Stopping viral replication frequently leads to PCR negativity1,2
PCR NEGATIVITY IN HBeAg-POSITIVE PATIENTS
(HBV DNA ≤300 COPIES/mL) AT WEEKS 24 AND 52 (n=921)
3,4,†
Therapeutic Response, the primary efficacy end point at week 524
of HBeAg-positive patients treated with TYZEKA
of HBeAg-positive patients treated with TYZEKA
Therapeutic Response was a composite serologic end point requiring suppression of HBV DNA to <5 log10 in conjunction with either loss of HBeAg or normal ALT at week 52.
24-week PCR negativity correlates with increasing rates of e-seroconversion
THE NUMBER OF HBeAg-POSITIVE PATIENTS WHO SEROCONVERTED
AT WEEK 52 WHO WER PCR NEGATIVE AT WEEK 24
3,†,‡,§,||,¶
Guidelines recommend e-seroconversion as an important goal of therapy1,2
patients in GLOBE who achieved undetectable HBV DNA levels by week 24 went on to e-seroconvert with TYZEKA after 1 year of therapy3,5
- Seroconversion rates for the entire GLOBE study population were 23% and 22% after 1 year for patients treated with TYZEKA or lamivudine, respectively4,§,||
- Patients with ALT >2 x ULN had e-seroconversion rates of 27% and 24% when treated with TYZEKA or lamivudine, respectively3,§,||
24-week PCR negativity is an early indicator of minimized resistance
In the total HBeAg-positive patient population treated with TYZEKA, 6.0% (26/430) of patients experienced virologic rebound (≥1 log10 increase in HBV DNA from nadir) with genotypic mutations at week 52.3,**
At week 52, 145/430 (34%) and 19/227 (8%) HBeAg-positive and HBeAg-negative telbivudine recipients, respectively, had evaluable HBV DNA (≥1000 copies/mL). Genotypic analysis detected one or more amino acid substitutions associated with virologic failure (rtM204I, rtL801/V, rtA181T, rtL180M, rtL229W/V) in 49 of 103 HBeAg-positive and 12 of 12 HBeAg-negative patients with amplifiable HBV DNA and ≥16 weeks of treatment. These events may occur during long-term use with HBV oral antiviral therapy.
4
The optimal treatment duration with TYZEKA has not been established.
of HBeAg-positive patients treated with TYZEKA who achieved PCR negativity at week 24 developed resistance (HBV DNA ≥ 1000 copies/mL with genotypic mutations) at week 52¶,**
