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SOGC Infectious Diseases Committee Statement on Dolutegravir Use in Pregnancy

Data from an unplanned interim analysis of an observational study conducted in Botswana that was released on May 18, 2018, reported a possible increased risk of neural tube defect (NTD) in women taking dolutegravir preconception (0.9% vs 0.1% among non-DTG ART from conception).  

New data from the same study, published and also presented at the International AIDS Society meeting in July 2019, reporting the prevalence of NTDs in women taking DTG at conception was 0.3% compared with 0.1% among women taking non-DTG ART at conception.

The neural tube closes very early in embryonic development at day 28 post conception (6 week post last menstrual period in women with regular, 28-day cycles). This emphasizes the importance of pre-conception counselling and the importance of highly reliable contraception in WLWH as the best opportunity for risk reduction occurs prior to pregnancy.

Based on this data, revised, updated recommendations follow:

  1. Women who are taking any antiretrovirals including dolutegravir and become pregnant and are past 6-7 weeks of gestation should continue the same antiretroviral therapy if effective and well tolerated but have that regimen reviewed in light of pregnancy overall. Women who had dolutegravir exposure at conception should be advised to perform prenatal screening for NTD. Recommendation for termination of pregnancy on the basis of peri-conceptional dolutegravir exposure alone is not appropriate.
  2. If women who are taking dolutegravir present earlier than 6-7 weeks gestation, and wish to change from a dolutegravir regimen they should be counselled of the low absolute risk of dolutegravir exposure. This should be taken on balance with the potential risks of changing regimens given unknown tolerance and ability to adhere to a new regimen. A woman centered decision for a regimen switch or continuation of Dolutegravir based on her values should be made.
  3. Non-pregnant, reproductive aged women should have their pregnancy intentions and contraceptive use reviewed in each HIV visit. * Encourage the use of highly reliable methods of contraception (e.g. intrauterine device) and perform a pregnancy test prior to or at the time of initiating Dolutegravir based regimens. 
  4. Reproductive aged women who are not on highly reliable methods of contraception should be counseled on the risks associated with being on a dolutegravir containing regimen if they become pregnant and the safety of alternative regimens which do not carry the same NTD risk. Decisions to switch should be based on informed choice. If pregnancy is a possibility, switching to non-dolutegravir containing regimen should be considered.
  5. Given the lack of safety information on any new antiretroviral formulations, including but not limited to elvitegravir, bictegravir, TAF and cobisistat containing regimens, caution should be used in prescribing these in non-pregnant, reproductive aged women and they should be avoided in the first trimester of pregnancy when possible.
* For more detail see SOGC clinical practice guideline No. 354-Canadian HIV Pregnancy Planning Guidelines J Obstet Gynaecol Can 2018;40(1):94–114
 


Information on dolutegravir in pregnancy to date:

Data was released on May 18, 2018 based on an interim analysis of an NIH funded birth surveillance study, the Tsepamo study, based in Botswana. At that time, they found that in 11,558 women living with HIV in Botswana who became pregnant, 0.9% of babies (4 of 426) whose mothers became pregnant while taking dolutegravir had a NTD, compared with 0.1% of babies (14 of 11,173) whose mothers took other antiretroviral combinations (1,2). 

Since that time, further study data from the Tsepamo has been released and was presented at the International AIDS Society (IAS) conference on July 22, 2019. The new data reported that the prevalence of NTD associated with dolutegravir use in the first trimester was 0.30% (5 of 1683) compared to 0.1% (15 of 14, 792) in non-dolutegravir exposed pregnancies (10). 

