- |||||||||| Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Trial completion date: Management of Decompensated HCV Cirrhotic Patients (clinicaltrials.gov) - Dec 5, 2018 P=N/A, N=80, Completed, Recruiting --> Active, not recruiting Trial completion date: Jan 2018 --> Jun 2018
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma, Sovaldi (sofosbuvir) / Gilead
Enrollment open, Trial completion date: Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects (clinicaltrials.gov) - Dec 3, 2018 P3b, N=215, Enrolling by invitation, Trial completion date: Jan 2018 --> Jun 2018 Active, not recruiting --> Enrolling by invitation | Trial completion date: Mar 2019 --> Aug 2019
- |||||||||| ribavirin / Generic mfg., Sovaldi (sofosbuvir) / Gilead
Clinical, Journal: Editorial for Esteban et al. (Pubmed Central) - Oct 16, 2018 Active, not recruiting --> Enrolling by invitation | Trial completion date: Mar 2019 --> Aug 2019 No abstract available
- |||||||||| Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Trial completion: Phase 2 Study of Yimitasvir Phosphate Capsules (clinicaltrials.gov) - Aug 22, 2018 P2, N=129, Completed, Initiation date: Jun 2018 --> Oct 2018 Active, not recruiting --> Completed
- |||||||||| Sovaldi (sofosbuvir) / Gilead, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: Advances in HCV and Cryoglobulinemic Vasculitis in the Era of DAAs: Are We at the End of the Road? (Pubmed Central) - May 11, 2018 Rituximab, either alone or in combination with DAA, has also been shown to be effective...As with non-MC related HCV, undoubtedly long term outcome data will be forthcoming over the next few years. As we move forward successful therapy of HCV is not likely to be a challenge in contrast to access to therapy.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Enrollment closed, Phase classification: Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C (clinicaltrials.gov) - May 4, 2018 P=N/A, N=71, Active, not recruiting, Accompanied by high efficacy, the favourable effect of treatment on PROs improves patients' experience in this difficult-to-treat population with HCV. Recruiting --> Active, not recruiting | Phase classification: P4 --> PN/A
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma, Sovaldi (sofosbuvir) / Gilead
Enrollment closed, Trial completion date, Trial primary completion date: Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects (clinicaltrials.gov) - Apr 18, 2018 P3b, N=215, Active, not recruiting, Recruiting --> Active, not recruiting | Phase classification: P4 --> PN/A Recruiting --> Active, not recruiting | Trial completion date: Oct 2018 --> Mar 2019 | Trial primary completion date: May 2018 --> Jan 2019
- |||||||||| Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P3 trial: Phase 3 Study of Yimitasvir Phosphate Capsules (clinicaltrials.gov) - Apr 2, 2018 P3, N=360, Not yet recruiting,
- |||||||||| Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
New P2 trial: Phase 2 Study of Yimitasvir Phosphate Capsules (clinicaltrials.gov) - Mar 8, 2018 P2, N=129, Active, not recruiting,
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Journal: Chronic Hepatitis C and Chronic Kidney disease: Advances, Limitations and Unchartered Territories. (Pubmed Central) - Feb 17, 2018 While sofosbuvir, the only approved nucleotide NS5B inhibitor, has been the backbone of most pangenotypic therapeutic regimens, it has a limitation in those with advanced kidney disease...Globally genotype 3 is a common infection and thus this group with CKD presents a huge unmet need for effective therapies. Since therapy of HCV in renal transplant recipients has been highly successful, it provides an opportunity to expand the use of HCV infected organs in solid organ transplantation.
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Clinical Trial,Phase I, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal: Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. (Pubmed Central) - Feb 11, 2018 P3 Conclusions Once-daily treatment with glecaprevir-pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 ClinicalTrials.gov numbers, NCT02604017 and NCT02640157 .).
- |||||||||| velpatasvir (GS-5816) / Gilead
Journal: Intra-hepatic Depletion of Mucosal Associated Invariant T cells in Hepatitis C Virus-induced Liver Inflammation. (Pubmed Central) - Nov 30, 2017 Patient with renal impairment require close monitoring and should be treated by providers extensively experienced with SOF-containing regimens. In analyses of paired blood and liver samples from patients with chronic HCV infection before, during, and after antiviral therapy with sofosbuvir and velpatasvir, we found that intrahepatic MAIT cells are activated by monocyte-derived cytokines and depleted in HCV-induced liver inflammation.
- |||||||||| Sovaldi (sofosbuvir) / Gilead, ledipasvir/sofosbuvir / Generic mfg.
Journal: Disparate access to treatment regimens in chronic hepatitis C patients: data from the TRIO network. (Pubmed Central) - Nov 3, 2017 We evaluated patients in the TRIO network who were prescribed sofosbuvir (SOF)-based regimens to determine reasons for not starting treatment...In fact, almost half of the nonstart patients had advanced fibrosis scores (F3 or F4) and should have been prioritized to start treatment. As better treatment for HCV with high efficacy and low side effect rates become available, the disparity in access to treatment, as evidenced by the high nonstart rate in the Medicaid-covered group, must be resolved.
- |||||||||| pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Clinical Trial,Phase I, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal: Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment. (Pubmed Central) - Oct 21, 2017 P3 Conclusions Treatment with glecaprevir and pibrentasvir for 12 weeks resulted in a high rate of sustained virologic response in patients with stage 4 or 5 chronic kidney disease and HCV infection. (Funded by AbbVie; ClinicalTrials.gov number, NCT02651194 .).
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