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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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The alternative view With Brown Oteng

FOUR ANCIENT SOURCES OF HEALTH

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Hypocrites the father of medicine says “the SUN and salt are healers of the body”

The Sun is the star at the centre of the Solar System that supports all life by a process called photosynthesis. The same process is used by plants and other organisms to convert light energy into chemical energy that can later be released to fuel the organisms’ activities.

Photosynthesis is largely responsible for producing and maintaining the oxygen content of the Earth’

When an individual remains indoor they cannot get any vitamin D from the sun and are therefore unable to absorb calcium which is essential in healing.The most abundant mineral in the body is calcium to absorb calcium from your foods you must have vitamin D and that can be accomplished in minutes by being in the sun (in a swimsuit optional, mostly it is done by white people). We absorb Vitamin D in 20 seconds of being in the sun

BENEFITS OF SUNLIGHT
Direct sunlight is important for more functions as the hypothalamus and pituitary needs to regulate your sleep patterns, your weight, body temperature, sexual functions and to a degree water balance. Hormones are thus stimulated and are important for the regulation of nutrients in the body.

HEAD AND EYES
Your head and eyes needs sunlight, remove the cap sunglasses, artificial hair, wigs for a while to absorb sunlight through your head and eyes. OUR EYES needs sun too don’t believe the indoctrinating advertising by wearing sunglasses.

Sunglasses and make-up are not meant for beauty and fashion their purpose is to cause health problems to benefit corporations trading in the health sector.
The sun does not cause cancer, instead it is you shortage of certain elements that are required when in the sun that allow you to burn. Do you think the creator created the sun to cause health problems?

Once again the sun is a major benefactor to health and recovery from all illnesses when natural medicine is practiced. In the past EUROPE & USA hospitals would wheel their patients out into the sun daily for an hour or two because it’s very important for absortion of nutrients resulting in natural recovery.

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Know Your Specialist

Forgiveness is a virtue

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It’s hard to get through life without experiencing some resentment. Executive Director – Phronesis International College (PIC) and Counselling and Psychotherapist, Peacebuilding and Life Skills Education Specialist Dr Thelma Kgakgamatso Tlhaselo-Majela discusses forgiveness and why letting go is good for you.

What forgiveness?
Forgiveness is a process that positions one on a healing path by choice in an attempt to resolve the psychological stress and trauma one could be experiencing. These pains and emotional injuries may stagnate one into feelings of anger, bitterness and resentment and in worse cases depression, anxiety and post-traumatic stress disorders. If left for long, protracted unresolved psychological distress and or trauma could deepen one more into multiple losses.

It may generate hatred and desire to cause harm on the other and this can throw one into revenge and or vengeance. Forgiveness then starts from the cognitive ability to choose letting go of the emotional and cognitive baggage thus granting the self or inner being power to constructively open portals of intrapersonal empowerment. Moreover, a well-integrated process of forgiveness could shift one into an empathetic and compassionate psychological space filled with virtue and psycho-sociological attributes of restoration that accentuate positive benefits of healing.

In your experience,what are the common issues that need forgiveness?
Life by nature is riddled with so many issues and challenges characterised by diversity and complexity hence appropriate understanding is very important. People are social beings that co-exist through healthy connectedness and this may happen at the physical, personal, socio-cultural, psychological, financial, spiritual; political level to mention a few.
We all need a deepened awareness on how the intra-personal (within self), inter-personal (with others), inter-group (within groups) and international (nation to nation) relational connections play out in life. These healthy relationships deserve to be developed, nurtured and protected lest they become dysfunctional and corrosive.

The common issues for forgiveness are varied and highly individualised. One person may look at what another is struggling with and may consciously or unconsciously belittle it because for them it appears an easy or small matter but people are unique and this deserves respect. The relational betrayals, emotional injuries, corrosive conflicts and intractable may result in residual emotions that can cause people to drift into anger and bitterness. In such accounts, people may find themselves responding through avoidance or seeking revenge which has the potential to cycle one back into deeper pain.

The complexity of forgiveness may originate from the nature and quality of the relationship one had, the nature of the wrong committed with the cognitive interpretations one ascribes to the event. This includes significant others such as spouses (couples), children, family relatives, colleagues, bosses and subordinates in the work place.

