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In early 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of dasabuvir for people with hepatitis C compared with standard therapies. The following results apply to people who have a chronic HCV infection without cirrhosis and who have not had any previous treatment.The manufacturer provided one relevant study. One group of participants (69 people) took dasabuvir as part of a triple therapy together with ribavirin and the combination drug ombitasvir / paritaprevir / ritonavir. Another group (34 people) had standard therapy with peginterferon, ribavirin, and telaprevir. The results are described below.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: May 4, 2015

In early 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of ledipasvir / sofosbuvir compared with standard therapies for the treatment of hepatitis C infection.The following results apply to cases of chronic hepatitis C (genotype 1) in people with liver cirrhosis who have had no other previous treatment. The patients did not also have an HIV infection. For this group, IQWiG performed a historical comparison with data from a total of ten studies. One of these studies looked into treatment with ledipasvir / sofosbuvir, and the other nine examined the double combination of peginterferon alfa and ribavirin.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: March 2, 2015

In early 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of dasabuvir for people with hepatitis C compared with standard therapies. The following results apply to people who have a chronic HCV infection (genotype 1a) but do not have liver cirrhosis and have previously had unsuccessful treatment.The manufacturer provided one relevant study. One group of participants (19 people) took dasabuvir as part of a triple therapy, together with ribavirin and the combination drug ombitasvir / paritaprevir / ritonavir. Another group of participants (7 people) had standard therapy with peginterferon, ribavirin, and telaprevir. The results are described below.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: May 4, 2015

In early 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of the fixed combination ombitasvir / paritaprevir / ritonavir in people with hepatitis C compared with standard therapies. The following results apply to people with a chronic HCV infection (genotype 1a) without cirrhosis who have not had any previous treatment.The manufacturer provided one relevant study. One group of participants (69 people) took the fixed combination ombitasvir / paritaprevir / ritonavir as part of a triple therapy together with dasabuvir and ribavirin. Another group (34 people) had a standard therapy with peginterferon, ribavirin, and telaprevir. The results are described below.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: May 4, 2015

In early 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of ledipasvir / sofosbuvir compared with standard therapies for the treatment of hepatitis C infection.The following results apply to cases of chronic hepatitis C (genotype 1) in people without liver cirrhosis who have had no other previous treatment. The patients did not also have an HIV infection. For this group, IQWiG carried out a historical comparison with data from a total of nine studies. Three of these studies looked into treatment with ledipasvir / sofosbuvir and the other six examined the triple therapy with peginterferon alfa, ribavirin, and boceprevir or telaprevir.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: March 2, 2015

In early 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of the fixed combination ombitasvir / paritaprevir / ritonavir for people with hepatitis C compared with standard therapies. The following results apply to people with a chronic HCV infection (genotype 1a) without liver cirrhosis who have previously been treated unsuccessfully.The manufacturer provided one relevant study. One group of participants (19 people) took the fixed combination ombitasvir / paritaprevir / ritonavir as part of a triple therapy together with dasabuvir and ribavirin. Another group (7 people) had standard therapy with peginterferon, ribavirin, and telaprevir. The results of this study are described below.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: May 4, 2015

In early 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of dasabuvir for people with hepatitis C compared with standard therapies. The following results apply to people with a chronic HCV infection (genotype 1b) who do not have cirrhosis and have not had any previous treatment.The manufacturer provided one relevant study. One group of participants (83 people) took dasabuvir as part of a dual therapy, together with the drug combination ombitasvir / paritaprevir / ritonavir. Another group (41 people) had standard therapy with peginterferon, ribavirin, and telaprevir. The results are described below.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: May 4, 2015

In early 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of the fixed combination ombitasvir / paritaprevir / ritonavir for people with hepatitis C compared with standard therapies. The following results apply to people with a chronic HCV infection (genotype 1b) without cirrhosis who have not had any previous treatment.The manufacturer provided one relevant study. One group of participants (83 people) took the fixed combination ombitasvir / paritaprevir / ritonavir as part of a dual therapy together with dasabuvir. Another group (41 people) had a standard therapy with peginterferon, ribavirin, and telaprevir. The results of this study are described below.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: May 4, 2015

