Saturday, August 25, 2018

No Amount Of Alcohol Is Good For Your Health

NPR - Heard on All Things Considered
The Latest Scientific Advice On Drinking Alcohol: Don't
A new study published in The Lancet finds alcohol is associated with 2.8 million deaths each year worldwide. Researchers conclude that there is no safe level of alcohol and say the risks outweigh the potential benefits
Source: https://www.npr.org/2018/08/24/641706025/the-latest-scientific-advice-on-drinking-alcohol-dont




Article
No Amount Of Alcohol Is Good For Your Health, Global Study Says
August 24, 20183:42 PM ET
Samantha Raphelson
No amount of alcohol is safe, according to The Global Burden of Diseases study, which analyzed levels of alcohol use and its health effects in 195 countries from 1990 to 2016.
Source: https://www.npr.org/2018/08/24/641618937/no-amount-of-alcohol-is-good-for-your-health-global-study-claims

The Lancet
Alcohol use and burden for 195 countries and territories, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016
Open Access
Published: August 23, 2018
DOI:https://doi.org/10.1016/S0140-6736(18)31310-2

Linked Article
No level of alcohol consumption improves health
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Summary
Background
Alcohol use is a leading risk factor for death and disability, but its overall association with health remains complex given the possible protective effects of moderate alcohol consumption on some conditions. With our comprehensive approach to health accounting within the Global Burden of Diseases, Injuries, and Risk Factors Study 2016, we generated improved estimates of alcohol use and alcohol-attributable deaths and disability-adjusted life-years (DALYs) for 195 locations from 1990 to 2016, for both sexes and for 5-year age groups between the ages of 15 years and 95 years and older.

Methods
Using 694 data sources of individual and population-level alcohol consumption, along with 592 prospective and retrospective studies on the risk of alcohol use, we produced estimates of the prevalence of current drinking, abstention, the distribution of alcohol consumption among current drinkers in standard drinks daily (defined as 10 g of pure ethyl alcohol), and alcohol-attributable deaths and DALYs. We made several methodological improvements compared with previous estimates: first, we adjusted alcohol sales estimates to take into account tourist and unrecorded consumption; second, we did a new meta-analysis of relative risks for 23 health outcomes associated with alcohol use; and third, we developed a new method to quantify the level of alcohol consumption that minimises the overall risk to individual health.

Findings
Globally, alcohol use was the seventh leading risk factor for both deaths and DALYs in 2016, accounting for 2·2% (95% uncertainty interval [UI] 1·5–3·0) of age-standardised female deaths and 6·8% (5·8–8·0) of age-standardised male deaths. Among the population aged 15–49 years, alcohol use was the leading risk factor globally in 2016, with 3·8% (95% UI 3·2–4·3) of female deaths and 12·2% (10·8–13·6) of male deaths attributable to alcohol use. For the population aged 15–49 years, female attributable DALYs were 2·3% (95% UI 2·0–2·6) and male attributable DALYs were 8·9% (7·8–9·9). The three leading causes of attributable deaths in this age group were tuberculosis (1·4% [95% UI 1·0–1·7] of total deaths), road injuries (1·2% [0·7–1·9]), and self-harm (1·1% [0·6–1·5]). For populations aged 50 years and older, cancers accounted for a large proportion of total alcohol-attributable deaths in 2016, constituting 27·1% (95% UI 21·2–33·3) of total alcohol-attributable female deaths and 18·9% (15·3–22·6) of male deaths. The level of alcohol consumption that minimised harm across health outcomes was zero (95% UI 0·0–0·8) standard drinks per week.

Interpretation
Alcohol use is a leading risk factor for global disease burden and causes substantial health loss. We found that the risk of all-cause mortality, and of cancers specifically, rises with increasing levels of consumption, and the level of consumption that minimises health loss is zero. These results suggest that alcohol control policies might need to be revised worldwide, refocusing on efforts to lower overall population-level consumption.

