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Author Topic: Dolutegravir and birth defects  (Read 996 times)

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Offline awakening

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Dolutegravir and birth defects
« on: May 19, 2018, 07:07:21 am »
This news does not bode well for dolutegravir manufacturer GSK, though further investigation is needed to confirm, the warning itself will cause some doctors to stop prescribing to child bearing age women. To me the sample size seems small enough to potentially be a coincidence (4 women affected), but larger research will tell more.

Quote
The US Food and Drug Administration (FDA) and the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) have warned that women with HIV who take dolutegravir (Tivicay, GlaxoSmithKline) at the time of conception or during the first trimester of pregnancy appear to be at higher risk of giving birth to infants with neural tube defects, including spina bifida.

https://www.medscape.com/viewarticle/896911
~~~~
[month/date/year]
3/1/16: Tested neg (Oral swab)
6/17/16: Diagnosed poz (finger prick), confirmed w/Multispot assay
6/17/16: VL 22,900, CD4 - 524 cells/uL (30%)
7/2/16: Started Triumeq (DTG+ABC+3TC)
8/1/16: VL 30
10/4/16: VL <20, CD4 - 630 (31%)
1/4/17: VL 90
2/7/17: Undetected
4/17/17: Undetected, CD4 - 695 (33%)
7/20/17: VL 75
8/21/17: VL <20
11/27/17: VL<20
3/26/18: VL<20, CD4 - 701 (36%)
5/14/18: Switch to Juluca (DTG+RPV)
6/11/18: VL<20
7/25/18: Undetected, CD4 - 632 (38%)
1/22/19: VL<20

Offline Jim Allen

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Re: Dolutegravir and birth defects
« Reply #1 on: May 19, 2018, 07:26:10 am »
That link seems to be behind a login page, so i've added the FDA statement, study and the EMA statement and review.

Its basically a precautionary move based on the earlier published observational and preliminary results from an ongoing observational study in Botswana, and a pending  review from the EMA calling out that a review is ongoing, and until than dolutegravir should not be used in women seeking to become pregnant as its seems to be an issue at conception

Here is the FDA statement.
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608168.htm

Earlier publication November 
https://aidsinfo.nih.gov/guidelines/html/3/perinatal/447/dolutegravir--tivicay--dtg-

Review and publication:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/05/news_detail_002956.jsp&mid=WC0b01ac058004d5c1

Quote
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 it has issued the following precautionary advice:

Dolutegravir HIV medicines should not be prescribed to women seeking to become pregnant.

Women who can become pregnant should use effective contraception while taking dolutegravir medicines.

The study, which looked at babies born to 11,558 HIV-infected women in Botswana, showed that 0.9% of babies (4 of 426) whose mothers became pregnant while taking dolutegravir had a neural tube defect, compared with 0.1% of babies (14 of 11,173) whose mothers took other HIV medicines. Final results are expected in about a year.

Women who have been prescribed dolutegravir should not stop taking their medicine without first consulting their doctor.

EMA will update the recommendations as necessary when it concludes its assessment.
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Offline Jim Allen

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Benefits of dolutegravir treatment for all substantially outweigh the risks
« Reply #2 on: December 28, 2018, 04:31:34 am »
We discussed the birth defects from Tivicay in first trimester before. Here was the POZ.com write-up at the time: https://www.poz.com/article/tivicay-may-cause-birth-defects-taken-first-trimester

The new study/publication below however advocates more universal use of Tivicay as first-line treatment as the benefits overall to the population outweighs the risks to the smaller group of women who conceive whilst taking this regime.

In Full:
http://www.aidsmap.com/Benefits-of-dolutegravir-treatment-for-all-substantially-outweigh-the-risks/page/3405723/
In short:

Quote
Benefits of dolutegravir treatment for all substantially outweigh the risks

Providing an antiretroviral regimen of dolutegravir, tenofovir and lamivudine to all adults living with HIV in sub-Saharan Africa, regardless of viral suppression or plans to have children, would prevent more ill health than policies which restricted use of the regimen in women of childbearing potential or people with suppressed viral load, a modelling study published in The Lancet HIV shows. Moreover, it would be cost saving.

Key findings
If people with viral loads above 1000 copies/ml on an existing first-line regimen and women intending to have children were excluded from dolutegravir treatment, only 43% of adults living with HIV would receive dolutegravir over a 20-year period. If only women intending to have children were excluded from dolutegravir treatment, 54% would receive the drug.

Over 20 years, the most restrictive dolutegravir prescribing guidelines would result in 4% fewer people having a viral load below 1000 copies/ml than with a universal dolutegravir policy, but the death rate in people on ART would be almost twice as high (1.25 deaths per 100 person-years vs 0.72 per 100 person-years).

Looking at adverse birth outcomes, the modelling found that neural tube defects would occur in 0.6% of births under a policy of universal dolutegravir prescribing, compared to 0.03% of births if women intending to have children were excluded from receiving dolutegravir. But because of the greater potency of dolutegravir and better viral suppression, the rate of mother-to-child transmission would be lower under a universal dolutegravir policy than if all restrictions applied (2.8% versus 3.9%).

Looking at the development of dolutegravir resistance the rationale for the policy of restricting first-line switches to those with a viral load below 1000 copies/ml the modelling showed that 6.7% of people over a 20-year period would have dolutegravir resistance (transmitted or acquired) under a universal policy. In comparison, 4.4% would have resistance under the policy of restricting first-line switches.

The universal dolutegravir regimen averted the largest number of disability-adjusted life years (DALYs) per year (58,200), compared to 22,300 for the most restrictive policy. DALYs measure the amount of life lost in a population as a result of premature death or disability.

For a country of 10 million people, all the dolutegravir regimens would save between $5 million and $10 million a year, with the greatest saving associated with the universal dolutegravir regimen.

The universal dolutegravir policy showed an incremental cost-effectiveness ratio of $44 compared to tenofovir, lamivudine and dolutegravir when restricted to people with viral load below 1000 copies/ml. All other policies showed fewer DALYs averted and higher cost and were therefore dominated.

The researchers say that the findings can be used to inform the development of national policies on dolutegravir use and that the views of people living with HIV on the risks and benefits identified in this analysis should also be sought as part of the national policy development process.
.
« Last Edit: December 28, 2018, 04:36:32 am by JimDublin »
HIV 101 - Everything you need to know
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Transmission and Risks:
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Read more about Testing here:
HIV Testing
Read about Treatment-as-Prevention (TasP) here:
HIV TasP
You can read about HIV prevention here:
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Read about PEP and PrEP here
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