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Transcript of NIH Workshop, 2 March 2014 Simon Collins: Long-acting formulations: A community perspective NIH...
![Page 1: NIH Workshop, 2 March 2014 Simon Collins: Long-acting formulations: A community perspective NIH Workshop, Boston March, 2014 Simon Collins.](https://reader035.fdocuments.us/reader035/viewer/2022072016/56649ef15503460f94c02f25/html5/thumbnails/1.jpg)
NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info
Long-acting formulations:A community perspective
NIH Workshop, Boston March, 2014
Simon CollinsHIV i-Base
![Page 2: NIH Workshop, 2 March 2014 Simon Collins: Long-acting formulations: A community perspective NIH Workshop, Boston March, 2014 Simon Collins.](https://reader035.fdocuments.us/reader035/viewer/2022072016/56649ef15503460f94c02f25/html5/thumbnails/2.jpg)
NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info
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
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NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info
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)
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NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info
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
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NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info
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
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NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info
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?
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NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info
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
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NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info
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
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NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info
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)
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NIH Workshop, 2 March 2014 Simon Collins: www.i-Base.info