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Oral drug combo cures genotype-1 hepatitis-C

MD-FM Thursday October 31st, 2013 




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

P1: HEPATITIS: Interferon-free oral drug regimen cured genotype-1 hepatitis-C

PETER: Hello and with me is Sarah Maxwell. To begin with, we report from the American Association for the Study of Liver Diseases meeting held in Washington, DC this week. A new drug combination has apparently cured patients with genotype-1 hepatitis-C without using interferon, and that’s irrespective of treatment history or the presence of cirrhosis… 

SARAH: Yes, the LONESTAR study — published in The Lancet looked at one cohort of 60 treatment naïve patients and another consisting of 40 patients who had failed protease inhibitor therapy. They were all given an oral regimen combining nucleotide polymerase inhibitor sofosbuvir together with the HCV inhibitor ledipasvir and they were randomized to receive ribavirin therapy or not:

LAWITZ: “We found that 95% of patients were hepatitis-C undetectable 24 weeks after they finished therapy. This means they were cured of their hepatitis-C. The combination tablet was also well tolerated and there were no treatment discontinuations due to adverse events from the medication.” 

SARAH: That was lead study author Dr. Eric Lawitz from the Texas Liver Institute. And MDFM caught up with co-author Fred Poordad at the meeting in Washington who was looking to the future: 

POORDAD: “All oral therapies are a reality, they are coming very quickly and we should be able to achieve sustained response rates over 90% in almost every patient population in the genotype-1 category.” 

SARAH: So potentially it could be “Sayonara interferon?” Well maybe… Professor Margaret Hellard from Australia wrote a commentary The Lancet, she stressed to me that there were cost issues to be borne in mind here and she had this message for the practicing community:

HELLARD: “Start to get ready. There’s going to be a paradigm shift occurring in hepatitis-C treatment over the next couple of years where we have direct acting agents that are, simple, tolerable and patients will want them. We need to know how to be using them and we need to be working out who will be getting priority, depending on cost and government regulations. But as well as hepatologists, over the next three, five, ten years depending on cost, these medications will be able to move out more broadly into the community and into primary care. I can see a future where people don’t need to be going to a liver clinic to have their hepatitis-C managed, a well trained primary care practitioner [, a general practitioner, whatever the name is depending on the country,] will be able to manage people with hepatitis-C who don’t have advanced liver disease.” 

SARAH: That was Margaret Hellard from the Burnet Institute in Melbourne.  


P2: Adding sofosbuvir brought high response rates in genotype-3 hepatitis-C

PETER:  And during the AASLD’s late breakers session, Dr. Lawitz presented very encouraging results for the difficult to treat genotype-3 hepatitis-C who have failed interferon and ribavirin treatment. By adding sofosbuvir to this regimen, during 12 weeks, response rates skyrocketed to 83 percent, even in those with cirrhosis. These are apparently the highest response rates in the cirrhotic genotype-3 population in recent times.  


P3: Pimavanserin improved symptoms for Parkinson’s disease psychosis

PETER: For patients with Parkinson’s disease psychosis, a new drug — pimavanserin — significantly improved symptoms in a study reported in The Lancet. Everyone had an initial two weeks of a non-pharmacological intervention, based on improving social interaction between the person and their carer…

SARAH: Yes, then, 200 patients were randomized to either: the selective serotonin 5-HT2A inverse agonist or a placebo, for six weeks. After 43 days, there was a 40% improvement in psychotic symptoms in those taking pimavanserin compared to 14% with placebo.

PETER: Yes, around half of all patients with Parkinson’s experience psychosis but there isn’t any licensed first-line treatment is there?

SARAH: No there isn’t. And, as well as Parkinson’s, the authors say pimavanserin could potentially be used to treat psychotic symptoms in patients with Alzheimer's and other dementias too…

BALLARD: “The study basically showed a very significant benefit in terms of psychotic symptoms and that was both rated by independent raters, the global outcome rated by the clinicians who were treating the individuals and by their carers as reflected in their stress. So there were three independent measures really, which all showed very positive outcomes and the treatment was very well tolerated.”

SARAH: That was Clive Ballard from Kings College, London. He added that promoting social interaction benefited a lot of these patients, and that it’s a sensible thing to do before considering a pharmacological approach.


P4 : In-ambulance bivalirudin significantly improved major bleeding

PETER: For patients with ST-elevation myocardial infarction being transported to the hospital for primary percutaneous coronary intervention, jump-starting treatment — in the ambulance — using bivalirudin, significantly reduced major bleeding compared to using a heparin with optional glycoprotein 2B3A inhibitors.

