Background: Chronic Hepatitis C (CHC) infection is the most common chronic liver disease in patients with end-stage renal disease (ESRD) and highly prevalent on hemodialysis patients. The DOPPS data reported an overall prevalence of 13.5 percent among adult hemodialysis patients. The reported data in Pakistan reflected 26.02% hemodialysis patients with HCV infection. Over the last few years, the direct-acting antivirals have been revolutionary in the treatment of hepatitis C, and sofosbuvir (SOF) is the backbone of most modern treatment strategies with better prognosis of the infection and tolerability. The aim of the study was to assess the effectiveness and safety of Sofosbuvir regime on HCV infected patients on hemodialysis (HD) in the local population as per routine practice. Method: This was an observational, prospective; single-center study enrolled 30 HCV HD subjects on sofosbuvir ribavirin regime for 12 weeks. Results: As per results of 30 subjects' (n= female 13, 44% and n = male 17, 56 %) with mean age ± standard deviation 60.5 ± 7.5 years. On SOF/ribavirin (RBV) treatment for 12 weeks, the sustained virological response rate was 100% (27 of 27) at 12 weeks. 95% confidence interval, (95 to 100). No patients had virologic failure during treatment. No patient had treatment discontinuation due to side effects. Adverse events were reported in at least 10% of the patients were mainly pruritus, fatigue, and nausea. No serious adverse event reported. Conclusion: The Sofosbuvir based antiviral therapy is safe and effective in the treatment of HCV with ESRD, including HD patients with a high rate of SVR in patients.
Background: Globally, Hepatitis C is the primary causes of acute and chronic hepatitis in end-stage renal disease patients and highly prevalent in hemodialysis patients. In Asia, Hepatitis C Virus (HCV) infection has become a serious public health problem, whereas, in Pakistan, 26.02% hemodialysis patients are infected with HCV infection. The advent of direct-acting antivirals (DAAs) has brought HCV treatment into a revolutionized era. Among the approved DAAs, sofosbuvir (SOF) is the only one that has a significant renal elimination whereas daclatasvir (DAC) is not eliminated by the kidneys. The aims of the study were to assess the effectiveness and safety of SOF and DAC combination in HCV infected patients on Hemodialysis (HD) in the local population as per routine Pakistani practice. Methodology: An observational, prospective, single-centre study was conducted from December 2017 till September 2018 at the Nawaz Sharif Kidney Hospital, Swat, Pakistan. Total 27 HCV-HD subjects on SOF/DAC regime for 12 weeks, were enrolled in the study. The study was conducted as per the ICH-GCP Guidelines. The collected data was analyzed using SPSS Software version 19 and p-value < 0.05 was considered significant. Results: As per the results of 27 subjects', (n= female 12, 44.5% and n = male 15, 55.5 %), 21 subjects were naive and 6 were the treatment experienced group (with SOF/RBV) with mean age of 35.5±9.6 years. On SOF/DAC treatment for 12 weeks, the sustained virological response (SVR) rate was 100% (27 of 27) at the post treatment follow-up visit after 12 weeks. No patients had a virological failure or lost to followup during the study. The reported adverse events (AE's) were mainly nausea, headache and fatigue, no serious AE reported. Moreover, no treatment discontinuation due to side effects was observed. Conclusion: The combination of the full dose of SOF-DAC for 12 weeks provides a highly effective, safe and well-tolerated therapy for Pakistani patients with HCV on HD in routine Pakistani practice.
Background: Head and neck cancer (HNC) is one of the most common cancers in Pakistan. Disease free survival in HNC remains poor due to inefficient loco-regional disease control. The aim of the present study was to assess the response rate and toxicity of concomitant vinorelbine and External radiation therapy (ERT) in advanced Head and Neck cancer in local Pakistani population. The study as per Good Clinical Practice (GCP) guidelines was conducted at the oncology department of Nishat hospital Multan from 2015 to 2017. Methodology: An observational, prospective study with enrolment of 50 patients of advanced head and neck cancer was followed to analyze the outcome for radiosensitization. Primary tumor sites were tongue in 15 (30%) patients; lower lip in 6 (12%); buccal cavity in 5 (10%); cheek in 5 (10%); tonsil in 4 (8%); larynx in 6 (12%); hypopharynx in 5 (10%); and parotid in 4 (8%) patients. Initial clinical stage was: IV in 23 (46%) patients and III in 27 (54%) patients. Vinorelbine (VNB) was given at dose of 10 mg i.v. infusion weekly with ERT (3D conformal radiation plan). Response rate was evaluated after at least 8 doses. Response evaluation criteria in Solid Tumors (RECIST) was used to assess complete response (CR) and partial response (PR); progressive disease (PD) and stable disease (SD). Toxicity was assessed using common toxicity criteria version 3.0 (CTCV3.0). Results: 44 out of 50 patients were evaluable for response rate and toxicity. Immediate response was 90% CR. After 24 months of followup CR, PR, SD, and PD were seen in 26 (59%), 6 (13%), 7 (15%) and 6 (13%) patients respectively. Grade III mucositis and dysphagia were observed in 19 (43%) and 8 (18%) patients respectively, grade III skin rash in 14 (30%) patients, grade-II peripheral neuropathy was seen in 3 (6%) patients. Conclusion: The study showed that vinorelbine as a radiosensitizer in advanced HNC is a feasible option with acceptable toxicities. A large study is required to define its definite role.
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