Dapivirine

Dapivirine
Identifiers
DrugBank DB08639

Dapivirine (TMC120) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed at Janssen Therapeutics (formerly Tibotec Therapeutics).[1] The International Partnership for Microbicides (IPM) has held exclusive worldwide rights to dapivirine since 2014,[2] building upon a 2004 royalty-free license to develop dapivirine-based microbicides for women in resource-poor countries.[3]

An monthly intra-vaginal ring containing dapivirine has been developed as a form of HIV prevention for women. Two Phase 3 clinical trials of intra-vaginal dapivirine rings for HIV prevention were completed in 2015 and results were announced at the 2016 Conference on Retrovirology and Opportunistic Infections (CROI). The ASPIRE Study (MTN-020) reported a 27% reduction in HIV-1 acquisition (95% CI 12-57%, p=0.007), with a trend toward greater protection in women over age 21 and no significant protection for women under age 21.[4] The Ring Study (IPM-027) reported a 31% reduction in HIV acqusition (95% CI 0.9-51.5%, p=0.040) also with a trend toward greater efficacy in women over age 21.[5] In both trials, more than 80% of returned rings showed signs of drug depletion indicating at least some use, and more than 80% of blood samples from participants in the active arm had levels of dapivirine consistent at least 8 hours of continuous use preceding the blood test. Neither trial could evaluate whether the product was used consistently between study visits.

References

  1. ↑ "Johnson & Johnson to Acquire Tibotec-Virco (NYSE:JNJ)". www.investor.jnj.com. Retrieved 2016-04-13.
  2. ↑ hseltzer. "IPM Receives Worldwide Rights to HIV Prevention Medicine". www.ipmglobal.org. Retrieved 2016-04-13.
  3. ↑ ipm-admin. "Dapivirine (TMC120)". www.ipmglobal.org. Retrieved 2016-04-13.
  4. ↑ Jared M. Baeten. "A Phase III Trial of the Dapivirine Vaginal Ring for HIV-1 Prevention in Women". Retrieved 2016-04-13.
  5. ↑ Annalene Nel. "Safety and Efficacy of Dapivirine Vaginal Ring for HIV-1 Prevention in African Women". Retrieved 2016-04-13.
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