Funding Bill & Melinda Gates Foundation.
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Observational Data: Drinking coffee can be part of a healthy diet

Cleveland Clinic Reports
New research says you can drink as much as eight cups a day.
Cleveland Clinic’s Julia Zumpano, RD, did not take part in the research, but says the study showed that regular ground coffee had the most benefit. The researchers noted their results were based on observational data and should be interpreted with caution. “Nevertheless, these results provide further evidence that coffee drinking can be part of a healthy diet and may provide reassurance to those who drink coffee and enjoy it,” the authors concluded. Complete results of the study can be found in JAMA Internal Medicine.
July 2017
Observational evidence published in Annals of Internal Medicine
Journal Review - Richard Lehman
Coffee: wake up and smell the confounding
Two big observational studies suggest that coffee drinking is associated with longevity. You drink coffee, and would like to believe good things about coffee. So your first instinct, as you sip the aromatic liquid and feel the caffeine buzz, is to rejoice. But you are a scientist: look closer. The first study is of the EPIC cohort, where E stands for European. Over half a million Europeans recorded their coffee consumption on one occasion. Those who claimed to drink the most had a slightly higher rate of survival at 16.4 years than those who said they did not drink coffee. There was a markedly lower rate of death from gastrointestinal causes. Epidemiologically, it’s quite intriguing, but I defy anyone to conduct a randomised trial for a sufficient length of time. So at best we can say that coffee drinking is unlikely to be harmful. The same message emerges from a study of 185 855 Americans of mixed ethnicity, after adjustment for confounders. The coffee drinkers were a bit less likely to die over a period of 16 years, compared with non-coffee-drinkers. Don’t let your coffee get cold while you muse on these matters. Observational evidence is observational evidence and will never be anything more.
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Friday, August 24, 2018

Treatment in HCV genotype 1b patients with advanced fibrosis and cirrhosis

PLoS One. 2018 Aug 23;13(8):e0202777. doi: 10.1371/journal.pone.0202777. 

Hepatic decompensation during paritaprevir/ritonavir/ombitasvir/dasabuvir treatment for genotype 1b chronic hepatitis C patients with advanced fibrosis and compensated cirrhosis.
Hsieh YC1, Jeng WJ1,2,3, Huang CH1,2, Teng W1, Chen WT1, Chen YC1,2, Lin SM1,2,3, Tai DI1,2, Lin CY1,2, Sheen IS1,2.

Full Text

Abstract
BACKGROUND AND AIM: 
Hepatic decompensation is a severe on-treatment adverse event for chronic hepatitis C treated with paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD). Till now, few papers regarding on-treatment hepatic decompensation have been reported. The study aims to analyze the general feature and predictive factors of on-treatment hepatic decompensation in hepatitis C virus (HCV) genotype 1b-infected patients with advanced fibrosis and compensated cirrhosis who receive treatment with PrOD.

METHODS: A real-word cohort enrolled 189 HCV genotype 1b patients with advanced fibrosis and compensated cirrhosis treated with 12-week PrOD. Clinical and laboratory data were analyzed between patients with and without on-treatment hepatic decompensation.

RESULTS: The sustained virologic response rate at 12 weeks after treatment was 97.3% in HCV subtype 1b patients with advanced fibrosis and cirrhosis. On-treatment hyperbilirubinemia (total bilirubin >2 mg/dL) occurred in 27 (14.3%) patients, and the incidence of the increase of total and direct form bilirubin was significantly different during treatment between patients with Child-Turcotte-Pugh score 5 and score 6. Five (18.5%) hyperbilirubinemia patients progressed to hepatic decompensation. Older age (adjusted OR: 1.2, 95% CI: 1.0-1.4) and albumin ≤3.6 g/dL (adjusted OR: 10.4, 95% CI: 1.3-81.2) may be two predictors for on-treatment hepatic decompensation by multivariate analysis.

CONCLUSIONS: PrOD is an effective direct-acting antiviral agent for antiviral therapy in HCV genotype 1b patients with advanced fibrosis and cirrhosis. Hyperbilirubinemia is possibly the early warning feature of on-treatment hepatic decompensation. This serious adverse event of on-treatment hepatic decompensation is not common. Older age and low baseline albumin level may be predictive factors.


PMID: 30138456 DOI: 10.1371/journal.pone.0202777
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Frequent antiviral treatment failures in patients infected with hepatitis C virus genotype 4

Hepatology. 2018 Aug 19. doi: 10.1002/hep.30225. [Epub ahead of print]

Frequent antiviral treatment failures in patients infected with hepatitis C virus genotype 4, subtype 4r.
Fourati S1,2, Rodriguez C1,2, Hézode C2,3, Soulier A1,2, Ruiz I2,3, Poiteau L1,2, Chevaliez S1,2, Pawlotsky JM1,2.

