Tag: South Africa

Categories : HIVTags :

Some in Free State only Given ARVs for Two Weeks at a Time

On By ModernMedia

Both health minister Dr Joe Phaahla and health authorities in the Free State last week denied claims from activists that there are shortages of antiretroviral medicines at health facilities in the province. Authorities did however confirm that some people living with HIV are only given a two-week supply of medicines at a time.

“I can confidently say that there are no stockouts or shortages of ARVs in the Free State,” Phaahla told Spotlight at the World AIDS Day commemoration event in Mangaung.

This was reiterated by spokesperson for the Free State Department of Health, Mondli Mvambi saying, “We do not have shortages of HIV medicines in the province.”

He says allegations of patients not receiving their medication are very serious and cannot be taken lightly. He says should the department hear from patients who are not receiving their HIV medicine, they will investigate.

But Makhosazana Mkhatshwa, a research officer at the Treatment Action Campaign (TAC), says in the past three months, nine clinics in the province indicated that patients have left their facility without the medicine that they needed and of these nine clinics, three of them had sent people home because there was a stockout of HIV medication. She says impacted clinics include Poly Clinic and MUCPP in Mangaung, and Namahadi Clinic in Thabo Mofutsanyana District.

According to community-led monitoring group Ritshidze’s latest report on clinic services in the Free State, there were 40 patient reports this year of shortages of HIV medication compared to 13 patient reports last year. The report states that the most commonly reported medicine shortages by public healthcare users were contraceptives, HIV, and TB medicines. The report was based on monitoring at 28 clinics. TAC is a Ritshidze partner organisation.

Only 7 or 14-day supply for some

One woman Spotlight spoke to at the World AIDS Day commemoration event held in Mangaung last week says she is a patient at Pule Sefatsa Clinic in Botshabelo, Mangaung. “I am forced to go to clinic every week because they only give me a supply for eight days. This is an inconvenience for me because I have to skip work every week just to get my medication.”

Another public healthcare user from Bloemfontein tells Spotlight that for two weeks in October he was stranded without ARVs. He says that he is usually given a 14-day supply at a time. When he requested a full month’s supply to last him through a work-related trip to Cape Town he says his request was declined at the Poly Clinic at Pelenomi Hospital. He says he ended up going without medication.

Aron Malete, District Health Manager for Mangaung, told Spotlight there are no ARV shortages in the district, but asked for details of the above cases so that he could investigate.

The problem is not stockouts per se, but a shortage of medication, says Sello Mokhalipi, Secretary General of Positive Action Campaign.  “You will find that there is a shortage of ARVs for seven days, then the next week it will be available,” he says.

Mokhalipi, like other activists Spotlight spoke to, is opposed to giving people only a seven or 14-day supply of medication at a time. He says people should be given enough for three to six months.

When Spotlight put the concerns and calls for multi-month dispensing to Mvambi he says, “We have identified people who are clinic hoppers who steal medicine. They get three months and thereafter run to another clinic to get another three months’ supply. To curb this practice,” Mvambi says, “we keep people on seven and 14 days’ supply The idea is to give them a few days because they claim to have forgotten their clinic cards.”

According to him, people get three months’ supply when they have their clinic card because clinic staff can verify who they are and what medicine they have been receiving.

Doing ‘exceptionally well’ but there are concerns

According to Phaahla who delivered a speech at the World AIDS Day commemoration event, the province has done “exceptionally well in terms of testing, having already surpassed the 94 percent threshold”. Phaahla said 94 percent of people who are living with HIV in the province know their status, 86 percent of those who know their status are on antiretroviral treatment, and 92 percent of those who are on treatment are virally suppressed.

He, however, singled out some districts such as Xhariep and Lejweleputswa where he says the “number of people with HIV and on treatment fare poorly on the target of being virally suppressed”. “This,” Phaahla says, “is very concerning and we must urgently intervene to create a balance among the targets in order to achieve zero new infections by 2030. This includes ensuring that services are brought closer to the people and that our health facilities are adequately resourced with medicine and related necessities.”

“Results for each of the sub-populations vary with adult females at 95 – 91 – 93, adult males at 93 – 77 – 93, and children at 82 – 65 – 68,” says Mvambi. “To achieve the 95 – 95 -95 targets the Free State must increase the number of adult men on ART by 25 745, adult women on ART by 9 744, and children on ART by 5 138.”

“As you can see,” says Mvambi, “the women are more likely to get tested, be initiated on ART, and have their viral load suppressed than their counterparts.”

According to the Free State Department of Health’s latest annual report for the financial year 2021/2022, the number of patients initiated on ARV treatment dropped from 36 776 in 2019/2020 to 26 364 in 2021/2022. In the report, the department states that it failed to meet its target for retaining adults on ART in care. The ART adult remain-in-care rate in 2019/20 was 68%. In 2020/21, it dropped to 52.8% and picked up in 2020/21 at 67.3%. Among the reasons the department cites are the high number of loss to follow-up of clients and “poor tracing by community healthcare workers due to poor supervision”.

