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Questions remain on safety of ART pill, DTG-Tsepamo Study

Rachel Raditsebe

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There have been no new cases of neural tube defects (NTD) reported among infants born to women taking dolutegravir (DTG) at conception, as ongoing surveillance on NTD link to dolutegravir,continues according to scientists.

In 2014, researchers in Botswana began a 4-year surveillance study, called Tsepamo, of all babies born to both HIV-infected and uninfected mothers at eight clinics to evaluate the safety of ART in pregnancy and the frequency of neural defects. This rare condition can cause large holes in the spine or can prevent the top of the skull from forming.

Neural tube formation occurs during the first 28 days of pregnancy. The Tsepamo study was initially designed to look at whether efavirenz, the first-line antiretroviral used in Botswana at the time, was associated with neural tube defects. But when dolutegravir became the first-line treatment in Botswana in 2016, it was added to the study.

An unplanned interim analysis of data from a cohort of pregnant women living with HIV in Botswana was then conducted at WHO’s request to help inform the guidelines review process in 2016. The interim analysis identified four cases of Neural Tube Defects (NTD) among 426 infants born to women who were taking DTG at the time they became pregnant.

Immediately after, safety alerts were issued, governments and health organisations including the World Health Organisation changed their guidelines to recommend against the use of dolutegravir by women who might become pregnant.

However, at the seventh Botswana International HIV Conference themed; ‘Time to End It: Find Treat and Prevent-The Last Mile’, Principal Medical Officer at the Health and Wellness Ministry, Dr Max Kapanda reported since that cut off date of May, 180 babies have been born to women taking the drug during conception and none have such defects, Dr Kapanda reported.
Between May and July, there have only been two more neural tube defects among this cohort: one in an infant exposed to DTG started during pregnancy at eight weeks’ gestation and one birth to an HIV negative woman.

He however stressed that the new findings don’t clear the air. “This is still a preliminary signal and we need more data to confirm or refute it,” he said.
The Tsepamo study continues, with an additional 10 sites planned including Bamalete Lutheran Hospital, Palapye Primary Hospital, Kanye SDA Hospital and Letlhakane Primary Hospital amongst others.

Researchers expect to capture nearly 72% of all births in the country and to have information on another 1200 conceptions in women taking the drug by March 2019. The final analysis in March 2019 will include NTDs, all major malformations as well as other adverse birth outcomes. “A lot still hangs on Tsepamo and its important for the public to know the what the risks and benefits are,Dr Kapanda said. He however also said that“if it is shown that DTG is the cause of defects, it will be stopped altogether on women of child bearing age. But beyond the current issue of DTG, the aim for this study is for Botswana to build a robust birth defect system”. Meanwhile the ministry has urged women taking DTG not to stop therapy, but seek help from their health providers.

Those who are pregnant and have conceived while on DTG should alert their healthcare providers so they can be counselled and advised appropriately. For those women who are currently on DTG and do not desire pregnancy at this time, should consult their healthcare providers for effective contraception in addition to the use of condoms.

DTG has been the drug of choice for people living with HIV as it has very few side effects, is easier to take (one small tablet taken daily), and patients are less likely to develop resistance. In 2015, the World Health Organisation (WHO) recommended DTG as an alternative first-line regimen for adults and adolescents.

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Sun Health

U=U strides in HIV prevention

Rachel Raditsebe

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HIV positive Gumisayi Bonzo (47) knows first-hand the fear and worry that accompanies every sexual encounter for a serodiscordant couple. This is a situation whereby two people are in a relationship and sexually active but one of them is HIV-positive while the other is HIV-negative.

“Our sex life was a big challenge, with me wanting to use about two condoms at a time, putting barriers during sexual intercourse like no kissing because I was afraid of passing on the virus to my her,” Bonzo shared in an interview with SunHealth on the side-lines of a regional capacity strengthening meeting for African National Human Rights Institutions (NHRIs) in Johannesburg recently.
“My partner is negative and a transgender woman and right from the get go we were dealing with a lot of backlash from both of our families of why we shouldn’t be together. But we perceived and went through a lot of counselling.

“It was in one of those sessions that a doctor explained to them about the growing body of evidence that if Bonzo took her antiretroviral medication religiously and on time, and her viral load was low she would not pass on the virus to her partner.“You don’t know what a load off my shoulders that was. I have been on ARVs for the past 20 years and never defaulted. So we decided that I would go get a viral load test and it was undetectable.

