- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Concomitant use of PPI and SOF/VEL: Evidence from Clinical trials and Real-World data (New Hall) - Jan 6, 2024 - Abstract #APASL2024APASL_718;
In RCTs and RWD, the single-tablet regimen of SOF/VEL for 12 weeks was effective in patients with concomitant PPI use. These data support the use of SOF/VEL according to labeled recommendations with respect to co-administration of PPIs and other acid reducing agents.
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Evaluating utilization and management of comedications for DDIs among HCV patients initiating DAAs (New Hall) - Jan 6, 2024 - Abstract #APASL2024APASL_717;
Background and Aims: This analysis compared rates and management of comedications with drug-drug interactions (DDI) risk among patients initiating direct-acting antiviral (DAA) treatment with sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB) for chronic hepatitis C (HCV). Use of DDI comedications was identified among a substantial proportion of patients, with higher rates in GLE/PIB initiators.
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Eradication of Hepatitis C virus from interferon to DAA in jailed prisoners. (New Hall) - Jan 6, 2024 - Abstract #APASL2024APASL_638;
One mortality is decompensated hepatitis and it was not reverse after DAA treatment. The SVR of DAA treatment is extremely excellent as 100% in the coinfection with HBV/HIV.
- |||||||||| ribavirin / Generic mfg., sofosbuvir/velpatasvir / Generic mfg.
Simplify CHC Treatment: SOF-based treatment regimens in CHC patients with untested genotypes (New Hall) - Jan 6, 2024 - Abstract #APASL2024APASL_582;
A simplified treatment without genotype testing and optimized follow-up is simple and feasible in the management of patients with chronic hepatitis C. It reduces the economic burden on patients, and SOF-based regimens can achieve high SVR12. 479
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Sofosbuvir/Viplatasvir/Vosigrivir Retreatment of Hepatitis C Failed a NS5A-containing DAAs Regimen (New Hall) - Jan 6, 2024 - Abstract #APASL2024APASL_561;
The two cases we reported showed the use of Sofosbuvir/Viplatasvir/Vosigrivir combined with or without ribavirin therapy for patients who failed DAA treatment with NS5A inhibitors is effective and well tolerated. This group of cases represents an effective re-treatment program with good curative effects and few side effects.
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie
High efficacy of interferon-free therapy for acute hepatitis C in China (New Hall) - Jan 6, 2024 - Abstract #APASL2024APASL_516;
According to patients' characteristics, 76 patients started treatment in the first four weeks (76/129, 58.91%), 27 patients started treatment between four and eight weeks (27/129, 20.93%), and 26 patients started treatment between eight and thirty-six weeks (26/129, 20.15%); following 15%, the following DAA regimens were prescribed: daclatasvir/yasunaprevir (6.2%; 8/129), sofosbuvir/radipavir (3.1%; 4/129), ombitasvir/paritaprevir/ritonavir (16.2%; 21/129), grazoprevir/elbasvir (59.6%; 77/129) and sofosbuvir/velpatasvir (14.7%; 19/129). Interferon-free DAA regimens can achieve 100% SVR12 in AHC patients with a favorable safety profile if treatment durations similar to CHC are used.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Trial completion date, Trial primary completion date: Expanding the Pool in Orthotopic Heart Transplantation (clinicaltrials.gov) - Jan 4, 2024
P2, N=20, Active, not recruiting,
Interferon-free DAA regimens can achieve 100% SVR12 in AHC patients with a favorable safety profile if treatment durations similar to CHC are used. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Journal: Ulcerative colitis coexisting with hepatitis C: A rare occurrence. (Pubmed Central) - Dec 24, 2023
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 This case underscores the need for nuanced treatment in managing concurrent UC and HCV, considering potential drug interactions and disease impacts.