NOTE: An employee of the TAC is quoted in this article. Spotlight is published by SECTION27 and the TAC, but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : COVIDTags : 1 Comment

Study Pushes Back Date of Omicron’s Origin

On By ModernMedia
PCR device for detecting pathogens like SARS-CoV-2 (symbolic image) © Charité | Arne Sattler

Seemingly out of nowhere, the Omicron variant was first detected in South Africa and rapidly spread around the world. Now, a study published in the journal Science shows that Omicron’s predecessors existed on the African continent long before cases were first identified, suggesting that Omicron emerged gradually over several months in different countries across Africa.

Since the beginning of the pandemic, the coronavirus has been constantly changing. The biggest leap seen in the evolution of SARS-CoV-2 to date was observed by researchers a year ago, when a variant was discovered that differed from the genome of the original virus by more than 50 mutations. First detected in a patient in South Africa in mid-November 2021, the variant later named Omicron BA.1 spread to 87 countries around the world within just a few weeks. By the end of December, it had replaced the previously dominant Delta variant worldwide.

Since then, speculations about the origin of this highly transmissible variant have centred around two main theories: Either the coronavirus jumped from a human to an animal where it evolved before infecting a human again as Omicron, or the virus survived in a person with a compromised immune system for a longer period of time and that’s where the mutations occurred. A new analysis of COVID samples collected in Africa before the first detection of Omicron now casts doubt on both these hypotheses.

The analysis was carried out by an international research team led by Prof Jan Felix Drexler, a scientist at the Institute of Virology at Charité and the German Center for Infection Research (DZIF). Other key partners in the European-African network included Stellenbosch University in South Africa and the Laboratory of Viral Hemorrhagic Fever (LFHB) in Benin. The scientists started by developing a special PCR test to specifically detect the Omicron variant BA.1. They then tested more than 13 000 respiratory samples from COVID9 patients that had been taken in 22 African countries between mid-2021 and early 2022. In doing so, the research team found viruses with Omicron-specific mutations in 25 people from six different countries who contracted COVID in August and September 2021 – two months before the variant was first detected in South Africa.

To learn more about Omicron’s origins, the researchers also sequenced the viral genome of some 670 samples. Such sequencing makes it possible to detect new mutations and identify novel viral lineages. The team discovered several viruses that showed varying degrees of similarity to Omicron, but they were not identical.

“Our data show that Omicron had different ancestors that interacted with each other and circulated in Africa, sometimes concurrently, for months,” explains Prof Drexler. “This suggests that the BA.1 Omicron variant evolved gradually, during which time the virus increasingly adapted to existing human immunity.” In addition, the PCR data led the researchers to conclude that although Omicron did not originate solely in South Africa, it first dominated infection rates there before spreading from south to north across the African continent within only a few weeks.

“This means Omicron’s sudden rise cannot be attributed to a jump from the animal kingdom or the emergence in a single immunocompromised person, although these two scenarios may have also played a role in the evolution of the virus,” says Prof Drexler.

“The fact that Omicron caught us by surprise is instead due to the diagnostic blind spot that exists in large parts of Africa, where presumably only a small fraction of SARS-CoV-2 infections are even recorded. Omicron’s gradual evolution was therefore simply overlooked. So it is important that we now significantly strengthen diagnostic surveillance systems on the African continent and in comparable regions of the Global South, while also facilitating global data sharing. Only good data can prevent policymakers from implementing potentially effective containment measures, such as travel restrictions, at the wrong time, which can end up causing more economic and social harm than good.”

Source: Charité – Universitätsmedizin Berlin

Categories : HIVTags :

First HIV Prevention Injection Approved in SA

On By ModernMedia
Image of a syring for vaccination
Photo by Mika Baumeister on Unsplash

By Marcus Low

The South African Health Products Regulatory Authority (SAHPRA) has authorised an injection containing the antiretroviral cabotegravir for use to prevent HIV infection, according to drugmaker ViiV Healthcare.

“We are very pleased that this week, SAHPRA granted regulatory approval of Apretude or cabotegravir long-acting injectable,” ViiV Healthcare spokesperson Catherine Hartley told Spotlight. “It brings a much-needed innovative HIV prevention option to the communities that need it most, including women and adolescent girls where challenges with adherence, limited efficacy, and stigma have hindered the impact of current PrEP options.”

At the time of publication, SAHPRA had not yet confirmed the registration, although Spotlight understands a media statement on the issue is imminent. The regulator received ViiV Healthcare’s initial application for approval in November 2021.

ViiV Healthcare has not disclosed at what price it will offer the shot in South Africa or other African countries. The company has, through a deal with the Geneva-based Medicines Patent Pool, agreed to grant voluntary licenses to at least three generic producers that could potentially supply the injection to South Africa. It is however expected to take three to five years before any of the generics will be ready.

