Background The combination of sofosbuvir and daclatasvir is a potent, pangenotypic regimen suitable for mass-scale hepatitis C treatment, especially in resource-limited countries where newer, expensive combinations are not available. This combination has been widely tested on genotype 4. However, Phase III trials of this combination in other genotypes have been cost prohibitive. With the introduction of generic, low-cost sofosbuvir and daclatasvir, large-scale studies in resource-limited countries are now possible. Methods Sofosbuvir at 400 mg and daclatasvir at 60 mg were coformulated into a fixed-dose combination (FDC) tablet (Sovodak, Rojan Pharma, Tehran, Iran). Patients from 46 centers were dosed for 12 or 24 weeks with or without ribavirin, in line with existing guidelines. Responses to treatment were evaluated 12 weeks after the end of treatment (for a sustained virological response at Week 12; SVR12). Results There were 1361 patients recruited. Overall, the patients were 21% female, with a mean age of 50 years; 39% were cirrhotic; 22% were treatment-experienced; 47% were genotype 1, 41% were genotype 3, and 2% were other genotypes. The genotype was not known in 10% of the patients. The intention-to-treat and per-protocol SVR12 rates were 94.7% and 98.8%, respectively. The safety profile was unremarkable, treatment was well tolerated, and compliance with the single-tablet regimen was excellent. Conclusions The treatment with FDC of sofosbuvir and daclatasvir achieved high SVR12 rates, equivalent to those seen in Phase III trials of other pangenotypic options, and has been conducted at a similar scale in a representative, real-world population at a cost of under $100 per patient, which makes this combination suitable for elimination protocols in resource-limited countries. Clinical Trials Registration NCT03200184.
BACKGROUND Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders with chronic abdominal pain and altered bowel habit without any organic reason. Sleep disorders may be associated to IBS. OBJECTIVE We aimed to assess sleep disturbances and depression-anxiety-stress in IBS patients. METHODS In this analytical cross sectional study from November 2013 to May 2014, A total of 123 IBS patients were recruited by simple random sampling. IBS was diagnosed using ROME-III criteria. Demographic and basic data were driven from all patients then Pittsburg Sleep Quality Index questionnaire was utilized to estimate sleep quality and DASS (depression anxiety stress scale) questionnaire was filled out for depression, anxiety and stress. RESULTS The mean age of patients was 29±9, where 48 cases (39%) were male. Twelve cases (10%) had a background disease. Types of IBS in patients were included 38% diarrhea, 42% constipation and 20% mixed. From all IBS patients 87 (71%) cases had depression, 97 (79%) patients stress, 94 (76%) patients had anxiety. Seventy-six (62%) cases of IBS patients had poor sleep quality. Simultaneously employing predictors demonstrate that gender, background disease, and type of IBS did not statistically significant. On the other hand, depression (P=0.034, OR=2.35), anxiety (P=0.011, OR=3.022), and stress (P=0.029, OR=2.77) were significantly effect on sleep quality in poor sleepers. CONCLUSION Many of IBS patients is suffering from poor sleep quality. It seems that sleep disorder should be considered and treated in this patients.
Rates based on age-adjusted incidence of colorectal cancers over a 10-year period in Kerman, the biggest province of Iran, were estimated from 2003 to 2013. Data were obtained from the population-based cancer registry unit of Kerman University of Medical Sciences (CR-KMU). Information included age, sex, city, ICD-O and year of registry. Our trend analyses cover 3.91% of the Iranian population. The data set comprised cases diagnosed from 2003 to 2013.The population of over 20 years was interpolated using 2003 and 2010 censuses. Then, truncated age-adjusted incidence rates were calculated. Increase was noted from 2003-2009 to 2010-2013 for 731 cancer cases considered in the analysis. The increases was most prominent in 2009. Totally, the frequency of the cancer was greater in males. Moreover, calculating truncated age-adjusted incidence rate indicated that the most prevalent age of colorectal incidence was in the 50-59 year age group except in 2007-2008 and 2012-2013, when greatest incidences occurred in people aged 60-69 years. Our data revealed that the incidence rates of colorectal cancer have increased over the past decade in our region of Iran.
Background:Non-alcoholic steatohepatitis (NASH) is a progressive form of nonalcoholic fatty liver disease. Several studies suggest that pentoxifylline (PTX) can improve the disease outcome.Objectives:We aimed to compare the effect of pentoxifylline with placebo on liver aminotransferases and cytokines, including interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-α), and interleukin 8 (IL-8) in patients with NASH.Patients and Methods:Thirty patients with NASH were included in the study, based on ultrasonography and 1.5-fold mean change from baseline serum levels of liver aminotransferases. Patients with NASH were randomized to receive 1200 mg PTX (the intervention group) or placebo (the placebo group) for 6 months. The serum levels of liver aminotransferases and cytokines were compared between the intervention and placebo groups, at various time points.Results:The serum levels of liver aminotransferases were significantly reduced at 3 months and at 6 months, compared with baseline, in both groups. The serum levels of IL-6 were significantly decreased, in both groups, only at 6 months, compared with baseline. Compared to the placebo group, the serum level of TNF-α was significantly decreased in the intervention group, at 6 months. The serum level of IL-8 was increased, in both groups, after 6 months, without reaching clinical significance. There was no significant difference in serum levels of liver aminotransferases and cytokines, between intervention and placebo groups.Conclusions:Decreases in the serum levels of liver aminotransferases and cytokines, in both groups, are related to low-calorie diets and exercise, rather than PTX.
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