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Journal: Patients with Hepatitis C Undergoing Direct-Acting Antiviral Treatment Have a Lower SARS-CoV-2 Infection Rate. (Pubmed Central) - Dec 23, 2023
It revealed that patients diagnosed with COVID-19 during DAA treatment experienced only mild symptoms, and none died, suggesting a potential protective effect of DAA treatment against severe outcomes of SARS-CoV-2 infection. The findings contribute to the understanding of the interplay between HCV, DAA treatment, and SARS-CoV-2 infection, highlighting the need for continued monitoring and healthcare measures for individuals with chronic conditions during the ongoing COVID-19 pandemic.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Trial completion date: Lung Transplant HCV, Pilot Study (clinicaltrials.gov) - Dec 6, 2023
P1, N=26, Active, not recruiting,
Active, not recruiting --> Completed Trial completion date: Apr 2023 --> Dec 2024
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Trial completion date, Trial primary completion date: The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients (clinicaltrials.gov) - Nov 18, 2023
P2, N=73, Active, not recruiting,
The prognosis of decompensated cirrhotic patients receiving DAA was stratified by liver function at 12 Trial completion date: May 2024 --> Mar 2025 | Trial primary completion date: May 2024 --> Mar 2025
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30% (clinicaltrials.gov) - Nov 13, 2023
P4, N=606, Completed,
Trial completion date: May 2024 --> Mar 2025 | Trial primary completion date: May 2024 --> Mar 2025 Not yet recruiting --> Completed | N=350 --> 606 | Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: Dec 2022 --> Aug 2023
- |||||||||| sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Journal, Real-world evidence, Real-world: Real-world value of direct-acting antivirals for hepatitis C at Kaiser Permanente Southern California. (Pubmed Central) - Oct 24, 2023
Further studies are warranted after the availability of other DAAs to confirm findings with no limitations. DAA treatment at KPSC is predicted to significantly reduce HCV-related morbidity and mortality, providing an anticipated return on investment in drug costs after 3 years of treatment.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Journal, HEOR: Health-related quality of life in patients aged 6-18?years with chronic hepatitis C treated with sofosbuvir/velpatasvir. (Pubmed Central) - Sep 22, 2023
A significant proportion of children with chronic hepatitis C have decreased HRQL in all dimensions, but effective treatment with SOF/VEL leads to an improvement in some areas of well-being. As the effect of HCV on HRQL is more pronounced in older patients, treatment of younger children should be indicated to prevent them from experiencing decreased HRQL due to ongoing HCV infection in the future.
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Enrollment change: USE-Hep C: Utilization of Hepatitis C Positive Kidneys in Negative Recipients (clinicaltrials.gov) - Sep 13, 2023
P2/3, N=54, Completed,
As the effect of HCV on HRQL is more pronounced in older patients, treatment of younger children should be indicated to prevent them from experiencing decreased HRQL due to ongoing HCV infection in the future. N=30 --> 54
- |||||||||| Daklinza (daclatasvir) / BMS
Journal: Hepatitis C Retreatment With First-Line Direct Acting Antiviral Drugs. (Pubmed Central) - Sep 11, 2023
P=N/A
Sofosbuvir (S), daclatasvir (D), ledipasvir, or velpatasvir (V) containing first-line hepatitis C virus (HCV) treatment regimens fail to cure viremia in 5-10%...Two among three, in whom retreatment failed, achieved SVR12 following another course of sofosbuvir/velpatasvir/ribavirin for 24 weeks...HCV retreatment could be a treatment option if second-line anti-HCV drugs are not available. Successful retreatment could be achieved, in a large proportion, with the use of first-line drugs for 24 weeks with ribavirin
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Trial completion date, Trial primary completion date: Expanding the Pool in Orthotopic Heart Transplantation (clinicaltrials.gov) - Sep 11, 2023
P2, N=20, Active, not recruiting,
Successful retreatment could be achieved, in a large proportion, with the use of first-line drugs for 24 weeks with ribavirin Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Enrollment status, Trial completion date, Trial primary completion date: Therapy for Hepatitis C Virus (HCV) in Primary Treatment Failure in Pakistan (clinicaltrials.gov) - Sep 7, 2023
P=N/A, N=318, Enrolling by invitation,
Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023 Recruiting --> Enrolling by invitation | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Sep 2024
- |||||||||| Daklinza (daclatasvir) / BMS
Journal: Efficacy and Safety of Directly Acting Antivirals in Patients with Hepatitis C Infection on Hemodialysis. (Pubmed Central) - Aug 31, 2023
Recruiting --> Enrolling by invitation | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Sep 2024 Sofosbuvir combination therapy offers an excellent response in dialysis patients irrespective of the genotype and presence of cirrhosis with minimal monitoring as in non-chronic kidney disease (CKD) patients.
- |||||||||| Avastin (bevacizumab) / Roche, Tecentriq (atezolizumab) / Roche
Journal: Unusual Initial Presentation of Hepatocellular Carcinoma as a Clavicular Head Mass. (Pubmed Central) - Aug 28, 2023
Sofosbuvir combination therapy offers an excellent response in dialysis patients irrespective of the genotype and presence of cirrhosis with minimal monitoring as in non-chronic kidney disease (CKD) patients. This case demonstrates a very unusual HCC presentation, the importance of a thorough workup of bone metastasis, and the limited value of AFP for HCC screening, even in disseminated disease.