Executive Director of the HIV prevention organisation AVAC confirmed news of the authorisation late Wednesday in a social media post, calling it a critical step in making the injection available to millions that could benefit from the shot.

Thursday’s announcement makes South Africa at least the third African country to approve the shot for use, following similar approvals in Zimbabwe, Uganda, and Botswana. A duo of large clinical trials led in part by South African researchers found that people who were given an injection of the antiretroviral cabotegravir every other month were about 80% less likely to contract HIV than those on the HIV prevention pill.

The bi-monthly shot likely outperformed the pill, the World Health Organization explains in new guidelines, mainly because it was easier for people to get an injection every two months than to take the pills every day.

Previously, Spotlight reported that pilot projects are slated to begin providing access to the HIV prevention shot early next year. Demonstration projects run in partnership with the national health department and research organisations the Wits Reproductive Health and HIV Institute and Ezintsha are expected to offer patients a choice of the HIV prevention shot, pill, or monthly vaginal ring.

The pilot projects, sometimes called “demonstration” projects, will be looking to help answer major questions about an eventual national rollout, including how to create national awareness campaigns about the HIV prevention injection and how to provide it outside of hospitals and clinics and closer to communities.

SAHPRA authorisation marks the first step toward an eventual national rollout, according to national health department HIV prevention technical advisor Hasina Subedar. Subedar spoke to Spotlight in July at the International AIDS Conference. In particular, the finer details of the registration – which are still not public – will guide who can and can’t receive the shot, for instance.

Many will be watching to see whether the injection will be made available to pregnant and breastfeeding people, who remain at high risk for contracting HIV in South Africa. Early data presented at the International AIDS Conference in July suggests that the injection is safe to use during pregnancy, although research is ongoing.

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : HIVTags :

Supporting Men Living with HIV Own their Health

On By ModernMedia

According to World Population Review, South Africa has one of the highest HIV prevalence in the world; ranking 4th with 19.1% in 2020, coupled with the highest burden of people living with HIV (PLHIV) globally, at an estimated 8.45 million.

In an effort to address these issues, and particularly change the stigma associated with the disease, the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development (USAID) and the National Department of Health (NDoH) partnered with Project Last Mile and FCB Joburg to launch MINA. For Men. For Health, an initiative aimed at encouraging men to get tested for HIV and provide communal support to begin – and stay on – treatment for those who tested HIV positive.    

The campaign seeks to unpack the societal stigmas that result in men not wanting to get tested and then to adhere to taking Antiretroviral Treatment (ART). Beyond this, the campaign provided a safe space for men to express and share their experiences and fears and to address the various misconceptions about living with HIV. Leaning on insights garnered through community coaches and interactions with men living with HIV, a platform was created which gave men the tools and resources they need to take control of their lives and their HIV status. This was MINA. For Men. For Health.

The campaign’s concept emanated from the idea that men could dispel fears of prioritising their health, giving them exposure to a community of men just like them, which remains a great source of support. In the execution stage, this was coupled with brand ambassadors and social media assets that carried the campaign on social platforms, including collateral for presence and awareness in clinics across the country in severely affected communities. The in-clinic journey was an integral part of the campaign as it was vital to intercept and engage clients in real-time who may have been at the clinic for other reasons, to consider getting tested for HIV or begin/continue with their treatment.

MINA. For Men. For Health has demonstrated success in areas where individuals were exposed to brand messaging. Some key statistics include:

1. For every R17 of PEPFAR funding, R51 of earned media was generated.

2. On average, 48 000 more men tested for HIV per quarter in MINA. For Men. For Health activity facilities than non-activity facilities post-launch.

3. Nationally, first quarter post-launch saw a 7% increase in men’s linkage to care.

There has been a notable increase in the number of men who tested for HIV over the campaign period, with more than 107 290 men having tested since campaign’s inception in November 2020, with a subsequent increase in men commencing ART.

“The efforts and campaigns providing a positive narrative around HIV are now showing success across the board in combating the perceptions around the disease. In addition, the campaign is generating a positive framework to aid men living with HIV to express themselves, get the necessary care, and remain on treatment.” says Rodney Knotts, Senior Marketing Advisor at USAID.

“Currently, we are looking at ways to increase the presence of MINA. For Men. For Health, as mass media and social marketing have long been used as tools to increase education, decrease stigma, and promote behaviour change in the fight against HIV/AIDS in South Africa,” says Jonathan Wolberg, Creative Director at FCB Joburg.

Although South Africa has made significant strides over the last decade in combating HIV-AIDS, complacency will turn back the clock on gains made through consistent community engagement, screening and treatment.

MINA. For Men. For Health continues to play an essential role in addressing this public health challenge that still very much has a place in South African society. 

