IMPROVED HBsAg LOSS BY 120weeks OF PEGINTF PLUS NUCS
IMPROVED HBsAg LOSS RATE IN CHRONIC HEPATITIS B PATIENTS TREATED WITH PROLONGED PEGINTERFERON α-2A COMBINED WITH NUCLEOS(T)IDE ANALOGUE
Aims: To investigate the improved HBsAgresponse in chronic hepatitis B (CHB) patients treated with prolonged peginterferon α-2a combined with nucleos(t)ide analogue.
Methods: One hundred and fifty-two CHB patients treated with peginterferon α-2a plus nucleos(t)ide analogue from Jan 2007 to Sep 2012 were retrospectively investigated. The mean treatment duration was 79 weeks (range 24-120 weeks). Serum HBsAglevels at baseline, week 12, 24, 36, 48, 72, 96 and 120 of treatment were detected
Results: The cumulative HBsAgloss rates of patients treated at 48-week, 96-week and 120-week with peginterferon α-2a plus nucleos(t)ide analogue were 8.55% (13/152), 26.97% (41/152) and 29.61% (45/152), respectively. The time to HBsAgloss was 74.93±27.21 weeks. Most HBsAgloss occurred during week 49-96. The HBsAglevel at week 12 of treatment in 45 patients who obtained HBsAgloss was 1.91±1.27log10IU/mL, which was significantly lower than baseline (3.22±0.82log10IU/mL) (t=5.759, P< 0.01). However, the HBsAglevel at baseline in 107 patients who did not obtain HBsAgloss was 3.57±0.96 log10 IU/mL and HBsAglevels reduction at week 12, 24, 48, 96 and 120 were 0.24±0.38, 0.45±0.60, 0.83±0.84, 1.29±1.05 and 1.66±1.66 log10IU/ml, respectively (Figure 1). As expected, the HBsAglevel at week 12 of treatment was not significantly different from that at baseline in this group of patients (t=1.529, P=0.128), while that at week 96 was significantly decreased compared with week 48 (t=2.166, P=0.033).
Conclusion: Prolonged peginterferon α-2a combined with nucleos(t)ide analogue treatment could increase the cumulative HBsAgloss rate. In patients who do not obtain HBsAgloss, prolonged therapy could reduce the HBsAglevel and improve the anti-viral response. The reduction of HBsAglevel of week 12 from baseline could be a predictor of HBsAgclearance
as said many times max hbsag clearance by pegintf is between 48 and 96 weeks of therapy, response at 48weeks is very low (about 8% in this study) and at 96weeks three times more (about 27%), 120 weeks 29.61%
What is the injection dose for 96 and 120 weeks treatment? Is it always 180 mcg for first 48 weeks followed by 135 mcg for second 48 weeks of treatment? and for third 48 weeks also 135 mcg? Or treatment can be prolonged with 180 mcg for 96 and 120 weeks?
in italy it is routine from many years to have prolonged pegintf, it is also the rule for hdv and other diseases like MS and others, of course at full dose....it is just a matter of sides effects, most patients have no or tollerable sides effects and they can go on whatever.
a trial in china made pegintf mono for 5-6 years, i posted years ago, and they increased response to very high numbers, i dont remember the number but it was in the order of 30-50%
of course this makes sense in responders by 12-24 weeks to go on and all clear hbsag, those not responding are not kept on pegintf because in non responders there is no benefit on prolonged
not 96weeks but 6 years or more like other human trials did, peginterferon is not a poison it is just an immune modulator.....
actually most human trials from drug makers look in the direction of chronic drug managment, stopping all efforts to clear definitively, we have the tolls to clear hbv definitively already, the non response to sequential treatment nuc+peg is 10% on lam plus adv, this is nothing, this is almost close to the nucs non response on hbeag pos
Just found an article on interferon use for 12 years with one patient who finally cleared HBV and HDV
Chronic delta hepatitis is an uncommon but severe form of chronic viral hepatitis for which there is currently no satisfactory therapy. A patient with chronic delta hepatitis was treated with interferon alfa, 5 million units daily for 12 years. Serial serum samples were tested for routine liver tests and selected samples for quantitative levels of hepatitis B surface antigen (HBsAg) and hepatitis delta virus RNA. Liver biopsies were performed before, during, and after an initial 1-year course of therapy and again after 3 and 10 years of continuous therapy. With initiation of interferon therapy, serum aminotransferase levels decreased to normal range, became abnormal again when the dose was reduced, and increased to pretreatment levels when therapy was stopped. With reinstitution and prolonged therapy, aminotransferase levels became persistently normal; after several years, both hepatitis delta virus RNA and serum HBsAg became undetectable. Liver biopsy, which initially revealed cirrhosis, showed gradual improvement in inflammatory and fibrosis scores and, after 10 years, no abnormalities or fibrosis. Therapy was stopped, and the patient remained free of evidence of infection. In conclusion, long-term therapy with interferon alfa in high doses led to resolution of chronic delta hepatitis, disappearance of hepatitis delta and B virus markers, and improvement in fibrosis.
thanks very interesting, i do believe it is more the cost and the advantage of keeping most patients infected to drive the small and short use of pegintf than the real fact of sides.and all these long studies confirm this
among my relatives only old age had sides (i person) while all the others had no sides effects (i mean really minor sides)
is there a big risk for developing autoimmune disease while on interferon therapy?
i dont think so because only patients already having problems like worsened and they were not put on high blood levels of vit d which manages autoimmunity.if we go on high d blood levels we improve pegintf response and prevent any autoimmune disease
i ve also seen vitd levels increase ip10 production studies but i have not checked them fully.vit d increase ip 10 and ip10 increases pegintf response because it increases when intf increases to manage the autoimmnity
those on prolong therapy never developped any different sides than those on 24 weeks, i dont think it has any risk.if one has sides he will fell them alreay at 24 weeks and choose if to stop
" A patient with chronic delta hepatitis was treated with interferon alfa, 5 million units daily for 12 years." Does any one know how to covert 5 million units of interferon daily in terms of pegasys dose? 5 million daily x 7 days = 35 million units per week does it equal 180 mcg weekly of pegasys dose?
5million units of ifn alpha per day will result in a zigag curve of actual ifn concentrations , due to the short half life.
But it amounts in the average to a very high concentration, possibly equivalent to a double dose of 40 kilodalton pegasys per week. that is 360 mcg.
Thanks for reply. I can not find studies for prolonged treatments with 180 mcg for another 48 weeks. All studies I found say 180 mcg for first 48 weeks then reduced dose to 135 mcg next 48 weeks. Do you presonally think it safe to prolong with 180 mcg for next 48 weeks or dose must be reduced?
the reaction to ifn is quite different between patients. Prolonged ifn therapy is frequently used at full dose for 72 weeks in partial responders in HCV. They also sometimes use double dosing for the 48 or even 72 weeks in repeat treatments to achieve SVR. Autoimmune reactions and long term sequelae are frequent among those treated in that way, even longtime after svr.
The patient in that paper was. quite unique in that he tolerated ifn so well. I had a discussion about him with dr. lau long time ago and she told me that he almost refused to get off ifn.
a person calling himself double dose often discussed the aspects of this treatment on the hcv board. Go and check his posts.
Next week will be my 48th week of interferon I will have to make decision on which dose to prolong my treatment. I will insist on full dose with Dr for at least 72 weeks. Thanks for sharing your experience with us.
do you know your vit d25oh level?it would be interesting to see members experience on vit d and pegintf and see if vitd25oh 80-90ng/ml has influence on sides effects, no autoimmune reactions in prolonged or double dose and increased respose
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