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

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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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BoMRA warns of cancer-causing impurity

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Botswana Medicines Regulatory Authority (BoMRA) is investigating if ranitidine, a common heartburn medicine, has a chemical contamination, which could cause cancer.
The drug is also known as Zantac, Uptake, Austin and R-Lok.

BoMRA issued a warning recently following an announcement on September 13, by the US Food and Drug Administration (FDA) that it had learned that some ranitidine medications, including those known by the brand name Zantac, contain low levels of N-nitrosodimethylamine (NDMA), an impurity that could cause cancer.

NDMA is a possible cancer-causing chemical linked to liver damage. Since last year, the FDA has been investigating NDMA and other impurities in blood pressure and heart failure medicines known as angiotensin receptor blockers or ARBs. However, the FDA cautioned that levels of the NDMA appeared low and not much higher than when the chemical is present in foods like processed or grilled meat. The FDA said: “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods”.

Over-the-counter ranitidine is approved to prevent and relieve heartburn and can be prescribed to prevent ulcers of the stomach and intestines. In a statement, BoMRA told people they could still keep taking the medicine or ask doctors to prescribe one of many drugs that treat heartburn or ulcers. The health product watchdog cautioned patients who had been prescribed Ranitidine from stopping without an alternative, advising patients instead to talk to their health professionals before they stop or switch to other medicines.

“BoMRA is urgently liaising with the registered suppliers of ranitidine-containing medicines to investigate the presence of NDMA in Botswana ranitidine products; and will update the public on the outcome of these investigations,” reads the statement.

BoMRA Spokesperson, Israel Kgosidiile said there is no evidence at this stage that the impurity has caused any harm to patients.
“There is no recommendation for patients who have ranitidine to stop taking it. If a patient has any questions they should speak to their doctor or pharmacist,“ he stated.

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Know Your Specialist

‘Cancer took away my boobs, not my life’

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Sun Health: What events led up to your diagnosis, or, how did you discover that you were suffering from cancer?

Mpho Kgaodi:My journey with Breast cancer started in 2012. Around April I felt a lump on my right breast. It was not painful at all, just slightly itchy. It was on the upper part of my breast. I ignored it for about three days but it kept nagging me and then I decided to go see my doctor. He also confirmed that there was a lump on my breast He sent me for mammogram that confirmed an abnormality on the structure of my right breast. I then went to see him with the results and he informed me that there are two ways to test that lump – Biopsy, which meant that he will be taking a piece of that lump to send it to the laboratory for examination and the other option was to totally remove the lump, Lumpectomy. I decided that he removes the whole lump, because I really didn’t want that Lump on my breast.

SH: We know that about 10% of all breast cancers are hereditary. Are there other women affected in your family?
MK: I don’t know of any other woman or even man in my family who has had cancer, though it is hereditary.

SH: What were your first thoughts when you received the diagnosis?
MK: I cried for a brief moment. I was overwhelmed with emotions, fear of death. I quickly recovered from that dreadful thought and remembered that I have a great husband and three boys. I felt that I had so much to live for.The doctor informed me about the options I had regarding treatment and he gave me time to think about it. I drove back home to Lobatse and by the time I arrived at my house, I had already made up my mind that I am going for total removal of the breast. I broke the news to my family and they were just as shocked as I was when the doctor broke the news to me. I explained to them my decision to go for surgery and they were very supportive. Few weeks later, I went for a mystectomy.

SH: How long were you in treatment

MK: The surgery was followed by Chemotherapy. The first time I walked into the oncology centre, I found so many people there already. I then realised that I am not the only person with cancer, it is so many of us. It gave me strength and courage. I had heard that the side effects of chemo are brutal, seeing those people made me realise that if others can do it so can I. I decided to go for it as I had so much will and spirit to stay alive and raise my kids. After the second session of chemo, I started losing my hair, nail beds turned black. I was never discouraged though, despite my aching body and the constant nausea after chemo. I had six cycles of it. In 2013 around April again, I experienced severe pain on my left breast, but with no Lump. My doctor again recommended I go for a mammogram. It confirmed cancer which was still at stage 1. I then insisted that they remove the breast. I would lose both my breasts but I knew staying alive for my boys was more important. Other people thought the pain was psychological, and I knew what I felt and my mind was made up. I had the second mastectomy and had to go through another cycle of chemo which I completed. I am now on oral medication. I take my tablet daily. It is recommended that I take it for ten years. I have just started on my year 6 on the tablet. I do go for regular check ups, to establish if the cancer is not back.

SH: What helped keep your spirits up and gave you support during this period?

MK: A good friend of mine and colleague told me about Journey of Hope Botswana. He introduced me to them, and I had tremendous support from them. I also went to Cancer Association Botswana to introduce myself. My family has also been my backbone, supporting me through it all. I am so greatful. On days that my spirits are low, I always take my mind to positive thoughts. I try to remind myself of the good times, sometimes I even find myself laughing out loud.

SH: How has this affected you at a psychological level?

MK: My life has not really changed for the worst. Like the saying “when life gives you lemons, make lemon aid out of them”. I lost my job after the second diagnosis of cancer. While this affected my family financially I never got discouraged, as this gave me time to take care of my family. I am a full time stay home mom. I walk this journey with my family. My boys understand that I had Cancer but now I am okay. They sometimes check if I have taken my medication, and they would even ask about my next appointment. I am blessed to have them.

SH: Facing the diagnosis of breast cancer is one of the most feared experiences in our society. What has been your experience as you worked with communities through Cancer Association of Botswana (CAB)?

MK: Working with CAB has been eye opening. Through motivational talks and other actives like the annual stiletto walk, the message has been positively received. There is still a lot to be done though, especially to make people understand that breast cancer is NOT a death sentence. So many lives can be saved.

SH: Amongst raising awareness, cancer awareness month is about celebrating individuals like yourself and their triumphs over cancer. Is there anything you would like to say to the community of cancer survivors and women in general?

MK: I have learnt so much from being diagnosed with cancer. I appreciate life more. I never used go and see a doctor without any pains or any thing “wrong” with my body. Now I do it regularly and so far I always get a clean bill of health. I encourage everybody to do regular self -breast examination. It is easy, convenient, cost-effective and can really help with early detection. I believe there is a lot to be done as far as breast cancer awareness. Remember men can also have breast cancer.

To all those who are going through cancer at the moment, remember you are not alone. Let’s walk this journey together. Let’s walk with Hope, Courage and Strength. There is life after cancer. Cancer took away my boobs it did not take my life. As October is breast cancer awareness, let’s support those affected, honour the survivors and remember the fallen.
PINK RIBBON ALWAYS

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