Abstract
Introduction:
A six-month isoniazid as tuberculosis preventive therapy in people living with HIV (PLHIV) in Eritrea was first introduced in 2014. After two years of impressive roll out, prescribers became reluctant to administer isoniazid preventive therapy (IPT) due to rumors of isoniazid-related liver injuries and/or some of their patients started to experience tuberculosis (TB) shortly after completion of a six-month isoniazid.
Objective:
This study was conducted to evaluate benefit-risk balance the use of IPT in PLHIV in Eritrea using a qualitative benefit-risk assessment.
Methods:
The benefit-risk of IPT as compared to taking no prophylactic treatment was evaluated using the Universal Methodology for Benefit-Risk Assessment (UMBRA) framework. Published and unpublished data on benefits and risks of IPT, and risk perceptions of IPT providers were explored. To facilitate the decision-making process, key benefits and risks of IPT were identified, weighted, hierarchically displayed in a value tree, and presented in a summary table along with a forest plot.
Results:
It was estimated that use of a six-month IPT by 1000 patients prevented 32 cases of incident TB, three cases of TB-related mortalities and 31 cases of all-cause mortalities with an estimated extra risk of 42 cases of drug-induced liver injury when compared to those with no prophylactic treatment. At 65 months of follow-up, those exposed to IPT had better probability of TB-free follow-up compared to the unexposed (p<0.001). This qualitative benefits-risk assessment identified two key benefits (prevention of incident TB and higher TB-free survival) and one important risk (liver injury) that could greatly impact the benefit-risk balance of IPT in PLHIV in Eritrea. Liver injury could be significantly reduced with routine liver function monitoring. Fear of isoniazid-induced liver injury that limited acceptability and implementation of IPT was found to be a challenge.
Conclusion:
From the researchers’ perspective, the benefit-risk balance of IPT in PLHIV compared to no prophylactic treatment, in Eritrea, could be favorable if administered with routine liver function monitoring.
A six-month isoniazid as tuberculosis preventive therapy in people living with HIV (PLHIV) in Eritrea was first introduced in 2014. After two years of impressive roll out, prescribers became reluctant to administer isoniazid preventive therapy (IPT) due to rumors of isoniazid-related liver injuries and/or some of their patients started to experience tuberculosis (TB) shortly after completion of a six-month isoniazid.
Objective:
This study was conducted to evaluate benefit-risk balance the use of IPT in PLHIV in Eritrea using a qualitative benefit-risk assessment.
Methods:
The benefit-risk of IPT as compared to taking no prophylactic treatment was evaluated using the Universal Methodology for Benefit-Risk Assessment (UMBRA) framework. Published and unpublished data on benefits and risks of IPT, and risk perceptions of IPT providers were explored. To facilitate the decision-making process, key benefits and risks of IPT were identified, weighted, hierarchically displayed in a value tree, and presented in a summary table along with a forest plot.
Results:
It was estimated that use of a six-month IPT by 1000 patients prevented 32 cases of incident TB, three cases of TB-related mortalities and 31 cases of all-cause mortalities with an estimated extra risk of 42 cases of drug-induced liver injury when compared to those with no prophylactic treatment. At 65 months of follow-up, those exposed to IPT had better probability of TB-free follow-up compared to the unexposed (p<0.001). This qualitative benefits-risk assessment identified two key benefits (prevention of incident TB and higher TB-free survival) and one important risk (liver injury) that could greatly impact the benefit-risk balance of IPT in PLHIV in Eritrea. Liver injury could be significantly reduced with routine liver function monitoring. Fear of isoniazid-induced liver injury that limited acceptability and implementation of IPT was found to be a challenge.
Conclusion:
From the researchers’ perspective, the benefit-risk balance of IPT in PLHIV compared to no prophylactic treatment, in Eritrea, could be favorable if administered with routine liver function monitoring.
Original language | English |
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Awarding Institution |
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Supervisors/Advisors |
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Award date | 24 Apr 2024 |
Place of Publication | Rotterdam |
Print ISBNs | 978-94-6365-975-2 |
Publication status | Published - 24 Apr 2024 |