- |||||||||| 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., ledipasvir/sofosbuvir / Generic mfg.
Reimbursement, US reimbursement, Journal, Medicaid: Utilization, reimbursement, and price trends for Hepatitis C virus medications in the US Medicaid programs: 2001-2021. (Pubmed Central) - Dec 25, 2023
The introduction of multiple DAA agents slightly changed their prescription prices but remained high during the study period. The recent increase in HCV incidence cases indicates accessibility issues for costly and effective DAA agents, with treatment guidelines and policies playing a critical role in shaping these trends.
- |||||||||| ledipasvir/sofosbuvir / Generic mfg.
PK/PD data, Journal: Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancies: A Pharmacokinetic Study. (Pubmed Central) - Nov 5, 2023
P1/2
The similarity in the drug exposure, efficacy, and safety clinical end points between patients with and without hematological malignancy support their therapeutic equivalence. Further studies with a larger sample size may be required to confirm the safety of LDV/SOF in patients with ALL and to recommend appropriate dosing in children with hematological malignancies, if needed.
- |||||||||| 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
Elimination of mother-to-child transmission is urgently needed, and this study has shown that treatment of HCV during pregnancy may be a pragmatic approach for the greater benefit of both mother and the newborn. 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.
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Journal, Adverse events: Reported adverse events related to use of hepatitis C virus direct-acting antivirals with opioids: 2017-2021. (Pubmed Central) - Oct 1, 2023
Low numbers of DAA AE reports with opioids may provide reassurance to prioritize HCV treatment in this population. These data contribute to evidence supporting the continued scale-up of DAA treatment among people who use drugs to achieve HCV elimination goals.
- |||||||||| 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.
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD)
Hepatectomy In A Patient With Hepatocellular Carcinoma (South: Hall D-7) - Jul 20, 2023 - Abstract #ASA2023ASA_2506;
He has history of hepatitis C virus with sustained virologic response (SVR) after a course of treatment with ledipasvir/sofosbuvir, and hepatocellular carcinoma that recurred despite treatment with transarterial chemoembolization (TACE)...What is elbasvir/grazoprevir?...The nurse inquires if you need blood products for this case.7) What is your vascular access of choice?8) Will you place an arterial line?9) Will you place a central venous catheter?10) Do you need to measure central venous pressure (CVP) during the procedure?11) Does the position of the tumor alter your anesthetic plan?12) Do you need blood products for this case?You place an 18-gauge IV in the holding area and sedate the patient with 2 mg of midazolam...You perform a spinal anesthetic with 250 micrograms of preservative free morphine then perform a smooth induction of anesthesia with propofol, lidocaine, fentanyl and rocuronium. You then place an arterial line, a 16 Ga IV, and initiate maintenance of anesthesia with isoflurane.13) Will you maintain the patient with crystalloid or colloid?14) How will you manage intraoperative fluid administration?15) Should you utilize cell salvage?After nearly 2 hours of dissection, the patient
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD)
Hepatectomy In A Patient With Hepatocellular Carcinoma (South: Hall D-7) - Jul 20, 2023 - Abstract #ASA2023ASA_1348;
He has history of hepatitis C virus with sustained virologic response (SVR) after a course of treatment with ledipasvir/sofosbuvir, and hepatocellular carcinoma that recurred despite treatment with transarterial chemoembolization (TACE)...What is elbasvir/grazoprevir?...The nurse inquires if you need blood products for this case.7) What is your vascular access of choice?8) Will you place an arterial line?9) Will you place a central venous catheter?10) Do you need to measure central venous pressure (CVP) during the procedure?11) Does the position of the tumor alter your anesthetic plan?12) Do you need blood products for this case?You place an 18-gauge IV in the holding area and sedate the patient with 2 mg of midazolam...You perform a spinal anesthetic with 250 micrograms of preservative free morphine then perform a smooth induction of anesthesia with propofol, lidocaine, fentanyl and rocuronium. You then place an arterial line, a 16 Ga IV, and initiate maintenance of anesthesia with isoflurane.13) Will you maintain the patient with crystalloid or colloid?14) How will you manage intraoperative fluid administration?15) Should you utilize cell salvage?After nearly 2 hours of dissection, the patient
- |||||||||| Mycobutin (rifabutin) / Pfizer, Lupin
Journal: Concomitant Treatment of Tuberculosis and Hepatitis C Virus in Coinfected Patients Using Serum Drug Concentration Monitoring. (Pubmed Central) - Jun 29, 2023
Development of an assay for ledipasvir and sofosbuvir (LDV/SOF) serum concentrations for therapeutic drug monitoring (TDM) can ensure adequate therapy...Therapeutic drug monitoring was performed for LDV, SOF, and rifabutin during therapy...Utilizing serum drug concentration monitoring to guide dosing, correction of transaminitis were achieved, which allowed the use rifamycin-containing TB therapy. These findings suggest that concomitant therapy of TB/HCV is possible, safe, and effective.
