High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis

Gane, Edward; Poordad, Fred; Wang, Stanley; Asatryan, Armen; Kwo, Paul Y.; Lalezari, Jacob; Wyles, David L.; Hassanein, Tarek; Aguilar, Humberto; Maliakkal, Benedict; Liu, Ran; Lin, Chih Wei; Ng, Teresa I.; Kort, Jens; Mensa, Federico

doi:10.1053/j.gastro.2016.07.020

Cited by 95 publications

(98 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Previous studies have shown that lower SVR12 rates were achieved in patients with GT1b treated with OBV/PTV/r who have the NS5A Y93H polymorphism at baseline compared to HCV GT1b patients without this polymorphism [17]. As a result, JSH guidelines for the management of hepatitis C virus infection does not recommend treatment with OBV/PTV/r for patients with the NS5A Y93 polymorphism [1,13].…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection with and without cirrhosis

Chayama¹,

Suzuki²,

Sato³

et al. 2017

Journal of Hepatology

View full text Add to dashboard Cite

Background The once-daily, all oral, RBV-free, pangenotypic direct-acting anti-viral regimen consisting of co-formulated NS3/4A protease inhibitor glecaprevir and NS5A inhibitor pibrentasvir (G/P), demonstrated high rates of sustained virologic response (SVR) in phase 2 and 3 studies outside Japan. Methods CERTAIN-1 is a phase 3, open-label, multicenter study assessing the safety and efficacy of G/P (300/ 120 mg) once daily in Japanese patients with chronic HCV GT1 infection. Patients without cirrhosis received 8 weeks of G/P or 12 weeks of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r, 25/150/100 mg); patients with cirrhosis received G/P for 12 weeks. The primary efficacy endpoint was non-inferiority of G/P compared to OBV/PTV/r by assessing SVR at post-treatment week 12 (SVR12) among non-cirrhotic patients without the NS5A Y93H polymorphism. Results SVR12 was achieved by 128/129 (99.2%; one patient lost to follow-up) non-cirrhotic patients in the 8-week G/P Arm (including 23/23 patients with the NS5A Y93H polymorphism) and 52/52 (100%) patients in the 12-week OBV/PTV/r Arm. No patients from the G/P Arm prematurely discontinued the study drug or experienced a treatment-emergent serious adverse event (TESAE). Three patients from the OBV/PTV/r Arm experienced five TESAEs and one of these patients discontinued the study drug due to TESAEs. All 38 (100%) patients with compensated cirrhosis achieved SVR12; in this group, no TESAEs were reported and one patient discontinued treatment due to an AE. Conclusions CERTAIN-1 study results demonstrate high efficacy and favorable tolerability of G/P in GT1-infected Japanese patients including those with the NS5A Y93H polymorphism, with no virologic failures observed.

show abstract

Section: Discussionmentioning

confidence: 99%

“…Figure 1 shows the study design. The treatment duration of G/P for patients without cirrhosis and with compensated cirrhosis was based on both the results from the global Phase 2 SURVEYOR-I and SURVEYOR-II studies [17,18], and the clinical exposure-response simulation predicted range (data not shown).…”

Section: Methodsmentioning

confidence: 99%

Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection with and without cirrhosis

Chayama¹,

Suzuki²,

Sato³

et al. 2017

Journal of Hepatology

View full text Add to dashboard Cite

show abstract

“…The glecaprevir/pibrentasvir combination has recently been licensed by EMA and will become available by the end of 2017, while the triple combination of sofosbuvir/velpatasvir/voxilaprevir has recently been approved by the FDA [11]. Still other combinations such as elbasvir/ruzasvir/uprifosbuvir are currently under evaluation in phase III trials [12]. Of note, at least in Italy, sofosbuvir and sofosbuvir/ledipasvir are no longer reimbursed by the national healthcare system since May 2017.…”

Section: Treatment Perspectives With New Drugsmentioning

confidence: 99%

Current and future challenges in HCV: insights from an Italian experts panel

et al. 2017

View full text Add to dashboard Cite

show abstract

“…It is becoming clear that developing therapeutic strategies with diferent modes of action would be necessary to address the various limitations of current DAAs. Third generation pangenotypic antivirals are currently in inal phases of development: voxilaprevir [16], glecaprevir [17] (both NS3/NS4 protease inhibitors) and pibrentasvir (NS5A inhibitor) [17]. Antivirals with alternate mechanism of action, such as by restricting viral entry or cell-to-cell spread could help expand the scope of antiviral strategies for the management of hepatitis C. Chapters 14 and 15 describe some of the new paradigms in antiviral strategies to preclude HCV entry, such as through monoclonal antibodies and small molecules.…”

Section: Future Perspectivesmentioning

confidence: 99%

Introductory Chapter: Treatment of Viral Hepatitis - Current Challenges and Future Perspectives

Allam¹,

Waked²

2017

Advances in Treatment of Hepatitis C and B

View full text Add to dashboard Cite

High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis

Abstract: In cirrhotic HCV GT1- or GT3-infected patients, ABT-493 plus ABT-530 with or without RBV achieved SVR12 rates of 96%-100% and was well tolerated. ClinicalTrials.gov identifiers NCT02243280 and NCT02243293.

Cited by 95 publications

References 28 publications

Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection with and without cirrhosis

Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection with and without cirrhosis

Current and future challenges in HCV: insights from an Italian experts panel

Introductory Chapter: Treatment of Viral Hepatitis - Current Challenges and Future Perspectives

Contact Info

Product

Resources

About