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In two phase 3 trials involving patients with hepatitis C virus infection, including those with cirrhosis, 12 weeks of sofosbuvir–velpatasvir resulted in a sustained virologic response in 99% of patients with genotype 2 and 95% of those with genotype 3. Hepatitis C virus (HCV) genotypes 2 and 3 account for an estimated 35% of global HCV infections, affecting up to 58 million persons. 1 , 2 Unlike HCV genotype 1, genotypes 2 and 3 are common in low-income regions in Asia, sub-Saharan Africa, Latin America, and Eastern Europe. 1 Before the advent of direct-acting antiviral agents, HCV genotypes 2 and 3 were grouped together in treatment guidelines as “easy-to-treat” genotypes. However, recent studies have shown that HCV genotype 3 is associated with more rapid disease progression and lower rates of response to treatment than is HCV genotype 2, especially in patients with cirrhosis . . .

In this phase 3 study involving patients with HCV genotype 1, 2, 3, 4, or 6 and decompensated cirrhosis, sofosbuvir–velpatasvir with or without ribavirin for 12 weeks or sofosbuvir–velpatasvir for 24 weeks resulted in high rates of sustained virologic response. The number of patients with decompensated cirrhosis caused by chronic infection with the hepatitis C virus (HCV) is projected to rise in the coming decade. 1 For many years, the only treatment option for such patients was liver transplantation. Recently, however, clinical trials of newly approved direct-acting antiviral agents have shown that it is possible to treat HCV infection safely and effectively in patients with decompensated cirrhosis and that successful treatment is associated with early improvement in liver function. 2 – 11 The possible long-term benefits of treatment on existing liver disease remain unknown. The only regimen that is currently approved for the . . .

In two studies of sofosbuvir for previously untreated HCV infection, patients with genotype 1, 4, 5, or 6 had a 90% rate of sustained virologic response in a single-group study. In a study of sofosbuvir–ribavirin versus peginterferon–ribavirin for patients with genotype 2 or 3, the response rate was 67% in each group. As many as 170 million persons are chronically infected with the hepatitis C virus (HCV) worldwide, and more than 350,000 die annually from liver disease caused by HCV. 1 , 2 Estimates of the number of persons in the United States who have chronic HCV infection range from 2.7 million to 5.2 million. 3 , 4 For previously untreated cases of HCV genotype 1 infection (representing more than 70% of all cases of chronic HCV infection in the United States), the current standard of care is 12 to 32 weeks of an oral protease inhibitor combined with 24 to 48 weeks of peginterferon alfa-2a . . .

In two randomized trials, the oral nucleotide polymerase inhibitor sofosbuvir combined with ribavirin for 12 or 16 weeks was effective in patients with chronic HCV genotype 2 or 3 infection for whom interferon therapy either was not an option or had failed. When studied in clinical trials, the current standard-of-care therapy for patients with hepatitis C virus (HCV) genotype 2 or 3 infection — pegylated interferon in combination with ribavirin for 24 weeks — resulted in a sustained virologic response in 70 to 85% of patients who had not received prior treatment and in 55 to 60% of those who had received treatment. 1 – 4 However, a substantial proportion of patients with HCV infection remain untreated owing to absolute or relative contraindications to interferon therapy, such as hepatic decompensation, autoimmune disease, and psychiatric illness. 5 In addition, interferon causes a range of constitutional symptoms . . .

In two randomized, open-label trials, the combination of glecaprevir and pibrentasvir given once daily for 8 or 12 weeks achieved high rates of sustained virologic response in patients with HCV genotype 1 or 3 infection who did not have cirrhosis.

In this study in patients with HCV genotype 1 infection and prior treatment failure, those assigned to 12 weeks or 24 weeks of treatment with ledipasvir and sofosbuvir, with or without ribavirin, had high rates of sustained response (94 to 99% in all groups). Among the estimated 170 million people in the world who have chronic hepatitis C virus (HCV) infection, approximately 60% have the genotype 1 strain of the virus. 1 The treatment of patients infected with HCV genotype 1 is evolving rapidly. 2 – 6 At the end of 2013, the Food and Drug Administration (FDA) approved two new direct-acting antiviral agents for the treatment of HCV infection: the nucleotide polymerase inhibitor sofosbuvir (Gilead Sciences) and the protease inhibitor simeprevir (Janssen Therapeutics). 7 , 8 Among the regimens that have been approved by the FDA for patients with HCV genotype 1 infection who have not had a . . .

