- |||||||||| Sovaldi (sofosbuvir) / Gilead, yimitasvir (DAG181) / Dongguan HEC TaiGen Biopharma, HEC Pharm
Enrollment closed: Phase 3 Study of Yimitasvir Phosphate Capsules (clinicaltrials.gov) - Apr 10, 2019 P3, N=362, Active, not recruiting, No abstract available Not yet recruiting --> Active, not recruiting
- |||||||||| ravidasvir (PPI-668) / Presidio Pharmaceuticals, Inc, Ascletis, Pharco Pharmaceuticals, Sovaldi (sofosbuvir) / Gilead
Journal: A new potent NS5A inhibitor in the management of hepatitis C virus: ravidasvir. (Pubmed Central) - Apr 3, 2019 ...It is a potent NS5A inhibitor that was formerly known as PPI-668...Even more, HCV variants that had reduced susceptibility to ravidasvir are completely susceptible to other DAA. Finally, a large multicenteric registrational phase 3 clinical trial that included large percentages of difficult to treat patients (such as cirrhotic and interferon experienced patients) has been fully accomplished and proved high sustained virologic response rates (SVR12) rates with well acceptable safety and tolerability profiles in management of genotype 4 HCV patients.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Clinical, Journal: Primary Liver Diffuse Large B-Cell Lymphoma following Complete Response for Hepatitis C Infection after Direct Antiviral Therapy. (Pubmed Central) - Mar 27, 2019 We review the evidence supporting possible mechanisms of lymphomagenesis after successful hepatitis C therapy, particularly involving late "second-hit" mutations after viral-induced DNA damage and antiviral therapy facilitating the emergence of latent malignant B-cell clones by decreasing local inflammation and immune surveillance. More reports may help elucidate any association between hepatitis C antiviral therapy and late lymphoid malignancies.
- |||||||||| 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.
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