27 Dec 2013

CME: Can.Soc.CLINICAL HYPNOSIS

CANADIAN SOCIETY OF CLINICAL HYPNOSIS (ONTARIO DIVISION) announces registration opening for: The Fundamentals of Hypnosis a two-day Introductory workshop - March 28th and 29th $575 until Feb 17th, then $625 Non-members can pay online to reserve their spot, but you still need to mail your registration form to establish eligibility. www.HypnosisOntario.com Book soon, attendance may be limited. Full details are in the attached brochure in Adobe PDF format

GILEAD: SOVALDI (Sofosbuvir) for Chr.HEP.C.

Health Canada Issues Notice of Compliance for Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C – Sovaldi Receives Marketing Authorization for Patients with Genotypes 1, 2, 3 or 4 HCV – – High Cure Rates (SVR 12) and Therapy Shortened to Just 12 Weeks for Many Patients – FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 16, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada has issued a Notice of Compliance for Sovaldi™ (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection. Sovaldi is indicated for use in adult patients with compensated liver disease, including cirrhosis, for the treatment of genotype 1 or 4 CHC in combination with pegylated interferon and ribavirin, and for the treatment of genotype 2 or 3 CHC in combination with ribavirin. The recommended dose and treatment duration for Sovaldi combination therapy is as follows: Treatment Duration Treatment-naïve patients with genotype 1 or 4 CHC Sovaldi + peginterferon alfa + ribavirin 12 weeks Patients with genotype 2 CHC Sovaldi + ribavirin 12 weeks Patients with genotype 3 CHC Sovaldi + ribavirin 16 weeks* * Consideration should be given to extending the duration of therapy beyond 16 weeks and up to 24 weeks guided by an assessment of the potential benefits and risks for the individual patient (these factors may include cirrhosis status and treatment history). Treatment regimen, duration and response to Sovaldi are dependent on viral genotype and patient population, and associated baseline factors. Sovaldi must not be administered as monotherapy. The Canadian Product Monograph is available at www.Gilead.ca. Gilead submitted the marketing application for Sovaldi in Canada on May 17, 2013 and was granted Priority Review by Health Canada. Gilead is awaiting federal and provincial reimbursement review for Sovaldi under the Canadian Common Drug Review process. Gilead anticipates that Sovaldi will be available to patients in Canada early next year. Sovaldi was approved in the United States on December 6, 2013 and applications are pending in the European Union, Australia and New Zealand, Switzerland and Turkey. “I believe sofosbuvir has the potential to transform HCV treatment in Canada as it addresses many unmet patient needs,” said Jordan Feld, MD, MPH, Staff Hepatologist, Toronto Western Hospital, Department of Medicine, Division of Gastroenterology. “The high cure rates, shortened treatment duration, and potential to eliminate or reduce interferon injections give us our best opportunity to successfully treat Canadians with hepatitis C.” An estimated 250,000 Canadians are living with chronic hepatitis C virus (HCV), but because the disease can progress for many years without causing noticeable symptoms, about 35 percent of these individuals do not know they are infected. HCV disproportionately impacts “baby boomers,” individuals born between 1945 and 1965, and the Canadian Liver Foundation now recommends that all Canadian baby boomers be tested for the virus. The current standard of care for HCV in Canada involves up to 48 weeks of therapy with a pegylated interferon (peg-IFN)/ribavirin (RBV)-containing regimen, which may not be suitable for certain types of patients. The marketing authorization is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, which evaluated 12 or 16 weeks of treatment with Sovaldi combined with either RBV or RBV plus peg-IFN. Three of these studies evaluated Sovaldi plus RBV in genotype 2 or 3 patients who were either treatment-naïve (FISSION), treatment-experienced (FUSION) or peg-IFN intolerant, ineligible or unwilling (POSITRON). NEUTRINO evaluated Sovaldi in combination with peg-IFN/RBV in treatment naïve patients with genotypes 1, 4, 5 or 6. Patients who achieve SVR12 are considered cured of HCV. Trial participants taking Sovaldi-based therapy achieved SVR12 rates of 50-90 percent. For full study details, see the Clinical Studies section of the Product Monograph. Sovaldi combination therapy was well tolerated in clinical studies. Adverse events were generally mild and there were few treatment discontinuations due to adverse events. The most common adverse reaction occurring in at least 5 percent of patients receiving Sovaldi in combination with ribavirin was fatigue. Among patients receiving Sovaldi in combination with RBV and peg-IFN, the most common adverse reactions occurring in at least 5 percent of patients were fatigue, anemia, neutropenia, insomnia, headache and nausea. See below for Important Safety Information regarding contraindications, warnings and precautions, adverse reactions and drug interactions. Patient Assistance Program in Canada As part of its commitment to ensuring that people with hepatitis C can access Sovaldi, Gilead Sciences Canada has developed the Momentum Support Program™, which will launch on January 6, 2014. The program is designed to provide an integrated offering of support services for patients and healthcare providers, including: Access to dedicated case managers to help patients and their providers with insurance-related needs, including identifying alternative coverage options such as federal and provincially-insured programs. The Sovaldi Co-pay assistance program, which will provide financial assistance for eligible patients who need help paying for out-of-pocket medication costs. For more information regarding Sovaldi or the Momentum Program in Canada, please call the Gilead Sciences Canada medical information line at 1-866-207-4267. About Sovaldi Sovaldi is an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. Sovaldi is a direct-acting agent, meaning that it interferes directly with the HCV life cycle by suppressing viral replication. Treatment regimen and duration for Sovaldi are dependent on both viral genotype and patient population. Treatment response varies based on baseline host and viral factors. Sovaldi must not be administered as monotherapy. - See more at: http://www.gilead.com/news/press-releases/2013/12/health-canada-issues-notice-of-compliance-for-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c#sthash.wY1SdSIb.dpuf

BMJ: COITUS PORTALIS

Like a virgin (mother): analysis of data from a longitudinal, US population representative sample survey BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f7102 (Published 17 December 2013) Cite this as: BMJ 2013;347:f7102 Amy H Herring, professor12, Samantha M Attard, PhD candidate23, Penny Gordon-Larsen, professor23, William H Joyner, the reverend4, Carolyn T Halpern, professor25 Author Affiliations Correspondence to: A H Herring amy_herring@unc.edu Abstract Objective To estimate the incidence of self report of pregnancy without sexual intercourse (virgin pregnancy) and factors related to such reporting, in a population representative group of US adolescents and young adults. Design Longitudinal, population representative sample survey. Setting Nationally representative, multiethnic National Longitudinal Study of Adolescent Health, United States. Participants 7870 women enrolled at wave I (1995) and completing the most recent wave of data collection (wave IV; 2008-09). Main outcome measures Self reports of pregnancy and birth without sexual intercourse. Results 45 women (0.5%) reported at least one virgin pregnancy unrelated to the use of assisted reproductive technology. Although it was rare for dates of sexual initiation and pregnancy consistent with virgin pregnancy to be reported, it was more common among women who signed chastity pledges or whose parents indicated lower levels of communication with their children about sex and birth control. Conclusions Around 0.5% of women consistently affirmed their status as virgins and did not use assisted reproductive technology, yet reported virgin births. Even with numerous enhancements and safeguards to optimize reporting accuracy, researchers may still face challenges in the collection and analysis of self reported data on potentially sensitive topics.