Evaluation of protease inhibitors based anti-retroviral regimen induced liver injury at Zewditu memorial hospital.
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Date
2019-09
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Addis Abeba University
Abstract
Background: The inclusion of protease inhibitors (PIs) in therapeutic regimens has a significant
impact on the success of the treatment; these classes have been associated with liver-related injury
in some individuals. Rates of hepatotoxicity from registration trials of various PIs have
ranged from 1% to 9.5%, of which few patients had serious liver-related outcomes.
Objective: To evaluate the incidence, severity, patterns, time dependent and risk factors of PIs
based anti-retroviral regimens induced liver injury.
Methods: An observational cohort prospective study was conducted at anti-retroviral treatment
clinic of Zewditu memorial hospital. All patients that were HIV positive and candidate for PI
based regimens, and fulfilling other eligibility criteria were included in the study. The study was
conducted from March 1, 2018 to December 30, 2018 (including follow up period for total of 6
months).
Results: Out of 142 study participants, overall, liver injury of any grade was observed in 25
(17.6%) participants. From 35 PI based naïve participants, 3 patients developed liver injury during
the
study
period.
Majority
of
the
participants
21
(84%)
developed
cholestatic
pattern
of
liver
injury.
Overall
incidence
of
grade
1,
2
and
3
were
16
(64%),
6
(24%)
and
3
(12%)
respectively.
The
incidence of liver injury was high (57.1%; 4/7) within 25-48 weeks from the starting PI
based regimens. Cotrimoxazole prophylactic therapy and previous first line on AZT/3TC/NVP
were significantly associated with liver injury.
Conclusion: Overall, liver injury of any grade was observed in 25 (17.6%) participants while
only 3 (12%) participants developed grade-3 liver injury. None of the participants developed
grade-4 liver injury and no liver related death was reported during the study period.
Recommendation: Regular follow up of liver function tests is important to monitor liver toxicities
in
HIV
positive
patients,
particularly
with
PIs-based
regimen.
Further
study
need
to
be
conducted
with
large
sample
size
and
long
term
follow
up
to
identify
the
mechanism
and
risk
factors
associated
with
PIs.
Description
Keywords
Incidence, Severity, Protease enzyme inhibitor, Drug induced liver injury, Liver injury.