Extract from the Clinical Evaluation Report for Sofosbuvir
... The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical ...
... The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical ...
Extract from the Clinical Evaluation Report for Sofosbuvir
... (TPV) and boceprevir (BOC), were approved for treatment of CHC GT-1. The rationale was the improvement in SVR rates to 63% and 79% when these drugs were combined with PEG+RBV.14 These regimens also allow treatment options for patients previously failing to achieve SVRs, with SVR approximately 70-86% ...
... (TPV) and boceprevir (BOC), were approved for treatment of CHC GT-1. The rationale was the improvement in SVR rates to 63% and 79% when these drugs were combined with PEG+RBV.14 These regimens also allow treatment options for patients previously failing to achieve SVRs, with SVR approximately 70-86% ...
Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir
... NOTE: This submission was considered at the same time as the submission to register Viekira Pak RBV which contains applications for the Viekira Pak product presented as combination packs with different strengths of ribavirin (Submission number PM-201401438-1-2). The data in these submissions overlap ...
... NOTE: This submission was considered at the same time as the submission to register Viekira Pak RBV which contains applications for the Viekira Pak product presented as combination packs with different strengths of ribavirin (Submission number PM-201401438-1-2). The data in these submissions overlap ...
HIGHLIGHTS OF PRESCRIBING INFORMATION
... cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation. (5.1) • ALT Elevations: Discontinue ethinyl estradiol-containing medications prior to starting VIEKIRA PAK (alternative contraceptive methods are recommended). Perform hepatic laboratory testing on all patients during the ...
... cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation. (5.1) • ALT Elevations: Discontinue ethinyl estradiol-containing medications prior to starting VIEKIRA PAK (alternative contraceptive methods are recommended). Perform hepatic laboratory testing on all patients during the ...
Review Advances in nucleoside monophosphate prodrugs as anti
... which might not be present in the cell line used for antiviral activity evaluation [31]. The chemical stability of the prodrug in cell culture media, buffer and plasma will help eliminate prodrugs with no potential for oral delivery or with a short half-life (t1/2). The NTP is synthesized and tested ...
... which might not be present in the cell line used for antiviral activity evaluation [31]. The chemical stability of the prodrug in cell culture media, buffer and plasma will help eliminate prodrugs with no potential for oral delivery or with a short half-life (t1/2). The NTP is synthesized and tested ...
hepatitis A - Department of Health
... disease is common in children. Jaundice may occur in 70–80% of those infected as adults. Fulminant hepatitis can occur but is rare. The overall case– fatality ratio is low but is greater in older patients and those with pre-existing liver disease. There is no chronic carrier state and chronic liver ...
... disease is common in children. Jaundice may occur in 70–80% of those infected as adults. Fulminant hepatitis can occur but is rare. The overall case– fatality ratio is low but is greater in older patients and those with pre-existing liver disease. There is no chronic carrier state and chronic liver ...
November 2015 – Positive Recommendations (Word 80KB)
... DRUG, SPONSOR, TYPE OF SUBMISSION AMINO ACID FORMULA with VITAMINS and MINERALS without METHIONINE, THREONINE and VALINE and LOW IN ISOLEUCINE oral liquid: powder for, 30 x 18 g ...
... DRUG, SPONSOR, TYPE OF SUBMISSION AMINO ACID FORMULA with VITAMINS and MINERALS without METHIONINE, THREONINE and VALINE and LOW IN ISOLEUCINE oral liquid: powder for, 30 x 18 g ...
Review Nucleotide prodrugs for HCV therapy
... polymerase and an apparent lack of proof reading [4]. The current therapy for treating chronic HCV infection consists of regular injections of α-interferon (IFN) with daily oral administration of ribavirin (RBV). This standard of care (SOC) regimen does not act by directly attacking the virus but fu ...
... polymerase and an apparent lack of proof reading [4]. The current therapy for treating chronic HCV infection consists of regular injections of α-interferon (IFN) with daily oral administration of ribavirin (RBV). This standard of care (SOC) regimen does not act by directly attacking the virus but fu ...
02 C61(COOH)2 INTERACTING.indd
... which was given the name of buckyminsterfullerene (C60) (KROTO et al., 1985). Since then, the fullerenes have become a very active field of research with a variety of possible derivatives. Currently, the use of such nanosized functionalized or pristine systems, as chemical and biological sensors, ha ...