“MINA. For Men. For Health is all about changing and mainstreaming conversations around HIV.  With our above-the-line, digital and in clinic campaign, we not only hope to support and empower men living with HIV, but also their partners, families and communities.  Our goal is to impact social change and perceptions for all South Africans around this completely treatable chronic condition,” says Amanda Manchia, PLM Strategic Marketing Project Lead.

If you’d like to be part of the MINA. For Men. For Health movement, visit www.minaformenforhealth.co.za or  @MINAForMenForHealth on Facebook.

Categories : Expert Opinion HIVTags :

Opinion: Keep an Eye on Quality as We Rush to Test People for HIV

On By ModernMedia
HIV themed candle
Image by Sergey Mikheev on Unsplash

By René Sparks

As we approach World AIDS Day on 1 December, healthcare providers will be offering HIV screening and testing as part of a comprehensive health service.

The theme for this year’s World AIDS Day is: “Equalise and Integrate to End AIDS”.

One aspect in which more equality is arguably needed is between the quality of HIV testing services and aiming to test as many people as possible.

Progress against targets?

It is estimated that 13.9% of South Africa’s population is living with HIV and that the absolute number of people living with HIV in the country has increased from 3.8 million in 2002 to 7.8 million in 2021. This number has continued to rise since the death rate has declined much more rapidly than the rate of new HIV infections.

The most widely used measure of a country’s HIV response in recent years has been the UNAIDS 90-90-90 targets. These aim at 90% of people living with HIV knowing their status, 90% of those diagnosed started on ARVs, and 90% of those on ARVs being virally suppressed by 2020. The goal post has now shifted to 95-95-95.

Earlier this year, Health Minister Dr Joe Phaahla said that in South Africa we are on  94-78-89.

This indicates that we are close to reaching the first 95. It also suggests that our HIV testing efforts have generally been a success, including the introduction of HIV Rapid Testing and HIV Self Screening as HIV testing models. But, as we collectively meet these targets, it is important to focus on the quality of HIV rapid testing to ensure that we align with HIV testing standards.

Focus on quality

The quality of HIV Rapid testing to some extent depends on laboratories, but often it is driven by HIV counsellors and service delivery NGOs. As a public health professional managing the National HIV Testing Quality Assurance and Laboratory Systems Strengthening programme, seconded to the Department of Health through SEAD Consulting, it is my job to support NGOs, the Department of Health, and the Department of Correctional Services in implementing quality assurance of HIV Testing and in improving the laboratory systems between health facilities and the National Health Laboratory Service.

As someone who has worked in all aspects of primary healthcare, I am painfully aware of the shortcuts sometimes taken, but also of the impossible expectation of ‘quick services’ linked to HIV testing.

As a healthcare provider, I received peer mentorship upon entry into primary healthcare settings – but I later learnt that this mentorship provided incorrect guidance on HIV testing.

This gave me sleepless nights and fuelled my desire to support other healthcare workers in conducting quality HIV testing to avoid possible misdiagnosis and delays to critical treatment. It is imperative that everyone understands their role when it comes to HIV testing and that we move away from siloed approaches in prevention and curative spaces but integrate both quality and ambitious targets. One cannot be seen in isolation from the other.

So, how are HIV tests supposed to be done?

Firstly, there are multiple things to look out for when having an HIV test done. HIV testing should be conducted by a trained healthcare worker, using nationally approved test kits which are kept in temperature-controlled spaces. Test kits should not be exposed to extreme heat of more than 30 degrees Celsius as it fries the device, which could lead to incorrect results.

Secondly, each test has an expiry date, its own pipette (plastic or glass device to collect the blood), its own buffer (liquid that assists the blood to move across the test strip) and its own incubation time (time it takes for a reaction or outcome of the test).

When being tested, the fingertip needs to be cleaned with an alcohol-based swab, and then the first drop of blood should be wiped away to avoid contamination of the sample. The second drop of blood is then collected with the specific pipette to the required amount for that test. Once collected, the blood is inserted into the well of the test and the required number of drops of buffer is added. Lastly, the timer is set to the manufacturer’s time for each test kit.

The time is of utmost importance, as reading it too early could lead to false HIV-negative results, whereas reading it too long after the time could lead to false HIV-positive results. It is for this reason that each HIV tester needs to have a digital timer that is able to count down and sound an alarm when the time has been reached.

Additional aspects linked to the quality of HIV testing are Personal Protective Equipment (Aprons, gloves, and sanitiser) – these need to be worn by the HIV tester as part of infection control. Also important are ice packs – if you are being tested in a gazebo in the community, the HIV tester needs to ensure that the HIV test kits are kept cool to avoid malfunction or damage.

These are the basics we must get right.

The quality of HIV testing is as important as getting the test done. Too often short cuts, time constraints, and lack of staff impact the quality of testing. To be in a position where we can really celebrate the numbers – the progress – it is essential that we must get these basics right.

*Sparks is a Public Health Professional at SEAD consulting, a co-convenor at the School of Public Health, University of the Western Cape, a Senior Aspen New Voices Fellow, and a Global Atlantic Fellow for Health Equity.

