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Sofosbuvir cures hepatitis C genotype 2 or 3 patients without treatment options

 MD-FM Thursday May 2nd, 2013


• Sofosbuvir with ribavirin: towards interferon free cures for HCV

• Excess long-term mortality following non-variceal upper GI bleeding

• Targeting dietary vitamin D intakes and plasma 25-hydroxyvitamin D in healthy infants

• Yoghourt reasonable means of boosting calcium intake

• Cinacalcet in chronic kidney disease: no mortality benefit

• Peri-operative SSRIs bring morbidities


GENERIQUE

 

Sarah:

MD FM — Medical News from around the world with Peter Goodwin.


P1-P2

PETER:

Hello. And with me is Sarah Maxwell.

To begin with: hepatitis C and a quantum step forward in therapy towards an era beyond interferon.


SARAH:

Yes, and four research studies using the drug sofosbuvir were presented at the Annual Meeting of the European Association for the Study of the Liver Diseases in Amsterdam, reporting the potential for interferon-free cures for Hepatitis C.

Dr Ira Jacobson told us about the, POSITRON trial treating hepatitis genotypes two and three with a combination of ribavirin and sofosbuvir in patients who — for whatever reason — couldn’t be treated with interferon, and so had no options:


IRA JACOBSON 01

The results were dramatic.  In our study we compared sofosbuvir and ribavirin to placebo pills for 12 weeks, and I would emphasise that 12 weeks is a very short duration therapy compared to earlier therapies for hepatitis C, and the sustained virologic response rate, which is really the same as cure, was 78 per cent in the active treatment group with sofosbuvir and ribavirin and, predictably, zero per cent in the control patients or placebo recipients: because hepatitis C almost never goes away by itself.

  

SARAH:

In the past all new agents had to be tried on top of interferon, which itself can cure the disease but doesn’t work well in genotypes 2 and 3 and has unpleasant side effects.  Dr Jacobson told us how sufosbuvir with ribavirin achieved high rate cure rates in difficult-to-treat patients:


IRA JACOBSON 02

When we divided the study population into the two different genotypes which have often been lumped together in the past because they’re roughly similarly responsive to interferon: genotype two only being slightly better we do find quite a difference between genotypes two and three in terms of cure in this trial and also other work that was presented at the same meeting in the past week: specifically: the cure rate in genotype two was very dramatic: 93 per cent and the genotype three it was 61 per cent so clearly there’s some differential between the two which is not reflected in the early decline of the virus because it’s very rapid in both groups all of the patients responded to the therapy in that week 12 at the end of treatment they had undetectable viral RNA in their blood which reflects very profound viral suppression.

We’ve entered a new era in the treatment of hepatitis C therapy  with the completion for the first time of phase three trials an interferon free regimen which is much better tolerated and of shorter duration is capable of curing the majority of patient and the overwhelming majority of the patients with the strain of the virus called genotype 2

 


SARAH:

Dr Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, at the Weill Medical College of Cornell University, in New York City. The paper’s written up in the New England Journal of Medicine.


PETER:

This all looks very exciting, so: is there a prospect of having a pan-genotype treatment for hepatitis C infection?


SARAH:

Well hopefully yes. Though I should say that the optimum duration of therapy is still be determined, especially in patients with cirrhosis. The New England Journal editorial comment was quite outspoken: Joost Drenth from Nijmegen’s comment article had the title: No More Room for Interferonologists!


 

JOOST DRENTH 01

 

Treatment of hepatitis C is going to change with two to three years from the standard of care as we have now with interferon ribavirin and telapovir and prosipovir the protease inhibitors to a completely new treatment with one of two or maybe three pills a day and that you can cure patients in a very high percentage and that we are going to treat patients with soposbuvir probably an other direct anti viral drug in combination with ribarvirin

 


SARAH:

Joost Drenth, Professor of Molecular Gastroenterology and Hepatology at Radboud University in  Nijmegen, The Netherlands


VIRGULE MUSICALE


P3

PETER:

Upper gastrointestinal bleeding is an indicator of trouble ahead for your patient, according to a report in PLoS Medicine.


SARAH

Yes a team from Nottingham University has reported data from 16 000 patients of long term mortality after non-variceal upper GI bleeding. They found there was an excess of deaths from both GI- and non-GI-related causes.


COLIN CROOKS

We found that there was an excess for all causes of death following a bleed for up to five years following the episode we found that over half those causes were not related to the upper gastrointestinal tract at all and were due to other comorbidities such as other types of malignancies or cardiovascular disease.

 


SARAH

The data showed that an upper GI bleed conferred an excess GI-related mortality of as much as 13 per cent, that was in the in older patients, and that mortality not related to GI causes went up by as much as 20 per cent:


COLIN CROOKS 02

We think the importance of this is that often people look at bleeds as a very dingle issue thing and that that they’re treating the cause of the bleed in the stomach. But from our study we thought there needs to be a deeper understanding of the situation that when someone’s had a bleed you need to consider whether there’s something else going on whether the bleeds a marker that a patient’s getting sicker from other things that might not necessarily be directly related to the gastrointestinal tract. 


