A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe.

If the new applications are approved, EDURANT, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children.

“We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC. “These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”

The expanded pediatric applications are supported by data from the Phase 2 PAINT and PICTURE studies, which showed that EDURANT, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive pediatric patients, respectively. Given these data, Janssen is seeking an expanded indication to allow use in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) and treatment-experienced virologically suppressed children (with HIV-1 RNA <50 copies/mL) weighing 10 kg or more.

In 2022, the FDA approved the world’s first long-acting injectable HIV-1 treatment option for adolescents 12 years of age and older. This regimen consists of Janssen’s long-acting rilpivirine and ViiV Healthcare’s long-acting cabotegravir and requires as few as six treatments per year.

Read also: Phase 3 trial of Rybrevant plus chemotherapy in lung cancer meets primary endpoint: Janssen

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Guyana has agreed to go ahead with the next step of China’s physical infrastructure-centered Belt and Road Initiative, according to a joint statement issued by the two countries to mark the end of President Irfaan Ali’s one-week official visit to that Asian giant. “The Guyana side expressed willingness to discuss and conclude the Joint Action ...

Managing
victims of severe burns carries a much higher cost than any other form of care in medicine, according to local plastic surgeon Dr Guyan Arscott.

He has thrown his full support behind an initiative by Petrojam to raise funds for the construction of a well-equipped burn centre in Jamaica to help minimise the need to fly patients overseas for treatment.

Dr Arscott, who is one of the plastic surgeons at the University Hospital of the West Indies (UHWI), gave the information in a video presentation that was played at the dinner and launch of the fund-raising campaign last week at the Jamaica Pegasus hotel in St Andrew.

The aim is to raise roughly $250 million, initially, for construction and purchasing equipment.

"The cost of managing burns is inestimable. This highlights the need for the burn care facility. We can actually engage the treatment earlier in this country. One of the big benefits we see coming is the collaboration it allows us to have with major centres in the United States," Dr Arscott said.

He pointed out that when severe burn cases come to the UHWI it creates a strain on the institution, underscoring the need for a dedicated, properly staffed and well-equipped burn centre.

"There are always burn injuries coming in, but the major burns are not in the majority, but when they come the demand is great on everything. You need to call out everything. If you don't, the cry for a fly out comes up. The air ambulance fee is approaching US$50,000. The care after that costs millions of dollars. We see the cost of little procedures that we do here, and [overseas] things ballon up in terms of the cost," Arscott said.

He shared that currently at the burn unit at UHWI there is a team, which includes general surgeons, plastic surgeons, intensivists, physiotherapists, a range of nurses and occupational therapists.

"All that team has to manage the patient intensively from they come in to the long term where they need rehabilitation," he said.

Dr Christopher Tufton, minister of health and wellness, said that while there is a need for the modern facility, the burn units across the island that offer limited care have done well to treat the many patients each year.

"There is a misnomer that we have no burn unit. I want to clear that up. We do have facilities at UHWI, Bustamante Hospital for Children, Cornwall Regional Hospital, and Kingston Public Hospital. We see about 1,000 patients a year, most of them not severe. The current infrastructure is able to treat with these patients, but we don't in cases of severe burns. For that reason, this advanced unit is necessary to save lives. For that reason the Ministry of Health will be a critical part of advancing the cause going forward," he said.

Added to saving lives, the advanced unit will set Jamaica apart from other nations in the Caribbean.

"I think it is important, because Jamaica is always seen as a regional hub for advanced medical care. A lot of people come here for care. Some of the smaller islands don't have the capacity and they have to go to Miami or some other place and it's far more expensive. By providing this unit, we can provide additional support to our brothers and sisters in the Caribbean region. The dynamics of our environment is changing, which makes us more susceptible for the demand for a service such as this one."

Telroy Morgan, incoming general manager of Petrojam, said that the company is delighted to "lead the fund-raising efforts to establish a world-class burn care facility at the University Hospital of the West Indies".

He added that, "Beyond the scope of Petrojam and it's boundaries, we ensure that our involvement in community and national development is key. So as a part of our corporate social responsibility, this burn unit is a flagship project to us."

Petrojam has committed to giving the first $10 million towards the project, while West Indies Petroleum has pledged $5 million.

Last week we explored anaesthesia, surgery, and what to expect in the days leading up to your child's procedure.

Now that you are aware of the basic expectations, let's move to the big one — surgery day.