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : General InterestTags :

Very Few South Africans can Swim, Says the NSRI. It Aims to Change this

On By ModernMedia

With summer and the holidays approaching, soon thousands of adults and children will flock to the country’s shorelines and public pools. But many who live inland and in poor communities do not have access to safe water bodies and have not learned how to swim. Children play unsupervised in rivers and farm dams.

In Riebeek Kasteel last year, a grade six learner found his way into a dam within walking distance of his school, Meiring Primary. Just 12 years old, he drowned.

Now a bright red container stands at the school. It is one of the National Sea Rescue Institute’s (NSRI) “survival swimming centres”.

Andrew Ingram, NSRI drowning prevention manager, says swimming is an “essential skill”.

The first of its kind, the 12-metre shipping container contains a six-metre heated swimming pool, a changing room, an office and a camera monitored by the NSRI. The water is one metre deep, making it possible for the learners’ feet to touch the ground. The facility can also be locked up to avoid children accessing it unsupervised.

The design is inspired by previous work done with lifeguard containers. Almost everything is donated – the container, the pool’s fibreglass and resin, pumps and the filtration systems. The cost would otherwise be about R650 000.

After the Riebeek Kasteel installation in March, a second centre was set up in Tombo Village, Eastern Cape. Two more are expected next year – in KZN and the Northern Cape.

“We don’t teach the children how to swim, we teach them how to survive,” says Petro Meyer, an NSRI Instructor in Riebeek Kasteel. She said the valley gets very hot in summer and parents are away working. Children then “go to the dams and to the rivers and they swim alone without supervision”.

Meyer says they teach students four things: breath control, orientation, floating and moving through water. Children should be able to swim at least five metres once training is complete. Since the survival school opened, she says that they’ve given about 1,400 lessons.

A 2021 study on drowning prevention by the World Health Organisation found drowning to be the third most common accidental death in the world.

Brenton Cupido, principal at Meiring Primary, said there are no other public pools. The closest public one is 20 minutes by bus to Malmesbury and costs R30.

Riebeek Kasteel has many poor families and many parents at his school are farm workers and the majority depend on social grants.

“The farmers try to stop the learners [from using the farm dams] but they can’t be everywhere,” he says.

Cupido said the government should see that “there is a need for swimming pools in the rural areas with proper supervision”, and this would “prevent further tragedy”. “I don’t want to go through another … drowning again,” said Cupido.

“We have that peace of mind, that if our children … fall in the water, they know how to survive,” he said.

Another NSRI project is the over 1300 pink buoys across South Africa used as assisted floating devices in case of emergencies. These can be found in dams, rivers and the seaside. The NSRI also runs free swimming lessons at various municipal pools in the Western Cape.

According to the NSRI, only 15% of South Africans can swim (we cannot verify this statistic but it is highly likely that most South Africans cannot swim – editor). “If your parents can’t swim, it’s very likely that you won’t learn to swim,” said Ingram. “It’s expensive to learn to swim”.

With the survival centres, the NSRI hopes to “instil a culture of swimming in poor communities where it wouldn’t have been possible previously”.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : COVID Healthcare Politics and RegulationsTags :

Supreme Court of Appeal Reverses Controversial Ivermectin Ruling

On By ModernMedia
Gavel
Photo by Bill Oxford on Unsplash

The Supreme Court of Appeal (SCA) has set aside a controversial supervisory order, granted in April 2021, compelling the South African Health Products Regulatory Authority (SAHPRA) to report back to court every three months on access to ivermectin for use in the treatment of COVID patients.

The court has ruled that there was no evidence to justify the order made by Pretoria High Court Judge Cassim Sardiwalla, that affected parties had not asked for the order, and that they had not been heard before he made it.

The judge had also failed to provide his reasons for making it, the court said.

The issue has its genesis in four applications, one by the African Christian Democratic Party in 2021 against SAHPRA seeking access to ivermectin for the treatment of COVID.

At that time, SAHPRA, which was wary of its use saying there was no reliable research to prove its efficacy, had already put in place its “controlled compassionate use” programme in response to reports of illicit ivermectin-containing products entering the South African market. The programme was stopped in May this year.

In terms of that programme, permission was granted to five importers of unregistered oral solid dosage forms of ivermectin. Health facilities were permitted to hold bulk stock but individual applications were still required. SAPHRA said it would monitor its use.

The ACDP and others approached the court for orders directing SAHPRA to remove restrictions and do “all things necessary to regulate and ensure the manufacture” of ivermectin until such time as clinical evidence demonstrated that it was not effective in the treatment of COVID.

The matter was settled along the same lines as SAHPRA’s programme.

But Judge Sardiwalla, in making the settlement agreement an order of court, also granted a “supervisory order”, putting SAHPRA under his judicial authority in respect of ivermectin.

