Saturday, December 1, 2018

Namibia's success in the fight against HIV

Harvey Davis comes to open the gate to his dusty, wind swept compound in the remote part of northern Namibia.

"Welcome, welcome, it's been so long since we've had visitors," he exclaims at the two health workers.

The 79-year-old summons his wife, Ruth Nasidengo, who is 40, from their home. She emerges with two babies, clinging to each arm.

This is the front line in Namibia's war against HIV, where a data-driven on-the-ground approach has helped it become one of the most successful countries in tackling its spread.

The red-uniformed health workers are field officers, who report to a troop commander, who in turn is under a division commander. Rather than guns, their weapons are a small plastic table and a cooler bag filled with ice packs and HIV tests.

Leontine Iipinge and Maria Johannes have walked more than 3km (2 miles) from their base in the Oshana region to visit the couple.

The initials TCE, meaning Total Control of Epidemic, stand out in bold letters on their shirts. It is a programme run by a national NGO, Development Aid from People to People (Dapp Namibia).

The field workers are two of more than 200 TCE health workers serving a population of nearly 182,000.

Mrs Nasidengo, a mother of twins, has been living with HIV for over a decade and has been a client of TCE for two years.

But this visit is about her husband as he is about to get his first home HIV test.

The ice packs in the cooler maintain the correct temperature for the rapid tests.

With his 11-month-old daughter, Dora, sitting on his lap Mr Davis watches as Ms Iipinge unpacks and disinfects her instruments and pricks his finger.

"I'm not worried," he quips, "but it sure looks like Dora is."

Detective work
As the 15 minutes tick by before the result is known, Ms Iipinge explains how testing the partners of people with HIV helps contain the spread of the virus.

Back at their base in Oshakati town, they compile data of all people known to be HIV-positive and then set about tracing their sexual partners to establish their HIV status.

The rapid test looks for HIV antibodies in the blood and the results are indicated by stripes appearing in the window of the device.

As Mr Davis and his daughter watch, a single stripe appears showing that he is HIV-negative (two stripes indicates a positive result). But he is still referred to a hospital as he needs to be given drugs that reduce the risk of contracting the virus from someone who is HIV-positive by 90%.

TCE field officers have worked in this area for 14 years.

They have built community trust and respect but not everyone can be easily persuaded to take an HIV test.

The next stop for Ms Iipinge and Ms Johannes is about 12km away and they are heading to the home of Lucas Angula in the Evululuko township.

He found out that he was HIV-positive just last month, but it had taken his wife, Matilda Ipandula, 10 years to convince him to take the test:

'We would always fight and argue whenever I brought up the issue of HIV testing with my husband," she says.

"He refused to listen and that's why I asked our neighbour to get involved. It was difficult but it had to be done."

The neighbour, Emirita Kuutondokwa, now forms part of Mr Angula's trio, a support group made up of someone who is HIV-positive and two others.

He says their encouragement has helped him deal with his diagnosis and take the drugs that help contain the spread of the virus.

Support is a key ingredient to the success in containing the spread of HIV here.

Close to Mr Angula's house, a small knot of people have gathered under a Marula fruit tree.

They are singing a song, in the Oshiwambo language, about how they are the lucky ones.

This is what is known as a Community Adherence Club - a group of 12 people who are all HIV-positive.

They take turns to collect medication from the clinic 20km away. This frees the remaining 11 to get on with other things and avoids clogging up the clinic.

'Not about the money'
After seeing to her clients, the division commander, Ms Johannes, joins the group to shake off the tension of the day as they dance around the tree.

"When you get into this, it's first about the job and the salary but as you stay it becomes about the people and the passion," she says.

"I've had field officers here who have only stayed for five months because they feel what they get as a salary does not compensate the time they spend at work but the ones that stay, they have passion to be with the people, to work with the people, to improve the lives of the people."

