Eric Lawitz1, Greg Sullivan2, Maribel Rodriguez-Torres3, Michael Bennett4, Fred Poordad5, Mudra Kapoor6, Prajakta Badri7, Andrew Campbell8, Lino Rodrigues9, Yiran Hu10, Tami Pilot-Matias11, Regis A Vilchez12. 1. The Texas Liver Institute, University of Texas Health Science Center, 607 Camden, San Antonio, TX 78215, USA. Electronic address: lawitz@txliver.com. 2. Parkway Medical Center, 1160 Huffman Road, Birmingham, AL 35215, USA. Electronic address: dgregs@gmail.com. 3. Funadación de Investigación, Avenida Munoz Rivera 998, Rio Piedras, Puerto Rico 00927, USA. Electronic address: mrodrigueztorres@fdipr.com. 4. Medical Associates Research Group, 8008 Frost Street, Suite 200, San Diego, CA 92123, USA. Electronic address: michael.bennett@marginc.com. 5. The Texas Liver Institute, University of Texas Health Science Center, 607 Camden, San Antonio, TX 78215, USA. Electronic address: poordad@txliver.com. 6. AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: mudra.kapoor@abbvie.com. 7. AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: prajakta.badri@abbvie.com. 8. AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: andrew.campbell@abbvie.com. 9. AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: lino.rodrigues@abbvie.com. 10. AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: yiran.hu@abbvie.com. 11. AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: tami.pilotmatias@abbvie.com. 12. AbbVie Inc., 1 N. Waukegan Road, North Chicago, IL 60064, USA. Electronic address: regis.vilchezbonilla@abbvie.com.
Abstract
OBJECTIVES: To examine the safety and efficacy of ombitasvir and ABT-450 with ritonavir (ABT-450/r) ± ribavirin (RBV) in treatment-naïve, non-cirrhotic adults with chronic HCV genotype 1-3 infection. METHODS: Patients in this open-label, exploratory, phase 2, multicenter study received ombitasvir (25 mg QD) and ABT-450/r (200/100 mg QD) ± RBV for 12 weeks. Primary efficacy endpoint was HCV RNA < lower limit of quantitation (LLOQ) from week 4 through 12. Sustained virologic response 12 weeks post-treatment (SVR12) was a secondary endpoint. RESULTS: Sixty-one patients were enrolled. Among genotype 1-, 2-, and 3-infected patients, respectively, HCV RNA was<LLOQ from week 4 through 12 in 10 (100%; 95% CI 69-100), 9 (90%; 56-100), and 7 (70%; 35-93) receiving the RBV-containing regimen and 9 (90%; 56-100), 8 (80%; 44-97), and 2 (18%; 2-52) receiving the RBV-free regimen. Among genotype 1-, 2-, and 3-infected patients, respectively, SVR12 was achieved by 10 (100%), 8 (80%), and 5 (50%) receiving the RBV-containing regimen, and 6 (60%), 6 (60%), and 1 (9%) receiving the RBV-free regimen. The most common adverse events were fatigue, nausea, and headache. One patient discontinued due to an adverse event. CONCLUSIONS: In this study, ombitasvir and ABT-450/r ± RBV regimens were generally well-tolerated. Sustained virologic response was achieved in most patients with HCV genotype 1 or 2 infection, but low SVR rates were observed in HCV genotype 3-infected patients.
OBJECTIVES: To examine the safety and efficacy of ombitasvir and ABT-450 with ritonavir (ABT-450/r) ± ribavirin (RBV) in treatment-naïve, non-cirrhotic adults with chronic HCV genotype 1-3 infection. METHODS:Patients in this open-label, exploratory, phase 2, multicenter study received ombitasvir (25 mg QD) and ABT-450/r (200/100 mg QD) ± RBV for 12 weeks. Primary efficacy endpoint was HCV RNA < lower limit of quantitation (LLOQ) from week 4 through 12. Sustained virologic response 12 weeks post-treatment (SVR12) was a secondary endpoint. RESULTS: Sixty-one patients were enrolled. Among genotype 1-, 2-, and 3-infected patients, respectively, HCV RNA was<LLOQ from week 4 through 12 in 10 (100%; 95% CI 69-100), 9 (90%; 56-100), and 7 (70%; 35-93) receiving the RBV-containing regimen and 9 (90%; 56-100), 8 (80%; 44-97), and 2 (18%; 2-52) receiving the RBV-free regimen. Among genotype 1-, 2-, and 3-infected patients, respectively, SVR12 was achieved by 10 (100%), 8 (80%), and 5 (50%) receiving the RBV-containing regimen, and 6 (60%), 6 (60%), and 1 (9%) receiving the RBV-free regimen. The most common adverse events were fatigue, nausea, and headache. One patient discontinued due to an adverse event. CONCLUSIONS: In this study, ombitasvir and ABT-450/r ± RBV regimens were generally well-tolerated. Sustained virologic response was achieved in most patients with HCV genotype 1 or 2 infection, but low SVR rates were observed in HCV genotype 3-infected patients.
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