Telbivudine (Tyzeka) Continues to Produce Good Results for CHB patients

interdetect

Method
Participants from GLOBE and another trial, Study 015, were offered a chance to receive open-label telbivudine for an additional 2 years in an open-label extension study (Study 2303). At EASL, the researchers presented pooled GLOBE/Study 015 efficacy and safety data for 503 patients (293 HBeAg positive and 210 HBeAg negative) who did not have genotypic resistance to telbivudine after 2 years and who continued taking the drug for 3 years. Most participants in the extension study were men and people of Asian race/ethnicity.

Results

HBV DNA suppression and ALT normalization were maintained in both HBeAg positive and HBeAg negative patients who took telbivudine for 3 years.

Among the 210 HBeAg negative participants, 85% achieved undetectable HBV DNA (< 300 copies/mL) and 84% experienced ALT normalization at year 3.
   3年治疗结束，HBeAg阴性患者中，85%达到了HBV DNA低于300copies/mL的定量下限。84%ALT恢复正常。

Among the 293 HBeAg positive patients, 75% achieved undetectable HBV DNA and 83% experienced ALT normalization at year 3.
   3年治疗结束后，HBeAg阳性患者中，75%达到了HBV DNA低于300copies/mL的定量下限。83%ALT恢复正常。

55% of these patients experienced HBeAg loss and 39% achieved HBeAg seroconversion.
    55%的患者HBeAg消失，39%出现HBeAg血清学转换。

1.5% experienced hepatitis B surface antigen (HBsAg) loss and 0.4% (1 person) achieved HBsAg seroconversion.

HBeAg positive participants who had undetectable HBV DNA at week 24 of telbivudine therapy in the original GLOBE/Study 015 trials were more likely to achieve undetectable HBV DNA (87%), ALT normalization (86%), and HBeAg seroconversion (40%) at year 3.

Telbivudine continued to be generally well-tolerated at year 3, with a safety profile similar to that observed at year 2.

13% of patients experienced grade 3/4 creatine kinase (CK) elevation, 4% developed muscle pain, 0.6% experienced muscular weakness, and 0.3% developed myositis (muscle inflammation).
   13% 3/4级CK升高，4%肌肉疼痛，0.6%肌肉无力，0.3%肌肉炎症。

The rate of peripheral neuropathy (including paresthesia, neuralgia, polyneuropathy, and sensory loss) was low, at < 1%
  外周神经痛较低<1%
No cases of rhabdomyolysis, lactic acidosis, or other new serious safety concerns were observed with continued telbivudine use through year 3.

5.7% of HBeAg negative patients and 8.8% of HBeAg positive patients developed genotypic resistance to telbivudine at 3 years.
    3年耐药 5.7%  8.8%

In a subset of 66 patients (all but 2 HBeAg positive) who discontinued telbivudine after achieving good response in the original GLOBE/Study 015 trials but continued follow-up during the extension study, 70% maintained low or undetectable HBV DNA, 64% maintained normal ALT, and 90% maintained HBeAg loss and HBeAg seroconversion.

(6.合.彩).足球.篮球...各类投注开户下注

第一投注.现金网:招代理年薪10万以上:6668.cc