Abstract
This single-arm, open-label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide-naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(-) compensated CHB of self-described Black/African American race received ETV 0.5 mg daily for 52 weeks; 37 patients completed 52 weeks of treatment. At Week 48, 29/40 (72.5%, noncompleter = failure) patients achieved the primary endpoint of HBV DNA <50 IU/mL. Rates for HBeAg loss (11/22; 50%) and HBeAg seroconversion (9/22; 41%) were high, possibly due to the high HBV genotype A prevalence (70%). No patient experienced virological breakthrough. Samples for resistance testing were available in 6/8 patients with HBV DNA >50 IU/mL at Week 48 or last on-treatment visit. No ETV resistance was detected. The safety profile of ETV was consistent with that observed in ETV registration trials. This study shows that in Black/African American patients with CHB, ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and Asian patients in ETV Phase III studies.
| Original language | English |
|---|---|
| Pages (from-to) | 74-76 |
| Number of pages | 3 |
| Journal | Journal of Viral Hepatitis |
| Volume | 21 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 1 2014 |
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Keywords
- antiviral therapy
- hepatitis B e antigen
- hepatitis B virus DNA
- nucleos(t)ide analogue
ASJC Scopus subject areas
- Hepatology
- Infectious Diseases
- Virology
Cite this
Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B. / Jeffers, Lennox J; Van Rensburg, C. J.; Banks, A.; Schechter, M.; Schmidt, S. J.; Hu, W.; Llamoso, C.; Parana, R.
In: Journal of Viral Hepatitis, Vol. 21, No. 1, 01.01.2014, p. 74-76.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B
AU - Jeffers, Lennox J
AU - Van Rensburg, C. J.
AU - Banks, A.
AU - Schechter, M.
AU - Schmidt, S. J.
AU - Hu, W.
AU - Llamoso, C.
AU - Parana, R.
PY - 2014/1/1
Y1 - 2014/1/1
N2 - This single-arm, open-label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide-naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(-) compensated CHB of self-described Black/African American race received ETV 0.5 mg daily for 52 weeks; 37 patients completed 52 weeks of treatment. At Week 48, 29/40 (72.5%, noncompleter = failure) patients achieved the primary endpoint of HBV DNA <50 IU/mL. Rates for HBeAg loss (11/22; 50%) and HBeAg seroconversion (9/22; 41%) were high, possibly due to the high HBV genotype A prevalence (70%). No patient experienced virological breakthrough. Samples for resistance testing were available in 6/8 patients with HBV DNA >50 IU/mL at Week 48 or last on-treatment visit. No ETV resistance was detected. The safety profile of ETV was consistent with that observed in ETV registration trials. This study shows that in Black/African American patients with CHB, ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and Asian patients in ETV Phase III studies.
AB - This single-arm, open-label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide-naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(-) compensated CHB of self-described Black/African American race received ETV 0.5 mg daily for 52 weeks; 37 patients completed 52 weeks of treatment. At Week 48, 29/40 (72.5%, noncompleter = failure) patients achieved the primary endpoint of HBV DNA <50 IU/mL. Rates for HBeAg loss (11/22; 50%) and HBeAg seroconversion (9/22; 41%) were high, possibly due to the high HBV genotype A prevalence (70%). No patient experienced virological breakthrough. Samples for resistance testing were available in 6/8 patients with HBV DNA >50 IU/mL at Week 48 or last on-treatment visit. No ETV resistance was detected. The safety profile of ETV was consistent with that observed in ETV registration trials. This study shows that in Black/African American patients with CHB, ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and Asian patients in ETV Phase III studies.
KW - antiviral therapy
KW - hepatitis B e antigen
KW - hepatitis B virus DNA
KW - nucleos(t)ide analogue
UR - http://www.scopus.com/inward/record.url?scp=84890558306&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84890558306&partnerID=8YFLogxK
U2 - 10.1111/jvh.12144
DO - 10.1111/jvh.12144
M3 - Article
C2 - 24112755
AN - SCOPUS:84890558306
VL - 21
SP - 74
EP - 76
JO - Journal of Viral Hepatitis
JF - Journal of Viral Hepatitis
SN - 1352-0504
IS - 1
ER -