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Long-acting formulations: A community perspective NIH Workshop, Boston March, 2014 Simon Collins

Long-acting formulations: A community perspective NIH Workshop, Boston March, 2014 Simon Collins HIV i-Base. Background. • I’ve discussed long-acting injections in HIV+ meetings for more than 10 years • My personal preference for daily oral tablets is NOT representative

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Long-acting formulations: A community perspective NIH Workshop, Boston March, 2014 Simon Collins

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  1. Long-acting formulations: A community perspective NIH Workshop, Boston March, 2014 Simon Collins HIV i-Base

  2. Background • I’ve discussed long-acting injections in HIV+ meetings for more than 10 years • My personal preference for daily oral tablets is NOT representative • STRONG COMMUNTY SUPPORT AS AN EXCITING OPTION • Caveat: must remain a choice

  3. Advantages • Adherence – less chance to forget • Improved privacy • Reduced GI and other side effects (better targeting), cost and waste (less API, less protein-binding) • Perhaps reduced monitoring • Examples: contraception & depot antipsychotics (Adams CE, 2001; Schooler NR, 2003)

  4. Adherence • Many people adhere well but most common problem is – “just forgetting” • Differences between starting treatment and maintenance treatment (starting is perhaps more difficult) • Takes doctors views out of issues for treatment failure etc – possible research developments

  5. HIV+ women • Preferred choice for contraception (Tsehaye, Int J Family Med. 2013) • Regional: In E. Africa & S. Africa >40% of overall contraceptive use is injectable/implant (UN, World Contraceptive Use, 2007) • Privacy: HIV and gender-based violence

  6. Children & adolescents • All about adherence for children & taking risks is part of adolescence • Normalise childhood • Reduced resistance fewer drug options for children) • Impact on long-term health • Regulatory issues: challenge to study invasive options, volume?

  7. Resource-limited settings • Reduce supply issues: stock-outs still common in many regions • Reduced need to travel: often considerable distances + cost • Confidentiality – and link to secrecy and violence

  8. Urgency as PrEP • Urgency for fast track development • Macaque efficacy similar to TDF/FTC • Regulatory pathways already developed (for TDF/FTC) • Overcomes adherence issues: a primary limitation of oral PrEP

  9. Oustanding issues • Need for combination essential • Should be a choice • Volume, frequency and formulation: 3 > 2 > 1mo; IM vs SC; sterility, stability, timing? • Oral sensitisation (EMA mandated) vs antidote? • Cost & access? (Ross E et al, IDWeek 2013)

  10. Thanks:UK-CAB and ECAB forums, Tim Horn (TAG), Kenly Sikwesi (ITPC), Polly Clayden (i-Base).

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