Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry.

BACKGROUND & AIMS: We conducted an open-label phase 2 study to assess the efficacy and safety of the oral nucleotide polymerase inhibitor sofosbuvir in combination with ribavirin in patients of Egyptian ancestry, chronically infected with genotype 4 hepatitis C virus (HCV). METHODS: Treatment-naive and previously treated patients with genotype 4 HCV were randomly allocated in a 1:1 ratio to receive sofosbuvir 400mg and weight-based ribavirin, for 12 or 24 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response (HCV RNA <25IU/ml) 12 weeks after cessation of therapy (SVR12). RESULTS: Thirty treatment-naive and thirty previously treated patients were enrolled and treated for 12 weeks (n=31) or 24 weeks (n=29). Overall, 23% of patients had cirrhosis and 38% had diabetes. 14% of treatment-naive patients were interferon ineligible and 63% of treatment-experienced patients had prior non-response. SVR12 was achieved by 68% of patients (95% CI, 49-83%) in the 12-week group, and by 93% of patients (95% CI, 77-99%) in the 24-week group. The most common adverse events were headache, insomnia, and fatigue. No patient discontinued treatment due to an adverse event. CONCLUSIONS: The findings from the present study suggest that 24 weeks of sofosbuvir plus ribavirin is an efficacious and well tolerated treatment in patients with HCV genotype 4 infection.

Local Radiation Therapy for Palliation in Patients With Multiple Myeloma of the Spine.

Purpose: The objective of this study was to assess a contemporary cohort of patients with multiple myeloma referred for palliative radiation to the mobile spine for clinical and radiological responses. Materials/Methods: The records of patients treated between 2009 and 2016 with radiotherapy for multiple myeloma of the spine were retrospectively reviewed. Demographics, systemic therapy, radiation dose, number of fractions, radiographic response based upon adapted RECIST criteria, and symptomatic response were recorded. Results: Eighty eight patients and 98 treatment courses were analyzed. All courses were analyzed for symptomatic response and 61 of the treatment courses were available for radiologic follow-up. The median follow-up was 9.7 months with a median radiation dose of 25 Gy (12.5-50 Gy) delivered in a median of 10 fractions (5-25 fractions). Fifty-four percent of patients had a high-risk lesion. Symptomatic response as measured by a decrease of ≤5 points on the pain related scale was 83% and 34% of patients had a decrease of >5 points. Of 35% of patients that had neurologic impairments prior to treatment, improvement was identified 83% of the time. Radiographic response was noted as 13% complete response, 16% partial response, 57% stable disease, and 13% disease progression. Specifically, high-risk lesions treated with radiation alone demonstrated no regression with only 10% demonstrating partial response. Conclusion: This retrospective series of patients treated with palliative intent for multiple myeloma using various dose and fractionation schemes showed favorable symptomatic relief in most patients. Radiographic response did not correlate with clinical response with fewer patients having radiologic disease regression. Longer follow-up is necessary to determine if the lack of radiologic response is associated with clinically relevant recurrent pain.