Sometimes, it may be people we do not know that have hurt us such as a murderer, rapist or an abuser and may not even acknowledge that they have done anything wrong to us. It may also be about the symbolic losses where the people and or situations to forgive do not physically exist such as a dead person or a geographic disconnection. In such cases, the existential reality of the phenomenon remains true, real and alive in the psyche of the emotionally injured person and requires a healing process.

Is it possible to forgive when one is still angry and can you forgive someone who does not think they have done anything wrong?
Forgiveness is a process that one does by choice for oneself and not for the perpetrator because one understands that the pain and suffering one is experiencing has a direct injurious effect on one’s life. Similarly, revenge and vengeance which for long has been one of the rudimentary human responses can only promote increased pain as it stagnates one into more hurt and pain.

It often cycles one back into psychological trauma hence one needs to perceive value addition in engaging in forgiveness because it can be logically and rationally incomprehensible when one is caught up in this quagmire. A bitter-angry person may grapple with cognitive dissonance which is an internal struggle to understand why they have to release someone who according to them deserves a punishment or better still refuses to acknowledge that they have done anything wrong.

But irrespective of the reason, holding on to anger, bitterness and resentfulness within the inner self can only grant one false gratification that they are holding the perpetrator to ransom. Needless to say, we have no control on how the other person thinks and feels and we may actually be subjecting ourselves to increased injury and punishment from the very issue we are contending with.

Seeking professional help will assist one to work through the psychological defence mechanisms such as denial, repression, rationalisation, reaction formation, regression to mention a few that may promote dysfunctional tendencies in un/forgiveness processes. Notwithstanding, people need to be assisted with respect for human dignity within them and never be forced and or coerced into forgiveness when they are not ready to do so. Given that anger will consume the person already holding the pain and hurt whether it is perceived or real, working on forgiveness can be a desirable option to open the healing process.

Can you discuss the rewards or benefits of forgiveness?
As can be seen, it often pays to work through forgiveness hence the concept of working it out because people respond to pain and trauma differently. The rewards and benefits shared in this context are not by any means exhaustive because there are several psycho-social models for assisting people to process forgiveness issues and this requires well trained service providers.

*People who are angry and bitter are often not desirable in social contexts because they may consciously or unconsciously spill this negative energy on other people and this tends to repel instead of attract social connections. At intra-personal level, we are likely not to find our inner life peaceful and enjoyable if we are ever stuck psychosocially on anger and bitterness because it may promote self-hate, poor self-concept and negative self-esteem. So it pays to be gentle to love yourself enough to desire good emotions about and towards other people for that will rub corrosively on your personal well-being. The benefits of forgiveness include enabling one to circumvent these psychological pains and trauma that can affect quality of life with self and others which may compound stress levels.

In extreme cases people may sink into depression and anxiety which could ripple into other areas of life such as sexual dysfunction, eating disorders, substance use and abuse, relational conflicts and psychosomatic illness. Forgiveness builds a healthy mindset and that attracts a healthy personality which consequently leads to healthy social and physical well-being. Forgiveness fills the inner space with good attributes and this is shared with others. We then by addressing forgiveness issues reduce on maladaptive tendencies and lift on psychosocial protection thus leading to safeguarding the intra-personal, familial, corporate and societal communities from effects such as divorce and relational stressors.

At corporate and industrial level, a socio-psychological space that is riddled with un/forgiveness is a breeding ground for visible and invisible costs. For instance, a huge cost can emanate from a collective environment that is unproductive because of collective stress and restlessness. A workplace where people are transparent and honest and regard others with respect to deserve forgiveness often tends to promote healing communities where others feel safe and do not fear hence they can work to the optimum level of their potential.

We also benefit as a nation when we are characterised by forgiveness because we have a strategic desire to promote a knowledge-based community as the foundation for transformational change. Botswana considers people as a reservoir for knowledge and wisdom to lead as change agents and if we are a community that is unable to work through issues of forgiveness, we may create or nurture a psycho-sociological space that disempowers collective construct for healing communities.

A Motswana who is able to forgive is likely to live with people from other backgrounds and has a healthy and broader capacity of dealing with diversity and differences with virtue and competencies for the 21st century to advance the nation at local, regional and international level.

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