANALYSIS2

Of 12,531 patients treated with MAVYRET (18 studies), 3657 were clearly characterized as TN, NC and treated for 8 weeks according to label (9 studies)2

METHODOLOGY2

LIMITATIONS2

HIGH CURE RATES ACROSS A WIDE RANGE OF PATIENTS1,3

HIGH CURE RATES IN PATIENTS TAKING PPIs3

Nearly 1/3 of diagnosed HCV patients aged ≥12 years have been prescribed a PPI.4 Some may also be using OTC formulations.

HIGH CURE RATES IN COMPENSATED CIRRHOTICS1,9

Treatment-Naïve, Compensated Cirrhotic 8-Week Efficacy Per Protocol Results1,7

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE1,15

PEOPLE WHO INJECT DRUGS (PWID)

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE1,15

MEDICATION-ASSISTED TREATMENT (MAT)

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE3 ALCOHOL USE

REAL-WORLD EFFECTIVENESS IN PATIENTS WITH SUBSTANCE USE OR PSYCHIATRIC DISORDERS18

HIGH CURE RATES IN PATIENTS WITH A HISTORY OF DEPRESSION OR BIPOLAR DISORDER3

HIGH CURE RATES IN HIV-COINFECTED PATIENTS3

HIGH CURE RATES IN PATIENTS WITH SEVERE RENAL IMPAIRMENT1,3

HIGH CURE RATES IN KIDNEY OR LIVER TRANSPLANT PATIENTS WITHOUT CIRRHOSIS1,19

EFFICACY AND SAFETY IN CHILDREN ≥3 YEARS1,20,21

EFFICACY AND SAFETY IN CHILDREN ≥3 YEARS1,20,21

HIGH CURE RATES IN 8 WEEKS FOR ALL GENOTYPES1,3

INDICATION1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATION1

INDICATION1

IMPORTANT SAFETY INFORMATION1

INDICATION1

IMPORTANT SAFETY INFORMATION1

INDICATION1

IMPORTANT SAFETY INFORMATION1

INDICATION1

INDICATION1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

REAL-WORLD EFFECTIVENESS IN THE LARGEST MAVYRET META-ANALYSIS²

Of 12,531 patients treated with MAVYRET (18 studies), 3657 were clearly characterized as TN, NC and treated for 8 weeks according to label (9 studies)²

METHODOLOGY²

LIMITATIONS²

HIGH CURE RATES ACROSS A WIDE RANGE OF PATIENTS^1,3

HIGH CURE RATES IN PATIENTS TAKING PPIs³

Nearly 1/3 of diagnosed HCV patients aged ≥12 years have been prescribed a PPI.⁴ Some may also be using OTC formulations.

HIGH CURE RATES IN COMPENSATED CIRRHOTICS^1,9

Treatment-Naïve, Compensated Cirrhotic 8-Week Efficacy Per Protocol Results^1,7

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE^1,15

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE^1,15

HIGH CURE RATES IN PATIENTS WITH SUBSTANCE USE³
ALCOHOL USE

REAL-WORLD EFFECTIVENESS IN PATIENTS WITH
SUBSTANCE USE OR PSYCHIATRIC DISORDERS¹⁸

HIGH CURE RATES IN PATIENTS WITH A HISTORY OF DEPRESSION OR BIPOLAR DISORDER³

HIGH CURE RATES IN HIV-COINFECTED PATIENTS³

HIGH CURE RATES IN PATIENTS WITH SEVERE RENAL IMPAIRMENT^1,3

HIGH CURE RATES IN KIDNEY OR LIVER TRANSPLANT PATIENTS WITHOUT CIRRHOSIS^1,19

EFFICACY AND SAFETY
IN CHILDREN ≥3 YEARS^1,20,21

EFFICACY AND SAFETY IN CHILDREN ≥3 YEARS^1,20,21

HIGH CURE RATES IN 8 WEEKS FOR ALL
GENOTYPES^1,3

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

INDICATION¹