Glecaprevir/Pibrentasvir: Mavyret, Maviret

CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.

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Phase
Study Indication or Disease
Study Name
M13-595 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Randomized, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
M13-590 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)
M13-594 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered with Daclatasvir in Adults with Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)
M15-464 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 2 Infection (ENDURANCE-2)
M15-828 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Open-Label, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults with Genotype 2 Chronic Hepatitis C Virus Infection (CERTAIN-2)
M13-596 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients with Chronic Hepatitis C Virus Genotype 1 – 6 Infection (MAGELLAN-2)
M14-868 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5, or 6 Infection (SURVEYOR-II)
M14-867 AbbVie_IU_icons_outlined_v3 HCV Phase 2 An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects with Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I).
M15-594 AbbVie_IU_icons_outlined_v3 HCV Phase 3 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults with Chronic Hepatitis C Virus Infection (CERTAIN-1)
M15-462 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults with Chronic Hepatitis C Virus Genotype 1 – 6 Infection (EXPEDITION-4)
M14-172 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Single Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)
M15-410 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy
M13-583 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
M14-730 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 – 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2)
M16-127 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally Impaired Adults with Chronic Hepatitis C Virus Genotype 1-6 Infection
M15-592 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults with Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection (VOYAGE-1)
M16-126 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults with Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
M15-593 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection (VOYAGE-2)
M16-156 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naïve Adults in Brazil with Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection
M13-576 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
M16-135 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Single Arm, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Compensated Cirrhosis
P17-094 AbbVie_IU_icons_outlined_v3 HCV PMOS Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir plus Pibrentasvir in Patients with Chronic Hepatitis C Genotypes 1 to 6