Does headache represent a clinical marker in early diagnosis of cerebral venous thrombosis? A prospective multicentric study.

The main aim of this study is to look for early clinical markers of cerebral venous thrombosis (CVT). As headache represents the major clinical manifestation at presentation we focused our attention on this symptom. We present the preliminary results of a prospective multicentric study that includes cases diagnosed as CVT in the participating centres. We have so far studied 35 patients (5 males and 30 females) from the ages of 18 to 78. The most frequent manifestation was headache (77.1%). It was more frequently localised (66.7%) and continuous (77.8%). The onset of pain was mostly acute-subacute (38.5%-50.0%) and the intensity moderate-severe (37.0%-51.9%). On univariate analysis, we found a positive correlation between CVT, acute headache onset (p=0.001) and severe headache (p=0.004). These preliminary results seem in accordance with our previous findings in the retrospective study, suggesting that CVT is more often associated with acute-onset headache of severe intensity

Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B

OBJECTIVE: Treatment with peginterferon α-2a (PegIFN) for 48 weeks is the standard of care for selected HBeAg-negative patients chronically infected with hepatitis B virus (HBV), but with limited treatment efficacy. A study was undertaken to investigate whether treatment extension to 96 weeks improves the outcome in this patient population. METHODS: 128 HBeAg-negative patients (120 genotype D) were randomised to weekly 180 μg PegIFN for 48 weeks (group A, n=51), 180 μg PegIFN for 48 weeks followed by 135 μg weekly for an additional 48 weeks (group B, n=52) or 180 μg PegIFN plus lamivudine (100 mg/day) for 48 weeks then 135 μg PegIFN for 48 weeks (group C, n=25). Endpoints were alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (primary), HBV DNA <2000 IU/ml and HBsAg clearance at 48 weeks after treatment. RESULTS: Forty-eight weeks after treatment, six patients in group A and 13 in group B achieved alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (11.8% vs 25.0%, p=0.08), 6 vs 15 patients had HBV DNA <2000 IU/ml (11.8% vs 28.8%, p=0.03), 0 vs 3 achieved HBsAg clearance (0% vs 5.8%, p=0.24) and 0 vs 5 had HBsAg <10 IU/ml (0% vs 9.6%, p=0.06). While extended PegIFN treatment was the strongest independent predictor of response, the combination with lamivudine did not improve responses. Discontinuation rates were similar among the groups (19.6%, 23.1%, 32.0%, p=0.81) and were mostly due to PegIFN-related adverse events. CONCLUSIONS: In HBeAg-negative genotype D patients with chronic hepatitis B, PegIFN treatment for 96 weeks was well tolerated and the post-treatment virological response improved significantly compared with 48 weeks of treatment

A response guided approach to peginterferon alfa-2a therapy based on HBsAg levels at weeks 12 and 24 improves response rates in HBeAG-negative, genotype D chronic hepatitis B patients

Study purpose : A stopping rule at week 12 of peginterferon alfa-2a (PEGASYS; PEG-IFN\u3b1-2a) therapy has been proposed and validated previously as HBeAg-negative, genotype D patients with no HBsAg decline and HBV DNA <2 log decline at week 12 had a low chance of sustained post-treatment response. In the current analysis we determined whether HBsAg or HBV DNA quantification at week 24 could provide further information about post-treatment response in those who would remain on therapy after the initial stopping criteria were applied. Methods: HBeAg-negative patients who had received PEG-IFN\u3b1-2a for 48 (arm A; n=47) or 96 weeks (arm B; n=46)as part of the PegBeLiver study (91% genotype D), and had HBsAg values at baseline, week 12, 24 and 48 and HBV DNA levels available at baseline, week 12 and week 24 were included in the analysis. Response was defined as HBV DNA <2000 IU/mL 1 year post-treatment. HBsAg and HBV DNA cut-off levels at week 24 associated with post-treatment response were determined by ROC analysis. Results: Overall, 8 patients in arm A (17%) and 10 patients in arm B (22%) had no HBsAg decline and HBV DNA decline 7500 IU/mL at week 24 had a low chance of sustained response in arm A (7%, 1/15) and no chance of response in arm B (0%, 0/10). Patients with HBsAg 7500 IU/mL at week 24 of PEG-IFN\u3b1-2a had high negative predictive values for sustained post-treatment response (93% for 48 weeks treatment and 100% for 96 weeks treatment). This could be a potential second-step stopping rule for PEG-IFN\u3b1-2a in patients predominantly infected with genotype

A randomized study comparing 48 and 96 weeks peginterferon alfa-2a therapy in genotype D HBeAg negative chronic hepatitis B.

Forty-eight treatment with PegIFN alpha2a (PegIFN) is the standard of care for selected HBeAg negative patients chronically infected with hepatitis B virus (HBV), however with a limited treatment efficacy. We investigated whether treatment extension to 96 weeks improves outcome in this patient population. Design: 128 (120 genotype D) HBeAg-negative patients were randomized to weekly 180 \u3bcg PegIFN for 48 weeks (group A, n=51) or 180 \u3bcg PegIFN for 48 weeks followed by 135 Ig weekly for additional 48 weeks (group B, n=52) or 180 \u3bcg PegIFN plus lamivudine (100 mg/day) for 48 weeks then 135 \u3bcg PegIFN for 48 weeks (group C, n=25). Endpoints were alanine aminotransferase normalization plus HBV DNA <3,400 IU/mL (primary), HBV DNA <2,000 IU/mL and HBsAg clearance at 48-week post-treatment. Results Forty-eight weeks post-treatment, 6 patients of group A versus 13 of group B achieved alanine aminotransferase normalization plus HBV DNA <3,400 IU/mL (11.8% vs 25.0%, p=0.08), 6 versus 15 patients had HBV DNA <2,000 IU/mL (11.8% vs 28.8%, p=0.03), none versus 3 achieved HBsAg clearance (0% vs 5.8%, p=0.24), and none versus 5 had HBsAg <10 IU/mL (0% vs 9.6%, p=0.06). While extended PegIFN treatment was the strongest independent predictor of response, combination of lamivudine did not improve responses. Discontinuation rates were similar among groups (19.6%, 23.1%, 32.0%, P=0.81) and mostly due to PegIFN-related adverse events. Conclusions In HBeAg-negative genotype D patients with chronic hepatitis B, PegIFN treatment for 96 weeks was well tolerated and improved post-treatment virological response significantly, compared with 48 weeks of therapy