... which was given the name of buckyminsterfullerene (C60) (KROTO et al., 1985). Since then, the fullerenes have become a very active field of research with a variety of possible derivatives. Currently, the use of such nanosized functionalized or pristine systems, as chemical and biological sensors, ha ...
Word 81KB
... available to ensure patients receiving medicines on the PBS are being treated according to the best available evidence and that the cost of the treatment remains justified. This places the financial burden on the Commonwealth for the upfront risk associated with the uncertain clinical benefit of bli ...
... available to ensure patients receiving medicines on the PBS are being treated according to the best available evidence and that the cost of the treatment remains justified. This places the financial burden on the Commonwealth for the upfront risk associated with the uncertain clinical benefit of bli ...
Genvoya - Gilead
... Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir prodrugs in both animal toxicology studies and human trials. In clinical trials of GENVOYA, there have been no cases of Fanco ...
... Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir prodrugs in both animal toxicology studies and human trials. In clinical trials of GENVOYA, there have been no cases of Fanco ...
Prescribing Information
... Possible clinically significant adverse reactions from greater exposure of concomitant drugs or components of ZEPATIER. Significant decrease of elbasvir and grazoprevir plasma concentrations which may lead to reduced therapeutic effect of ZEPATIER and possible development of resistance. See Tabl ...
... Possible clinically significant adverse reactions from greater exposure of concomitant drugs or components of ZEPATIER. Significant decrease of elbasvir and grazoprevir plasma concentrations which may lead to reduced therapeutic effect of ZEPATIER and possible development of resistance. See Tabl ...
Acetaminophen and Your Liver
... • The maximum dose will be reduced from 8 pills (4,000 mg) to 6 pills (3,000 mg) per day • The dosing interval will be changed from every 4 to 6 hours to every 6 hours. ...
... • The maximum dose will be reduced from 8 pills (4,000 mg) to 6 pills (3,000 mg) per day • The dosing interval will be changed from every 4 to 6 hours to every 6 hours. ...
HCV 2014 a guide to understanding Hepatitis C
... many people, the treatment duration is much shorter than before. Now, we have interferon-free therapy for HCV genotypes 1, 2 and 3. Importantly, the side effects of the newer treatments will be much less than the side effects of interferon-based therapies. Today, medical providers are much more know ...
... many people, the treatment duration is much shorter than before. Now, we have interferon-free therapy for HCV genotypes 1, 2 and 3. Importantly, the side effects of the newer treatments will be much less than the side effects of interferon-based therapies. Today, medical providers are much more know ...
PegIntron - Merck.com
... Alpha interferons, including PegIntron, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or s ...
... Alpha interferons, including PegIntron, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or s ...
IRTRA® Combination Tablets LD/HD
... About trichlormethiazide Trichlormethiazide is a thiazidal antihypertensive diuretic originally created by the US based Schering-Plough Corp. (now Merck & Co., Inc.) and has been marketed for more than 50 years in Japan. It reduces the burden of heart by putting internal extra water outside a body a ...
... About trichlormethiazide Trichlormethiazide is a thiazidal antihypertensive diuretic originally created by the US based Schering-Plough Corp. (now Merck & Co., Inc.) and has been marketed for more than 50 years in Japan. It reduces the burden of heart by putting internal extra water outside a body a ...
hepb-epi-pathophysio
... Likelihood of cirrhosis / HCC in the next 10-20 yrs Likelihood of sustained viral suppression after a defined course of treatment ...
... Likelihood of cirrhosis / HCC in the next 10-20 yrs Likelihood of sustained viral suppression after a defined course of treatment ...
March 2015 - Positive Recommendations
... • that there is the high clinical need for all oral interferon-free treatments of CHC to be made available on the PBS, • that these treatments would be cost-effective at $15,000/QALY range and that there was no basis on which to recommend that any one treatment be more expensive than another, • ther ...
... • that there is the high clinical need for all oral interferon-free treatments of CHC to be made available on the PBS, • that these treatments would be cost-effective at $15,000/QALY range and that there was no basis on which to recommend that any one treatment be more expensive than another, • ther ...
Evidence-based consensus on the diagnosis, prevention and
... are still required. Results from their work have shown that from the last 10 years the prevalence of chronic HCV can be reduced up to more than 45% further needs antiviral treatment combined with the NSPs and OSTs that can reduce the rate of treatment to a large extent to get reduction in prevalence ...