This reported decline in the risk of neural tube defects has downgraded the ‘safety signal’ of concern for use of dolutegravir however the risk remains higher than other antiretroviral drug exposure groups. Moreover, data recently reported, from 22 sites in Botswana not included in the Tsepama study, between 2014-2019, showed a rate of NTD of dolutegravir exposed pregnancies of 0.65% compared to 0.08% in non-dolutegravir exposed pregnancies (11). Canadian surveillance data on congenital anomalies in pregnancies exposed to dolutegravir pre-conception and in the first trimester did not show a significant difference in overall rate of congenital anomalies between women on antiretroviral therapy compared with those not exposed; 3.9% vs 3.0%. Of the 4 of the 80 neonates born to women on dolutegravir during the first trimester who had congenital anomalies, none had NTD (12). (In Canada, folic acid is recommended prior and during pregnancy, which has been shown to reduce the rates of NTD). 

A systematic review of safety of dolutegravir in pregnancy (4) reported information on congenital anomalies in 442 women exposed to dolutegravir. This review, included data from six main studies including, an ongoing observational study in Botswana with 845 women on dolutegravir compared to 4,593 women on efavirenz; 142 women reported to be taking dolutegravir during pregnancy (88 exposed in first trimester) from the antiretroviral pregnancy registry; 81 pregnancies from EPPICC, PANNA, NEAT-ID; dolutegravir phase 3 trials; dolutegravir post marketing surveillance; and 15 women enrolled in IMPAACT P1026s. Of the total of 442 women exposed to dolutegravir in pregnancy 16 had congenital anomalies (3.6%), which is in keeping with the global rate of congenital anomalies of 3-5%. Of the congenital anomalies, most were polydactyly, which is a common anomaly in children of African descent (1%), and there were two renal cysts. None were documented to be NTD. In a single center retrospective cohort analysis from Sweden (5), 36 pregnant women seen at the Karolinska University Hospital were treated with dolutegravir; 14 before pregnancy and 22 started during pregnancy. There were 4 early spontaneous abortions, one late termination and no congenital malformations. 

Overall, the data reported to date appears to reaffirm that there is a small increased risk of NTDs, in the Botswana setting, in dolutegravir exposed pregnancies, however, that the absolute risk is very low. As a result, the WHO has recommended dolutegravir based regimens for first line therapy in all adults due to their risk/benefit analysis for population-based treatment recommendations in sub-Saharan Africa. (WHO press release regarding dolutegravir in pregnancy (10)
https://www.who.int/news-room/detail/22-07-2019-who-recommends-dolutegravir-as-preferred-hiv-treatment-option-in-all-populations)


General background on congenital anomalies and neural tube defects:

It is important to note that at a population level approximately 4-5% of infants have major congenital anomalies. Therefore, any increased risk associated with prescribing Dolutegravir should be considered in this context. With the advent of modern prenatal screening capabilities, prenatal genetic testing and detailed ultrasound examinations for fetal anomalies, the majority of these anomalies can be recognized. NTD occur at variable rates in different populations and in different countries. The incidence of NTD in Canada is approximately 0.04%. This has decreased from 0.076%, (6) following folate supplementation in grain products, which started in 1998. 

In Canada, although there is folate supplementation in food, additional folate supplementation is recommended 12 weeks prior to conception and through at least the first 12 weeks of the pregnancy. In low risk women (without a prior or family history), the supplementation in multivitamins of 0.4-0.6mg of folic acid is sufficient or prenatal vitamins which contain 1mg (7).

Studies globally have shown variability in rates of NTDs from 5.2/10,000 live births to 75.4/10,000 live births in African countries (8). Of note, the highest rate is less than 0.1% which is the rate noted in women living with HIV on non-dolutegravir containing regimens in the above-referenced report from the Botswana surveillance study. NTDs appear very early in the embryo development, as the neural tube closure is at day 28 post conception (6 weeks post LMP in women with very regular 28 day cycles). (14,15)


In summary, this information on dolutegravir is less concerning than the initial data from May 2018, but it highlights the importance of careful consideration when prescribing ART for women of reproductive potential or during pre-conception. In countries where individualized, patient specific prescribing can be conducted, choosing regimens that have long track records of safety in pregnancy is the wisest option. It takes many years of post-marketing surveillance to reveal if there are concerns regarding low event rate complications including teratogenicity. Few pre-licensure studies include women and very few include pregnant women so new drugs on the market need to be assumed to have unknown risks in pregnancy and caution should be exerted in prescribing to women in reproductive age (13). 


