Title

One year on: Updated WHO guidelines on first line treatment for people living with HIV

Code

SUSA13

Session Type

Non-Commercial Satellite

Venue

Palacio de Valparaíso 1

Date Time

Sunday 21 July, 14:45 - 16:45

Co-Chairs:

Elaine J. Abrams, ICAP at Columbia University, United States
Serge Eholie, Treichville University Teaching Hospital, Cote D'Ivoire

Organizer:

WHO

WHO will present highlights from recent updates to the 2018 Interim Guidelines on first-line and second-line antiretroviral regimens. This satellite will review the current status of safety and efficacy of DTG and other new ARV regimens, including the basic science models, pregnancy cohorts, clinical trial evidence, risk benefit modelling and community values and preferences that fed into updated recommendations. WHO will share the most recent information on NNRTI pre-treatment resistance and implications for the use of DTG in first-line HIV treatment. The satellite will also share country policy uptake and implementation of DTG based regimens and explore how ministries have addressed a women’s center approach, integration of DTG use and SRH, and monitoring for side effects. A panel with representation from Ministries of Health, researchers, implementers and women living with HIV will review the implications of these new directions for HIV treatment programmes.

14:45	Welcome by co-chairs Elaine J. Abrams, ICAP at Columbia University, United States Serge Eholie, Treichville University Teaching Hospital, Cote D'Ivoire

14:50	Directions from the updated WHO guidelines: the role of DTG for treating and preventing HIV infection - Opening remarks Ren Minghui, World Health Organization, Switzerland

14:55	DTG based regimens in first- and second-line HIV treatment – updates to the WHO guidelines Meg Doherty, World Health Organization, Switzerland	Slides

15:10	Review of what we know now about the signal of risk of neural tube defects with DTG use at conception Lynne Mofenson, Elizabeth Glaser Pediatric AIDS Foundation, United States

15:20	Modeling the benefits and harms of DTG use in pregnancy Landon Myer, University of Cape Town, South Africa	Slides

15:30	The role of pre-treatment NNRTI drug resistance and DTG use – evidence from the 2019 Global Report on HIVDR Silvia Bertagnolio, World Health Organization, Switzerland	Slides

15:40	Q&A

15:55	Panel Discussion: Implementation of DTG: How to scale up treatment, respect client choice and monitor for risk and integrate SRH – what we have learned in the last year and how to apply this to the years to come Meg Doherty, MD, WHO, Switzerland

15:55	Views from women seeking HIV treatment Valeriia Rachynska, All Ukrainian Network of People Living with HIV/AIDS, Ukraine

16:00	Views from Botswana's country programme Tendani Gaolathe, BCCP and Harvard-Botswana AIDS Initiative, Botswana

16:05	Paediatric Treatment and care Angela Mushavi, Zimbabwe Ministry of Health and Childcare, Zimbabwe

16:10	Views on DTG use from Brazil Felipe Perini, Ministry of Health, Brazil

16:15	How to improve access to DTG and SRH services Maurine Murenga, Global Fund Advocates Network, Kenya

16:20	PEPFAR remarks on TLD transition Ambassador Deborah Birx, US President's Emergency Plan for AIDS Relief (PEPFAR), United States

16:30	Q&A

16:40	Closing remarks Elaine J. Abrams, ICAP at Columbia University, United States Serge Eholie, Treichville University Teaching Hospital, Cote D'Ivoire

AUTHOR

Laura Waters

SUMMARY

July 2019 WHO guidelines, with some recommendations based on embargoed data were presented. Essentially dolutegravir preferred 1st line, including in women of childbearing potential, efavirenz 400mg alternative & TAF for special circumstances only due to lack of data (pregnancy, use with rifamycins & consequences of possible weight gain).

HIGHLIGHTS

The decision to make dolutegravir the preferred first-line 3rd agent was driven by several factors: 1) Neural tube defect (NTD) data: embargoed Tsepamo cohort update & other cohorts presenting here at IAS 2019 2) Pre-ART NNRTI resistance >10% in 12/18 reporting countries; higher rates in women 3) Analysis of two published modeling studies: the risk of NTD was contextualized against absolute risks of negative outcomes from using efavirenz instead: increased sexual & mother-to-child transmissions, more maternal/infant deaths. We also saw data on impact of dolutegravir on folate receptors (results varied, potentially negative impact observed only at supra-clinical concentrations). Animal studies also varied but high concentration dolutegravir toxicity in zebrafish reversed by folate. No evidence that folate will prevent any dolutegravir–related harm but it does improve general population outcomes. Despite WHO recommendations, many high HIV prevalence countries do not have polices for folate food fortification.

CRITICAL ASSESSMENT

Presenting risk of neural tube defects associated (maybe) with dolutegravir contextualised within absolute risks of other negative outcomes was enlightening. Relative risks, particularly presented in isolation, are not the most helpful way to shape guidelines or individual choice; absolute risks, including risks of switching to alternatives, should be included as standard. This session highlighted the lack of choice and confusion following the first presentation of the Tsepamo data, highlighted by variation in national guidelines responses. The inclusion of significant numbers of country and community representatives on the writing group ensured informed choice was, rightly, central to the 2019 update.