Patients with cirrhosis resulting from chronic hepatitis C virus (HCV) infection are at risk of life-threatening complications, but consistently achieve lower sustained virological response (SVR) than patients without cirrhosis, especially if treatment has previously failed. We assessed the efficacy and safety of the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir, with and without ribavirin. In this multicentre, double-blind trial, between Oct 21, 2013, and Oct 30, 2014, we enrolled patients with HCV genotype 1 and compensated cirrhosis who had not achieved SVR after successive treatments with pegylated interferon and protease-inhibitor regimens at 20 sites in France. With a computer-generated randomisation sequence, patients were assigned in a 1:1 ratio to receive placebo matched in appearance to study drugs for 12 weeks followed by once daily combination fixed-dose tablets of 90 mg ledipasvir and 400 mg sofosbuvir plus weight-based ribavirin for 12 weeks, or ledipasvir-sofosbuvir plus placebo once daily for 24 weeks. The primary endpoint was SVR 12 weeks after the end of treatment (SVR12), for which 95% CIs were calculated with the Clopper-Pearson method. This study is registered with ClinicalTrials.gov, number NCT01965535. Of 172 patients screened, 155 entered randomisation, 77 were assigned to receive ledipasvir-sofosbuvir plus ribavirin and 78 ledipasvir-sofosbuvir. 114 (74%) were men, 151 (97%), were white, 98 (63%) had HCV genotype 1a, and 145 (94%) had non-CC IL28B alleles. SVR12 rates were 96% (95% CI 89–99) for patients in the ledipasvir-sofosbuvir plus ribavirin group and 97% (91–100) in the ledipasvir-sofosbuvir group. One patient discontinued treatment because of adverse events while receiving only placebo. The most frequent adverse events were asthenia and headache, pruritus, and fatigue. Ledipasvir-sofosbuvir plus ribavirin for 12 weeks and ledipasvir-sofosbuvir for 24 weeks provided similarly high SVR12 rates in previous non-responders with HCV genotype 1 and compensated cirrhosis. The shorter regimen, when given with ribavirin, might, therefore, be useful to treat treatment-experienced patients with cirrhosis if longer-term treatment is not possible. Gilead Sciences.

In previously untreated patients with HCV genotype 1 infection without cirrhosis, the rate of sustained virologic response was 94% with 8 weeks of ledipasvir–sofosbuvir, 93% with 8 weeks of ledipasvir–sofosbuvir plus ribavirin, and 95% with 12 weeks of ledipasvir–sofosbuvir. More than 3 million people in the United States are chronically infected with the hepatitis C virus (HCV). 1 , 2 Although the number of new infections has been declining for decades, HCV-related morbidity and mortality are projected to continue rising for another 20 years. 3 One half to three quarters of persons currently infected with HCV have not received a diagnosis and are untreated; many will have progression to decompensated cirrhosis, hepatocellular carcinoma, and other liver complications. 3 , 4 Early diagnosis and treatment are essential to improve long-term health outcomes in this population. New guidelines from the Centers for Disease Control and Prevention . . .

In this trial involving previously untreated patients infected with hepatitis C virus (HCV) genotype 1, boceprevir in combination with peginterferon and ribavirin was more effective than peginterferon and ribavirin alone. Anemia was a common adverse effect of boceprevir. Chronic infection with the hepatitis C virus (HCV) affects more than 170 million people worldwide. 1 , 2 Rates of sustained virologic response associated with peginterferon–ribavirin therapy remain below 50% and are often less than 30% among patients who have HCV genotype 1 infection and certain baseline characteristics, such as advanced fibrosis, diabetes, coinfection with the human immunodeficiency virus (HIV), or African heritage. 3 – 9 Recent efforts to improve the rate of sustained virologic response have focused on oral direct-acting antiviral agents. 10 – 13 Boceprevir is a linear peptidomimetic ketoamide serine protease inhibitor that binds reversibly to the HCV nonstructural 3 (NS3) active site. . . .

In this trial in previously untreated patients with HCV genotype 1 infection and no cirrhosis, high rates of sustained response were achieved with three new direct-acting antiviral agents and ribavirin. Serious adverse events and treatment discontinuation were infrequent. Approximately 184 million people worldwide have chronic hepatitis C virus (HCV) infection, and more than 350,000 people die of HCV-related liver disease each year. 1 , 2 Until recently, the standard of care for chronic HCV genotype 1 infection was a first-generation protease inhibitor, telaprevir or boceprevir, with peginterferon and ribavirin; this therapy resulted in rates of sustained virologic response of 67 to 75% among previously untreated patients. 3 , 4 The new standard of care is peginterferon and ribavirin combined with either the nucleotide nonstructural (NS) 5B polymerase inhibitor sofosbuvir or the protease inhibitor simeprevir. 5 Peginterferon-based treatment is associated with clinically significant systemic . . .