Three new studies presented today at the International Liver Congress 2014 have helped clarify the optimal use of combination therapy with peginterferon and nucleoside analogues (NUCs) to achieve the best treatment outcomes in patients with chronic hepatitis B (CHB).
"Together these ground-breaking data will go a long way to influencing future CHB treatment guidelines," said EASL's Educational Councillor Professor Cihan Yurdaydin from the Department of Gastroenterology, University of Ankara, Turkey.
In the first study , CHB patients who had failed on prior long-term exposure to one of the nucleoside analogue (NUC) antivirals demonstrated high rates of complete response and HBsAg loss when prescribed a sequential combination of peginterferon and NUC.
In the second study , adding peginterferon to the nucleoside analogue entecavir was shown to enhance response rates and viral decline in HBeAg-positive CHB patients with compensated liver-disease, was generally safe and well tolerated, and may facilitate the discontinuation of entecavir.
Finally, data from a third study suggested that adding on a NUC for six weeks to PegIFNalfa-2a does not enhance treatment response, with no increase in HBeAg seroconversion rates beyond that achieved by PegIFNα-2a alone after 24 weeks follow-up.
Sequential combination therapy of peginterferon and nucleoside analogues results in high rates of complete response and HBsAg loss in CHB patients who have failed on prior long-term exposure to NUCs.
Chronic hepatitis B (CHB) patients who have failed on prior long-term exposure to one of the nucleoside analogue (NUC) antivirals may respond to a sequential combination of peginterferon and NUC.
Compared with NUC monotherapy, significantly more patients in the combination therapy group achieved complete response (HBeAg loss composited with HBV DNA< 2000 IU/ml) (60.24% vs. 13.8%) and HBsAg loss (27.7% vs. 0%).
"These new data are likely to result in clinicians giving greater consideration to the potential role of sequential combination therapies and the benefits this can deliver for patients," said Professor Yurdaydin.
192 patients who had received at least two years treatment with NUCs without achieving HBeAg loss or seroconversion were treated with 48-week combination therapy with additional Peg-IFN to on-going NUCs or NUCs monotherapy.
Out of this population, 83 patients were treated with combination therapy and 109 patients were treated with NUCs monotherapy. All patients were followed for a further 24 weeks and the HBsAg level was measured both during treatment and post-treatment.
The HBsAg level at baseline, week 12 and week 24 appeared to be strong predictors of treatment responses in the combination group.
In patients with baseline HBsAg< 1000 IU/ml, 100% patients achieved complete response and 91% patients achieved HBsAg loss
In patients with baseline HBsAg ≥1000IU/mL, the response rate was significantly lower in those who experience no decline in HBsAg level at week 12
However, patients with HBsAg decline of more than 0.5logIU/mL at week 12 or 1.5logIU/mL at week 24 still had a chance to achieve a treatment response
"These data suggest combination therapy can be guided by the baseline level of HBsAg as well as by monitoring the rate of HBsAg decline in response to treatment," Professor Yurdaydin added.
Peginterferon add-on during entecavir treatment enhances response rates and viral decline in HBeAg-positive hep B patients with compensated liver-disease, and may facilitate the discontinuation of entecavir.
Adding peginterferon to the nucleoside analogue entecavir enhances response rates and viral decline in HBeAg-positive CHB patients with compensated liver-disease, and is generally safe and well-tolerated. Importantly, peginterferon add-on appeared to prevent relapse and may therefore facilitate the discontinuation of nucleos(t)ide analogues.
At week 96 of the global ARES study, 31% patients in the peginterferon add-on group achieved combined HBeAg loss with hepatitis B virus (HBV) DNA levels < 200 IU/mL, compared to only 20% in the entecavir monotherapy group (p=0.107). 24% of patients in the add-on versus 11% in the monotherapy-arm achieved HBeAg-seroconversion with HBV DNA< 200IU/ml (p=0.029). After adjustment for the difference in HBV DNA levels at week 24, add-on therapy was independently associated with higher response rates (p=0.007).
In terms of other serological parameters, adding peginterferon to entecavir led to a greater decline in HBsAg (0.27 versus 0.04 log10IU/ml), HBeAg (1.10 versus 0.74 log10IU/ml), HBV DNA (1.24 versus 0.85 log10IU/ml) (all p100,000 copies/mL and ALT ≥2 times upper limit of normal were randomised to receive six weeks treatment with either:
adefovir 10mg/day and placebo entecavir
entecavir 0.5mg/day and placebo adefovir
or both placebos
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