本帖最后由 sir 于 2019-10-15 13:43 编辑
回复 平凡之路123 的帖子
SAFETY, TOLERABILITY, AND ANTIVIRAL ACTIVITY OF LEDIPASVIR/SOFOSBUVIR FOR HEPATITIS B INFECTION.
Background: Current therapies against hepatitis B (HBV)
can achieve hepatitis B surface antigen (HBsAg) loss only
in a very small proportion of patients Previously published
data showed a modest reduction in HBsAg levels when
patients coinfected with both HBV and hepatitis C (HCV)
were treated with 12 weeks of ledipasvir/sofosbuvir (LDV/
SOF). We conducted a proof-of-concept study to determine
if these unexpected observations can be replicated in a
monoinfected CHB population treated with LDV/SOF for
12 weeks. The primary and secondary efficacy endpoint is
the change from baseline to end of the 12 week therapy in
serum HBsAg (in log10 IU/mL) and HBV DNA (in log10 IU/mL),
respectively Methods: This phase 2, single site, open-label,
interventional pilot study evaluated the safety, tolerability,
and antiviral activity of LDV/SOF for the treatment of HBV.
Eligible participants were adults with monoinfected CHB
who are not on antiviral therapy and do not require therapy
All enrolled subjects received fixed dose combination LDV
(90mg) / SOF (400mg) once daily for 12 weeks, and were
followed for an additional 12 weeks posttreatment Results:
Eight subjects were enrolled – median age of 41 years (range
30-53), majority (7 of 8) were male, and 50% were black All
were HBeAg negative and normal baseline ALT The baseline
HBsAg ranged from 172 to 15,489 IU/mL (mean 6,348
IU/mL), while baseline HBV DNA was between 90 to 1,660 IU/
mL (mean 734 IU/mL) All related adverse events (AE) were
mild Most common related AE was headache (2 of 8) There
were no serious AE, no discontinuation due to AE, or hepatitis
flare. Only one subject had mild transient asymptomatic
increase in alanine aminotransferase (ALT) level All 8 enrolled
subjects completed the study The mean HBsAg Log10 decline
(from baseline) at end of treatment was 0.399 log10 IU/mL,
while the mean HBV DNA decline at this same time point was
0.473 log10 IU/mL. Half (4 of 8) had HBsAg decline >0.5 log10
IU/mL with largest decline of 0.662 log10 IU/mL Similarly, 4 of
8 (50%) had HBV DNA decline >1.0 log10 IU/mL with largest
decline of 1.356 log10 IU/mL. HBsAg and HBV DNA levels
returned to baseline posttreatment (Figure 1) Conclusion:
Ledipasvir/sofosbuvir when given for 12 weeks is safe and
well tolerated by patients with monoinfected chronic HBV
infection and appears to have a modest antiviral activity
against hepatitis B.
| 
楼主: sir
发表于 2019-10-13 12:11
