|98%||CURE RATE IN TREATMENT-NAIVE PATIENTS1,2 †|
|(n=1218/1248, ITT) SVR12 Range: 95%-99%|
Based on an integrated, pooled analysis of GT 1-6 TN NC and CC adult patients who received 8 weeks of MAVYRET from the following 8 phase 2/3 open-label clinical trials: ENDURANCE-1, -3, -5, 6; EXPEDITION-2, -5, -8; SURVEYOR-1 Part 2; and SURVEYOR-2 Parts 2 and 4. The primary endpoint of each study was SVR12. Please see clinical trial study designs below.
0.1% on-treatment virologic failure (n=1/1248)
0.6% relapse‡ (n=7/1226)
*Liver or kidney transplant recipients are not eligible for an 8-week regimen.
†Cure = sustained virologic response (SVR12); HCV RNA <LLOQ at 12 weeks after the end of treatment.
‡Relapse = HCV RNA ≥LLOQ after end-of-treatment response among subjects who completed treatment.
RATE DUE TO ADVERSE
Derived from 9 registrational phase 2 and 3 clinical trials that evaluated ~2300 adults1
- The most common adverse reactions ≥10% were headache (13%) and fatigue (11%)
- Most adverse reactions were mild in severity
- 1 subject experienced a serious adverse reaction
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)3
% CURE RATE
(n=3657, mITT SVR12)
In GT 1-4 TN NC patients3
Cure = sustained virologic response (SVR12); HCV RNA <LLOQ at 12 weeks after the end of treatment.
SEE FULL METHODOLOGY AND LIMITATIONS BELOW.
METHODOLOGY AND LIMITATIONS
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). Random-effects meta-analysis was used to determine SVR12 rates. mITT analyses excluded those with nonvirologic failure.
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.
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 SVR12.2
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.
GT 3, TN, NC 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.
GT 5-6, TN or PRS-TE, NC or CC subjects (n=84) received MAVYRET for 8 (n=75) or 12 (n=9) weeks.
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.
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.
GT 1-6, TN, CC subjects (n=343) received MAVYRET for 8 weeks.
SURVEYOR-1, PART 2 (PHASE 2)9,10
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)1,11-13
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.