Alcohol and hepatotropic viruses are major causes of liver fibrosis and liver cirrhosis. Colchicine is an anti‐inflammatory and anti‐fibrotic drug. This systematic review could not demonstrate any significant beneficial effects of colchicine on mortality, liver‐related mortality, liver complications, liver biochemistry, or liver histology of patients with liver fibrosis or liver cirrhosis due to alcohol, hepatitis B, hepatitis C, or unknown etiology. Colchicine was associated with a significant increase in adverse events. Accordingly, there seems to be no evidence for using colchicine for alcoholic, viral, or cryptogenic liver fibrosis/cirrhosis outside randomised clinical trials.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: April 20, 2005

Liver fibrosis is a change in the microscopic structure of the liver because of liver inflammation. After many years of excessive alcohol consumption, liver fibrosis progresses to cirrhosis. Abstaining from alcohol may stop the fibrosis from further progression into significant or severe fibrosis and cirrhosis. The latter lead to complications of underlying diseases, including cancer.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: January 22, 2015

Primary biliary cirrhosis (PBC) is a chronic disease of the liver that is characterised by destruction of bile ducts. Estimates of annual incidence range from 2 to 24 people per million population, and estimates of prevalence range from 19 to 240 people per million population. PBC primarily affects middle‐aged women. The forecast for the symptomatic patient after diagnosis is between 10 and 15 years. The cause of PBC is unknown, but the dynamics of the disease resemble the group 'autoimmune disease'. Therefore, one might expect a noticeable effect of administering an immune repressing drug (immunosuppressant). This review evaluates all clinical data on the immunosuppressant cyclosporin A for PBC.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: July 18, 2007

Heavy alcohol consumption causes alcoholic liver disease and may lead to a number of other concomitant diseases. Alcohol may damage the function of body organs and can cause cancer. Liver damage due to excessive alcohol consumption is usually presented as fatty liver (build‐up of fats in the liver), steatohepatitis (inflammation of the liver with concurrent fat accumulation in the liver), fibrosis (fibrous degeneration), alcoholic cirrhosis (scarring of the liver), and hepatocellular carcinoma (most common type of liver cancer). When liver fibrosis progresses, alcoholic cirrhosis occurs.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: March 2, 2016

Primary biliary cirrhosis (PBC) is a chronic disease of the liver that is characterised by destruction of bile ducts. Estimates of annual incidence range from 2 to 24 patients per million population, and estimates of prevalence range from 19 to 240 patients per million population. PBC primarily affects middle‐aged women. The forecast for the symptomatic patient after diagnosis is between 10 and 15 years. The cause of PBC is unknown, but the dynamics of the disease resemble the group 'autoimmune disease'. Therefore, one might expect a noticeable effect of administering an immune repressing drug (immunosuppressant). This review evaluates all clinical data on the immunosuppressant azathioprine in relation to PBC.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: July 18, 2007

Primary biliary cirrhosis is a chronic progressive cholestatic liver disease of presumed autoimmune aetiology. The clinical course might be improved by glucocorticosteroids. Only two small randomised clinical trials on this topic were identified. The trials were not large enough in terms of sample size or length of follow up to allow changes in mortality to be adequately evaluated. Glucocorticosteroids were associated with improvement in serum markers of inflammation and liver histology, both of which were of uncertain clinical significance. Glucocorticosteroids were also associated with adverse events, including reduced bone mineral density. Further trials are necessary if the effectiveness of glucocorticosteroids is to be properly evaluated.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: April 20, 2005

Primary biliary cirrhosis is an autoimmune disease of the liver. Chlorambucil has been used for patients with primary biliary cirrhosis as it possesses immunosuppressive properties. This review aimed to assess the beneficial or harmful effects of chlorambucil for primary biliary cirrhosis. The authors identified only one randomised trial, with 24 participants included. This trial compared chlorambucil with no intervention. The trial is small and at a high risk of bias, which suggests that the results may not be reliable. Meta‐analyses were not possible because of the inclusion of one trial only. Fisher's exact test and t‐test were used instead. Chlorambucil was not associated with significantly lower mortality when compared with no intervention. All patients on chlorambucil experienced adverse events, especially bone marrow suppression. Chlorambucil led to a significant improvement in mean serum levels of bilirubin, albumin, immunoglobulin M, serum aspartate aminotransferase activity, and hepatic inflammatory infiltrates. However, these outcomes are unvalidated surrogate outcomes for patient‐relevant outcomes. This means that improvement of these biochemistry measures cannot be taken as proof of improvement of patient‐relevant outcomes. It remains unclear whether chlorambucil can be supported or rejected for use in patients with primary biliary cirrhosis.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: September 12, 2012