SAHPRA and the Minister of Health applied for and were granted leave to appeal the order to the SCA.

Read the full judgment here

In heads of argument before the SCA, SAHPRA said its appeal concerned the propriety of the order directing an organ of state to report back to court and be subject to judicial supervision where the dispute had been settled and there was no evidence at all that SAHPRA and the minister would not comply with the settlement agreement.

“It was simply imposed without justification. The order constitutes a grave violation of the Constitution … it violates the rule of law, the right to a fair hearing and the principle of separation of powers,” it argued.

The judge, SAHPRA said, had improperly made findings on matters not in dispute and his written reasons for the supervisory order “do not constitute reasons at all”.

In the SCA ruling, Judge Clive Plaskett said Judge Sardiwalla had suggested to the parties that he “regarded himself as seized of all matters involving ivermectin” and had proposed the supervisory order.

Both SAHPRA and the minister indicated they would oppose this and filed further papers.

While the judge had indicated that he would hear the parties on 6 April 2021, his registrar had informed SAHPRA’s attorney that morning that he had made a decision, he would not hear arguments, and he would send his order to the parties shortly.

No reasons accompanied the order.

SAHPRA and the minister asked for reasons but when these were furnished, they made no mention of the supervisory order or why he granted it.

Judge Plaskett said the first difficulty with the order was that Judge Sardiwalla had not given SAHPRA and the minister a hearing despite knowing that they did not agree to it.

“He agreed to a hearing but inexplicably changed his mind. In these circumstances, an oral hearing was, without doubt, essential.

“Courts decide matters, particularly opposed matters, in open court and the exceptions to this rule are limited.”

Judge Plaskett said the fact that the order had not been applied for by any party required that it be set aside.

He said, further, there was a complete absence of evidence to justify it.

“Important as supervisory orders may be in appropriate cases, the granting of this type of relief must be carefully considered – and justified on the facts – particularly because of its separation of powers implications.

“In this case, not only was there no evidence as to the necessity of a supervisory order but the fact that SAHPRA and the minister had settled the matter and agreed to an order suggests that there was probably no necessity for one.

“Had he allowed the parties to argue the matter, he would have been informed of the separation of powers problem …

“Finally, it strikes me as telling that the reasons he furnished made no mention of the supervisory order – and this despite being pertinently asked to furnish reasons on this very issue,” Judge Plaskett said, upholding the appeal, and setting aside the order.

The ACDP originally opposed SAHPRA’s appeal but shortly before the SCA hearing, it withdrew its opposition on the basis that no cost order would be made against it. The SCA therefore did not order costs.

The ivermectin programme was stopped in May this year.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : COVIDTags :

The Need for Long-COVID Rehabilitation in South Africa

On By ModernMedia
Photo by Alex Green on Pexels

By Ufrieda Ho

“I think I’m in trouble,” came the message through to Professor Veronica Ueckermann one evening during the first surge of COVID-19 in South Africa in the winter of 2020. It was a distressed call made by a 48-year-old theatre nurse who worked alongside Ueckermann in the ICU frontline. Ueckermann, who is also a professor of internal medicine at the University of Pretoria and an ICU specialist, shifted into high gear with other doctors to save their colleague who was diagnosed with COVID-19.

They succeeded.

But what they didn’t know then was that months later the nurse would be ailing from ongoing medical symptoms put down to the catch-all of long-COVID.

“It’s a case study, but it was also very close to my heart,” says Ueckermann, who has become a specialist and researcher on the long-term effects of COVID. She recently presented on long-COVID during a webinar of the South African Academy of Family Physicians. “The nursing sister had numerous comorbidities, including a raised BMI, diabetes, hypertension, and asthma. When her symptoms didn’t get better, the hospital just wanted to have her medically boarded because they couldn’t be sure when she would be well enough to work again,” says Ueckermann.

She is cautious too, pointing out that there’s still little definitively known about long-COVID and new research is only in its infancy. Much of the difficulty lies in the wide-ranging symptoms and how individuals are affected. There are also varying recovery times, different underlying conditions and susceptibilities, and the reality that many people are simply not diagnosed. It makes the term “long-COVID” an umbrella term for everything from brain fog or mental confusion and fatigue to depression and shortness of breath and chest pains. Others also describe general body aches and continued loss of smell and taste.

The post-COVID condition

In October 2022, the World Health Organization (WHO) released a factsheet that states that between 10% and 20% of people who are diagnosed with COVID-19 continue to have symptoms beyond three months of first getting ill and develop what the WHO refers to as post-COVID condition. Many more people say symptoms plague them still even after nearly two years.

“The condition can be debilitating, causing disabling symptoms and functional deficits. It can significantly impact people’s ability to work, engage and participate fully in family and community life. Mental health effects can directly result from long-COVID, but may also develop due to prolonged suffering and distress caused by the condition,” reads the WHO factsheet.

