Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 229

Posts Tagged ‘chronic hepatitis C’

Virologic Response in Patients with Chronic Hepatitis C

Posted by fidest press agency su domenica, 22 ottobre 2017

historyMerck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced the presentation of findings from a retrospective database analysis of patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or 4 infection who have chronic kidney disease (CKD) and were treated with ZEPATIER® (elbasvir and grazoprevir) in the U.S. Department of Veterans Affairs (VA) healthcare system. Among patients who completed therapy, the analysis showed 95.6 percent (714/747) of patients with severe CKD (stages 4-5, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2) and 97.1 percent (758/781) of patients with moderate CKD (stage 3, defined as eGFR 30-59 mL/min/1.73 m2) achieved sustained virologic response (SVR), defined as HCV RNA below the limit of quantification at least 10-12 weeks after the end of treatment. For patients with missing HCV RNA data after at least 10-12 weeks after treatment completion, analyses were conducted on a post-hoc basis using the last HCV RNA data available after week 4 after therapy completion. The response rates in the real-world setting of the VA further supplement findings from controlled clinical studies of ZEPATIER. These findings will be presented today at The Liver Meeting® 2017 taking place in Washington, D.C.
In the United States, ZEPATIER is indicated for the treatment of chronic HCV GT1 or GT4 infection in adults. ZEPATIER is indicated for use with ribavirin (RBV) in certain patient populations. The U.S. Prescribing Information for ZEPATIER includes a Boxed Warning about the risk of hepatitis B virus (HBV) reactivation in patients co-infected with HCV and HBV. In controlled clinical studies of ZEPATIER, SVR was the primary endpoint defined as HCV RNA less than lower limit of quantification at 12 weeks after the cessation of treatment (SVR12).The retrospective observational analysis included 5,845 patients with chronic HCV infection who received ZEPATIER (elbasvir and grazoprevir) between February 1 and December 31, 2016. Patients were identified from the VA Corporate Data Warehouse, a national repository of VA electronic medical records. Presence of chronic kidney disease was measured via eGFR, per the National Kidney Foundation’s Modification of Diet in Renal Disease equation. Of 4,693 patients evaluated in the per protocol population, 16.6 percent (781/4693) had CKD stage 3 and 15.9 percent (747/4693) had CKD stages 4 or 5. Please see additional information below about the design, methodology and limitations of this observational analysis.
Most patients with chronic kidney disease in the analysis were male (96.9%, 1481/1528); African American (67.5%, 1031/1528) and either had GT1a infection (52.2%, 798/1528) or GT1b infection (42.1%, 644/1528). The mean age for patients in the study with chronic kidney disease was 64.9 years. Comorbid conditions as defined by ICD-9/10 codes in the VA database included depression (58.5%, 894/1528), diabetes (69.2%, 1057/1528), compensated cirrhosis (18.6%, 284/1528), and HIV (5.0%, 76/1528). In the study, 19.9 percent of patients (304/1528) were coded as having decompensated cirrhosis; ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). See Selected Safety Information below for more information. (photo: MERCK)

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The European Commission has granted marketing authorization for Vosevi® for the treatment chronic hepatitis C

Posted by fidest press agency su giovedì, 7 settembre 2017

voseviFOSTER CITY, Calif.–BUSINESS WIRE–Gilead Sciences, Inc. (NASDAQ:GILD) announced that the European Commission has granted marketing authorization for Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a once-daily single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.Vosevi was authorized as a 12-week treatment regimen for patients with any genotype of chronic HCV infection, without cirrhosis or with compensated cirrhosis, who have previously failed therapy with a direct-acting antiviral (DAA)-containing regimen. A 12-week regimen was also authorized for use in DAA-naïve patients with compensated cirrhosis infected with any HCV genotype, with an option to shorten therapy to 8 weeks for those infected with genotype 3. For DAA-naïve patients without cirrhosis, the recommended treatment duration is 8 weeks.
Gilead also announced an extension of the marketing authorization for Harvoni® (ledipasvir 90mg/sofosbuvir 400mg). Previously authorized for the treatment of adults with chronic HCV genotype 1, 3, 4, 5 or 6 infection, the indication for Harvoni has been extended to include the treatment of chronic HCV genotype 1, 3, 4, 5 and 6 infection in adolescents aged 12 to < 18 years. Harvoni is the first direct-acting antiviral regimen to receive marketing authorization in the European Union extended for use in the adolescent population.
The approval of Vosevi is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4) evaluated 12 weeks of the single tablet regimen in patients with hepatitis C genotypes 1-6 previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of Vosevi in DAA-naïve patients with european commissionhepatitis C genotypes 1-6. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with Vosevi (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with hepatitis C genotypes 1-6 with and without cirrhosis treated with Vosevi (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and compensated cirrhosis treated with Vosevi (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse drug reactions among patients who received Vosevi in the POLARIS studies were headache, diarrhea and nausea.
Vosevi was approved by the U.S. Food and Drug Administration on July 18, 2017 for the re-treatment of adults with genotype 1-6 chronic HCV infection.
Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. rifampicin, rifabutin, St. John’s wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin) are contraindicated. Co-administration with strong OATP1B inhibitors (e.g. ciclosporin), rosuvastatin, dabigatran etexilate and ethinylestradiol-containing medicinal products is also contraindicated.Patients co-infected with hepatitis C and hepatitis B are at risk of hepatitis B virus reactivation and should therefore be monitored and managed according to current clinical guidelines. Caution and frequent renal monitoring is recommended for co-administration with certain HIV antiretroviral treatments (e.g. tenofovir disoproxil fumarate- and efavirenz-containing regimens). Safety has not been established in patients with severe renal impairment (glomerular filtration rate <30ml/min).
Full European Summary of Product Characteristics for Vosevi, Sovaldi, Harvoni and Epclusa are available from the EMA website at http://www.ema.europa.eu. (photo: vosevi)

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