- |||||||||| 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.
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Trial completion, Trial completion date, Trial primary completion date: CHROME: Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication (clinicaltrials.gov) - May 22, 2023
P4, N=87, Completed,
The study findings call for further population-based studies for clinical validation. Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Dec 2022 | Trial primary completion date: Jul 2023 --> Dec 2022
- |||||||||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Daklinza (daclatasvir) / BMS, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Retreatment of patients experiencing failure with Hepatitis C direct-acting antivirals (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_814;
Three class DAA regimens are a highly effective retreatment for HCV even in the presence of multiple NS5A and NS3 mutations. Figure: First line treatment Genotype RAS conferring reduced susceptibility Cirrhosis Re-treatment Outcome NS5A: Q30R (2) No (2) NS5A: Q30R; NS5B: D186V (1) Yes (1) SOF/VEL/VOX/RBV x 12/52 (3) SVR (3)1a (4) NS5A: Y93C (1) Pending (1) N/A PrOD/RBV x 8-12/52 (5) 1b (1) NS5A: Y93H (1) No (2) SOF/VEL/VOX x 12/52 (1) SVR (1) 1a (1) NS5A: Y93H/N, Q30E, M28V; NS3: Q80K (1) SOF/VEL/VOX/RBV x 12/52 (1) NS5A: A30K (1) NS5A: Y93H (1) SOF/VEL/VOX x 12/52 (2) SOF/DAC x 12-24/52 (4) 3 (3) NS5A: Y93H (1) No (4) SOF/VEL/VOX/RBV x 12/52 (1) SVR (4) NS5A: Q30R, K24N, M208T (1) G/P x 12/52 (1) Relapse (1) NS5A: Q30K (1) SOF/VEL/VOX x 12/52 (1) NS5A: L31V, H58D, Y93C/W (1) No (3) SOF/G/P x 16/52 (1) NS3: Q80K (1) SOF/DAC/RBV x 24/52 (1) SVR (3) NS5A: Y93C; NS3: Q80K (1) SOF/VEL x 24/52 (1) Relapse (1) Nil resistance (1) RIP (1) N/A 1a (7) Not tested (1) Yes (4) Transplant + SOF/VEL/RBV x 24/52 (1) 1b (1) NS5A: Y93H, P58A; NS3: Y56F (1) No (1) SOF/VEL/VOX x 12/52 (1) SOF/DAC x 24/52 (1)3 (2) Not tested (2) Yes (2) SOF/DAC/RBV x 24/52 (1) SOF/LDV +/- RBV x 8-12/52 (11) 4R (1) NS5B: S282C/S/T (1) No (1) SOF/G/P x 16/52 (1) SVR (5) NS5A: Y93H; NS3: Q80K (1) Yes (1) SOF/G/P x 12 weeks (1) SVR (1) NS5A: K24R; NS3: Q80K (1) No (1) SOF/VEL/VOX x 12/52 (1) SOF/VEL +/- RBV x 12/52 (3) 1a (3) Nil resistance (1) Yes (1) SOF/VEL/VOX/RBV x 12/52 (1) Relapse (2) 1a (1) NS3: Q80K (1) Yes (1) SOF/G/P x 12/52 (1) SVR (1)G/P x 8/52 (2) 3 (1) NS5A: Y93H (1) No (1) SOF/VEL/VOX x 12/52 (1) Relapse (1) DAC = daclatasvir; G/P = glecaprevir/pibrentasvir; PrOD = paritaprevir/ritonavir/ombitasvir/dasabuvir; RBV = ribavirin; SOF = sofosbuvir; SVR = sustained virological response; VEL = velpatasvir; VOX = voxilaprevir
- |||||||||| Mycobutin (rifabutin) / Pfizer, Lupin
Successful Treatment of Both Tuberculosis and Hepatitis C Virus Co-infected Patients With the Utilization of Therapeutic Drug Monitoring (Walter E. Washington Convention Center, Area I, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_5379;
have developed an assay for ledipasvir and sofosbuvir (LDV/SOF) plasma concentrations...All 5 patients received concomitant TB and HCV therapy with rifabutin along with LDV/SOF...Further, it may improve liver function and reduce overall incidence of DILI and duration of therapy in co-infected individuals. Larger scale research will determine if this treatment method is generalizable.
