The clinically relevant response on pain and quality of life and the limited adverse events prove clinical benefit of treatment with (188)Re-HEDP and support its use in routine clinical care. Its effectiveness appears comparable to that of external beam radiotherapy.
The scale‐up of rifampicin‐based prevention regimens is an essential part of the global leprosy strategy. Daily rifampicin may reduce the effectiveness of the oral contraceptive pill (OCP), but little is known about the effects of rifampicin at the less frequent dosing intervals used for leprosy prophylaxis. As many women of reproductive age rely on OCP for family planning, evaluating the interaction with less‐than‐daily rifampicin regimens would enhance the scalability and acceptability of leprosy prophylaxis. Using a semi‐mechanistic pharmacokinetic model of rifampicin induction, we simulated predicted changes in OCP clearance when coadministered with varying rifampicin dosing schedules. Rifampicin given as a single dose (600 or 1200 mg) or 600 mg every 4 weeks was not predicted to result in a clinically relevant interaction with OCP, defined as a >25% increase in clearance. Simulations of daily rifampicin were predicted to increase OCP clearance within the range of observed changes previously reported in the literature. Therefore, our findings suggest that OCP efficacy will be maintained when coadministered with rifampicin‐based leprosy prophylaxis regimens of 600 mg once, 1200 mg once, and 600 mg every 4 weeks. This work provides reassurance to stakeholders that leprosy prophylaxis can be used with OCP without any additional recommendations for contraception prevention.
Aim Scale up of rifampicin-based prevention regimens is an essential
part of the global leprosy strategy. Daily rifampicin may reduce the
effectiveness of the oral contraceptive pill (OCP), but little is known
about rifampicin’s effects at the less frequent dosing intervals used
for leprosy prophylaxis. Since many women of reproductive age who are
eligible for rifampicin-based regimens rely on OCP for family planning,
additional information characterising the interaction would enhance
scalability and acceptability of leprosy prophylaxis. Methods We used a
semi-mechanistic pharmacokinetic model to predict the expected induction
effect of rifampicin on OCP oral clearance (CL/F) when used for leprosy
prophylaxis. Rifampicin dosing schedules were selected based on
WHO-recommended and investigational leprosy prophylaxis regimens.
Uncertainty in the model was explored using a scenario analysis. Results
Hormonal contraceptive CL/F with rifampicin given as a single 600mg
dose, a single 1200mg dose, or as 600mg once every four weeks was
predicted to increase by a maximum of 12%, 14% and 14%, respectively,
and return to baseline before the next dose. Hormonal contraceptive CL/F
was predicted to increase by >20% with once-weekly and
once-daily dosing of 600mg rifampicin. Using a threshold of 20%,
rifampicin used for leprosy prophylaxis does not have a clinically
relevant interaction with OCP. Conclusion These modelling study findings
suggest that women using OCP can expect efficacy to be maintained with
coadministration of rifampicin-based leprosy prophylaxis and should
provide reassurance to stakeholders that leprosy prophylaxis need not be
accompanied by any additional specific recommendation about use of OCP.
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