Efficacy and safety of sofosbuvir based antiviral therapy for chronic hepatitis C infection in patients with advanced chronic kidney disease

Background: Screening studies for hepatitis C have proved that it is more prevalent in patients with renal diseases. Chronic hepatitis C infection in patients with kidney disease not only accelerates renal deterioration but also adversely effects morbidity and mortality. Availability of direct acting antiviral drugs has revolutionized treatment of hepatitis C even in difficult patients. In advanced kidney diseases, selection of treatment is difficult. Aim of this study was to evaluate the efficacy and safety of Sofosbuvir based DAAs in patients with advanced CKD.Methods: In this Quasi experimental study, CHC patients with or without cirrhosis having advance CKD (eGFR <30 ml/min per 1.73 m2) and/or on dialysis were enrolled. End points of the study were documentation of SVR 12 or discontinuation of therapy. Different regimens of oral DAAs with or without Ribavirin were used.Results: 86 patients with a median age of 53 years were enrolled. 37 patients were on maintenance dialysis and 49 were not on dialysis with eGFR <30 ml/min per 1.73 m2. Virological response was 92.68% at the end of treatment and SVR was achieved by 90.2% twelve weeks after therapy. Insomnia 14%, headache 11% and anemia 7% were main dverse effects. Mean eGFR and creatinine before and after treatment remained the same. Only 2 patients relapsed, both were on dialysis thrice weekly.Conclusions: All Sofosbuvir based regimens used for the treatment of CHC in patients with end stage renal disease are effective and well tolerated. Close follow up is advised to monitor side effects

Productivity of Clinical Trials Conducted at the Gulf Cooperative Council

Objectives: Clinical trial productivity has not been investigated in the Gulf Cooperation Council (GCC) region, including Oman, Saudi Arabia, United Arab Emirates (UAE), Qatar, Bahrain, and Kuwait. We aim to assess the productivity of clinical trials conducted in the GCC region. Specifically, we aim to estimate the number of clinical trials conducted and estimate the proportion of clinical trials conducted in the GCC countries published in peer-reviewed journals. Methods: The clinical trials registry of the U.S. National Library of Medicine (NLM) was searched for clinical trials conducted from January 2000 to October 2019. The productivity was assessed by the publication status of the trials in the registry and through the search in Medline indexed journals. Results: A total of 682 trials were found from the GCC region, with an overall trend of 4.1 trials each year. However, the clinical trial productivity from our area contributes to only 0.37% of the trials globally. When comparing the raw data, Saudi Arabia shows the highest proportion by contributing 66.6% of the clinical trials from the region (p &lt; 0.001). Oman contributed 3.5 %. After normalization to population, Qatar shows to be the highest with 42.78 trials per million. A total of 238 trials were conducted before 2016, of which 46.6% were published. Conclusion: Saudi Arabia is the leading country in clinical trial productivity in the GCC region. Countries should utilize the triple helix model to a partnership with industry and improve their contribution to science. Keywords: Productivity; Clinical Trials; Publication; Oman; Gulf Cooperative Council

Tenofovir-induced Leukocytoclastic Vasculitis

Tenofovir, a nucleotide analog, is one of the first-line medications recommended for the treatment of active chronic hepatitis B virus infection (CHB) and as a primary prophylaxis to prevent hepatitis B reactivation in cases of immunosuppression. We report the first case of tenofovir-induced leukocytoclastic vasculitis (LCV). A 43-year-old obese woman, who was known to have inactive CHB, was diagnosed with chronic immune thrombocytopenic purpura (ITP). She was treated with corticosteroid therapy and was put on tenofovir to prevent hepatitis B virus reactivation. A month later, she developed a skin rash, described as non-blanchable well-defined erythematous to violaceous papules and targetoid patches in her lower extremities. A skin biopsy showed features of LCV. The rash resolved completely within few days after replacing tenofovir with entecavir

Glycated hemoglobin (HbA1c) as diagnostic criteria for diabetes: the optimal cut-off points values for the Pakistani population; a study from second National Diabetes Survey of Pakistan (NDSP) 2016–2017

Aim Glycated hemoglobin (HbA1c) cut-off values as diagnostic tool in diabetes and prediabetes with its concordance to oral glucose tolerance test (OGTT) in Pakistani population.Methodology Data for this substudy was obtained from second National Diabetes Survey of Pakistan (NDSP) 2016–2017. With this survey, 10 834 individuals were recruited and after excluding known subjects with diabetes, 6836 participants fulfilled inclusion criteria for this study. Demographic, anthropometric and biochemical parameters were obtained. OGTT was used as standard diagnostic tool to screen population and HbA1c for optimal cut-off values. Participants were categorized into normal glucose tolerance (NGT), newly diagnosed diabetes (NDD) and prediabetes.Results Out of 6836 participants, 4690 (68.6%) had NGT, 1333 (19.5%) had prediabetes and 813 (11.9%) had NDD by OGTT criteria with median (IQR) age of 40 (31–50) years. Optimal HbA1c cut-off point for identification of diabetes and prediabetes was observed as 5.7% ((AUC (95% CI)=0.776 (0.757 to 0.795), p&lt;0.0001)) and 5.1% ((AUC (95% CI)=0.607 (0.590 to 0.624), p&lt;0.0001)), respectively. However, out of 68.6% NGT subjects identified through OGTT, 24.1% and 9.3% participants were found to have prediabetes and NDD, respectively by using HbA1c criteria. By using both OGTT and HbA1c criteria, only 7.9% and 7.3% were observed as prediabetes and diabetes, respectively.Conclusion Findings from second NDSP demonstrated disagreement between findings of OGTT and HbA1c as diagnostic tool for Pakistani population. As compared with international guidelines, HbA1c threshold for prediabetes and NDD were lower in this part of world. HbA1c as diagnostic tool might require ethnic or regional-based modification in cut-off points, validated by relevant community-based epidemiological surveys