AIMTo study impact of baseline mental health disease on hepatitis C virus (HCV) treatment; and Beck’s Depression Inventory (BDI) changes with sofosbuvir- and interferon-based therapy.METHODSThis is a retrospective cohort study of participants from 5 studies enrolled from single center trials conducted at the Clinical Research Center of the National Institutes of Health, Bethesda, MD, United States. All participants were adults with chronic HCV genotype 1 infection and naïve to HCV therapy. Two of the studies included HCV mono-infected participants only (SPARE, SYNERGY-A), and 3 included human immunodeficiency virus (HIV)/HCV co-infected participants only (ERADICATE, PFINPK, and ALBIN). Patients were treated for HCV with 3 different regimens: Sofosbuvir and ribavirin in the SPARE trial, ledipasvir and sofosbuvir in SYNERGY-A and ERADICATE trials, and pegylated interferon (IFN) and ribavirin for 48 wk in the PIFNPK and ALBIN trials. Participants with baseline mental health disease (MHD) were identified (defined as either a DSM IV diagnosis of major depression, bipolar disorder, schizophrenia, generalized anxiety, and post-traumatic stress disorder or requiring anti-depressants, antipsychotics, mood stabilizers or psychotropics prescribed by a psychiatrist). For our first aim, we compared sustained virologic response (SVR) and adherence (pill counts, study visits, and in 25 patients, blood levels of the sofosbuvir metabolite, GS-331007) within each study. For our second aim, only patients with HIV coinfection were evaluated. BDI scores were obtained pre-treatment, during treatment, and post-treatment among participants treated with sofosbuvir-based therapy, and compared to scores from participants treated with interferon-based therapy. Statistical differences for both aims were analyzed by Fisher’s Exact, and t-test with significance defined as a P value less than 0.05.RESULTSBaseline characteristics did not differ significantly between all participants with and without MHD groups treated with sofosbuvir-based therapy. Among patients treated with sofosbuvir-based therapy, the percentage of patients with MHD who achieved SVR was the same as those without (SPARE: 60.9% of those MHD compared to 67.6% in those without, P = 0.78; SYNERGY-A: 100% of both groups; ERADICATE: 100% compared to 97.1%). There was no statistically significant difference in pill counts, adherence to study visits between groups, nor mean serum concentrations of GS-331007 for each group at week 2 of treatment (P = 0.72). Among patients with HIV co-infection, pre-treatment BDI scores were similar among patients treated with sofosbuvir, and those treated with interferon (sofosbuvir-based 5.24, IFN-based 6.96; P = 0.14); however, a dichotomous effect on was observed during treatment. Among participants treated with directly acting antiviral (DAA)-based therapy, mean BDI scores decreased from 5.24 (pre-treatment) to 3.28 during treatment (1.96 decrease, P = 0.0034) and 2.82 post-treatment. The decrease in mean score from pre- to post-treatment was stat...

In 2010, Haiti suffered from a devastating earthquake; data on the impact on the tuberculosis (TB) epidemic are limited. From January to June 2013, we conducted active case finding at the household level in a slum in Port-au-Prince. Community health workers identified individuals with cough ≥ 2 weeks, and referred them for evaluation. Contact tracing was conducted for patients with active TB. Of an estimated 7,500 residents screened, 394 (5%) had cough and were tested for TB. One hundred (25%) were diagnosed with active TB; 53 (53%) were smear positive. Ninety of these TB index cases provided 317 contacts, and 44 (14%) were diagnosed with active TB; 17 (39%) were smear positive. Overall, 144 TB cases were detected in 6 months (1,920/100,000; national estimate 200/100,000). We found a high burden of undiagnosed TB in Port-au-Prince 3 years after the earthquake. Further assessment of the burden of TB is indicated.

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Outcomes of acute lymphoblastic leukemia (ALL) in older adults treated with chemotherapy are poor. The CD19/CD3 bispecific T-cell engager (BiTE) antibody blinatumomab is approved for refractory, relapsed or minimal/measurable residual disease (MRD)-positive B-cell ALL, but there is little experience in the upfront setting, including in older patients. We retrospectively analyzed outcomes of blinatumomab monotherapy in five newly diagnosed Philadelphia chromosome-negative B-cell ALL patients over 70 years. Three had cytokine release syndrome, treated with dexamethasone and/or tocilizumab, and four patients had neurotoxicity, treated with dexamethasone, without blinatumomab interruption. All five achieved complete remission (CR) after cycle one, three with undetectable MRD. All five were alive at 8 to 15 months. Three remained in MRD-negative CR. Two relapsed after cycle 3, one with extramedullary disease. In our small cohort of patients over 70 years, blinatumomab was safe initial therapy and produced a high response rate.

BACKGROUND: Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis, are among several chronic conditions approved for treatment with medical marijuana. Although evidence based on observational and animal studies is minimal, it is suspected that modulation of endocannabinoid receptors may improve inflammation and therefore symptoms associated with IBD. Individuals increasingly use the internet to gain information about alternative therapies. However, there are no studies that have evaluated online resources addressing medical marijuana and IBD. The study evaluated the readability and quality of online information readily accessible to patients and assessed the therapeutic claims, precautionary warnings, and evidence to support the use of cannabis in IBD. METHODS: A Google search using the terms “Marijuana IBD” was performed. Exclusion criteria included all veterinarian websites, duplicates and those which were non-accessible. Websites were then categorized by intended audience, either professional or consumer. Readability was determined using the validated Flesch-Kincaid Grade Level Calculation. The validated DISCERN questionnaire was used to assess quality, with scores rated as Excellent 66–75, Very Good 56–65, Good 46–55, Average 36–45, or Poor ≤35. Websites were reviewed for therapeutic claims, inclusion of references, precautionary information about marijuana use and whether they discussed approved treatments for IBD. Statistical analysis using a 2-tailed Fisher's Exact Test and a Two Sample T-test were used with a P-value set at <0.05. RESULTS: 100 websites were assessed with 89 websites meeting criteria for analysis. 75 (84%) were intended for consumers and 14 (16%) were for medical professionals. The average Flesch-Kincaid Grade level was 13.3, with no significant difference (P = 0.41) between consumer (13.2 grade level) and professional (14.0 grade level) websites. Quality was rated as “Average” (mean DISCERN score 42.6), with no significant difference (P = 0.08) based upon intended audience. Consumer websites offered significantly more (P = 0.04) claims of improvement in disease pathology and less frequently listed references (P = 0.002) than websites geared towards medical professionals. There was no significant difference between consumer and professional focused websites in the discussion of the approved therapy (P = 0.38). 19 of 89 (21.3%) websites included precautionary information regarding marijuana use in IBD with no significant difference in consumer sites compared to those for medical professionals (P = 0.17). CONCLUSION(S): This study demonstrated that a multitude of online resources exist with information on medical marijuana as alternative therapy for IBD patients. The majority of these websites were intended for consumers, however their readability grade level exceeds the National Institutes of Health 6th grade recommended reading level for medical information. While the quality of information was considered “Average” using a validated measure, there was variability in available evidence-based references and inconsistency in the inclusion of precautionary information as well as the therapeutic claims made by different websites. It is critical that readily available online information about cannabis therapy in IBD be readable, evidence-based and comprehensive in order to allow for informed medical decisions.