Newly released data by the US President's Emergency Plan for Aids Relief (Pepfar) shows it is this community-centred approach that has helped Namibia exceed some of the 90-90-90 targets set by UNAids in 2014.

The figures measure:

The percentage of people who are thought to be HIV-positive who know their status
The percentage of people who know their status who are taking antiretroviral drugs
The percentage of people who are taking the drugs who have an undetectable level of HIV
For Namibia, the figures are 86%, 96% and 91% respectively.

'No time to relax'
Its neighbour, South Africa, the country with the highest number of HIV infections in the world, scores 90-68-78.

But Health Minister Dr Bernard Haufiku says now is not the time for complacency.

"There is a real possibility that we will be able to reach our target by the date set by UNAids [2020], we just have to give it a little bit of a push because we are almost there, just a few percentage left. We need to focus, especially on the prevention campaigns in the field, targeting young people that have not been tested."

Namibia used to have one of the highest HIV-prevalence rates in the world, but in the past 15 years, the number of new HIV infections has halved.

But the high infection rate among young women aged 15-24 continues to worry health officials here.

The health minister adds that on the 30th anniversary of World Aids Day, on Saturday, he will be encouraging young men to get tested and treated.

In Namibia, it seems to be the older generation, men like Mr Davis and Mr Angula, who are setting the example.

Ms Johannes hopes that at some point she will no longer have to deliver bad news to her clients.

"I remember there was a day in 2015," she says.

"My first six clients of the day all tested positive. Telling six people they're HIV-positive, without a break… it's a day I'll never forget."

A group of nurses won the lottery but gave their winnings to two colleagues who needed it more

Stephanie Brinkman (middle) organized a lottery pool for the NICU staff at Mercy Children's Hospital in the St. Louis area. When the group won $10,000, they decided to give the cash to Gretchen Post (left), whose 17-year-old son died by suicide the night of the drawing, and to Casey Orellana (right), whose husband is battling cancer.
(CNN)At Mercy Children's Hospital, the nurses and staff of the neonatal intensive care pool the money to enter the lottery.

They've been doing it for for years, with varying degrees of success.
Last month, the staffers at the St. Louis-area hospital won big: $10,000 in the Mega Millions lottery.
But instead of divvying up the winning among the group, they gave it to two colleagues going through some tough times.
The joyous discovery
The lottery pool began as a way to bring some levity.
"We have a very stressful job, so it's just something fun that keeps us going," nurse Gretchen Post told CNN.
As last month's jackpot grew to $1.6 billion dollars, nurse -- and lottery pool organizer -- Stephanie Brinkman stayed up late and watched the results come in. Soon, her phone was lighting up with calls and messages from her colleagues. They had a winning ticket.
"I was so in shock, I couldn't believe it," Brinkman said.

FDA Updates on Angiotensin II Receptor Blocker (ARB) Recalls

FDA alerts patients and health care professionals to Teva’s recall of valsartan products due to NDEA
Update [11/27/2018] FDA is alerting patients and health care professionals to Teva Pharmaceuticals’ voluntary recall of valsartan-containing products manufactured using active pharmaceutical ingredient (API) from Mylan Pharmaceuticals. Mylan voluntarily recalled valsartan-containing products on November 20.
Teva is recalling all lots of amlodipine and valsartan combination tablets and amlodipine, valsartan, and hydrochlorothiazide (HCTZ) combination tablets due to the presence of N-Nitrosodiethylamine (NDEA). Teva has recalled other valsartan-containing products in recent months due to the presence of N-Nitrosodimethylamine (NDMA). With this recall, Teva has now recalled all their unexpired valsartan-containing products from the U.S. market.
The agency continues to investigate and test all angiotensin II receptor blocker (ARBs) for the presence of NDMA and NDEA and is taking swift action when it identifies these impurities that are above acceptable levels.
FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall. The agency reminds patients taking this medication or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. It also is important to know that not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

FDA Warns That Symptoms of a Serious Condition Affecting the Blood Cells Are Not Being Recognized with the Leukemia Medicine Idhifa (enasidenib)

The U.S. Food and Drug Administration (FDA) is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa (enasidenib). The Idhifa prescribing information and patient Medication Guide already contain a warning about differentiation syndrome. However, we have become aware of cases of differentiation syndrome not being recognized and patients not receiving the necessary treatment.

