i have to say that alinia 2g dose is more potent on hbsag with more than 4000iu/ml reductions in just a couple of months.interferon shows median decrease of only 1500iu/ml at 2 years.alinia should definitely be comboed with interferon
PEGBELIVER STUDY: HBSAG DECLINE AT WEEK 24 OF EXTENDED PEGINTERFERON ALFA-2A (PEG-IFNα-2A) THERAPY IS SIGNIFICANTLY ASSOCIATED WITH POST-TREATMENT RESPONSE IN HBEAG-NEGATIVE GENOTYPE D PATIENTS
P. Lampertico1*, M. Viganò1, A. Galeota Lanza2, E. Sagnelli3, M. Fasano4, V. Di Marco5, S. Bininsegna6, P. Farci7, S. Fargion8, T. Giuberti9, C. Iannacone10, B. Massetto11, E.B. Martins12, M. Colombo13
1Fondazione IRCCS Ca'Grande Ospedale Maggiore Policlinico, Milan, 2Azienda Ospedaliera Antonio Cardarelli Naples, Naples, 3Azienda Ospedaliera SS. Anna and Sebastiano, Caserta, 4Università degli Studi di Bari, Bari, 5(Di.Bi.M.I.S.) Università degli Studi di Palermo, Palermo, 6Università degli Studi di Padova, Padua, 7Università degli Studi di Cagliari, Monserrato, 8IRCCS Fondazione Policlinico, Università degli Studi di Milano, Milan, 9Azienda Ospedaliero- Universitaria di Parma, Parma, 10SPARC Consulting, Milan, 11Roche, Monza, Italy, 12Genentech, San Francisco, CA, USA, 13Fondazione IRCCS Ca'Grande Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy. *pietro.***@****
Background/aims: In genotype D-infected HBeAg-negative patients, PEG-IFNα-2a for 96weeks improved the sustained response rates versus 4weeks. We investigated whether the association between on-treatment HBsAg decline ≥10% and sustained response seen in the phase 3 HBeAg-negative study was seen in the PegBeLiver study.
Methods: HBeAg-negative patients received PEG-IFNα-2a 180 µg/week for 48weeks (Arm A), PEG-IFNα-2a 180 µg/week for 48weeks followed by PEG-IFNα-2a 135 µg/week for 48weeks (Arm B) or PEG-IFNα-2α 180 µg/week plus lamivudine 100 mg/day for 48weeks followed by PEG-IFNα-2α 135 µg/week for 48weeks (Arm C). HBV DNA < 2000 IU/mL 1-year post-treatment was analyzed according to HBsAg decline ≥10% or < 10% from baseline at on-treatment weeks12 and 24.
Results: HBsAg declined from baseline during PEG-IFNα-2α therapy to week48 and continued to decline to week96 in Arm B (table). In Arm C HBsAg levels increased after discontinuation of lamivudine, but decreased between weeks72-96. At week12, 30%(14/46), 23%(10/43) and 29%(7/24) of arms A, B and C, respectively, had achieved a ≥10% decline in HBsAg from baseline. At week24, 39%(17/44), 36%(15/42) and 29%(7/24), respectively, had ≥10% decline. In Arm B, response rate was higher in patients with ≥10% decline in HBsAg from baseline than in those with < 10%(table); reaching statistical significance at week24 (P=0.004).
Conclusions: This analysis confirms the utility of on-treatment HBsAg monitoring during PEG-IFNα-2a. In Italian genotype D patients, week12 appears to be too early to clearly differentiate responders from non-responders, possibly due to a slow decline in HBsAg. A decline in HBsAg ≥10% at week24 of PEG-IFNα-2a was significantly associated with response to 96 weeks of therapy.
Median change in HBsAg from baseline,IU/mL(log10 IU/mL)
A B C
Week48 -124(-0.02) -485(-0.08) -368(-0.01)
Week96 NA -1408(-0.20) -1066(-0.13)
Patients with HBV DNA <2000 IU/mL 1 year post-treatment according to on-treatment HBsAg decline,%(n/N)
≥10%, week12 14(2/14) 40(4/10) 14(1/7)
<10%, week12 9(3/32) 27(9/33) 24(4/17)
≥10%, week24 12(2/17) 60(9/15) 29(2/7)
<10%, week24 11(3/27) 15(4/27) 18(3/17)
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