- |||||||||| ledipasvir/sofosbuvir / Generic mfg.
Enrollment open, Trial completion date, Trial primary completion date: PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders (clinicaltrials.gov) - Mar 6, 2023
P3, N=24, Recruiting,
The increase in HCV incidence cases in recent years indicates accessibility issues for costly and effective DAAs medications. Unknown status --> Recruiting | Trial completion date: Dec 2020 --> Dec 2023 | Trial primary completion date: Apr 2020 --> Apr 2023
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Journal: Hepatitis C micro-elimination through the retrieval strategy of patients lost to follow-up. (Pubmed Central) - Feb 15, 2023
Ledipasvir/sofosbuvir [and likely other direct-acting antivirals] is an effective treatment for HCV in the presence of PCT and leads to clinical remission of PCT without additional phlebotomy or low-dose hydroxychloroquine treatment. Call back system can expand our reach to those unaware or ignoring chronic HCV infection patients and link them to treatment.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Sofosbuvir-based Regimen Achieved High Sustained Virological Response in Treatment Na (2nd floor Poster Area - 244) - Feb 15, 2023 - Abstract #APASL2023APASL_870;
This real-world study showed that SOF-based regimens were well-tolerated with a cure rate (at SVR12) of 100%, in treatment-naive adolescent patients with chronic HCV infection with diverse genotypes especially GT1b or GT3b in China. 842
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Trial completion date, Trial primary completion date: CHROME: Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication (clinicaltrials.gov) - Feb 3, 2023
P4, N=90, Active, not recruiting,
835 Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jul 2023
- |||||||||| Praluent (alirocumab) / Sanofi, Regeneron, velpatasvir (GS-5816) / Gilead, Repatha (evolocumab) / Amgen, Astellas
Journal, Adherence: Impact of list price changes on out-of-pocket costs and adherence in four high-rebate specialty drugs. (Pubmed Central) - Jan 20, 2023
Reducing list prices to approximate net prices (as a proxy for reducing rebates) resulted in lower patient OOP costs, particularly for those with coinsurance. Our findings suggest that future reduction of rebates may assist in patient affordability, although additional transparency is needed.
- |||||||||| ledipasvir/sofosbuvir / Generic mfg.
Review, Journal: Evidence for Implementation: HIV/HCV Coinfection and Pregnancy. (Pubmed Central) - Jan 19, 2023
A recent phase I study has shown promise with excellent safety profile for ledipasvir-sofosbuvir; demonstrating no episodes of perinatal transmission, 100% sustained virologic response, and no safety concerns...Phase 1 studies suggest that DAAs are well-tolerated and effective during pregnancy. Only through large, prospective clinical trials will we be able to understand the interaction of HCV and HIV during pregnancy and to evaluate safety and efficacy of DAAs in this key population.
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Enrollment closed: CHROME: Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication (clinicaltrials.gov) - Dec 19, 2022
P4, N=90, Active, not recruiting,
Only through large, prospective clinical trials will we be able to understand the interaction of HCV and HIV during pregnancy and to evaluate safety and efficacy of DAAs in this key population. Recruiting --> Active, not recruiting
- |||||||||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead
Retreatment of Chronic Hepatitis Infection: RealWorld Regiments and Outcomes from National Treatment Programs in Three Low- And MiddleIncome Countries (2F Room 201ABC) - Dec 18, 2022 - Abstract #APASL2023APASL_101;
Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) is the only evidence-based retreatment option in resource-limited settings recommended by WHO, based on trials showing 96-98% sustained virologic response at 12 weeks (SVR12, i.e., cure) in patients previously treated with another DAA-based regimen...Of the 1,462 patients retreated for HCV infection, the most common second-line therapy regimens and treatment durations were SOF/LDV+RBV for 24 weeks (31.8%), SOF/DCV+RBV for 24 weeks (30.7%), and SOF/VEL+RBV for 24 weeks (14.0%)...Overall, about 94% of the 1,070 retreated patients who received SVR12 testing (81.5% of 1,313) were cured, with all regimens achieving greater than 91% of patients cured. This retrospective analysis revealed that despite the lack of WHO-recommended regimens for HCV second-line therapy in three LMICs, alternative therapeutic regimens are being used by clinicians and resulted in high cure rates of HCV infection upon retreatment.
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