References:

  1. WHO Statement on DTG – Geneva 18 May 2018.
  2. European Medicines Agency statement. New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir. May 18, 2018.
  3. Tivicay® Product Monograph, ViiV Healthcare ULC, February 3, 2017.
  4. Hill A, Clayden P, Thorne C, Christie R, Zash R. Safety and pharmacokinetics of dolutegravir in HIV-positive pregnant women: a systematic review. Journal of Virus Eradication. 2018;4:66-71
  5. Bornhede R, Soeria-Atmadja S, Westling K, Pettersson K, Naver L. Dolutegravir in pregnancy-effects on HIV-positive women. European Journal of Clinical Microbiology & Infectious Diseases. 2018;37:495-500.
  6. Public Health Agency of Canada. Congenital Anomalies in Canada 2013 : A Perinatal Health Surveillance Report. Ottawa, 2013. 
  7. Wilson D et al. Pre-conception Folic Acid and Multivitamin Supplementation for the Primary and Secondary Prevention of Neural Tube Defects and Other Folic Acid-Sensitive Congenital Anomalies. J Obstet Gynaecol Can 2015;37(6):534-549.
  8. Zaganjor I, Sekkarie A, Tsang, BL, Williams J, Razzaghi H, Mulinare J, Sniezek JE, Cannon MJ, Rosenthal J. Describing the prevalence of neural tube defects worldwide: A systematic literature review. Plos One 2016;137:1-31.
  9. Health Canada letter June 7, 2018. RA-66998
  10. https://www.who.int/news-room/detail/22-07-2019-who-recommends-dolutegravir-as-preferred-hiv-treatment-option-in-all-populations
  11. Zash R., Holmes L, Diseko M, Jacobson, DL, Brummel S, Mayondi G, Isaacson A et al. "Neural-Tube Defects and Antiretroviral Treatment Regimens in Botswana." N Engl J Med, July 22, 2019.
  12. Money D, Lee T, O’Brien C, Brophy J, Bitnun A, Kakkar F , Boucoiran I, Alimenti A, Vaudry W, Singer J, Sauve LJ., for the Canadian Perinatal HIV Surveillance Program. Congenital anomalies following antenatal exposure to dolutegravir: a Canadian surveillance study. BJOG 2019; https://doi.org/10.1111/1471-0528.15838. 
  13. Mofenson, L. M., Pozniak AL, Wambui J, Raizes E, Ciaranello A, Clayden P, et al. "Optimizing responses to drug safety signals in pregnancy: the example of dolutegravir and neural tube defects." J Int AIDS Soc;2019 22(7): e25352.
  14. Detrait ER, George TM, Etchevers HC, Gilbert JR, Vekemans M, Speer MC. Human neural tube defects: developmental biology, epidemiology, and genetics. Neurotoxicol Teratol. 2005;27(3):515–524. doi:10.1016/j.ntt.2004.12.007
  15. Sadler, T. (2005), Embryology of neural tube development. Am. J. Med. Genet., 135C: 2-8. doi:10.1002/ajmg.c.30049
September 10, 2019
SOGC Infectious Diseases Committee Statement on Dolutegravir Use in Pregnancy
 

Health Canada: Cymbalta and the Risk of Postpartum Hemorrhage

The risk of postpartum hemorrhage has been included in the Warnings and Precautions and Patient Medication Information sections of the Canadian product monograph for Cymbalta.

Health Canada: The risk of postpartum hemorrhage has been included in the Warnings and Precautions and Patient Medication Information sections of the Canadian product monograph for Cymbalta.

