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Antiretroviral drugs for HIV post-exposure prophylaxis (PEP): Update

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Presentation on theme: "Antiretroviral drugs for HIV post-exposure prophylaxis (PEP): Update"— Presentation transcript:

1 Antiretroviral drugs for HIV post-exposure prophylaxis (PEP): Update
Kenneth Mayer Professor of Medicine Harvard Medical School Medical Research Director, The Fenway 2014

2 Focus on risk rather than exposure type: single guideline for all Preferred recommendations for adults, adolescents and children - Alignment with recommendations for ART Emphasis on simplification to support completion rates: - starter packs - adherence support Simplification and standardization towards a public health approach Focus on risk rather than exposure type: single guideline for all Preferred recommendations for adults, adolescents and children - Alignment with recommendations for ART Emphasis on simplification to support completion rates: - Full course prescription (28 day) - adherence support

3 Proportion completing PEP by population
Covariate Proportion Studies Patients completing PEP AIDS 2014: Abstract TUPE154

4 Eligibility for PEP: Best Practice Guidance
PEP should be offered, and initiated as early as possible to all persons with a HIV exposure, and ideally within a window of 72 hours Assessing the eligibility for PEP should be based on the HIV status of the source whenever possible and may include consideration of background prevalence and local epidemiological patterns* Exposures that may warrant PEP include: Bodily fluids (semen, cervicovaginal secretions, blood) Mucous membrane Exclusions for PEP would include: Index patient positive from another source Source is HIV negative In some settings with high background HIV prevalence all eligible exposures may be considered for PEP without a risk assessment * Reference the Swiss Statement and CDC guidelines

5 ATV, RAL, NVP (<3 years) and EFV* or DRV (>3 years)
Backbone drug Third drug Adults & adolescents Preferred TDF+XTC + LPV/r or ATV/r Alternative TDF+XTC* RAL/r or DRV/r or EFV* Children (≤ 10 years) AZT+3TC LPV/r TDF+XTC ABC+3TC ATV, RAL, NVP (<3 years) and EFV* or DRV (>3 years) * AZT + 3TC in case of intolerance/contraindication to TDF+XTC *concerns about CNS side effects

6

7 Supporting evidence: adults & adolescents
Backbone drugs TDF+XTC ART: 3 RCTs show fewer discontinuations due to AEs for TDF vs AZT (RR 0.6) PrEP: 4 RCTs found no difference in risk of SAEs comparing TDF+XTC vs placebo (RR 1.0) PEP: 15 observational studies found lower rates of discontinuations due to AEs with TDF+XTC (0.3%) compared to AZT (3.2%), and higher rates of PEP completion (78% vs 59%) 3rd drug LPV/r ATV/r Limited, low quality data to inform 3rd drug choice. Preference based on cost, availability, and experience with use in PEP Some data support good tolerability for RAL and DRV/r in PEP but cost/availability a limitation for resource-limited settings Data from ART shows good tolerabilty (<5% discontinuations in first 3 months) but limited data for PEP Poor acceptability among health providers and assaulted people Insufficient data about newer integrase inhibitors

8 Supporting evidence: children
Backbone drugs AZT+3TC PEP: Some published data for use in PEP (<5% discontinuation due to AE) ART: 1 RCT in naive HIV-infected children found no difference in adverse events comparing AZT+3TC and ABC+3TC Other considerations: Availability of age-appropriate formulations and alignment with adopted 1st line ART in countries, side-effect profile in the context of short-term exposure in HIV-negative population Third drug LPV/r PEP: No data is available on the use of 3rd drug for PEP ART: 3 RCTs in HIV-infected naive children less than 3 years found no difference in grade 3 and 4 AEs between LPV/r and NVP-based ART. Similarly, 1 RCT conducted in older children did not found a difference in AEs between PI and NNRTI use. Other considerations: LPV/r is currently the preferred choice for 1st (<3 years) and 2nd-line ART and drug is widely available and affordable compared to newest drugs such as DRV, ATV and RAL that are not available in age-appropriate formulations. Harmonization across populations and age-groups within childhood is of value.

9 Starter packs vs full prescriptions
Outcomes Partial course Full course Among those eligible at presentation Refused PEP 22.4% ( %) 11.4% ( %) Among those initiating PEP Completed PEP 53.2% ( %) 70.0% ( %) Stopped: exposed HIV+ve 0.3% ( %) 0.6% ( %) Stopped: source HIV-ve 8.2% ( %) 11.2% ( %) Stopped because of adverse drug reaction 6.8% ( %) 4.2% ( %) Defaulted on incomplete course 28.0% ( %) AIDS 2014: Abstract TUPE155

10 Enhanced adherence support
Control better Intervention better

11 NPEP Research Priorities
Access Understanding barriers to accessing PEP for all population groups Drug choice Research to inform future drug choices for adults, adolescents and children Toxicity monitoring Drug-drug comparisons Resistance profiling / regimen selection Drug – drug interactions The potential use of newer antiretrovirals ( DTG, RIL, EVG/cobi) for PEP. Adherence Optimal adherence interventions – effectiveness, resource considerations, cost effectiveness Impact of pill burden on adherence to PEP Follow up Optimal testing strategies at follow up Strategies and impact of transitioning from PEP to PrEP

12 Finalisation and publication
Next steps Draft guidelines GDG review Final Recs text External peer review Submit to GRC Finalisation and publication JULY EARLY AUG END AUGUST OCT Presentation on expected direction of PEP guidance

13 Acknowledgements Guideline Development Group
Chair: Kenneth Mayer (The Fenway Institute, USA) GRADE methodologist: Nandi Siegfried (Independent Consultant, South Africa) Linda Barlow (John Hopkins University and Makerere University, Uganda), Ferenc Bagyinszky (European AIDS Treatment Group, Belgium), Alexandra Calmy (Geneva University Hospital, Switzerland), Mohamed Chakroun (Fattouma Bourguiba Teaching Hospital, Tunisia), Esther C Casas (Medecins Sans Frontieres, The Netherlands), Kenneth Dominguez (Centres for Disease Control and Prevention, USA), Kimberley Green (Family Health International, Ghana), Christiane Rapparini (Universidade Federal de Rio de Janeiro, Brazil) Htin Aung Saw (Specialist Hospital Mingalardone, Myanmar), Francois Venter (WITS Reproductive Health and HIV institute, South Africa), Zhao Yan (The National Centre for AIDS/STD Prevention and Control, China Center for Disease Control and Prevention, China). UN partners Sathyanarayanan Doraiswarmy (The UN Refugee Agency (UNHCR), Switzerland), Lee-Nah Hsu (International Labour Organization (ILO), Switzerland), Atieno Ojoo (The United Nations Children’s Fund (UNICEF) Denmark), Wilma Doedens (The United Nations Population Fund (UNFPA)). WHO Coordination: Nathan Ford (HIV), Rachel Beanland (WHO consultant, HIV), and Cadi Irvine (WHO consultant, HIV). WHO steering group: Rachel Baggaley (HIV), Meg Doherty (HIV), Claudia Garcia Moreno Esteva (Reproductive Health and Research), Jane Ferguson (Maternal, Newborn, Child, Adolescent Health), Gottfried Hirnschall (Director, HIV), Martina Penazzato (HIV), Francoise Renaud (HIV), Marco Vitoria (HIV).


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