During a 2-year period in 2005–2007, we conducted surveillance of group A rotaviruses and other enteric agents among patients hospitalized with acute gastroenteritis in 8 different cities of the ...Russian Federation. Fecal specimens were gathered from 3208 children (including 2848 children aged <5 years) and 1354 adults who were admitted to hospitals in Moscow, St. Petersburg, Chelyabinsk, Nizhnii Novgorod, Tyumen, Khabarovsk, Makhachkala, and Yakutsk. Polymerase chain reaction was performed to detect rotaviruses of groups A and C, noroviruses of genogroups I and II, astrovirus, sapovirus, and enteric adenoviruses (group F). Group A rotavirus was the most common viral pathogen detected among children aged <5 years (43.6%), followed by norovirus (12.5%), whereas norovirus was the pathogen most commonly detected in adults (11.9%). P and G genotypes were determined for 515 rotavirus specimens, and the most prevalent genotypes were G1P8 (44.9%), G4P8 (40.0%), G2P4 (8.5%), and G3P8 (6.6%). This study is the first multicenter study of rotaviruses in the Russian Federation and documents the important burden of disease caused by this pathogen, which soon may be preventable by vaccination
This paper evaluates the impact of different medical care strategies for chronic hepatitis C patients in relation to its prevalence, frequency of adverse outcomes and mortality rate.
Coinfection with hepatitis D virus (HDV) accelerates the progression of liver disease associated with chronic hepatitis B. Bulevirtide inhibits the entry of HDV into hepatocytes.
In this ongoing ...phase 3 trial, patients with chronic hepatitis D, with or without compensated cirrhosis, were randomly assigned, in a 1:1:1 ratio, to receive bulevirtide subcutaneously at 2 mg per day (2-mg group) or 10 mg per day (10-mg group) for 144 weeks or to receive no treatment for 48 weeks followed by bulevirtide subcutaneously at 10 mg per day for 96 weeks (control group). Patients will complete 96 weeks of additional follow-up after the end of treatment. The primary end point was a combined response at week 48 of an undetectable HDV RNA level, or a level that decreased by at least 2 log
IU per milliliter from baseline, and normalization of the alanine aminotransferase (ALT) level. The key secondary end point was an undetectable HDV RNA level at week 48, in a comparison between the 2-mg group and the 10-mg group.
A total of 49 patients were assigned to the 2-mg group, 50 to the 10-mg group, and 51 to the control group. A primary end-point response occurred in 45% of patients in the 2-mg group, 48% in the 10-mg group, and 2% in the control group (P<0.001 for the comparison of each dose group with the control group). The HDV RNA level at week 48 was undetectable in 12% of patients in the 2-mg group and in 20% in the 10-mg group (P = 0.41). The ALT level normalized in 12% of patients in the control group, 51% in the 2-mg group (difference from control, 39 percentage points 95% confidence interval {CI}, 20 to 56), and 56% in the 10-mg group (difference from control, 44 percentage points 95% CI, 26 to 60). Loss of hepatitis B virus surface antigen (HBsAg) or an HBsAg level that decreased by at least 1 log
IU per milliliter did not occur in the bulevirtide groups by week 48. Headache, pruritus, fatigue, eosinophilia, injection-site reactions, upper abdominal pain, arthralgia, and asthenia were more common in the 2-mg and 10-mg groups combined than in the control group. No treatment-related serious adverse events occurred. Dose-dependent increases in bile acid levels were noted in the 2-mg and 10-mg groups.
After 48 weeks of bulevirtide treatment, HDV RNA and ALT levels were reduced in patients with chronic hepatitis D. (Funded by Gilead Sciences; MYR 301 ClinicalTrials.gov number, NCT03852719.).
Chronic hepatitis delta (CHD) is the most severe form of viral hepatitis and is associated with rapid progression to cirrhosis, decompensation, hepatocellular carcinoma, and end-stage liver disease.
...We report an exploratory analysis of EuroQol 5D visual analog scale (EQ-5D VAS) scores in patients with CHD after 48 weeks of treatment with bulevirtide (BLV) in an ongoing Phase 3 trial.
MYR301 (NCT03852719) is a randomized, open-label, parallel-group, multicenter trial that assigned 150 patients with CHD (1:1:1) to BLV 2 mg (n=49), BLV 10 mg (n=50), or control (n=51) for up to 3 years. Control patients received no BLV treatment until week 48 (W48). The EQ-5D VAS is a self-completed rating of patients’ quality of life (QOL) with a range of 0–100 (100=best health state). The QOL analysis was based on EQ-5D VAS scores at baseline and W48.
Baseline characteristics were well balanced across groups. At W48, patients with CHD treated with BLV 2 mg reported statistically significant improvement in QOL (by EQ-5D VAS) and significantly better EQ-5D VAS change from baseline scores when compared with control patients (Table). Changes from BL with BLV 10 mg were not statistically significant at W48 A cirrhosis-specific subgroup analysis indicated similar improvement trends among patients with or without cirrhosis; however, statistical significance was not reached.
Patients with CHD treated with BLV 2 mg experienced improvements in QOL measured by the EQ-5D VAS at W48. EQ-5D VAS scores significantly improved in the BLV 2 mg group compared with baseline and compared with controls at W48 but did not in the BLV 10 mg group. Further investigation is needed to understand the impact of BLV 10 mg and the long-term effects of BLV treatment.
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