As a result, we are alerting health care professionals and patients about the need for early recognition and aggressive management of differentiation syndrome to lessen the likelihood of serious illness and death. We are continuing to monitor this safety concern.

Health care professionals should describe to patients the symptoms of differentiation syndrome listed in the Medication Guide when starting Idhifa and at follow-up visits, and inform them to call their health care professional if such symptoms occur. Differentiation syndrome has occurred as early as 10 days and up to 5 months after starting the medicine. If patients experience unexplained respiratory distress or other symptoms, consider a diagnosis of differentiation syndrome and treat promptly with oral or intravenous corticosteroids (See Additional Information for Health Care Professionals).

Patients should contact your health care professional or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome while you are taking Idhifa:

Idhifa was approved in August 2017 to treat patients with acute myeloid leukemia (AML) with a specific genetic mutation called isocitrate dehydrogenase (IDH)-2 whose disease has come back or has not improved after treatment with other chemotherapy medicines. AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells. Idhifa works by blocking several enzymes that promote this abnormal blood cell growth.

In the clinical trial conducted for Idhifa’s approval, at least 14 percent of patients experienced differentiation syndrome. The manufacturer’s safety report, which included the period of May 1, 2018 to July 31, 2018, reported five cases of death associated with differentiation syndrome in patients taking Idhifa (See Data Summary). Until Idhifa was approved, differentiation syndrome had been associated only with induction chemotherapy in patients with a rare form of cancer called acute promyelocytic leukemia. Health care professionals and patients may not recognize the signs and symptoms of differentiation syndrome associated with Idhifa. Another recently approved drug for AML with a specific genetic mutation called isocitrate dehydrogenase (IDH)-1, Tibsovo (ivosidenib), also carries a risk of differentiation syndrome. Health care professionals should also be vigilant in monitoring for differentiation syndrome when prescribing Tibsovo and patients should alert their health care professional of any symptoms.

FDA Warns About Rare But Serious Risks of Stroke and Blood Vessel Wall Tears with Multiple Sclerosis Drug Lemtrada (alemtuzumab)

The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab). These problems can lead to permanent disability and even death. As a result, we have added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide. We have also added the risk of stroke to the existing Boxed Warning, FDA’s most prominent warning.

Alemtuzumab is also approved under the brand name Campath, which was approved in May 2001 to treat a type of cancer called B-cell chronic lymphocytic leukemia (B-CLL). The Campath drug label will also be updated to include these risks in the Adverse Reactions section under Postmarketing Experience.

Patients or their caregivers should seek emergency treatment as soon as possible if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries, called arterial dissection, which can include:

Most patients taking Lemtrada who developed stroke or tears in the artery linings, developed symptoms within 1 day of receiving Lemtrada. One patient reported symptoms that occurred 3 days after treatment.

Health care professionals should advise patients at every Lemtrada infusion to seek immediate emergency medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. The diagnosis is often complicated because early symptoms such as headache and neck pain are not specific. Promptly evaluate patients who complain of symptoms consistent with these conditions.

In the nearly five years since FDA approved Lemtrada in 2014 to treat relapsing forms of MS, we identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada (see Data Summary). This number includes only reports submitted to FDA,* so additional cases we are unaware of may have occurred. Twelve of these cases reported symptoms within 1 day of receiving Lemtrada. As a result, we have added a new warning about this risk in the Warnings and Precautions section of the prescribing information in the drug label. We have also added the risk of stroke to the existing Boxed Warning, FDA’s most prominent warning.