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Review, Journal: Direct-Acting Antiviral Therapy for Treatment of Acute and Recent Hepatitis C Virus Infection: A Narrative Review. (Pubmed Central) - Aug 18, 2023
Several DAA regimens, including the contemporary pan-genotypic combinations of sofosbuvir-velpatasvir and glecaprevir-pibrentasvir, have been shown to be safe and effective among people with acute and recent HCV infection, highlighting their potential in an HCV controlled human infection model. This article describes the natural history and management of acute and recent HCV infection in the era of DAA therapy and outlines a strategy for use of DAA therapies in the setting of an HCV controlled human infection model.
- |||||||||| ceftriaxone / Generic mfg., sofosbuvir/velpatasvir / Generic mfg., midodrine hydrochloride / Generic mfg.
Cryoglobulinemia-Induced Kidney Injury Secondary to Refractory Hepatitis C (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_1619;
She undergoes recurrent paracenteses with negative cultures however cell counts are concerning for spontaneous bacterial peritonitis (SBP) so she is started on ceftriaxone and switched to prophylaxis...Course complicated by acute kidney injury initially thought to be hepatorenal syndrome so she is started on albumin, midodrine and octreotide...Dialysis can clear these compounds so they should be administered post dialysis. Despite HCV viral clearance aiming to improve renal involvement, unfortunately this may not lead to clinical remission.
- |||||||||| Polyarteritis Nodosa Associated with Hepatitis C Infection (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_1524;
Cyclophosphamide and prednisone were started for PAN...Silver-stained section shows necrotizing inflammation of medium-sized artery and its tributary with complete lumen obliteration and focal transmural inflammation. Several arterial cross sections were similarly involved.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Review, Journal: Seroprevalence and Genotype Diversity of Hepatitis C Virus in the Caribbean-A Review. (Pubmed Central) - Jul 28, 2023
While trends point to a potentially higher prevalence of HCV, it will require well-designed random surveys to obtain better estimates of the infection seroprevalence, supported by strong public health laboratory systems. DAAs that are pan-genotypic should translate into treatments that are affordable, accessible, and available to improve cure rates and reduce the HCV burden in the population.
- |||||||||| Enrollment closed, Enrollment change, Trial completion date: KeY Treat: The Kentucky Viral Hepatitis Treatment Study (clinicaltrials.gov) - Jul 20, 2023
P4, N=374, Active, not recruiting,
DAAs that are pan-genotypic should translate into treatments that are affordable, accessible, and available to improve cure rates and reduce the HCV burden in the population. Recruiting --> Active, not recruiting | N=900 --> 374 | Trial completion date: Aug 2024 --> Dec 2024
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD)
Journal: The SHELTER Trial of Transplanting Hepatitis C Virus-Infected Lungs Into Uninfected Recipients. (Pubmed Central) - Jun 30, 2023
P1/2
We detected no clinically important differences in forced expiratory volume in 1?s between the HCV-RNA lung recipients versus matched comparators. SHELTER adds important evidence regarding the safety of transplanting HCV-RNA lungs into uninfected recipients and suggests QOL benefits.
- |||||||||| NATDAC (daclatasvir) / NATCO, Hetero
Journal: Impact of oral antiviral therapy against HCV on gut microbiota. A prospective study. (Pubmed Central) - Jun 2, 2023
All were treated with DAAs for 12 weeks (5 with Paritaprevir-Ombitasvir-Ritonavir-Dasabuvir, 3 with Sofosbuvir-Ledipasvir, 1 with Sofosbuvir-Ribavirin, 1 with Sofosbuvir-Daclatasvir, 1 with Sofosbuvir-Velpatasvir) and 100% achieved SVR12...Our study shows that viral eradication obtained with DAA is associated with a trend in restoring the heterogeneity of ?-diversity and in reducing the percentage of potentially pathogenic microbial species, although this benefit is less evident in patients with cirrhosis. Further studies with larger sample size are needed to confirm these data.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Journal, Head-to-Head: Eight versus twelve weeks of sofosbuvir-velpatasvir in treatment-na (Pubmed Central) - May 22, 2023
The study will provide data on the efficacy of 8 weeks of treatment as compared to the standard of care (12 weeks) in non-cirrhotic patients with chronic HCV infection. Treatment for a shorter duration may improve treatment compliance, reduce the cost of treatment, and ease the treatment implementation from a public health perspective.
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