Primary biliary cirrhosis is an uncommon chronic liver disease of unknown aetiology, affecting mostly women. It is characterised by progressive inflammation and destruction of the liver tissue, eventually progressing to liver cirrhosis and the need for liver transplantation. Methotrexate, a folic acid antagonist with immunosuppressive properties, has been used to treat patients with primary biliary cirrhosis. However, the evidence did not show a clear benefit of methotrexate on mortality or the need for liver transplantation in patients with primary biliary cirrhosis. This review is based on five randomised trials; four comparing methotrexate with placebo, and one comparing methotrexate with colchicine. Methotrexate, compared with placebo, has no significant beneficial effect on mortality and the need for liver transplantation is not significantly reduced. The effects of methotrexate on pruritus, fatigue, clinical complications, liver biochemistry levels, liver histology, and adverse events were not significantly different from placebo. There may be some beneficial effect on pruritus score (ie, an objective measure of subjective feeling of pruritus), but we cannot recommend methotrexate for this indication only, taken into account possible adverse events. In the small trial comparing methotrexate versus colchicine, methotrexate seemed to work superior to colchicine, but it is not clear if this stems from the fact that methotrexate exerts beneficial effects as colchicine exerts harmful effects. In comparison with both placebo and colchicine, methotrexate was associated with large risks of mortality and adverse events, but the increase did not reach statistical significance.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: May 12, 2010

Primary biliary cirrhosis is an uncommon, chronic liver disease of unknown etiology. D‐penicillamine, a cupruretic drug, has been tested in randomised clinical trials and is used to treat patients with primary biliary cirrhosis. After combining results from seven trials, D‐penicillamine did not appear to improve survival of patients. D‐penicillamine was associated with a four‐time increase of adverse events. There were no significant differences between D‐penicillamine and placebo/no intervention with respect to clinical changes, liver histology, and liver biochemistry.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: October 18, 2004

Primary biliary cirrhosis is a rare, chronic liver disease of unknown etiology. Colchicine, a plant alkaloid, has been used to treat patients with primary biliary cirrhosis and was tested in randomised clinical trials. When all identified trials were combined, colchicine appeared to be not significantly different from placebo/no intervention in respect to mortality, mortality and/or patients who underwent liver transplantation, liver complications, liver biochemistry, liver histology, and the occurrences of adverse events. Colchicine may reduce pruritus, but this finding may be due to bias. The addition of ursodeoxycholic acid did not significantly influence the effect of colchicine.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: April 19, 2004

Patients with primary biliary cirrhosis are mainly elderly women who are naturally prone to osteoporosis. Hormone replacement has been used worldwide to treat symptoms of menopause and to prevent chronic conditions such as osteoporosis. However, hormone replacement is associated with an increase in adverse events, several of which are serious. This review assessed the effect of hormone replacement on treatment of osteoporosis in women with primary biliary cirrhosis. We found no evidence of effect of hormone replacement on mortality and fractures in women with primary biliary cirrhosis. It seems that hormone replacement given to women with primary biliary cirrhosis is connected with a significant increase in the occurrence of adverse events compared with placebo or no intervention. Hormone replacement appears to have no effect on the lumbar bone mineral density compared with placebo or no intervention. Hormone replacement may decrease bone mineral density measured at the proximal femur. We did not find evidence to support the use of hormone replacement for osteoporosis in women with primary biliary cirrhosis.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: December 7, 2011

Cirrhosis is a chronic disorder of the liver. People with cirrhosis may develop hepatic encephalopathy, a condition that results in poor brain functioning. Hepatic encephalopathy may be clinically obvious (overt) with changes including poor concentration, tremor, and alterations in consciousness. Others have no obvious clinical changes (minimal) but, when tested, some aspects of brain function such as attention and the ability to perform complex tasks are impaired.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: May 6, 2016

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