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Dolutegravir preconception signal: time is up for shoddy surveillance

The news in May 2018 of a potential risk of neural tube defects in infants born to women taking dolutegravir (DTG) at the time of conception sent shockwaves through the HIV community. But, despite massive global investment, aggressive transition plans – as well as calls for years for more systematic recording of outcomes when women receive ART in pregnancy– few prospective birth registrieshave been established in other settings that can refute or confirm this finding. Meanwhile, women of child-bearing age, whether they intend to become pregnant or not, are being told that they must stick with (or go back to) efavirenz (EFV) – a drug that, before this news, was in the process of being replaced with DTG.

Published
16 July 2018
From
HIV i-Base
Dolutegravir: need to consider all pros and cons before switching in pregnancy

A young pregnant woman who switched from dolutegravir (DTG)-based ART, in response to the neural tube defect safety signal, experienced viral rebound on her new regimen. She needed to be switched back to DTG to achieve re-suppression and prevent vertical transmission.

Published
11 July 2018
From
HIV i-Base
Children born with HIV on treatment experience next-to-no developmental set-backs at the age of 5

New data on the impact of different treatment strategies on the neuro-development of young children living with HIV has been released, showing normal development in all areas apart from visual perception.

Published
25 May 2018
From
AVERT
BHIVA statement on Potential Safety Signal in Infants Born to Women Conceiving on Dolutegravir

The BHIVA HIV in Pregnancy Guidelines Writing group makes the following recommendations: all women wishing to conceive should be started on folic acid 5mg OD regardless of their cART regimen; all women commencing DTG should have a negative pregnancy test prior to initiation and ongoing method of contraception documented; we advise a review of all patient records of women aged up to 50yo on DTG with regards to conception plans, documented method of contraception and current pregnancy status; we recommend that women at risk of pregnancy be contacted by their clinic to discuss the DTG safety report, which should be clearly documented, and the woman seen in person if pregnant.

Published
23 May 2018
From
British HIV Association
Potential safety issue affecting women living with HIV using dolutegravir at the time of conception

WHO advises that countries and ministries follow the existing 2016 WHO Consolidated ARV Guidelines, and consider the following: Pregnant women who are taking DTG should not stop their ARV therapy and should speak with their health provider for additional guidance. If other first‐line ARVs cannot be used in women of childbearing age, DTG may be considered in cases where consistent contraception can be assured.

Published
21 May 2018
From
World Health Organization
Why the Dolutegravir Pregnancy Warning is Important — and What We Should Do Now

Based on the widespread and growing use of DTG-based regimens globally, these data on the potential risks of becoming pregnant while receiving DTG have immediate and broad clinical relevance.

Published
21 May 2018
From
NEJM Journal Watch
New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir

The European Medicines Agency (EMA) is evaluating preliminary results from a study which found 4 cases of birth defects such as spina bifida (malformed spinal cord) in babies born to mothers who became pregnant while taking dolutegravir. While EMA is assessing the new evidence, dolutegravir should not be used in women seeking to become pregnant.

Published
21 May 2018
From
European Medicines Agency
Anti-HIV drug combination does not increase preterm birth risk, study suggests

A drug combination aimed at preventing transmission of HIV from a pregnant woman to her fetus likely does not increase the risk for preterm birth and early infant death, according to a re-analysis of two studies funded by the National Institutes of Health. The research appears in the New England Journal of Medicine.

Published
26 April 2018
From
National Institutes of Health
HIV-positive, exposed children have worse neurodevelopmental outcomes

Children who are HIV-positive or have been exposed to the virus are at increased risk of having poorer outcomes regarding cognitive and motor development compared with children who are HIV-negative and have not been exposed, according to findings ...

Published
19 February 2018
From
Healio
NIH Begins Large HIV Treatment Study in Pregnant Women

The National Institutes of Health has launched a large international study to compare the safety and efficacy of three antiretroviral treatment regimens for pregnant women living with HIV and the safety of these regimens for their infants. The study will evaluate the current preferred first-line regimen for pregnant women recommended by the World Health Organization (WHO) and two regimens containing newer antiretroviral drugs that are becoming more widely used.

Published
24 January 2018
From
NIAID press release
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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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