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54 Diseases |  |
8 Trials |
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8 Trials |  |
2662 News |  |
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- | ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date, HEOR: Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection (clinicaltrials.gov) - Mar 16, 2018
P3, N=30, Enrolling by invitation, Sponsor: University Health Network, Toronto
Trial primary completion date: Dec 2017 --> Dec 2018
- | ledipasvir/sofosbuvir / Generic mfg.
Journal: New Hepatitis C Drugs Are Very Costly And Unavailable To Many State Prisoners. (Pubmed Central) - Mar 14, 2018
Prices for a twelve-week course of direct-acting antivirals such as sofosbuvir and the combination drug ledipasvir/sofosbuvir varied widely as of September 30, 2015 ($43,418-$84,000 and $44,421-$94,500, respectively)...State departments of corrections should consider collaborating with other government agencies to negotiate discounts with pharmaceutical companies and with qualified health care facilities to provide medications through the federal 340B Drug Discount Program. Helping inmates transition to providers in the community upon release can enhance the gains achieved by treating hepatitis C in prison.
- | ledipasvir/sofosbuvir / Generic mfg.
Trial completion date, Trial primary completion date: Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics (clinicaltrials.gov) - Mar 12, 2018
P4, N=30, Recruiting, Sponsor: University of Nebraska
Helping inmates transition to providers in the community upon release can enhance the gains achieved by treating hepatitis C in prison. Trial completion date: Aug 2019 --> Aug 2020 | Trial primary completion date: Aug 2018 --> Aug 2019
- | Sovaldi (sofosbuvir) / Gilead
Trial completion, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date: Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (clinicaltrials.gov) - Mar 8, 2018
P4, N=10000, Completed, Sponsor: Tanta University
Trial completion date: Aug 2019 --> Aug 2020 | Trial primary completion date: Aug 2018 --> Aug 2019 Recruiting --> Completed | N=6000 --> 10000 | Trial completion date: Dec 2018 --> Mar 2018 | Initiation date: Dec 2016 --> Jan 2015 | Trial primary completion date: Dec 2018 --> Jan 2018
- ||||| ledipasvir/sofosbuvir / Generic mfg.
Trial initiation date, Trial primary completion date: Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection (clinicaltrials.gov) - Mar 3, 2018
P3b, N=111, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Completed | N=6000 --> 10000 | Trial completion date: Dec 2018 --> Mar 2018 | Initiation date: Dec 2016 --> Jan 2015 | Trial primary completion date: Dec 2018 --> Jan 2018 Initiation date: Dec 2015 --> Dec 2015 | Trial primary completion date: Jan 2017 --> Jan 2017
- | P3 data, Journal: Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies. (Pubmed Central) - Feb 18, 2018
Among patients receiving OST, SVR12 was high among those receiving methadone (95%) and buprenorphine (96%). Sofosbuvir-based therapies are effective and safe in patients receiving OST.
- | ledipasvir/sofosbuvir / Generic mfg.
Trial completion, Trial initiation date, Trial primary completion date, IO biomarker: Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs (clinicaltrials.gov) - Feb 15, 2018
P4, N=36, Completed, Sponsor: Rockefeller University
Sofosbuvir-based therapies are effective and safe in patients receiving OST. Active, not recruiting --> Completed | Initiation date: Jan 2015 --> Nov 2016 | Trial primary completion date: Jan 2018 --> Nov 2016
- || Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Sovaldi (sofosbuvir) / Gilead
Trial completion date, Trial primary completion date: A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials (clinicaltrials.gov) - Feb 5, 2018
P=N/A, N=500, Enrolling by invitation, Sponsor: Gilead Sciences
Active, not recruiting --> Completed | Initiation date: Jan 2015 --> Nov 2016 | Trial primary completion date: Jan 2018 --> Nov 2016 Trial primary completion date: Apr 2023 --> Sep 2027 | Trial completion date: Apr 2023 --> Sep 2027
- ledipasvir/sofosbuvir / Generic mfg.
Enrollment open: APOSTLE: Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (clinicaltrials.gov) - Feb 5, 2018
P2, N=10, Recruiting, Sponsor: University of Maryland
Trial primary completion date: Apr 2023 --> Sep 2027 | Trial completion date: Apr 2023 --> Sep 2027 Not yet recruiting --> Recruiting
- | ledipasvir/sofosbuvir / Generic mfg.
Clinical, Journal: On-treatment HCV RNA in patients with varying degrees of fibrosis and cirrhosis in the SOLAR-1 trial. (Pubmed Central) - Jan 27, 2018
P2
On-treatment HCV RNA quantification is of limited clinical use in patients with advanced liver disease and/or liver transplantation and does not predict SVR12. ClinicalTrials.gov: NCT01938430.