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Abstract
Hepatitis C virus (HCV) genotype 4 is highly heterogeneous. HCV subtype 4r has been suggested to be less responsive to direct-acting antiviral (DAA) drug treatment than other genotype 4 subtypes. Among 537 DAA-treated patients who experienced a virological failure in France between 2015 and 2018, 121 (22.5%) were infected with genotype 4 and 27 of them (22.3%) with subtype 4r; subtype 4r was thus over-represented as compared to its prevalence in the French general population. Population sequencing of the NS3, NS5A and NS5B genes was performed in all subtype 4r patients at treatment failure and in 6 of them at baseline, while full-length HCV genome sequencing was performed in 2 baseline and 3 treatment failure samples by means of an original shotgun metagenomics method based on deep sequencing. At treatment failure, all subtype 4r patients harbored 2 to 3 dominant NS5A resistance-associated substitutions (RASs), including at least L28A/C/I/M/V and L30R. Among 13 patients exposed to sofosbuvir and an NS5A inhibitor (daclatasvir, ledipasvir or velpatasvir), 5 (38.5%) also harbored NS5B S282C/T RASs at treatment failure. An additional patient harbored S282C/T RASs at treatment failure by deep sequencing. The prevalence of S282C/T RASs at treatment failure was significantly higher in patients infected with genotype 4r than with other genotypes, including other subtypes of genotype 4.

CONCLUSION: 
The lower rates of SVR in patients infected with subtype 4r are related to the frequent preexistence at treatment baseline and subsequent selection by DAA treatment of both NS5A and NS5B S282 RASs. Our study suggests that these patients should be identified and receive a triple DAA combination regimen as first-line treatment. 

This article is protected by copyright. All rights reserved.

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PMID: 30125371 DOI: 10.1002/hep.30225
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Thursday, August 23, 2018

CLD Updates: Hepatitis B Diagnosis, Treatment, HBV in Pregnancy And Guidelines

CLD Updates
Review the following hepatitis B articles in the latest issue of Clinical Liver Disease (CLD) available on Wiley Online Library. CLD is an official digital educational learning resource from the American Association for the Study of Liver Diseases. Visitors are able to watch author interviews, access full-text articles, and download files in either HTML or PDF formats.

Reviews
Hepatitis B
Tram Tran, MD 
Bo Hyun Kim , M.D., W. Ray Kim , M.D.
Pages: 1-4 | First Published: 22 August 2018
Watch a video presentation of this article

Kathy Jackson , B.App.Sci., Stephen Locarnini , M.B.B.S, Ph.D., B.Sc. (Hons), F.R.C. (Path), Robert Gish , M.D. 
Pages: 5-11 | First Published: 22 August 2018
Watch a video presentation of this article
Watch the interview with the author

Marc G. Ghany , M.D., M.HSc., Timothy M. Block , Ph.D. 
Pages: 12-18 | First Published: 22 August 2018
Watch a video presentation of this article

Joseph C. Ahn M.D., Joseph Ahn M.D., M.S., F.A.A.S.L.D., F.A.C.G., A.G.A.F.
Pages: 19-23 | First Published: 22 August 2018
Watch a video presentation of this article
Watch the interview with the author 

Tatyana Kushner M.D., M.S.C.E., Monika Sarkar M.D., M.A.S.
Pages: 24-28 | First Published: 22 August 2018
Watch a video presentation of this article 

Brian J. McMahon M.D. 
Pages: 29-32 | First Published: 22 August 2018
Watch a video presentation of this article 

Norah A. Terrault, Anna S. F. Lok, Brian J. McMahon, Kyong‐Mi Chang, Jessica P. Hwang, Maureen M. Jonas, Robert S. Brown Jr, Natalie H. Bzowej, John B. Wong 
Pages: 33-34 | First Published: 22 August 2018
Watch a video presentation of this article
Watch the interview with the author

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Wednesday, August 22, 2018

Drop in Aussies seeking hepatitis C cure

More than 170,000 Australians are able to access subsidised medication to cure Hepatitis C but the number of people choosing to do so is declining.

Chief investigator Margaret Hellard told AAP she hopes to see 15,000 people a year accessing treatment to reduce the number of people dying and the rate of transmission.

Ensuring health practitioners are aware of the treatment, who is eligible and how to treat patients with hepatitis C is also part of the plan, being launched by Health Minister Greg Hunt in Canberra on Wednesday night.

It's hoped the partnership will result in a 65 per cent reduction in hepatitis C related deaths and an 80 per cent reduction in new infections....


Source: AAP
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Toxin at heart of drug recall shows holes in medical safety net

August 22, 2018

Toxin at heart of drug recall shows holes in medical safety net 
Alexandra Harney, Ben Hirschler
SHANGHAI/LONDON (Reuters) - A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.