“It doesn’t mean I don’t have the virus in me anymore, it’s just not detectable in my blood and so my partner and I wanted to know what it meant for us and our sex life.“We conducted further research on our own and decided it was worth trying not just for us but others especially adolescents born with the virus who have been led to believe they can’t have full lives like other ‘normal’people. “We started having unprotected sex and went for an HIV test six months later and she was still HIV negative. We have been doing that since 2015 and her status has not changed in that time,” Bonzo stated. For people living with HIV like Bonzo, the knowledge that undetectable virus equals un-transmittable is huge, “not only because it prevents us transmitting the virus to our loved ones but it removes fear,” she said.

“It removes the cloud that because you’re positive, you can’t do certain things. It’s the message that we give which for a long time has been negative and fearful. If we put fear in someone that just because they are HIV positive they can’t do this or that, you are taking away their self- esteem”.

In sharing her experience, Bonzo hopes to remove this cloud of fear and stigma from the community. But admittedly, it’s a difficult message for even the medical fraternity to spread.For a long time HIV/AIDS prevention messaging has been the long standing abstinence, be faithful and condomise. But now ARVs are being counted as a weapon to prevent the spread of HIV as well as to treat the virus, what the experts are now calling treatment-as-prevention. “Getting people to wrap their minds around that is really hard. But currently, no other intervention beyond abstinence shows such a level of protection against HIV. It’s probably even safer than condoms because things often go wrong with condoms,” said Deputy Executive Director of Wits University’s Reproductive Health and HIV Institute, Professor Francois Venter

“I can’t stress enough how strong the evidence that people who are on successful ARV treatment are 100 percent safe and will not transmit the virus,” said Prof Venter.While HIV new infection rates remain high in Southern Africa, there has been a slight decrease with South Africa at 44 percent, Botswana at 30 per cent and it’s similar in other countries in Southern Africa like eSwatini. And Prof Venter gives credit to the roll out of the Treat All campaign, a programme aimed at providing anti-retroviral treatment to all HIV positive people regardless of their CD4 count. Hundreds of health organisations worldwide including the Centre for Disease Control (CDC), now support the Undetectable = Untransmittable message.

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Positive Living

Let’s Rise Above Batho Ba Tla Reng Syndrome

Onalethata Mpebe

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In your life, you will constantly be surrounded by people who will judge you day in and day out. They will gossip about you when you succeed, and they will criticize and mock you when you fail. It is an absolute certainty that batho ba tla reng (people will talk).

How you respond to this certainty makes a world of difference for your life. Unfortunately, many people respond by shaping their lives around the approval of other people. Today, I want to encourage you to avoid living this way, which is what I call the the batho ba tla reng syndrome. We must learn how to respond when confronted by family or friends who challenge our decisions with the phrase “but what will people say?”

For me, the key to positive living is focusing on what pleases God, not people. People can never be pleased, unless humbled and influenced by the grace of God. The day I decided to go public about my HIV+ status, I didn’t consult anyone or ask anyone if I should. On that day, I found myself alone in my room, struggling with many suicidal thoughts. I remember that while I was fighting these thoughts, something inside of me urged me to share my HIV status with the public.

I made the decision on my own, even though I knew that my family would object. I told my cousin, who was fine with it. I also told my sister, who was against it. I told her that I am doing this for myself, to be free. She said that she didn’t understand what I was going through, but was worried about how I will handle negativity. I told her, “I don’t know how I will handle it, but I will see as time goes on.”

My mother was furious to find out I had gone public after I did it. She said: “ke eng o tsamaya o ikgasakgasa, ntha batho mo ba re ba itseng ga ba itatsetatse mo” (why did you go public, most people we know [who are HIV positive] never did that.) Many other family members began criticizing me for going public, but I chose not pay attention to negative things people were saying about me. I found amazing power within me which allowed me to rise above all of the judgment and negativity. I started paying more attention on building myself up as an HIV activist and motivational speaker. As a result, I began living my life the way I wanted.

Living this way is not without sacrifice, but for me, it is the only way to achieve my destiny. I found out that some people who I loved were trying to distract me from my life’s purpose. I just had to sever ties with the naysayers in order to pave the way to a much better and healthier life. The more I ignored the negativity, the more I found positivity within me, and from people who supported me.

My readers, please do not fall victim to the batho ba tla reng syndrome. Stop worrying what others think or say about you. When you care about what others think of you, you give your power away. You effectively disempower yourself. Worrying about what others think of you is the number one reason why people experience stress, anxiety, and fear. This is why we see many people today failing to accept their HIV status, to disclose to their partner and family, to adhere to medication and live a healthy lifestyle. Some people still fail to get tested for HIV or to enroll on ARV treatment because they are trapped in the batho ba tla reng syndrome. We must continue to rise above it!

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