... are still required. Results from their work have shown that from the last 10 years the prevalence of chronic HCV can be reduced up to more than 45% further needs antiviral treatment combined with the NSPs and OSTs that can reduce the rate of treatment to a large extent to get reduction in prevalence ...
55th Annual Meeting of the American Association for the Study of
... Hepatitis B and the Risk of Developing HCC It is known that patients with chronic hepatitis B who are hepatitis B e antigen (HBeAg)-positive are at greatest risk for both the progression of liver disease and the development of HCC.[3] What this implies, but what hasn't been clearly shown, is that th ...
... Hepatitis B and the Risk of Developing HCC It is known that patients with chronic hepatitis B who are hepatitis B e antigen (HBeAg)-positive are at greatest risk for both the progression of liver disease and the development of HCC.[3] What this implies, but what hasn't been clearly shown, is that th ...
Hepatitis B (HBV)
... • Spread is via unprotected sexual intercourse with an infected partner, sharing needles, accidental needle sticks, blood transfusions, hemodialysis, maternal-fetal route. • Symptoms occur in 25 to 180 days after exposure; symptoms include anorexia, nausea and vomiting, fever, fatigue, right upper q ...
... • Spread is via unprotected sexual intercourse with an infected partner, sharing needles, accidental needle sticks, blood transfusions, hemodialysis, maternal-fetal route. • Symptoms occur in 25 to 180 days after exposure; symptoms include anorexia, nausea and vomiting, fever, fatigue, right upper q ...
Reimbursement Support Request Form
... • You should not take Ribasphere alone to treat chronic hepatitis C infection. • Ribasphere may cause you to have a blood problem (hemolytic anemia) that can worsen any heart problems you have, and cause you to have a heart attack or die. People with a history of serious heart disease should not b ...
... • You should not take Ribasphere alone to treat chronic hepatitis C infection. • Ribasphere may cause you to have a blood problem (hemolytic anemia) that can worsen any heart problems you have, and cause you to have a heart attack or die. People with a history of serious heart disease should not b ...
Product Monograph
... GALEXOS® regarding their use in patients with hepatic impairment. PegIFN-alfa is contraindicated in patients with decompensated cirrhosis (e.g., Child-Pugh Class B or C). Hepatic Decompensation and Hepatic Failure GALEXOS® is not recommended for use in patients with moderate or severe hepatic impair ...
... GALEXOS® regarding their use in patients with hepatic impairment. PegIFN-alfa is contraindicated in patients with decompensated cirrhosis (e.g., Child-Pugh Class B or C). Hepatic Decompensation and Hepatic Failure GALEXOS® is not recommended for use in patients with moderate or severe hepatic impair ...
Sofosbuvir
Sofosbuvir (brand names Sovaldi, Hepcinat, Resof, Hepcvir, SoviHep) is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection. It has been marketed since 2013. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to four-fold reduced duration of therapy. Sofosbuvir allows most patients to be treated successfully without the use of peginterferon, an injectable drug with severe side effects that is a key component of older drug combinations for the treatment of HCV.Sofosbuvir inhibits the RNA polymerase that the hepatitis C virus uses to replicate its RNA. It was discovered at Pharmasset and developed by Gilead Sciences.In 2013, the FDA approved sofosbuvir in combination with ribavirin (RBV) for oral dual therapy of HCV genotypes 2 and 3, and for triple therapy with injected pegylated interferon (pegIFN) and RBV for treatment-naive patients with HCV genotypes 1 and 4. In 2014 a combination of sofosbuvir with the viral NS5A inhibitor ledipasvir was approved. This latter combination provides high cure rates in people infected with genotype 1 (the most common subtype in the U.S., Japan, and much of Europe) without the use of interferon, irrespective of prior treatment failure or the presence of cirrhosis.The price of sofosbuvir, quoted in various media sources as $84,000 to $168,000 for a course of treatment in the U.S., £35,000 in the UK for 12 weeks has engendered considerable controversy. In September 2014, Gilead announced that it would permit generic manufacturers to sell sofosbuvir in 91 developing countries and that it would sell a name brand version of the product in India for approximately $300 per course of treatment.It is on the World Health Organization's List of Essential Medicines, a list of the most important medications needed in a basic health system.