The WHO’s recommended treatment, however, is non-specific, stating: “Post-COVID-19 condition can be supported with help from their families, peers, employers, and the community and they can also benefit from tailored rehabilitation.”

According to the National Institute for Communicable Diseases (NICD), “Every long-COVID patient is different, as such, every patient will need treatment specific to their symptoms which can be managed by their family doctor or clinic. There are no drugs to prevent long-COVID. Long-COVID is not a contraindication to vaccination, and COVID-19 vaccination may even sometimes improve long-COVID symptoms. Long-COVID is treated by slow, stepwise rehabilitation, and appropriate management of symptoms.”

Greater awareness and education needed

Ueckermann agrees with the WHO’s call for greater awareness and education so patients feel heard and supported. Many people resort to joining online support groups through platforms like Facebook. They share their challenges and stories and give each other support when they feel misunderstood and frustrated that they can’t get well and doctors can’t help. Ueckermann says there needs to be help for patients’ individual needs because not finding solutions will add to mounting pressure on the healthcare system.

“Because of COVID disruptions, many cancers are now presenting at later stages. There are cases of TB and other illnesses that were neglected. And now we have long-COVID that requires diagnosis after diagnosis for exclusion so all of this drives up costs,” she says.

lung There are other associated costs for people who cannot work or are performing sub-optimally trying to work while feeling unwell. Children affected by long-COVID do worse at school and lose interest in their sports and other activities that they used to enjoy, she says.

Last year, Spotlight reported on a dedicated long-COVID clinic at Groote Schuur Hospital in Cape Town. As far as we could establish, such specialised long-COVID clinics are very rare in South Africa.

“Long-COVID remains inaccurately defined and as a result, standard treatment guidelines for the condition as a whole have not yet been developed,” says Foster Mohale, Spokesperson for the National Department of Health. “However, standard treatment guidelines to address the symptoms and conditions associated with long-COVID are in place,” he says. “These guidelines guide assessment and treatment, and provide criteria for referral from primary healthcare to more specialised services.”

Mohale adds that the burden of disease is of “enormous concern and needs to be better understood and quantified”. But says the department’s data shows that visits by adults to public sector primary healthcare facilities remain below pre-pandemic levels, which suggests that any increase in the burden of disease has not resulted in an increased burden on health services. He also emphasises the need to have up-to-date vaccinations, adding that “people who are vaccinated are less likely to develop long-COVID”.

Research ongoing

Ueckermann says it’s a positive development that as awareness is growing, so are studies, including studies by the Medical Research Council and many of the country’s universities. She says scientists are looking at everything from the role of green tea extracts and the use of SSRIs (Selective serotonin reuptake inhibitors) that are commonly used to treat depression.

“These are all ongoing studies, so we have to wait to see the data coming through but it’s promising that everyone is trying to understand exactly what this long-COVID is and the most important thing is that we continue making this a greater area of priority in healthcare,” she says. It matters for the growing number of patients, or for her colleague who she says still needs help to get from “doing better,” to fully recovered.

Republished from Spotlight under a Creative Commons 4.0 Licence.

Read the original article here.

Categories : Diseases, Syndromes and ConditionsTags :

TB Treatment can be Cut to Two Months for Some, Finds Landmark Study

On By ModernMedia

By Elri Voigt

Tuberculosis bacteria
Tuberculosis bacteria. Credit: CDC

Some cases of tuberculosis (TB) can be successfully treated in as little as two months – a third of the current standard of six months in South Africa and most other countries. This is according to early findings from the landmark TRUNCATE TB trial presented at last week’s Union World Conference on Lung Health.

Nick Paton, a professor of Infectious Diseases at the National University of Singapore and the chief investigator of the TRUNCATE trial, explains that the standard six-month treatment for drug-susceptible TB (DS-TB) is actually overtreating a lot of people who have the disease. The reason for the six-month mark for TB treatment is that a minority of TB patients need the long treatment regimen to avoid relapse, but the majority would be cured before the six-month mark.

Essentially, it’s a blunt, but generally, effective instrument used to protect a minority of TB patients.

The TRUNCATE trial set out to see if a two-month (eight weeks) novel combination of TB regimens would be feasible when compared to the standard six-month (24 weeks) treatment regimen. According to Paton, trial participants in the experimental arms of the study were initially given eight weeks of treatment, with the option of extending treatment to 10 to 12 weeks if they had persistent clinical disease after the eight-week treatment. If there was still active TB after that, participants were switched to the standard six-month treatment.

https://twitter.com/catherineeberry/status/1590290599369879553?s=20&t=OhVaVQBQb9CQ_JDfcFTbdQ

Study participants were monitored regularly through follow-up visits, which included TB symptom screening once a month and sputum smear tests every one to three months.

“The core [of the strategy] is it’s a very short period of initial treatment, plus you then do the monitoring and pick up people [who relapsed] early,” Paton says.