SARAH:

Mr Colin Crooks from the Division of Epidemiology and Public Health at Nottingham University in England.


VIRGULE MUSICALE


P4

PETER:

Some welcome guidance on Vitamin D supplements for babies now. Everybody you need to give them,   but: how much is optimum? Should you be guided by the baby’s plasma levels? These questions were raised in a clinical trial reported in JAMA:


SARAH

Canadian researchers randomised 130 breast-fed babies to four different levels of supplementation to look at blood levels reached, and to assess bone health.  Supplements of 400 international units a day are widely, but higher levels have been touted as beneficial. And babies have been doing fine in many counties on the 2 000 international units a day you get in cod liver oil.


HOPE WEILER:  01

It’s fairly rare when you look in the literature for dose response studies and they’re quite powerful because if we just looked at two dosages we would only k know better than the other but is one of them actually ideal or providing any benefit in the long run  and so by having our four dosages we were able to show that regardless of whether the baby met the target of 50 or 75 nano-mols per litre there were no additional benefits to bone health so from that standpoint then the 400 international units would be sufficient.


  

SARAH:

That was Dr Hope Weiler, Associate Professor and Canada Research Chair at McGill University’s School of Dietetics and Human Nutrition.

In the same edition of JAMA Dr Steve Abrams welcomed the study findings — which he told us provide solid data to give doctors everywhere more confidence in the standard recommendations on vitamin D supplements for babies:


STEVEN ABRAMS  02

The implications are that we need to make sure that the infants are getting their 400 units per day and that this should be the goal for practitioners and that older children are getting at least 600 units per day Preliminary studies have come out suggesting remarkable benefits for vitamin D need to be confirmed in controlled trials for now we have no doubt that Vitamin D’s important, that children should take vitamin D but we should be cautious about high dose vitamin D until there’s better data

 


SARAH

Dr Steve Abrams from Baylor College of Medicine in Houston.

 

VIRGULE MUSICALE


P5

PETER:

Supplements for adults now: calcium supplements are recommended in many countries and one way of getting your calcium, that was discussed at the Experimental Biology Annual Meeting just held in Boston,  is to recommend people to have three servings of dairy food a day.


SARAH:

Yes, but the conference heard that most people don’t get anywhere near this target! So there’s room for improvement bearing in mind that dairy products can deliver most of the calcium we consume. Dennis Savaiano told us that lactose intolerance is one of the reasons some people don’t eat a lot of dairy produce.


 

Savaiano 01

About three fourth of the world population lose…seventy-five million who have the potential for intolerance if they consume to much lactose 


SARAH:

Dennis Savaiano, Professor of Nutrition at Purdue University in Indiana, USA. But he reckons yoghurt could be a solution for these glucose intolerant patients.


 

Savaiano 02

 Yogurt bacteria contain high levels of the lactose enzyme and this enzyme actually acts in the intestin to help digest the lactose. So eating yogurt is like taking a digesting enzyme supplement among with you meal. But it’s a natural approach to doing that. And there are very well controlled, double blinded clinical trials that show, that lacose intolerant individuals can consume significant amount of yogurt, in fact as much yogurt as they want without, and not have symptoms of intolerance

 

SARAH :

The good news is that, according to Prof Dennis Saviano, all yogurts seem equivalent


Savianno 03

In fact I spent several years trying to make a super yogurt. It turned out that all the yogurts were super yogurts. I couldn’t do a better one because they all work extremely well. So the data is very strong and the yogurt is very well tolerated. And it’s a great source of calcium for individuals who are looking for calcium in a diet and are lactose intolerants


SARAH:

Dennis Savaiano, Professor of Nutrition at Purdue University in Indiana, USA

 

 

PETER:

 

Finally, in brief:

Cinacalcet reduces the need for parathyroidectomy in patients with chronic kidney disease stage 5D, but it doesn’t appear to improve all-cause or cardiovascular mortality. This is according to a systematic review and meta-analysis published in PLoS Medicine that looked at the benefits and harms of calci-mimetic therapy — including mortality and adverse events — in adults with chronic kidney disease. However, the authors conclude that additional trials are unlikely to change our confidence in the treatment effects of cinacalcet.  So: plus ça change!

And...

A paper in JAMA found that receiving selective serotonin reuptake inhibitors (SSRIs) in the perioperative period was associated with a higher risk of adverse events.
The study was on half a million patients over 18 who had major surgery at 375 U.S. hospitals. Those who took SSRIs were more likely to be obese, have chronic pulmonary disease or hypothyroidism, and more likely to have depression! Patients getting SSRIs also had higher odds of dying in the hospital mortality, of bleeding,  and of needing readmission at 30 days. So if you go under the “knife” maybe the best things is the adopt the British stiff upper lip!

That's all from MDFM for now. Sarah Maxwell and I will be back with more next week, so until then, from me Peter Goodwin, goodbye!

 

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Best of Science in Nutrition 2013: Yogurt for a healthier diet (EB & IUNS 2013)

Best of Science in Nutrition 2013: Yogurt for a healthier diet (EB & IUNS 2013)
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