ABSTRACT
INTRODUCTION: New regimens involving direct-acting antiviral agents have recently been approved for the treatment of HCV. Our aim was to assess the efficacy and safety of 12 or 24 weeks of Sofosbuvir 400 mg plus Daclatasvir 60 mg, with or without ribavirin (800-1000 mg) in treating chronic hepatitis C genotype 4 patients. METHODS: This is an open-label observational study that describes the effect of 12 week or 24 weeks of daily oral Sofosbuvir (SOF) 400 mg plus Daclatasvir (DCV) 60 mg with or without ribavirin (RBV) with dose adjustment if indicated. It included the first 1168 patients that fulfilled the inclusion and exclusion criteria and treated in the Egyptian Liver Research Institute and Hospital, Mansoura, Egypt. RESULTS: Sustained viral response after 12 weeks of end of treatment (SVR12) was achieved in 96.6% (95% CI 95.1-98.2%) of the patients receiving 12 weeks of DCV + SOF treatment, in 95.7% (95% CI 93.6-97.8%) of the patients receiving 12 weeks of DCV + SOF + RBV, in 93.3% (95% CI 90.0-96.6%) of those receiving 24 weeks of DCV + SOF, and in 92.2% (95% CI 85.4-98.9%) of patients receiving 24 weeks of DCV + SOF + RBV treatment. SVR12 rate was significantly higher in patients with no cirrhosis receiving DCV + SOF only for 12 weeks or 24 weeks (97.4 and 97.4%, respectively) than in patients with cirrhosis (91.7 and 88.9%, respectively). The most common adverse events were fatigue, headache, insomnia, and anemia. No treatment-related serious adverse events or death were reported in the studied groups. CONCLUSION: Treatment with SOF (400 mg) plus DCV (60 mg), with or without RBV (800-1000 mg) for 12 or 24 weeks, was effective and well tolerated in chronic hepatitis C genotype 4 patients. SVR rates were higher for patients with no cirrhosis. Addition of RBV has benefit only in treatment-experienced group receiving 24 weeks.
Subject(s)
Antiviral Agents/therapeutic use , Hepacivirus/genetics , Hepatitis C, Chronic/drug therapy , Administration, Oral , Adult , Antiviral Agents/administration & dosage , Carbamates , Drug Administration Schedule , Drug Therapy, Combination , Female , Genotype , Hepatitis C, Chronic/genetics , Humans , Imidazoles/administration & dosage , Imidazoles/therapeutic use , Male , Middle Aged , Pyrrolidines , Ribavirin/administration & dosage , Ribavirin/therapeutic use , Sofosbuvir/administration & dosage , Sofosbuvir/therapeutic use , Treatment Outcome , Valine/analogs & derivativesABSTRACT
Recent studies indicate an ectopic upregulation of the human leukocyte antigen G (HLA-G) in tumor cells that may favor their escape from antitumor immune responses. The role of HLA-G in breast cancer has not been defined. Other studies showed that HLA-G transcription may be silenced by epigenetic mechanisms or activated by stress. This work aimed to clarify the expression of HLA-G protein, estimate the possible prognostic role of HLA-G expression and identify if this expression is linked to the DNA index (DI) and S phase fraction (SPF) in breast cancer. HLA-G protein expression and the DNA parameters were studied by flow cytometry and serum secreted HLA-G (sHLA-G) levels were detected by enzyme-linked immunosorbent assay (ELISA) in 45 breast cancer patients and 40 female blood donors as healthy donors. Surface HLA-G was expressed on 40% and the cytoplasmic pattern with no membrane association in 24.4% of the malignant specimens. There was an increased serum sHLA-G level in patients as compared with controls. There were negative correlations between cytoplasmic HLA-G and both DI and SPF and between preoperative sHLA-G and SPF with no relations with patients' clinical outcome. We cannot establish that HLA-G protein can be a useful prognostic marker, but sHLA-G may be used as a tumor marker in breast cancer patients.