- | ledipasvir/sofosbuvir / Generic mfg.
New P4 trial: Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C (clinicaltrials.gov) - Jan 18, 2018
P4, N=1200, Recruiting, Sponsor: Tanta University
- | ledipasvir/sofosbuvir / Generic mfg.
Enrollment open: Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) (clinicaltrials.gov) - Jan 12, 2018
P4, N=15, Recruiting, Sponsor: University of Colorado, Denver
ClinicalTrials.gov: NCT01938430. Not yet recruiting --> Recruiting
- ||| ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed: Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection (clinicaltrials.gov) - Jan 9, 2018
P2, N=226, Active, not recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date, Adherence: Evaluation of HepCure Toolkit to Improve Harvoni Adherence (clinicaltrials.gov) - Jan 5, 2018
P=N/A, N=99, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2017 --> Dec 2018
- | ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed, Enrollment change: Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD) (clinicaltrials.gov) - Dec 29, 2017
P=N/A, N=11, Active, not recruiting, Sponsor: Massachusetts General Hospital
Trial primary completion date: Dec 2017 --> Dec 2018 Recruiting --> Active, not recruiting | N=24 --> 11
- | ledipasvir/sofosbuvir / Generic mfg.
Journal: Effectiveness of 8- or 12-weeks of ledipasvir and sofosbuvir in real-world treatment-naïve, genotype 1 hepatitis C infected patients. (Pubmed Central) - Dec 16, 2017
In treatment-naïve HCV genotype 1 patients, SVR was 95% in those treated for either 8 weeks or 12 weeks with ledipasvir and sofosbuvir. 8 week ledipasvir and sofosbuvir can reduce costs without compromising outcomes for those patients who qualify for such regimen.
- | ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Trial completion: Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa (clinicaltrials.gov) - Dec 13, 2017
P2, N=120, Completed, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
8 week ledipasvir and sofosbuvir can reduce costs without compromising outcomes for those patients who qualify for such regimen. Active, not recruiting --> Completed
- | ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Trial completion: SL50: Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 (clinicaltrials.gov) - Dec 8, 2017
P3, N=50, Completed, Sponsor: Tehran University of Medical Sciences
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | daclatasvir/sofosbuvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Enrollment open: The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia (clinicaltrials.gov) - Dec 7, 2017
P=N/A, N=50, Recruiting, Sponsor: Assiut University
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- | ledipasvir/sofosbuvir / Generic mfg.
Trial initiation date, Trial primary completion date: Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) (clinicaltrials.gov) - Dec 5, 2017
P4, N=15, Not yet recruiting, Sponsor: University of Colorado, Denver
Not yet recruiting --> Recruiting Initiation date: Aug 2017 --> Jan 2018 | Trial primary completion date: Dec 2018 --> Aug 2019
- | Sovaldi (sofosbuvir) / Gilead, ledipasvir/sofosbuvir / Generic mfg.
Journal: Safety and Efficacy of Sofosbuvir-Containing Regimens in Hepatitis C Infected Patients with Impaired Renal Function. (Pubmed Central) - Dec 1, 2017
However, these patients had higher rates of anaemia, worsening renal dysfunction and serious adverse events regardless of use of RBV. Patient with renal impairment require close monitoring and should be treated by providers extensively experienced with SOF-containing regimens.
- | ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed: Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir (clinicaltrials.gov) - Nov 14, 2017
P=N/A, N=15, Active, not recruiting, Sponsor: University of Colorado, Denver
Patient with renal impairment require close monitoring and should be treated by providers extensively experienced with SOF-containing regimens. Recruiting --> Active, not recruiting
- | Sovaldi (sofosbuvir) / Gilead
Enrollment change: Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (clinicaltrials.gov) - Nov 14, 2017
P4, N=6000, Recruiting, Sponsor: Tanta University
Recruiting --> Active, not recruiting N=1000 --> 6000
- | ledipasvir/sofosbuvir / Generic mfg.
Journal: Real-world effectiveness for 12 weeks of ledipasvir-sofosbuvir for genotype 1 hepatitis C: the Trio Health study. (Pubmed Central) - Nov 8, 2017
The real-world experience with LDV-SOF mirrors the SVR rates observed in clinical trials. Efforts to promote prescription within FDA recommendations are warranted.
- | ledipasvir/sofosbuvir / Generic mfg.
