- |||||||||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead
Journal: Sofosbuvir/velpatasvir/voxilaprevir for hepatitis C virus retreatment in decompensated cirrhosis. (Pubmed Central) - Mar 4, 2022 Authors noted that use of treatment regimens including a protease inhibitor did not increase the risk of hepatic decompensation. We would like to present additional data, particularly regarding the use of sofosbuvir/velpatasvir/voxilaprevir as a salvage therapy in this difficult-to-cure patient population.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Journal: Sofosbuvir/velpatasvir for 12 vs. 6 weeks for the treatment of recently acquired hepatitis C infection. (Pubmed Central) - Feb 8, 2022 P3 While risk of incident ALT elevations was increased among PI-based DAA initiators in both FIB-4 groups, risk of severe hepatic dysfunction and hepatic decompensation did not differ between PI and non-PI-based DAA initiators in either FIB-4 group. In this randomised study in recent HCV infection, 6 weeks sofosbuvir-velpatasvir did not meet the criteria for non-inferiority to standard 12 weeks duration.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
A MODEL TO ERADICATE HCV IN UNDOCUMENTED MIGRANTS AND LOW-INCOME REFUGEES IN ITALY ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_1137; The HCV RNA-positive subjects have been treated with sofosbuvir-velpatasvir for 12 weeks and followed for 12 months from the end of therapy...No subject had adverse event. This model seems to be effective to eradicate HCV infection among a difficult-to-manage population, such as undocumented migrants and low-income refugees
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
ADHERENCE IN THE ACTG A5360 HCV MINIMAL MONITORING (MINMON) TRIAL ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_1127; ACTG A5360 (MINMON) was a single-arm, open-label, multinational trial to evaluate the safety and efficacy of 12 weeks of Sofosbuvir/Velpatasvir (SOF/VEL) with reduced in-person visits and laboratory monitoring...Programs seeking to scale up the minimal monitoring strategy may consider additional support for younger individuals or those reporting current or past substance use. Week 4 self-reported adherence may also help identifying those who may need additional support.
- |||||||||| 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.
- |||||||||| ribavirin / Generic mfg., sofosbuvir/velpatasvir / Generic mfg.
Clinical, Retrospective data, Review, Journal: Sofosbuvir-velpatasvir in Mexican patients with hepatitis C: A retrospective review. (Pubmed Central) - Feb 2, 2022 The active role of the clinical pharmacist in the hepatology clinic facilitated the patient's ongoing engagement in care, leading to treatment success. Treatments with SOF/VEL and SOF/VEL/RBV were highly safe and effective, results coinciding with those of other international real-world studies.
- |||||||||| 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.
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Journal: Hepatitis C: Diagnosis and Management. (Pubmed Central) - Dec 29, 2021 In patients with compensated cirrhosis, posttreatment surveillance for hepatocellular carcinoma and esophageal varices should include abdominal ultrasonography (with or without alpha fetoprotein) every six months and upper endoscopy every two to three years. In the absence of cirrhosis, no liver-related follow-up is recommended.
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Journal: Liver Disease: Hepatitis C. (Pubmed Central) - Dec 16, 2021 Management results in rates of virologic cure of greater than 95% across genotypes. Patients who do not achieve SVR at 12 weeks should be referred to a subspecialist experienced in management of treatment failure.
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Observational data, Retrospective data, Journal, Real-world evidence: Prevalence of drug-drug interactions with pangenotypic direct-acting antivirals for hepatitis C and real-world care management in the United States: a retrospective observational study. (Pubmed Central) - Nov 24, 2021 Afdhal is a paid consultant/advisory board member for Gilead, Echosens, Ligand, Shionogi, and Trio Health; owns stock in Spring-Bank and Allurion and has stock options in SpringBank; receives royalty income from UpToDate; and is on the board of directors for the nonprofit Liver Institute for Education and Research. Data from this study were presented at the American Association for the Study of Liver Disease (AASLD) Liver Meeting 2019; November 8-12, 2019; Boston, MA, and the European Association for Study of the Liver (EASL) International Liver Congress 2020; August 27-29, 2020; virtual.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Enrollment closed: Expanding the Pool in Orthotopic Heart Transplantation (clinicaltrials.gov) - Nov 22, 2021 P2, N=20, Active, not recruiting, Data from this study were presented at the American Association for the Study of Liver Disease (AASLD) Liver Meeting 2019; November 8-12, 2019; Boston, MA, and the European Association for Study of the Liver (EASL) International Liver Congress 2020; August 27-29, 2020; virtual. Recruiting --> Active, not recruiting
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Journal: Outcomes of Short-Duration Anti-Viral Prophylaxis for Hepatitis C Positive Donor Kidney Transplants. (Pubmed Central) - Nov 16, 2021 We previously reported HCV transmission of 13% among D+/R- transplants with 2- to 4-day pangenotypic sofosbuvir/velpatasvir (SOF/VEL) perioperative prophylaxis, where one patient with HCV transmission was a nonresponder to first-line full-course DAA...All patients with HCV transmission achieved sustained virologic response post-full course therapy (including one non-responder from initial trial). A 1:1 matched analysis (N=102) with contemporary HCV D-/R- transplants (controls) showed that although the pre-transplant wait time was significantly shorter for D+/R- compared with D-/R- (mean: 1.8 vs 4.4 years; p<0.001), there were no differences in infections, rejection, development of de-novo donor-specific antibody, or transplant outcomes up to 6 months of transplant.
- |||||||||| ribavirin / Generic mfg., sofosbuvir/velpatasvir / Generic mfg.
Clinical, Journal: Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis. (Pubmed Central) - Nov 5, 2021 Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate (eGFR) declines than patients with CKD stage 2 (-0.42 mL/min/1.73m2/month; p = 0.01) or stage 3 (-0.56 mL/min/1.73m2/month; p < 0.001). SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Journal: Estimating the net value of treating hepatitis C virus using sofosbuvir-velpatasvir in India. (Pubmed Central) - Nov 4, 2021 Expected net benefits of treatment are substantial for non-cirrhotic (NC) and compensated cirrhotic (CC) patients (ranging from 5,98,003 INR for NC women to 1,05,25,504 INR for CC men). Increased earnings are not sufficient to fully offset cost of treatment for decompensated cirrhotic individuals but treatment may still be justified on the basis of the intrinsic value of health improvements and other treatment benefits.
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