Welcome to the Dolutegravir Debate
What is it? Salamander Trust has been asked by UNAIDS to bolster civil society’s advocacy, communications and consultations with women living with HIV and partners on two key issues: Dolutegravir (DTG) and cervical cancer. On November 15th 2018 Salamander Trust organised a webinar on Access to Treatment Options for Women Living with HIV.
Some Background: The WHO 2017 Consolidated Guideline on the Sexual and Reproductive Health and Rights (SRHR) of women living with HIV is a ground-breaking document, which upholds the rights of women in several key areas. Since 2013, Salamander played a major role facilitating the global values and preferences survey on the SRHR of women living with HIV. This fed into the development of the new consolidated guideline. As part of this process, WHO Department of Reproductive Health and Research asked Salamander to develop a checklist tool, to support women in countries to ensure the full implementation of the Guideline. This checklist has now been endorsed by the heads of 5 UN agencies.
Why this work now? UNAIDS has now asked Salamander to take this process further. This is because no matter how great the Guideline is, as our research with partners for UNWomen has shown, women continue to face challenges in accessing treatment options. Barriers to access and ‘options’ for women have become even more visible over recent months, following mixed reactions to the WHO HIV Department warning on May 8, 2018 citing a potential risk of neural tube defects (NTDs) for babies born to women taking Dolutegravir (DTG) during conception and pregnancy in Botswana. This was from preliminary unscheduled analysis of an ongoing birth surveillance study in Botswana. The study is called Tsepamo, and it reported an increased risk of NTDs among infants of women who became pregnant while taking DTG. Defects were reported in four out of 426 infants born to women who were put on DTG in pregnancy. The next formal analysis will occur after 31 March 2019 and will include women already exposed to DTG from conception before the recent change in guidance. Tsepamo has expand the study from 8 to 18 sites, increasing from 45% to 72% of births in Botswana. The next analysis will include: NTDs; all major malformations; and other adverse birth outcomes (stillbirth, preterm, small for gestational age and neonatal death).
What do we plan to produce? As an outcome of our work the following is planned before the end of 2018:
a) Create an advocacy brief that can be owned by all of us involved in the debate, to move access forward before the end of this year. This will highlight recommendations to: governments at the national level; technical partners such as UNAIDS and WHO to strengthen messaging and actions to support it; and reflect and communicate diverse realities, priorities and rights of women living with HIV around treatment and service options.
b) Set up a virtual sharing platform on whatsapp where information on what is happening can be shared in real time and support and linkages can be made across countries and regions.
c) Develop a series of 15-minute podcasts called The WHAVE (Women with HIV: Advocates, Voices, Empowered). These will be recorded by women living with HIV from around the world and will include a specific podcast on DTG.
Some key resources so far in chronological order – if you know of others you think we should add, please do send them to us:
- May 8: WHO Statement on DTG
- June 28: National Empowerment Network of people living with HIV in Kenya (NEPHAK)
– Letter to MoH Demanding DTG
- July 2018 Updated recommendations on first-line and second-line antiretroviral
regimens and post-exposure prophylaxis and recommendations on early infant
diagnosis of HIV: interim guidance
- July 1: Comparative safety of dolutegravir-based or efavirenz-based antiretroviral
treatment started during pregnancy in Botswana: an observational study: The Lancet
- July 11: iBase – Dolutegravir preconception signal: time is up for shoddy surveillance
- July 13 – 14: IAS2018: Communique of the Kigali Dolutegravir Stakeholder Meeting of
African Women Living with HIV, hosted by African Community Advisory Board (AfroCAB)
- July 16: NOTHING FOR US WITHOUT US: Statement by the AfroCAB on Dolutegravir
and neural tube defects in women living with HIV of child bearing age
- July 18: Time to realise our sexual and reproductive health and rights – the Lancet
- July 23 – Give Women Living with HIV full information on the benefits and risks of DTG,
Contraceptives for them to exercise choice – ICW East Africa
- July 2018 – The updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV – WHO
- Aug: IPPF Technical Brief: Dolutegravir for women living with HIV of reproductive age
- Aug 3: iBase – No additional neural tube defects among a further 170 preconception
dolutegravir exposures in Botswana: Tsepamo study (July 2018)
- August: ICW East Africa – WHO Reviews DTG Guidelines to Allow Women and Adolescents on Consistent FP Methods Access
- August 20: Dolutegravir drug is safe for women living with HIV: Martha Akello – New Vision
- August 31: Introducing the DolPHIN-2 Story – Liverpool Drug Interactions
- 1-4 October 2018: European Medicines Agency (EMA) Pharmacovigilance Risk
Assessment Committee (PRAC) confirmed its precautionary advice issued earlier this
year on the use of DTG in pregnant women and for use of effective contraception
while taking DTG in women who can become pregnant
- Sept – Nov 2018: Forum on the risks of preconception dolutegravir exposure: IAS – CDC.
- 13 Nov: iBase – Insufficient data on risk of neural tube defects with exposure to
elvitegravir or bictegravir exposure during preconception or first trimester
- 13 Nov: iBase – No additional neural tube defects with preconception dolutegravir:
data from three birth outcome cohorts.
- 30 Nov: Health GAP and Spotlight Policy Brief: Dolutegravir in Southern & Eastern Africa and the right to choose
- 13 Feb 2019: Webinar with Dr Rebecca Zash: more background info about the Tsepamo study
If you are a woman living with HIV who would like to join the debate please contact us through the CONTACT page on this website.