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Dapivirine Ring Previous Safety Experience

Dapivirine Ring Previous Safety Experience. MTN 020 Training. What do we know?. Side effects Pregnancy Resistance. Same rate as no ring groups in previous studies. Metrorrhagia is common. Pregnancy.

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Dapivirine Ring Previous Safety Experience

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  1. Dapivirine RingPrevious Safety Experience MTN 020 Training

  2. What do we know? • Side effects • Pregnancy • Resistance

  3. Same rate as no ring groups in previous studies Metrorrhagia is common

  4. Pregnancy • In rats, some effects on the developing fetus were observed following oral administration at maternally toxic doses (80 mg/kg and 320 mg/kg) of dapivirine • No effects in rats at the maternally non-toxic dose of 20 mg/kg/day, or in rabbits at up to 90 mg/kg. • Insufficient information is currently available on dapivirine administration in pregnant women • Measures should be taken to avoid dapivirine exposure in women of childbearing potential or during pregnancy

  5. Resistance • In vitro studies of dapivirinehave shown that NNRTI resistance mutants can develop when virus is cultured in the setting of low concentrations of dapivirine • Major mutations for resistance are Y181C, K103N, L100I and E138K • Clinical significance of these in vitro studies not known

  6. Conclusions • Safety: • To date, ring is safe and well tolerated • No treatment-related SAEs • Related AEs were similar in dapivirine and placebo rings groups in IPM studies, and consistent with background rates in the general population.

  7. Acknowledgements • IPM colleagues

  8. Questions?

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