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Sun Health

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

Rachel Raditsebe



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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Mental Health Series

The effects of dagga on mental health



Recently the South African Supreme Court legalised the private use of dagga. Individuals are allowed to consume dagga in private and also grow for private use. The judgement brought mixed reactions on the issue and further fuelled the debate on dagga.

There are those who have used this judgement to the detriment of their own health. The crux of the matter though is that adverse effects of dagga cannot be underemphasised as far as mental health is concerned. Dagga use is quite popular amongst the youth which ostensibly explains the prevalence of dagga related disorders amongst them.

Effects of dagga are instant upon use. When dagga is smoked, it gets into the blood stream and then blood –brain barrier. This results in depressed brain activity, the end result being production of a dreamy state manifesting as delusions or hallucinations.

Delusions are altered thoughts whereby one may think he is a president when the reality is he is not. Hallucinations on the other hand is when an individual has distorted perceptions of reality like seeing a lion when it’s not there!

Others effects include:
panic attacks
Impaired coordination and balance
Impairment in learning and memory

Various research studies have shown that heavy use of dagga facilitates the development of schizophrenia and substance use disorders. The amount of the drug used and the age at first use often place an increased vulnerability to develop these disorders. This explicitly explains why there are many youth who are having substance use disorders in our country.

Those using dagga may develop amotivational syndrome which basically means they have lost the willpower to do meaningful activities in life! This is basically the stroke that breaks the camel’s back, as other mental health problems may manifest from this.

Those whom are already diagnosed with mental health disorders can have symptoms of their conditions worsening when they use dagga. Depression and anxiety are often made worse by use of dagga. The false perception that taking dagga has a calming effect often predisposes those having mental health problems to take it in order to deal with their illness burden.

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Sun Health

Lymphedema Management Part II Post Breast Cancer



Lymphedema can occur to individuals who have had breast cancer treatment with radiation and/or surgical intervention with or without lymph nodes removal usually in the arm pit.

Lymphedema is a special type of swelling that occurs when there is excessive build of fluid that is rich in protein that is to become lymph due to an impairment in the transport of this fluid anywhere enroute to its final drainage site in the neck.

Lymphedema management is divided into two phases: Phase I Congestive/acute phase whose goal is to achieve the greatest decrease in volume of lymphedema and Phase II Maintenance phase, whose purpose is long term maintenance to ensure sustenance of goals achieved in Phase I.

Components of Phase I are, a) patient education about the condition, self management strategies. The patient will be advised to avoid certain medical procedures to be done on the affected side, e.g. blood pressure readings, pricking to withdraw blood.

These procedures especially the pricking will result in minor injury which in a normal functioning system is insignificant. The normal bodily response is that the body will respond as there is injury with insignificant swelling.

In the case of someone with risk to lymphedema this can be a trigger to full blown swelling, b) Meticulous skin and nail care to keep fungal infections and cellulitis at bay, c)Manual Lymphatic Drainage (MLD).

This is specialised manual (hands-on) technique whose purpose is to improve fluid removal from congested (swollen) areas where there is impediment of flow to using alternative routes to de-congest the areas.

For example, if there is lymphedema in the right arm from right partial mastectomy (breast tissue removal) with eight lymph nodes removal in the right arm pit. The alternative routes to drain) the right swollen hand/arm is to re-direct fluid to drain into the left armpit, right groin and maybe right breast bone areas.

Following this during a treatment session, d)multi-layered Compression Bandaging is used. Here special bandages are used which come in different sizes. Which technique to use when bandaging is influenced by the degree of swelling and staging of lymphedema.

The bandage system is tighter at the wrist and progressively becomes looser towards the arm. This creates graduated compression which facilitates fluid to flow from the wrist towards the armpit.
Initially the bandages are worn 24hrs/day at a time.

If there are wounds which is not as common when compared to the leg(s) preference is to co-treat with nursing care for them to manage the wounds while I manage the swelling concurrently. Immediately the patient does, e) therapeutic exercises to further drainage of fluid from the wrist to the armpit.

This phase I duration can be anywhere from three weeks to eight weeks and more if needs be. During this time the patient is taught to self bandage, gentle self manual lymphatic drainage, prepared for wearing and taking off of compression garments.

Phase II: Maintenance phase, this is initiated when there has been maximal limb (arm size) reduction in Phase I. The patient is fitted into a compression garment. This can either be custom made or off the shelf. Compression garment may be arm sleeve, glove with or without fingers.

The compression garments come in a variety of compression (Class I to IV). The therapist advicss on the compression garment class. Most patients use compression Class II and III. Ideally the patient is encouraged to wear the compression garment all the time.

From time to time there will be a relapse, that is, swelling starts and Phase I will need to be initiated. There are a number of treatment approaches that can be taken. Factors influencing choice include cancer disease stage, type of cancer, location of lymphedema, patient mental status.

It is not just lymphedema that needs to be treated. Other things to treat include scarring, pain and decreased function. If you suspect you have lymphedema bring it to the attention of your oncologist who will refer you to someone trained to manage this condition.

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