  • An observational study evaluating the risks of maternal outcomes associated with exposure to duloxetine during pregnancy demonstrated an increased risk of postpartum hemorrhage for women exposed to duloxetine.
  • The risk of postpartum hemorrhage was 36/1000 (95% confidence interval: 24.8-49.4) in women exposed to duloxetine close to delivery (final 30 days of pregnancy) compared to 23/1000 (95% confidence interval: 23.1-23.4) in women who were not exposed to duloxetine during pregnancy (adjusted relative risk: 1.53 [95% confidence interval: 1.08-2.18]).
  • When treating a pregnant woman, the use of duloxetine close to labour and delivery should only be considered if the potential benefit justifies the potential risk to the fetus and the mother.

Learn more here.

August 29, 2019
Health Canada: Cymbalta and the risk of postpartum hemorrhage
 

SOGC Statement – Access to Medical Abortion in Canada: A Complex Problem to Solve

A series of recent news articles have shone a light on the challenges surrounding access to medical abortion across the country, pointing out some of the major differences between provinces, the concentration of access at clinics that currently provide family planning and/or surgical abortion, and the disadvantages faced by those in smaller and remote communities.
 
As physicians, a key priority of the Society of Obstetricians and Gynaecologists of Canada (SOGC) is to try to reduce the number of women with an unplanned pregnancy. Research suggests that unintended pregnancies remain high, with as many as 61% of Canadian women having had at least one unplanned pregnancy. Free access to effective contraception has been shown to reduce abortion rates. We are strong advocates for awareness and access, and a national contraception access plan is required to reduce barriers to access as well as to support a range of family planning services with safe, modern methods of contraception. The personal, health care, and social costs of a single unintended or mistimed pregnancy are substantial. A comprehensive but targeted plan would address women in need of contraception who are not covered by private insurance or government assistance plans, and who could not otherwise afford contraception.
 
We believe that Canadians would be well served by a policy for national, equitable access to contraception and healthy family planning, and the promotion of gender equality and empowerment of women and girls to have full control over their bodies and lives, consistent with the important commitments that Canada has made globally.
 
Regardless of the situation, it is always a woman’s choice whether to continue with a pregnancy or not. When this choice is limited by personal resources or by where in the country she lives, her access to care or choice is clearly neither easy nor equitable and we have a problem requiring action.
 
Pregnancy and pregnancy termination are complex decisions not entered into lightly. Abortion is a necessary option; the only question is whether it will be accessible and safe, or restricted to those with means. Our goal is to ensure equal access to safe abortion for all Canadians and to have well-trained and prepared health care providers offering a choice of medical or surgical termination in a secure network of care, close to home. The SOGC, the College of Family Physicians of Canada (CFPC), and the Canadian Pharmacists Association worked together to create a comprehensive online training course for health care providers and, upon completion, the clinician is invited to join a network of providers to be able to consult, share clinical experience, and learn about research advances. So far, 2,904 providers have completed training. Both the SOGC and the CFPC have offered well-attended workshops at our annual conferences, which were open to licensed health care providers in Canada.
 
Although the health care providers who have taken this course come from all parts of the country, currently, access to medical abortion is predominantly in existing clinics providing family planning services. The entry of Mifegymiso into the Canadian market was attended by numerous restrictions and, initially, mandatory training. While this may become more normal in the future, it was the first medication to have such requirements thereby creating an aura of complexity and risk. Those restrictions have been eased as experience has shown the safety of the medication. It is not going too far to suggest that that safety record may, in part, be due to the cautious introduction, with a small cadre of doctors – family doctors and gynaecologists – and nurse practitioners that gained the necessary knowledge and experience, which now needs to be widely shared.
 
Adoption of change is slow. Although education and training are necessary, they are not sufficient to effect a major change. We need to work across many sectors to understand the local environment and those factors that will support or inhibit the introduction of medical abortion services, and find solutions specific to each community. Safe care requires a team. We recognize the reality that, while those living in small or large, urban or remote communities have the same need for access to pregnancy termination, there may be deeply felt opposition to abortion that impacts both women’s willingness to seek, or practitioners to provide care in the smaller communities. 
 