SARAH: Yes, the EUROMAX study — published in the New England Journal of Medicine — randomized over 2000 patients and found that at one month there were about 60% fewer major bleeds with bivalirudin. But, this didn’t translate into fewer deaths at 30-days…

STEG: “We were a little bit disappointed not to have a mortality reduction… However, EUROMAX was fairly underpowered for mortality, so there may very well be a mortality reduction... we are monitoring 1-year mortality and we will collect this data and see whether, as seen in other studies, a bleeding reduction early on translates into a mortality reduction at one year.”

SARAH: Lead study author Professor Philippe Gabriel Steg, from Hôpital Bichat-Claude Bernard in Paris. A downside that emerged with bivalirudin treatment, however, was that the rate of ACUTE stent thrombosis was higher:

STEG: “I don’t want to belittle the issue, however, I think the absolute numbers are small, most of these events happened very early, and it’s clearly a different prognosis if you have very early stent thrombosis or late stent thrombosis… So, I think, it’s a wrinkle on our results, but it certainly does not negate the clear benefits we saw in bleeding.”

SARAH: But, in some countries — like the US — the idea of using bivalirudin out of the hospital has still not caught on:

STEG: “The system of pre-hospital care in the US is fragmented, there are often no physician in the ambulance and no trained paramedics and because there are issues with medical liability. Whereas in many in countries in Europe, especially in France, Germany, the Netherlands, Denmark… treatment is literally started out of hospital.”

SARAH: And Professor Steg added that these results should help encourage the doubters take up this early approach:

STEG: “I think it’s going to increase the use of bivarudin in the US for those who were doubters, and have a clear impact in Europe where, really, emergency physicians were looking for some evidence and, I think, we clearly address that the benefits of bivaluridin are still present in the prehospital setting and in the modern care environment.”

SARAH: Professor Philippe Gabriel Steg, from France. And I turned to Professor Tony Gershlick for a UK perspective:

GERSHLICK: “Many centres in the UK now use bivalirudin in patients as they arrive at the front door in the cath lab and it seems that’s a good thing to do. So I think its all looking in the same direction: if you want to reduce bleeding, I think most people should use bivalirudin rather than use a heparin and a IIb IIIa recpetor antagonist.”

SARAH: Tony Gershlick from University Hospitals of Leicester.


P5: Testosterone therapy linked to more adverse events after coronary angiography

PETER:  For men who have had a coronary angiography, testosterone therapy is associated with increased adverse events. That’s according to a study — published in JAMA — that looked at a group of nearly 9000 men from the verterans’ administration system in the USA…

SARAH:  Yes, and they had all had a cardiac catherterisation and found to have low serum testosterone levels. The study showed there was about a 30% increased risk of heart attack, stroke or death over about 2 years in patients who were prescribed testosterone therapy compared to those who weren’t.

HO: “In our study we found that there is an association with increased risk and this hopefully will help them have a more informed discussion for the provider and their patients about whether to start testosterone therapy and or whether to continue it for those who are already on therapy.”

SARAH: That was lead study author Dr Michael Ho from the University of Colorado, Denver. The JAMA study was an observational study and an association is not necessarily a cause, but Anne Cappolla — who wrote an editorial in JAMA — says it’s still important to be cautious:

HO: “Everyone should be thinking, before they start anything, what are the potential benefits and what are the potential risks. The marketing out there is only talking about the benefits but there are potential risks. When we’re perturbing and adding on a new hormone, the wonder is: are we doing more good or are we doing more harm or are there specific people that maybe that ratio of good to harm maybe different and we have to think about the right population.”

SARAH:  Anne Cappola, from the Perelman school of medicine at the University of Pennsylvania and associate editor of JAMA.


B1: Brain signal disruption explains hyperalgesia, in patients with fibromyalgia

PETER:  Finally, in brief:  New research indicates that a disruption of brain signals for reward and punishment contributes to increased pain sensitivity, known as hyperalgesia, in fibromyalgia patients. Results published in Arthritis & Rheumatism, suggest that this altered brain processing might contribute to widespread pain and lack of response to opioid therapy in patients with fibromyalgia.  And...


B2: Protein placental growth factor test helps distinguish pre-eclampsia from high-blood pressure

PETER:  A new test, that checks the level of protein placental growth factor — PIGF — in the blood, could help doctors identify women who'll develop preeclampsia, from those who have high blood pressure during pregnancy. That's according to a study with 625 patients showing that, a low level of PIGF — less than 100 pg/ml at less than 35 weeks of pregnancy — is associated with preeclampsia.


PETER:  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!


Previous editions


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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