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.

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Background: The effects of probiotics on ulcerative colitis has still remained a contraversy. The aim of this study was to assess the effects of Lactobacillus casei strain ATCC PTA-3945 in treating ulcerative colitis. Materials and Methods: Thirty four patients with mild to moderately active ulcerative colitis randomly received a probiotic preparation of L. casei strain ATCC PTA-3945 (n = 17) or its placebo (n = 17) plus conventional medical therapy for their active disease. After a maximum of 2 months, remitted patients were again randomised to receive L. casei strain ATCC PTA-3945 or placebo, and also maintained on mesalazine or sulfasalazine tablets for a maximum of 6 months. Results: The numbers of patients achieving remission did not statistically differ between probiotic and placebo groups (82% vs. 76% at intention to treat analysis [P = 1.00], and 100% vs. 81.2% at per-protocol analysis [P = 0.23], respectively). The mean time to clinical remission were 25 days and 32 days in probiotic and placebo groups, respectively (P = 0.11). Relapse rates also did not significantly differ between probiotic and placebo groups (14.3% vs. 26.7% at ITT analysis [P = 0.65] and 16.7% vs. 33.3% [P = 0.64], respectively). Mean time to relapse were 96 days and 74 days in the probiotic and the placebo group, respectively (P = 0.51). Conclusion: The results of this preliminary study showed no significant effect by using L. casei strain ATCC PTA-3945 probiotic in the treatment of ulcerative colitis patients.

The present study aimed to explore the validity and reliability of the Persian version of the Youth Anxiety Measure for DSM-5 (YAM-5). Two groups of non-clinical children and adolescents were recruited. The first group (n = 520) was recruited via 4 schools of Tehran, Iran, and only completed the YAM-5. The second group (n = 557) was recruited via 4 schools of Tabriz, Iran. In addition to the YAM-5, they completed another anxiety scale and a depression scale. The exploratory factor analysis of data of the first group revealed a five factor model similar to the original model of the scale. The confimatory factor analysis showed that the five factor model fit with the data of second group. Also, the convergent validity was supported. The current findings, thus, provide support for validity and reliability of Persian version of the YAM-5 in a nonclinical sample of children and adolescents in Iran.