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446474 tn?1446347682

HCV Patients May Be Able to Delay Therapy

HCV Patients May Be Able to Delay Therapy
By Kristina Fiore, Staff Writer, MedPage Today

SAN DIEGO -- Hepatitis C patients without significant fibrosis may be able to delay triple therapy and wait for simpler, shorter, and potentially all-oral regimens that are currently under investigation, researchers said here.

The addition of new protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis) to previous standard therapy of interferon and ribavirin have significantly boosted sustained viral response for many patients, especially for blacks and Latinos, according to Maribel Rodriguez-Torres, MD, of the Fundacion de Investigation in Rio Piedras, Puerto Rico.

But patients with less severe disease may be able to hold off until a handful of newer agents -- offering less complex regimens that potentially cut the symptomatic interferon from the mix -- come to market, possibly within the next two years, Rodriguez-Torres said during a symposium at Digestive Disease Week (DDW) here.

"This is a slowly progressing disease and most of the time we have the time and opportunity to determine what's the best [treatment strategy] for our patients," she said. "Patients without significant fibrosis should wait. Those with more advanced disease should consider therapy today."

Triple Therapy Presents Challenges

Clinicians have cited a number of challenges with triple therapy. Both new agents are only indicated for patients with genotype 1 disease -- though this comprises the majority of patients -- and they add a significant cost to treatment, Rodriguez-Torres said.

The regimen is also complex and long-lasting, with both new agents adding multiple daily pills to ribavirin's four to six pills per day and weekly interferon injections, extending for 24 to 48 weeks.

There's also an increased risk of drug-drug interactions, as both new agents inhibit the common CYP34A metabolic pathway, potentially increasing levels of other drugs metabolized that way. That list includes some statins and ACE inhibitors, which "aren't unusual drugs," Rodriguez-Torres said.

Side effects include anemia, a concern because ribavirin already lowers blood hemoglobin levels, she said. Also, telaprevir appears to cause rash in more than 50% of patients.

Instead, a "dream regimen" is a simple one with fewer pills, contains only oral agents, spans all genotypes, and is highly effective with an excellent safety and tolerability profile -- though that possibility is not that far from reality, Rodriguez-Torres said.

Improvements Are on the Horizon

"We've never had such an explosion of drug development in the last 75 years compared to what we see now in chronic hepatitis C," she said. That robust pipeline includes not only a number of protease inhibitors and NS5A inhibitors -- which are typically genotype-specific -- but also nucleoside and cyclophilin inhibitors that are pan-genotypic.

Such robustness may help keep prices down as a result of increased competition, Rodriguez-Torres said. Also, the majority of drugs in development are dosed once or twice daily and some have a much shorter duration of therapy than the current standard of 24 to 48 weeks.

Early data also have shown that it's possible to drop interferon from the regimen. Last month at the European Association for the Study of the Liver meeting Barcelona, researchers reported that high proportions of patients has sustained virologic response rates with an all-oral regimen of ribavirin plus two investigational agents, ABT-450/r, a protease inhibitor, and ABT-072, a non-nucleoside NS5B polymerase inhibitor.

Also at that meeting, an early trial showed that a combination of daclatasvir, an NS5B inhibitor, plus GS-7977, a nucleotide NS5B inhibitor, led to rapid and sustained viral response in patients with genotypes 1-3, with or without ribavirin.

Treatment Issues Remain Complex

The pressing question facing clinicians, then, has been determining who to treat and when. Rodriguez-Torres said the simple answer is to treat those with severe fibrosis now, but hold off on treating those without significant fibrosis.

But Andrew Muir, MD, clinical director of hepatology at Duke University, told MedPage Today the decision should rest largely with the patient.

"I get concerned about us being too heavy handed deciding which patients should or should not get hepatitis C treatment," he said. "Our role should be to guide patients about potential options, and those discussions can take quite a bit of time."

He noted, however, that the side effects "will be much better for these patients with future therapies. But I have had patients elect to proceed with treatment even with early-stage disease. Some have felt it was the right time for them to proceed with treatment for a number of personal reasons. Some worried if they would have stable health insurance in the future."

On the other hand, Zobair Younossi, MD, of Inova Health System in Great Falls, Va., said some of his patients actually "warehouse themselves for regimens that do not include interferon."

Muir also noted that even some advanced fibrosis patients may be eligible for watchful waiting, since not all of them will progress quickly.

"If the patient has great risks to treatment, or if the patient does not think the chance of response is good enough to take on the side effects, then delaying therapy is the right thing for that individual [advanced fibrosis] patient as well," he told MedPage Today. "If they do not take treatment, they must get aggressive about liver wellness. That means no alcohol, get in shape and lose weight if needed, and get tight control of your blood sugars if you have diabetes."


Hector
11 Responses
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Avatar universal
I faced the same decision wait vs treat now. No liver disease.  I treated out of fear.  I was also crucified on this site for bringing up the question.  If you can wait physically and psychologically I would recommend the wait.  I treated and am clear of the virus.  But I paid a very high price with triple treatment.  I could have waited physically.  But my head wanted to be rid of this virus.  My line in the sand was 24 weeks.  Even though I didn't clear previously after 12 weeks on the old regime.  Luckily my docs didn't push me as a partial responder since they really didn't know.  48 weeks was not an option for me.

Good luck to all on this site.
Helpful - 0
317787 tn?1473358451
Thank you so much for posting, this is really interesting and so helpful for people who have not responded well to anything else
I went to Dr Younoussi's office for tx.

Right on!
Dee
Helpful - 0
Avatar universal
Thanks for sharing this article Hector.  My take away is that for those who have exhausted all treatment options, it is a race against time hoping that the new treatments come out before the liver decompensates, and for those who still have treatment options but who prefer to wait for all oral/interferon free treatments, it is still a gamble.  Let's hope that the competition between drug companies is high enough to motivate them to keep prices affordable and to work together for "the cure".
Advocate1955
Helpful - 0
1797925 tn?1341096204
Great article, thanks for posting.  Daclatasvir is a NS5A inhibitor (typo perhaps?)

http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now
Helpful - 0
1652596 tn?1342011626
hector, thanks so much for posting this news.  it's very interesting.  belle
Helpful - 0
131114 tn?1380083190
thanks hector- i am hoping this is so. i will know more in august!
Helpful - 0
163305 tn?1333668571
You might want to look at this web site:
http://www.change.org/petitions/gilead-sciences-a-phase-iii-collaboration-for-the-treatment-of-hepatitis-c
Helpful - 0
Avatar universal
My wife and I have attended the last 2 HEP C conferences at Scripps. The experts who know this stuff better than I say that by 2014-2015 RVR, or cure will be in the high 90% for most HEP C patients with very limited side effects. There is a massive rush between many competiting drug companies who are investing BILLIONS to "find the cure" because of course then they will make a ton of money. I say who cares, so long as we all can get cured.....without horrible side effects. This article was entirely consistent with what I learned at the seminar in May, 2012 and you just have to pray that your disease doesnt progress too far so you can wait until 2014 or 2015 for the treatment. Thanks for the info.
Helpful - 0
446474 tn?1446347682
I certainly hope so...

:D
/█\
.Π.

Hector
Helpful - 0
2136167 tn?1374728651
Hector thank you for posting that I wonder if my doctor knows all that
Helpful - 0
Avatar universal
Thx. for posting  H

Will
Helpful - 0
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