- |||||||||| Mycobutin (rifabutin) / Pfizer, Lupin
Successful, Concurrent Treatment of a Patient with Pulmonary Tuberculosis and Hepatitis C Infection Using Therapeutic Drug Monitoring (Room 207-208 (South Building, Level 2), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_5360; have developed a method to measure the DAA levels of ledipasvir and sofosbuvir (LDV/SOF) in blood...Sputum samples were smear positive for acid fast bacilli (AFB) and culture positive for Mycobacterium Tuberculosis (MTB) with a positive MTB polymerase chain reaction and no mutations for isoniazid or rifampin resistance on molecular analysis...This case illustrates the successful, simultaneous use of LDV/SOF and rifabutin in HCV/TB coinfection with significant public health implications. More robust research will determine if this treatment method is generalizable.
- |||||||||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie
TREATMENT WITH SOF/VEL/VOX IN HIV/HCV-COINFECTED PATIENTS PREVIOUSLY EXPOSED TO DAAs ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_1126; Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) is a pan-genotypic direct active antiviral (DAA) regimen approved for patients who have previously failed anti-HCV treatment with other DAAs...The type of previous regimens included sofosbuvir/ledipasvir in 50% patients, ombitasvir/paritaprevir/ritonavir plus dasabuvir in 9.4%, sofosbuvir plus daclatasvir in 9.4%, elbasvir/grazoprevir in 9.4%, glecaprevir/pibrentasvir in 9.4% and 13.4% other regimens...Liver cirrhosis and genotype did not influence treatment response (SVR by ITT 90% for cirrhosis and 85.8% for G3). Our findings suggest that SOF/VEL/VOX is a highly effective regimen for treatment of coinfected patients previously failing to DAA regimens, across all genotypes and in the presence of cirrhosis.
- |||||||||| Humalog pen (insulin lispro) / Eli Lilly, NovoLog (insulin aspart) / Novo Nordisk
Clinical, Reimbursement, Journal, Medicare: Patient and Payer Incentives to Use Patented Brand-Name Drugs vs Authorized Generic Drugs in Medicare Part D. (Pubmed Central) - Jan 20, 2022 The results of this cross-sectional study suggest that authorized generic drugs for insulin and direct-acting antiviral agents may lower out-of-pocket spending for patients but are unlikely to provide savings for Part D plans or Medicare. Instead, these drugs allow manufacturers to offer products at a lower list price without materially lowering net prices or profits.
- |||||||||| ledipasvir/sofosbuvir / Generic mfg.
Clinical, Journal: Responsible Inclusion of Pregnant Individuals in Eradicating Hepatitis C Virus. (Pubmed Central) - Jan 13, 2022 Our systematic review of publications on HCV treatment with DAAs in pregnancy revealed only one interventional study, which evaluated sofosbuvir/ledipasvir in 8 pregnant individuals...The exclusion of pregnant individuals without justification denies them and their offspring access to potential health benefits, raising justice concerns considering growing data on DAA safety and global efforts to promote equitable and comprehensive HCV eradication. Finally, we propose a path forward for research and treatment programs during pregnancy to help advance the goal of HCV elimination.
- |||||||||| ledipasvir/sofosbuvir / Generic mfg.
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea (clinicaltrials.gov) - Nov 29, 2021 P=N/A, N=1081, Completed, It could be an excellent strategy to eliminate HCV infection in HIV-coinfected MSM. Recruiting --> Completed | N=3000 --> 1081 | Trial completion date: Jan 2022 --> Jun 2021 | Trial primary completion date: Jan 2022 --> Jun 2021
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Clinical, Journal, HEOR: Cost-Effectiveness Analysis of Oral Direct-Acting Antivirals for Chinese Patients with Chronic Hepatitis C. (Pubmed Central) - Nov 24, 2021 Recruiting --> Completed | N=3000 --> 1081 | Trial completion date: Jan 2022 --> Jun 2021 | Trial primary completion date: Jan 2022 --> Jun 2021 Overall, SOF/VEL and LDV/SOF regimens are more likely to be cost-effective among various subgroups of Chinese patients with CHC.
- |||||||||| ledipasvir/sofosbuvir / Generic mfg.
Clinical, Journal: Ledipasvir/sofosbuvir-associated photosensitivity in a case with chronic hepatitis C. (Pubmed Central) - Nov 6, 2021 The most common adverse events associated with DAAs are fatigue and headache, but various abnormal cutaneous effects including photosensitivity have been reported, especially with the use of simeprevir/sofosbuvir. Here we present a case developing photosensitivity due to ledipasvir/sofosbuvir during the treatment of chronic hepatitis C.
- |||||||||| Arbidol (umifenovir) / Pharmstandard, Prezcobix (darunavir/cobicistat) / Gilead, J&J, Xofluza (baloxavir marboxil) / Roche, Shionogi
Clinical, Review, Journal: Clinical efficacy of antiviral agents against coronavirus disease 2019: A systematic review of randomized controlled trials. (Pubmed Central) - Nov 4, 2021 Further larger RCTs in other countries are warranted to support these findings. In contrast, the present findings of limited RCTs did not indicate the use of lopinavir/ritonavir, sofosbuvir/ledipasvir, baloxavir, umifenovir, and darunavir/cobicistat in the treatment of patients hospitalized for COVID-19.
- |||||||||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead
Trial completion date, Trial primary completion date: A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection (clinicaltrials.gov) - Nov 3, 2021 P=N/A, N=1609, Active, not recruiting, In contrast, the present findings of limited RCTs did not indicate the use of lopinavir/ritonavir, sofosbuvir/ledipasvir, baloxavir, umifenovir, and darunavir/cobicistat in the treatment of patients hospitalized for COVID-19. Trial completion date: Jan 2023 --> Dec 2021 | Trial primary completion date: Jan 2023 --> Dec 2021
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
[VIRTUAL] REAL-WORLD EFFECTIVENESS AND SAFETY OF INTERFERON-FREE DAAS FOR 14,676 HEPATITIS C (CHC) PATIENTS WITH GENOTYPES 1, 2, 3, 4 AND 6: A MULTINATIONAL STUDY () - Oct 21, 2021 - Abstract #AASLD2021AASLD_1179; In this diverse multinational real-world cohort of patients with genotypes 1, 2, 3, 4 and 6, the overall cure rate was 96.7%, despite large numbers of cirrhosis, HCC, prior treatment failure, GT3/6 and use of older DAA . SVR12 in GT3/6 patients with cirrhosis and TE was relatively lower but still excellent at about 90%.
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
[VIRTUAL] HEPATITIS C TREATMENT IN THE UNITED STATES, 2014–2020 () - Oct 21, 2021 - Abstract #AASLD2021AASLD_1158; This average number of persons living with hepatitis C treated is below the number needed to ensure elimination of hepatitis C as a public health threat in the United States by 2030. Public health interventions such as increased testing and improved linkage to care for groups experiencing disproportionate impact, and removal of restrictions to treatment are critical to improve access to treatment and eliminate hepatitis C as a public health threat in the United States .
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