Dolutegravir drug is safe for women living with HIV

Aug 20, 2018

The decision to deny all women of reproductive age access to Dolutegravir is unfair and curtails women’s right to attain the highest standard of care.

By Martha Akello 
 
The country is about to roll out new treatment guidelines on HIV. Key in these guidelines is the use of Dolutegravir among women of living HIV of child bearing potential.  Dolutegravir (DTG) is a new drug that has established efficacy, tolerability and a high genetic barrier to resistance. It is an effective first and possibly second-line HIV treatment. 
 
However, the drug has caused a lot of mixed reactions in recent past due to a warning that was issued by WHO on May 8, 2018 citing a potential risk of neural tube defects in babies born to women who were put on DTG in pregnancy in Botswana.  
 
The concern stems from a preliminary unscheduled analysis of an ongoing birth surveillance study in Botswana, which has reported an increased risk of neural tube defects among infants of women who became pregnant while taking DTG-based regimens. The study reported four cases of neural tube defects out of 426 infants born to women who were put on DTG in pregnancy.
 
The neural tube is the earliest form of the spinal cord in the developing fetus. It is formed by Day 28 of pregnancy, the time of high risk for Neural Tube Defects (NTDs). The study has, however, not ruled out any other causes of NTDs such as lack of folic acid, meaning we cannot authoritatively say that DTG caused the birth defects seen in babies born of mothers who were using the drug until another phase of the study comes to conclusion sometime in 2019 as another cohort of women on DTG are being followed up.
 
After the WHO concern, many countries including Uganda, Kenya, among others that had plans to roll out DTG quickly came out to pronounce that DTG would not be given to women of reproductive potential in the country unless they are on a long term family planning method including sterilisation.
 
Women this age who were already on DTG were advised to revert back to Efavirenz. This has attracted a lot of reaction from the community of women living with HIV across the continent protesting the blanket decision by different governments without consulting them. With this reaction, the WHO revised its guidelines in July to allow access to information and choice for women living with HIV. African governments however, are still struggling with the decision whether to allow women access DTG or not even after the new guidelines. Never mind they acted so first to deny the women the drug on the first alert. 
 
Uganda has particularly excluded women between 15 and 49 years DTG and advises that they would be given Efavirenz. Women within this age group who are already on DTG are advised to get back to Efavirenz.
 
The decision to deny all women of reproductive age access to Dolutegravir (DTG) is unfair and curtails women's right to attain the highest standard of care. This is because women of reproductive age have differing needs and priorities when it comes to antiretroviral treatment. What works for one woman may not work for another. Take for example, during a dialogue to find out what women who are likely to be affected felt, some girls this age are in school and not planning a pregnancy so they did not see a reason why their male age mates should get DTG and have a stable life in school, while they are denied the same because they are in what is considered reproductive age.
 
So they would be struggling with drugs with major side effects like dizziness while their male counterparts are sailing through.  Taking care of such preferences is important for improving adherence among Adolescent Girls and women living with HIV of reproductive age, who by the way are not doing very well in matters adherence in the country.
 
We cannot claim to be very much concerned about the babies women living with HIV are yet to have, and not be concerned about the women's health. After all, the health of that yet to be conceived baby will depend on how healthy the mother is. And judging from past experiences, women living with HIV have always gone an extra mile to protect their babies. A case in point are women who had to get off Efavirenz when they conceived many years back because it was deemed unsafe during pregnancy. Similarly, if women are given information on the risks and safety of DTG, they will be able to make that decision that best works for them. Let us never forget that children have always been a great motivation for women living with HIV to see to live for another day. 
 
Four babies out of the 426 is a regrettable number and women living with HIV are concerned about this. But we must realise that most drugs have benefits and risks and the decision to use them involves a tradeoff between the benefits and the risks. Current regimens too have their issues but women have endured them. 
 
For many years, there has been a push to integrate Sexual Reproductive Health Services into ART clinics. This would see many more women and girls accessing FP services. DTG has once again offered us a great opportunity to integrate services, this is because a woman on DTG is expected to be on a consistent family planning method.  We should use this opportunity as a country to put our SRHR services right as opposed to shying away from the challenge at hand. Sexual Reproductive Health Rights and Services for women living with HIV are very important for their reproductive health decisions and choices.
 
We appreciate that so much conflicting guidance on one drug in a short period of time like it has happened with Dolutegravir can leave even the well-meaning un sure of what to do. But importantly, let us make decisions guided by a human rights based approach.
 
Let us consult the beneficiaries for us to make informed guidelines. And let us respect autonomy. In 2017, WHO released consolidated guidelines on the Sexual Reproductive Health and Rights of women living with HIV and section 4.3 of the Guidelines provided for a human rights based approach to ART. So as Ministry of Health puts final touches on its guidance, we are hoping that they will be guided by the 2017 WHO guidelines, discussion on the DTG internationally and the new guidance on DTG from WHO.
 
If the guidelines fail to take into account these and the voices of the women living with HIV, it will mean that we are choosing to run our show away from the conversation on DTG. 
 
What giving DTG to women can do to Uganda's HIV response
For very long, Uganda's HIV response has stagnated. We are even running campaigns such as Kiki Ekiganye seeking answers to what else we can do to put the response on track. DTG for women living with HIV would be a bold step to rewriting this narrative.
 
It would be a bold step for the following reasons:
Improving access to Family Planning: To have DTG, one needs to be on a consistent Family Planning method. This would give us the opportunity to raise access to Family Planning. Remember it is twice as hard for AGYW living with HIV to access family planning services because of the stigma they are likely to face in some health facilities. Accessing Family Planning for these young ladies is likely to raise eye brows because they are expected ‘to not add themselves problems'. 
 
Viral load suppression:  among young women in Uganda is still very low with younger women at 44.9%. DTG is very effective in viral suppressing people with high viral loads with about two months.
 
Adherence: When we met adolescent girls and young women living with HIV to talk about DTG, many confessed to have abandoned their current regimen of Efavirenz because it has adverse effects such as dizziness, depression which has literally made it difficult for them to operate normally and fend for themselves. Those who had been shifted to DTG confessed that their lives had greatly improved because DTG has less side effects and has offered them the chance to live their lives in full once one again, being able to work and fend for their families with normalcy. Adolescent girls and young women continue to gain increased attention because they are the only age group where HIV related mortality is going up because they do not adhere to their treatment.  
 
Treatment is prevention: We all know that treatment is prevention. With the current rate of 360 girls getting infected per week, we cannot afford to sleep over the decision to roll out DTG to all including the adolescents. This is because, even those infected continue to have a normal sex life and they are relating with partners who may or may not be living with HIV. 
 
The writer is the communications officer of the International Community of Women Living with HIV Eastern Africa (ICWEA)
 
 

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