Journal: High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in HCV-infected patients treated with sofosbuvir-containing regimens. (Pubmed Central) - Nov 5, 2017
Two cases, both on sofosbuvir/simeprevir (without interferon or ribavirin), had complications consistent with autoimmune events (score 3, 'likely treatment-related'), and one experienced a flare of autoimmune hepatitis...Decompensation/events was independently associated with lower baseline albumin (OR = 0.12/g/dL, P = 0.01) and higher total bilirubin (OR = 4.31/mg/dL, P = 0.01). Reduced hepatic function at baseline increased the risk of liver decompensation/events.
- | 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.
- | ledipasvir/sofosbuvir / Generic mfg.
Trial termination: Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study (clinicaltrials.gov) - Oct 30, 2017
P4, N=1, Terminated, Sponsor: University of Texas Southwestern Medical Center
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. Active, not recruiting --> Terminated; failure to recruit
- | ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Trial completion: Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency (clinicaltrials.gov) - Oct 27, 2017
P2b, N=38, Completed, Sponsor: Gilead Sciences
Active, not recruiting --> Terminated; failure to recruit Active, not recruiting --> Completed
- | ledipasvir/sofosbuvir / Generic mfg.
Journal: NS5A Resistance-Associated Substitutions in Patients with Genotype 1 Hepatitis C Virus: Prevalence and Effect on Treatment Outcome. (Pubmed Central) - Oct 26, 2017
Active, not recruiting --> Completed Pretreatment ledipasvir-specific RASs that were present in 8-16% of patients have an impact on treatment outcome in some patient groups, particularly treatment-experienced patients with genotype 1a HCV.
- | ribavirin / Generic mfg.
Journal: Persistence of Virologic Response after Liver Transplant in Hepatitis C Patients Treated with Ledipasvir / Sofosbuvir Plus Ribavirin Pretransplant. (Pubmed Central) - Oct 25, 2017
Among a small population of HCV patients with decompensated cirrhosis, virologic response to ledipasvir / sofosbuvir plus ribavirin prior to liver transplantation was maintained after transplantation, even if treatment was stopped early. Administration of ledipasvir / sofosbuvir plus ribavirin before liver transplant can prevent post-transplant HCV recurrence.
- | ledipasvir/sofosbuvir / Generic mfg.
New P1 trial: A clinical study in healthy adults to compare the bioavailability of Harvoni tablets to that of pediatric granules. (EUDRACT) - Oct 21, 2017
P1, N=42, , Sponsor: Gilead Sciences, Inc.
- ledipasvir/sofosbuvir / Generic mfg.
New P2 trial: APOSTLE: Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (clinicaltrials.gov) - Oct 17, 2017
P2, N=10, Not yet recruiting, Sponsor: University of Maryland
- ||||||| ledipasvir/sofosbuvir / Generic mfg.
Trial completion: Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection (clinicaltrials.gov) - Oct 16, 2017
P3b, N=384, Completed, Sponsor: Gilead Sciences
Administration of ledipasvir / sofosbuvir plus ribavirin before liver transplant can prevent post-transplant HCV recurrence. Active, not recruiting --> Completed
- | ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date: Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD) (clinicaltrials.gov) - Oct 5, 2017
P=N/A, N=24, Recruiting, Sponsor: Massachusetts General Hospital
Active, not recruiting --> Completed Trial primary completion date: Dec 2017 --> Dec 2018
- ||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) / J&J, Gilead
Trial completion: Co-STARs: Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment (clinicaltrials.gov) - Oct 5, 2017
P3b, N=150, Completed, Sponsor: Gilead Sciences
Trial primary completion date: Dec 2017 --> Dec 2018 Active, not recruiting --> Completed
- | ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date: Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics (clinicaltrials.gov) - Sep 25, 2017
P4, N=30, Recruiting, Sponsor: University of Nebraska
Active, not recruiting --> Completed Trial primary completion date: Aug 2017 --> Aug 2018
- ||| ledipasvir/sofosbuvir / Generic mfg.
Trial completion: Use-Results Surveillance Study of Harvoni (clinicaltrials.gov) - Sep 18, 2017
P=N/A, N=3294, Completed, Sponsor: Gilead Sciences
Trial primary completion date: Aug 2017 --> Aug 2018 Active, not recruiting --> Completed
- | ledipasvir/sofosbuvir / Generic mfg.
Journal: Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial. (Pubmed Central) - Sep 14, 2017
P4
Patients received treatment with ledipasvir-sofosbuvir, which was provided on site, according to U.S. Food and Drug Administration labeling requirements...Nurse practitioners and PCPs with compact didactic training could substantially expand the availability of community-based providers to escalate HCV therapy, bridging existing gaps in the continuum of care for patients with HCV infection. National Institutes of Health and Gilead Sciences.
- ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date: Study of Hepatitis C Treatment During Pregnancy (clinicaltrials.gov) - Sep 14, 2017
P1, N=15, Recruiting, Sponsor: University of Pittsburgh
National Institutes of Health and Gilead Sciences. Trial primary completion date: Sep 2018 --> Sep 2019
- | ledipasvir/sofosbuvir / Generic mfg.
New P4 trial: Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients. (clinicaltrials.gov) - Sep 12, 2017
P4, N=20, Recruiting, Sponsor: Kaiser Permanente
- | ledipasvir/sofosbuvir / Generic mfg.
Trial completion: HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection (clinicaltrials.gov) - Aug 28, 2017
P2, N=20, Completed, Sponsor: HepNet Study House, German Liverfoundation
Trial primary completion date: Sep 2018 --> Sep 2019 Active, not recruiting --> Completed
- | ledipasvir/sofosbuvir / Generic mfg.
New P2 trial: Antiviral Agent HARVONI (clinicaltrials.gov) - Aug 25, 2017
P2, N=21, Not yet recruiting, Sponsor: National Taiwan University Hospital
- | ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Journal: Optimal timing for hepatitis C therapy in US patients eligible for liver transplantation: a cost-effectiveness analysis. (Pubmed Central) - Aug 17, 2017
Treatment of HCV prior to liver transplantation appears to be the most cost-effective strategy for patients with a MELD score <25. For patients with a MELD ≥25 or decompensated cirrhosis, preemptive post-liver transplantation treatment before HCV recurrence is the most cost-effective strategy.
- | ledipasvir/sofosbuvir / Generic mfg.
Enrollment open: Harvoni Treatment Porphyria Cutanea Tarda (clinicaltrials.gov) - Aug 15, 2017
P2, N=49, Recruiting, Sponsor: Wake Forest University Health Sciences
For patients with a MELD ≥25 or decompensated cirrhosis, preemptive post-liver transplantation treatment before HCV recurrence is the most cost-effective strategy. Not yet recruiting --> Recruiting
- | ledipasvir/sofosbuvir / Generic mfg.
Enrollment change, Trial withdrawal: DAA in the Risk of Recurrence After Curative Treatment of HCC (clinicaltrials.gov) - Aug 7, 2017
P4, N=0, Withdrawn, Sponsor: Taipei Veterans General Hospital, Taiwan
Not yet recruiting --> Recruiting N=130 --> 0 | Not yet recruiting --> Withdrawn
- | Copegus (ribavirin) / Bausch Health, ledipasvir/sofosbuvir / Generic mfg.
Journal: Evaluation of Proton Pump Inhibitor Use on Treatment Outcomes with Ledipasvir and Sofosbuvir in a Real-World Cohort Study. (Pubmed Central) - Aug 3, 2017
These data from a cohort of real-world patients receiving hepatitis C antibody therapy with LDF/SOF ± RBV support the prescription labeling suggesting that patients take no more than low-dose (20-mg omeprazole equivalents) PPI daily. (Hepatology 2016;64:1893-1899).
- | daclatasvir/sofosbuvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Trial initiation date: The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia (clinicaltrials.gov) - Jul 12, 2017
P=N/A, N=50, Not yet recruiting, Sponsor: Assiut University
(Hepatology 2016;64:1893-1899). Initiation date: Jul 2017 --> Nov 2017
- | ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date: Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD) (clinicaltrials.gov) - Jul 12, 2017
P=N/A, N=24, Recruiting, Sponsor: Massachusetts General Hospital
Initiation date: Jul 2017 --> Nov 2017 Trial primary completion date: Apr 2017 --> Dec 2017
- | ledipasvir/sofosbuvir / Generic mfg.
Enrollment change: Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia (clinicaltrials.gov) - Jul 12, 2017
P4, N=600, Active, not recruiting, Sponsor: National Institutes of Health Clinical Center (CC)
Trial primary completion date: Apr 2017 --> Dec 2017 N=1000 --> 600
- | Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) / AbbVie, Enanta Pharma, Exviera (dasabuvir) / AbbVie
Trial primary completion date: DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) (clinicaltrials.gov) - Jul 6, 2017
P2/3, N=32, Recruiting, Sponsor: Humanity & Healthy GI and Liver Centre
N=1000 --> 600 Trial primary completion date: Jun 2017 --> Dec 2017