China’s Zhejiang Huahai Pharmaceutical (600521.SS), which produces bulk ingredients for drugmakers, told its customers in late June it had found NDMA in its valsartan, an off-patent blood pressure drug originally developed by Novartis (NOVN.S). The discovery means that some of the 10 billion pills containing valsartan sold worldwide last year to prevent heart attacks and strokes had traces of N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen. No one has been reported as sickened by the toxin, once used in the production of liquid rocket fuel... 

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Tuesday, August 21, 2018

Hepatitis C - Adverse events from DAAs can persist for months after treatment

Of Interest
March 14, 2018
March 24, 2018
May 30, 2018

Article
Adverse events from DAAs can persist for months after treatment, study finds
Liz Meszaros, MDLinx | August 21, 2018
Adverse events (AEs) related to treatment with direct-acting antivirals (DAAs) may persist after treatment in a significant number of patients with chronic hepatitis C, according to results from a study published in the European Journal of Gastroenterology and Hepatology. Clinicians and patients should be aware of this possibility.

 Abstract: Outcome and adverse events in patients with chronic hepatitis C treated with direct-acting antivirals: a clinical randomized study

“This real-life study is to the best of our knowledge the first to examine the rate of AEs in patients with hepatitis C virus (HCV) genotype (GT) 1 infection, randomized to one of two different DAA regimens in a real-world setting,” noted these authors, led by Christina Sølund, MD, PhD, Department of Infectious Diseases and Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark.

Recently, the development of DAA agents has revolutionized the treatment of chronic hepatitis C, which is estimated to affect more than 70 million people worldwide. Before the advent of DAAs, the standard of care for these patients consisted of treatment with pegylated-interferon and ribavirin (RBV), lasting for 24 to 48 weeks, which not only had significantly lower cure rates and tolerability, but also carried a high incidence of severe AEs.

Now in their second iteration, DAAs have changed the playing field in the treatment of chronic hepatitis C by directly targeting the proteins responsible for viral replication. Improved sustained virologic responses (SVR) of 90% or more and good tolerability and efficacy in patients who have historically been difficult to treat—such as those with liver cirrhosis, liver transplantation, or previous treatment failures—have characterized the second-generation DAAs.

Few studies, however, have compared different DAA regimens. For this reason, Dr. Sølund and colleagues conducted their investigation. They included 96 patients with chronic hepatitis C with either GT1 or GT3, who were randomized to two different treatment arms. The first was comprised of 72 patients infected with GT1, who were treated for 12 weeks with ledipasvir/sofosbuvir/RBV vs paritaprevir/ombitasvir/ritonavir/dasabuvir/RBV. The second group consisted of 24 patients infected with GT3, who were treated with daclatasvir/sofosbuvir/RBV for 12 weeks vs a 24-week course of sofosbuvir/RBV.

Unfortunately, due to a change in national treatment guidelines, the GT3 treatment arm was prematurely terminated. Therefore, efficacy data are available from both GT3 and GT1 patients, but the incidence of AEs is available only for GT1 patients.

Cure was achieved by 97% of GT1 patients and 83% of GT3 patients, with SVR at 12 months. Virologic failure occurred in only one G3 patient.

Adverse events occurred in 97% of GT1 patients with the most common being anemia, fatigue, and headache.

“We found no statistically significant difference in AEs, neither between treatment groups nor in relation to anemia or cirrhosis. The overall rate of AEs was comparable to other real-world studies, but the frequency of the most common AEs, such as anemia (78%), fatigue (74%), headache (74%), pruritus/eczema (46%), and heartburn/abdominal discomfort (38%), was higher in our study,” they added.

Only 3% of GT1 patients discontinued treatment due to AEs. Notably, 45% of patients with AEs thought to be related to a DAA regimen still manifested the AEs at 4 weeks after treatment. At 12 weeks this was still the case in 11% of patients.

“We consider this an important finding that can be used when informing the patient about AEs that might be caused by the DAA regimen, despite the number of patients included in our study being relatively small,” noted the authors. “The low discontinuation rate reflects that AEs possibly induced by DAA treatment are rarely treatment limiting, even when DAA treatment is given in combination with RBV,” they concluded.

This study received support from the Faculty of Health and Medical Sciences, University of Copenhagen and from Hvidovre Hospital Research Foundation, the Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, the Capital Region of Denmark’s Research Foundation, the Innovation Fund Denmark project 060-2009-3, the Novo Nordisk Foundation, and the Danish Research Council.

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