Ombitasvir, Paritaprevir and Ritonavir tablets, Dasabuvir tablets: Viekira Pak, Holkira Pak

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
M15-310 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co administered with Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
M13-386 AbbVie_IU_icons_outlined_v3 HCV Phase 2 An Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
M10-459 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-333 After Discontinuation of ABT-333 Therapy in HCV Genotype 1-Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-333 Clinical Studies
M13-389 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL–II)
M13-098 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus Ribavirin (RBV) in Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)
M12-267 AbbVie_IU_icons_outlined_v3 HCV Phase 2 An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 with Ritonavir (ABT-450/r) Dosed in Combination with ABT-072 and Ribavirin (RBV) in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
M14-252 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)
M13-004 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Treatment-Naïve and Treatment-Experienced Japanese Adults with Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT I)
M12-746 AbbVie_IU_icons_outlined_v3 HCV Phase 2 An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) Dosed in Combination with ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-Responder Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
M13-774 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With and Without Ribavirin Compared to Telaprevir Co-administered with Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve Adults with Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE-I)
M11-646 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)
M10-380 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Blinded, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination with Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
M14-490 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)
M13-961 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)
M13-099 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
M11-652 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 with Ritonavir (ABT-450/r) in combination with ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects with Genotype 1 Chronic Hepatitis C Virus Infection
M13-862 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered with Ribavirin Compared to Telaprevir Co-administered with Pegylated Interferon α-2a and Ribavirin in Treatment-Experienced Adults with Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE-II)
M12-114 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination with Peginterferon α-2a and Ribavirin (pegIFN/RBV) in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
M13-393 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in Adults with Chronic Hepatitis C Virus Infection (PEARL-I)
M12-536 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults with Chronic Hepatitis C Virus Infection
M14-153 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) Co-administered with Ribavirin (RBV) for 12 or 16 Weeks in Treatment-Naïve and Treatment-Experienced Japanese Adults with Genotype 2 Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT-II)
M11-602 AbbVie_IU_icons_outlined_v3 HCV Phase 2 A Blinded, Randomized, Placebo-controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-450 with Ritonavir (ABT-450/r), ABT-333 or ABT-072 Each Administered Alone and in Combination with Peginterferon α-2a and Ribavirin (PegIFN/RBV) in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
M14-103 AbbVie_IU_icons_outlined_v3 HCV Phase 2 An Open-label, Single-Arm, Phase 2 Study to Evaluate the Combination of ABT-450/r/ABT-267 and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Hepatitis C Virus (HCV) Infection taking Methadone or Buprenorphine
M14-002 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV)
M12-998 AbbVie_IU_icons_outlined_v3 HCV Phase 2 An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) Dosed in Combination with ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects with Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection
M14-225 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Treatment-Naïve or Treatment-Experienced Adults in Brazil with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ III)
M14-004 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir with and without Dasabuvir Coadministered with and without Ribavirin in Adults with Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)
M13-102 AbbVie_IU_icons_outlined_v3 HCV Phase 3 A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
M14-251 AbbVie_IU_icons_outlined_v3 HCV Phase 2 An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in US Veterans With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-VA)
M15-582 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Low-Dose Ribavirin QD in Subjects with Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)
M14-726 AbbVie_IU_icons_outlined_v3 HCV Phase 3 Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma (GEODE – I)
P15-695 AbbVie_IU_icons_outlined_v3 HCV PMOS Real World Evidence of the Effectiveness of Paritaprevir/r – Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients with Chronic Hepatitis C - An Observational Study in Austria (REAL)
M14-226 AbbVie_IU_icons_outlined_v3 HCV Phase 3 Chronic Hepatitis C Virus (HCV) Infection, with Severe Renal Impairment or End Stage Renal Disease (RUBY-I)
M14-242 AbbVie_IU_icons_outlined_v3 HCV Phase 2 An Exploratory Study to Evaluate the Kinetics of Viral Load Decline with Ombitasvir/Paritaprevir/Ritonavir (Ombitasvir/Paritaprevir/r) and Dasabuvir Therapy with Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment-Naïve Adults with Genotype 1a Chronic Hepatitis C Virus (HCV) Infection
M15-684 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Open Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)
M14-243 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Exploratory Study to Evaluate Immune Restoration Following Removal of Viral Antigen in Treatment-Naïve and Treatment-Experienced Adults with Genotype (GT) 1a Chronic Hepatitis C Virus (HCV) Infection Administered Ombitasvir/ABT-450/Ritonavir with Dasabuvir and Ribavirin (RBV) for 12 Weeks
M15-461 AbbVie_IU_icons_outlined_v3 HCV Phase 3 An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults with Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End Stage Renal Disease (RUBY-II)