At the Bustamante Hospital for Children, we ask that you arrive to the operating theatre (OT) by 7:00 the morning of the surgery. When you arrive, a nurse will check your child's weight and vitals (rate of breathing, pulse, blood pressure and oxygen level). The surgeon and anaesthesiologist will do a quick reassessment to make sure all is well. They will ask (again) about any cold, cough, or fever. If your child is sick on surgery day, the procedure will be postponed. Depending on the type of procedure, the surgeon may use a pen or marker to sign the body part for operation. This prevents confusion and possible mistakes.

Your child will change into a surgery gown, cap, and booties. At most hospitals, every patient on the day case surgery list is given the same appointment time. Of course, not everyone's surgery is done at the same time. So expect that there will be a waiting period — some patients longer than others. This helps the medical team to work effectively. While patient A is getting vitals done, patient B is talking to the surgeon, and patient C is talking to the anaesthesiologist. We appreciate this may be less than convenient, so we ask you to remain patient.

The first patient brought into OT is usually the youngest baby, followed by the patient closest in age, and so on. While you wait, your child won't be allowed to eat or drink anything.

When it is your child's turn for the surgery, a medical team member (doctor or nurse or porter) will take the baby from you and escort him or her into the operating room. The anaesthesiologist will place a mask over the baby's mouth and nose, and allow the baby to breath in anaesthetic gases to put the him or her to sleep. Once baby is completely asleep, the surgery can begin.

During the procedure, the anaesthesiologist monitors the baby's vitals continuously. After the procedure is over, the baby will be transported from the operating theatre to the recovery room, where we continue to monitor the vitals as well as the bandage covering the surgical cut. Once he wakes up, you can visit! the baby will be groggy or sleepy for a little while as the anaesthesia wears off. When the baby is fully awake, all vitals are normal, and he or she can drink sips of clear fluids without vomiting, the baby will be allowed to go home. You will be given a prescription (usually pain medications and any other medication the baby may need) with instruction of when and how long these should be administered. You will be advised about the possible complications to look out for, and to bring the child back if you are concerned. You know your child best, so call the doctor/hospital or come in if you are concerned. It is better to come in and be told everything is fine than to stay home and a complication worsens. Depending on the procedure, you will likely also be given a follow-up appointment to be reviewed in clinic.

As with every medical intervention, there are possible complications. The most common complications are nausea and vomiting, sore throat, being sleepy for longer than usual, and confusion after waking up. If you've never seen a video of a child waking up from anaesthesia and saying weird and wonderful things, do yourself a favour and do an internet search right now.

Some other possible complications from anaesthesia are:

- Damage to teeth or cuts/bruises to mouth (lips, tongue, gums, throat)

•nerve injury arising from how child was positioned during a long surgery

•being aware/partially awake during anaesthesia

• allergic reaction to the anaesthetic medications

•dangerous high body temperature as a side effect of the anaesthetic drugs (malignant hypothermia)

•spasm in the throat — the muscle of the throat closes up

-•wheezing

• organ damage

• death (This is very rare, but unfortunately still possible)

All the above also applies if your child requires admission to the ward before and after surgery, for example, for brain or heart surgeries, or your child may need to be admitted to the Intensive Care Unit after surgery — but we'll talk about that in another article.

Dr Tal's Tidbit

Knowing what to expect on surgery day can help to alleviate some of your concerns. The important roles of anaesthesiologists cannot be overstated. Their work creates the foundation for successful surgeries, promoting better overall outcomes for our little ones.

Dr Taleya Girvan has over a decade's experience treating children at the Bustamante Hospital for Children, working in the Accident and Emergency Department and Paediatric Cardiology Department. Her goal is to use the knowledge she has gained to improve the lives of patients by increasing knowledge about the health-care system in Jamaica. Dr Tal's Tidbits is a series in which she speaks to patients and caregivers, providing practical advice that will improve health care for the general population. E-mail: dr.talstidbits@gmail.com IG @dr.tals_tidbits.

In
a show of generosity and community spirit, Red Stripe employees recently came together under the Red Stripe Voluntary Donor Blood Programme to host another blood drive, donating an impressive 70 units of blood.

Here, brand manager for Guinness and spirits Nadine Hylton makes her blood donation while being comforted by a skilled nurse from the National Blood Transfusion Service. The event was hosted in the Occupational Health Centre at Red Stripe's Spanish Town Road brewery.