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Infergen/Actimmune/ribavirin trials for PEG nonresponders
I got lucky. I was invited to a dinner in NYC put on by InterMune, the makers of Infergen and Actimmune (gamma interferon). The speaker was Dr. Larry Blatt, who helped invent the Infergen molecule. Because of the astonishing potential of their early trials (65% EVR), they're going to do a full-scale trial that includes ribavirn, for an entire 48 weeks, geared toward PEG nonresponders. The best part - NO PLACEBO. Everyone gets a potential SVR dose of all drugs. There is growing evidence that ribavirin may play an important role in the early phase of treatment.
This info has not yet been announced on InterMune's website, and probably won't be for a while. I'm hoping I'll also find out recruitment info early too, so I'm building a list of people who have not responded to PEG who may be interested in participating in this trial.
You can get the details at:
http://www.mkandrew.com
This info has not yet been announced on InterMune's website, and probably won't be for a while. I'm hoping I'll also find out recruitment info early too, so I'm building a list of people who have not responded to PEG who may be interested in participating in this trial.
You can get the details at:
http://www.mkandrew.com
What an awesome idea, a national pt registry so stats like mine can be accessed by any researcher. can you imagine all the pharmaceuticals playing together nicely?
What a task to achieve, but how priceless the data could be. The general population not on clinical trials also included in stats. Even better if all hcv infected with all alt tx or lack of also registered.
I have a dream....
What a task to achieve, but how priceless the data could be. The general population not on clinical trials also included in stats. Even better if all hcv infected with all alt tx or lack of also registered.
I have a dream....
Hi Scott - I agree with you completely: warts and all, combo tx is the best medicine we've got and I'm very grateful to have been one of the lucky few who had access it. Navigating uncertainty is definitely one of the challenges of this disease and, as you point out, one doesn't have to go very far to get to the edge of what's currently known.
Our decisions aren't made any easier by incomplete studies. For example, regarding the value of extended tx, it may well be true that more than 48-weeks has value, particularly for late-responders, but IMHO the patient data to support this is not in yet. In the two studies you cited above, the Drusano one is based on extrapolating 48-week results (no patient actually did more than 48) and the Brouwer one is a publication of a 96-97 study that's been around for a while as an abstract. While interesting, it doesn't compare 12 vs 18 months, which is the main question for 1s!(though a 15% response rate at 18 months is better than the 28% reported by <a href="http://www.hivandhepatitis.com/2003icr/38easl/docs/032103b.html">Balan</a>).
One thought I've been mulling over for a while is that a voluntary patient registry, whereby patients provide access to their records to a central clearinghouse, would supply much more data. To maintain credibility, the records would need to be screened by a nurse/pa volunteer and there's the costs of hosting the database, maintaining privacy, etc. For example, discounting the applicability to the US population of studies like <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14996350">Kasahara ety al</a>, which showed a huge difference in mortality rate for those who benefit from SVR, would be a lot harder in the presence of a large-scale patient registry.
Our decisions aren't made any easier by incomplete studies. For example, regarding the value of extended tx, it may well be true that more than 48-weeks has value, particularly for late-responders, but IMHO the patient data to support this is not in yet. In the two studies you cited above, the Drusano one is based on extrapolating 48-week results (no patient actually did more than 48) and the Brouwer one is a publication of a 96-97 study that's been around for a while as an abstract. While interesting, it doesn't compare 12 vs 18 months, which is the main question for 1s!(though a 15% response rate at 18 months is better than the 28% reported by <a href="http://www.hivandhepatitis.com/2003icr/38easl/docs/032103b.html">Balan</a>).
One thought I've been mulling over for a while is that a voluntary patient registry, whereby patients provide access to their records to a central clearinghouse, would supply much more data. To maintain credibility, the records would need to be screened by a nurse/pa volunteer and there's the costs of hosting the database, maintaining privacy, etc. For example, discounting the applicability to the US population of studies like <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14996350">Kasahara ety al</a>, which showed a huge difference in mortality rate for those who benefit from SVR, would be a lot harder in the presence of a large-scale patient registry.
as best I can tell, the origin of "12-week rule" goes back at least to the Neumann, Perelson <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9756471">Science,'98</a> paper that first characterized HCV viral kinetics and weighs in with a whopping 379 citations. By adapting a simple mathematical model for viral replication and fitting it to observed data the authors provided estimates of virion half-life and production which have remained largely unchanged. A key finding was that rapid decline in viral load is predictive of the effectiveness of ifn therapy. This finding has been confirmed over and again. One of the most influential studies is the <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12939591">Davis , et al</a> paper that retrospectively analyzed the Manns peg-intron data. From Tables 1 of that paper, of 511 patients on a peg+800mg regime 131 did not have a 2 log drop by week 12 and of those <em>none</em> reached SVR. From Table 4, of 188 patients on a peg+10.6mg/kg regime, 45 did not reach a 2-log drop by week 12 and again none reached SVR. The predictive value of early viral response has been reinforced in other ways. Neumann's <a href="http://www.natap.org/2003/AASLD/day3_2.htm">presentation</a> at last Oct's AASLD showed that, at the cost of 3-5 VL tests during the first 4 weeks, you could obtain the same strong negative predictive forecast ("it's not going to work") by week 4. Many strains of HCV are simply unfazed by IFN (see <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11952150">He and Katze</a> or <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12734407">Pavio and Lai</a> and there doesn't seem to be any data that suggests such strains will succumb to longer therapy.
The question of when riba works its <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14988824">magic</a> doesn't seem to have much of an aswer yet. Though there's evidence that <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15057741">later (post 20)</a> dosage reductions (of ifn and riba) don't affect outcome, if your goal is SVR rather than fibrosis reduction, I haven't seen any studies that confirm you can drop the riba before the ifn.
The question of when riba works its <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14988824">magic</a> doesn't seem to have much of an aswer yet. Though there's evidence that <a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15057741">later (post 20)</a> dosage reductions (of ifn and riba) don't affect outcome, if your goal is SVR rather than fibrosis reduction, I haven't seen any studies that confirm you can drop the riba before the ifn.
There will be a documentary airing on PBS this fall. It has been in the works for about two years.
It is being made by the people who produce "The Infinite Mind."
<a href="http://www.lcmedia.com/hepcfilm.htm">PBS's HepC Documentary</a>
Many local PBS stations have done programs on hepatitis C. Most concentrate only on the treatments, but this looks at the history, the industry and advocacy.
Should be interesting.
thanbey
It is being made by the people who produce "The Infinite Mind."
<a href="http://www.lcmedia.com/hepcfilm.htm">PBS's HepC Documentary</a>
Many local PBS stations have done programs on hepatitis C. Most concentrate only on the treatments, but this looks at the history, the industry and advocacy.
Should be interesting.
thanbey
I'm so glad to see you have joined us and offering so much great information! I have never seen you before but you have probably been around longer then me as I just came to this forum early December. Thanks for posting your website and I am currently reading that also!
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