If we only focus on clinical skill, we will see slow progress. To expedite implementation, we need to attend to all the dimensions; at a community, facility, and health systems level. Professional societies play a key role in continuing medical education, but the provincial government does indeed have a major opportunity to improve access, as it has done with procedures such as hips and knees.
 
Canada has long been at the forefront of ensuring its population has the freedoms, opportunities, and equalities that all people seek. However, we believe that we can do better in this case and must do what is right to provide sexual health education, free access to contraception, and access to all pregnancy options by removing barriers to access for medical termination of unwanted pregnancies.
July 24, 2019
SOGC Statement – Access to Medical Abortion in Canada: A Complex Problem to Solve
 

About the SOGC

The SOGC is one of Canada’s oldest national specialty organizations. Established in 1944, the Society’s mission is to promote excellence in the practice of obstetrics and gynaecology and to advance the health of women through leadership, advocacy, collaboration, and education.

The SOGC has over 4,000 members, comprised of obstetricians, gynaecologists, family physicians, nurses, midwives, and allied health professionals working in the field of sexual reproductive health.


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The Journal of Obstetrics and Gynaecology Canada (JOGC) publishes original research, reviews, case reports, and commentaries by Canadian and international authors, pertinent to readers in Canada and around the world. The Journal covers a wide range of topics in obstetrics and gynaecology and women’s health covering all life stages including the evidence-based Clinical Practice Guidelines, Committee Opinions, and Policy Statements that derive from standing or ad hoc committees of The Society of Obstetricians and Gynaecologists of Canada.

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ALARM was developed by obstetricians/gynaecologists, family physicians, midwives and nurses, who jointly continue to maintain and teach the course. Backed by the SOGC, the ALARM course arose out of our work to improve the care provided to women, babies, and families during pregnancy, labour, and postpartum.

  • The content of the course is evidence-based and incorporates the Canadian practice guidelines, so participants who complete the course gain an understanding of the latest best practices for providing care.
  • The ALARM course objective is to evaluate, update and maintain the competence of obstetricians/gynaecologists, family physicians, midwifes and nurses.
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The ALARM certificate will be awarded only to those who pass the written examination and who attend the course in its entirety.

If you are unable to attend an ALARM course but would like to purchase an ALARM manual, please download this form and submit it by email to alarm@sogc.com.

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Please note that there are upcoming ALARM courses planned that are not yet listed below. They will be added as soon as logistical aspects are finalized.


If you would like to hold an ALARM course in your community, please contact us at alarm@sogc.com. Please note that a minimum of 12 participants is required.

Should you have any questions about your registration, please do not hesitate to contact us at alarm@sogc.com.

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The ALARM program would not be possible without the efforts of specialists, physicians, nurses and midwives trained to teach this course to their peers. In order to maintain the quality of this highly recognized program, the ALARM Committee has identified specific requirements for instructors throughout Canada.

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  • Be actively providing intrapartum obstetrical care

If you meet the above requirements and wish to participate in the ALARM instructor course, please submit an application at the link below. Please note, a letter of recommendation from your employer, department head or a current ALARM Course Director is required.


If you are selected, you will be sent a registration link for the course. At this point, you will be able to pay your registration fees ($650 plus applicable taxes for OB/GYN and FP doctors; $500 plus applicable taxes for Registered Nurses and Registered Midwives) and receive access to the course materials.

Your participation at the ALARM instructor course is not a guarantee that you will become a qualified ALARM Instructor. 

To become a qualified ALARM instructor, you must:
  • Complete the Instructor course
  • Teach a course
  • Receive a favourable evaluation from the Course Director

Please note you will be required to teach once every three years to maintain your status as an active instructor following a successful completion of the evaluation process. If you fail to do so, you will have to take another ALARM course or Instructor course to maintain your active instructor status.

Space is limited to 24 participants per course. 

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