A total of 674 trial participants were recruited from March 2018 to March 2022 across 18 sites in Thailand, Indonesia, the Philippines, Uganda, and India. Four patients withdrew from the trial and 10 participants died during the trial.

Paton tells Spotlight that the overall death rate was low and there was no difference in the death rate between the standard treatment arm and the TRUNCATE strategy arms. The causes of death were mixed, he adds, and often the precise cause was unknown

For the final results, 660 participants were evaluated at week 96. In other words, about two years of follow-up occurred.

Encouraging results

Paton explains that the trial used the TRUNCATE strategy, which initially involved using four treatment arms containing a novel combination of TB drugs and comparing the results to a control arm consisting of the standard six-month treatment. Later, two TRUNCATE strategy arms were selected to complete the latter half of the study. He notes that it was a pragmatic decision to stop two of the arms, to ensure better data.

“You do substantially cut down the amount of time on treatment overall.”

Professor Nick Paton, chief investigator of the TRUNCATE trial.

In the first of the two remaining experimental arms, 184 study participants received a regimen consisting of high-dose rifampicin (35mg per kg, reduced to 20mg per kg as a precaution following a liver injury-related death), isoniazid, pyrazinamide, ethambutol, and linezolid (600mg). In the second, 189 study participants received a regimen consisting of bedaquiline (400mg/d for two weeks then 200mg three times a week), isoniazid, pyrazinamide, ethambutol, and linezolid (600mg). The standard treatment arm had 181 participants.

In the standard treatment arm, 98% completed treatment and 3% had to be re-treated before week 96.

In the TRUNCATE strategy arms, overall, 91% completed the eight-week treatment and stopped treatment by week 12. 17%, (ranging from 13 to 23% by arm) had re-treatment, and 2% of participants did not complete initial treatment due to withdrawing from the trial, death, or defaulting on treatment.

A comparison of the two experimental TRUNCATE arms with the standard treatment arm showed that the TRUNCATE arm with bedaquiline and linezolid was non-inferior to the standard treatment arm, while the high dose rifampicin and linezolid arm fell just short of meeting the non-inferiority criteria. Efficacy was calculated based on the proportion of unsatisfactory outcomes at week 96. Unsatisfactory outcomes were classified as death, still having active TB, or still being on TB treatment at week 96.

“The idea was that if we added those [unsatisfactory outcomes] up and that was the same in the standard treatment arm as the TRUNCATE strategy arm then that shows that this strategy in principle, can work,” Paton tells Spotlight.

The mean total days on treatment were reduced in the TRUNCATE strategy arms when compared to the standard treatment arm, which was 180 days. For high-dose rifampicin-linezolid, the average total days on treatment was 106 days, and in the bedaquiline-linezolid arm, it was 85 days.

“So, clearly the net effect is to decrease the average time on treatment,” Paton says. “You do substantially cut down the amount of time on treatment overall.”

He adds that the proportion of participants that had Grade 3 or 4 adverse events, serious adverse events, or who died did not differ between the standard treatment arm and the TRUNCATE strategy arm. The proportion of participants with respiratory disability at week 96 also did not differ.

The only cases of acquired drug resistance were two cases observed in the bedaquiline and linezolid arm. This is a frequency of 1.1% according to Paton. One of these participants missed several treatment doses, while the other did not miss any doses. Both were successfully re-treated.

Initially, they wanted to enroll participants who were co-infected with HIV in the later stages of the trial, but none could be enrolled in time, so currently there is no data on how well it works in people living with HIV who also have TB, says Paton.

“The trial has shown that alternatives to systematically over-treating the large majority of people with TB can be successful. This is an important new research direction which has the promise to improve outcomes for patients and programmes,” Paton says. “The strategy may be refined in future to improve outcomes using alternative drug regimens or alternative approaches to monitoring. Ongoing analysis from the trial will further enhance our understanding.”

PK and safety data

At last week’s conference, Christopher Cousins, project leader of the TRUNCATE trial presented the first level of pharmacokinetic (PK) analysis from the trial. The PK results were taken from week eight of the study.

AUC for the high-dose rifampicin was four to six times higher than in the standard dose and exceeded the proposed efficacy targets in the majority of patients.

After fasting overnight, participants took an observed dose of their medication at the trial site and had blood sampling done over a 12-hour period. The data is based on 96 participants in the two experimental arms.

He says the AUC (which represents total drug exposure over time – AUC = area under the curve) for the high-dose rifampicin was four to six times higher than in the standard dose and exceeded the proposed efficacy targets in the majority of patients. This supports the hypothesis that high-dose rifampicin would enhance treatment sterilisation in the eight-week regimen.

The data also showed what seems to be a drug-drug interaction between rifampicin and linezolid, but this didn’t appear to be significant enough to abolish anti-mycobacterial efficacy.

According to Cousins, the bedaquiline concentrations at the end of week eight in the bedaquiline and linezolid arm were comparable to the concentrations seen after 24 weeks of treatment for drug-resistant TB (currently both bedaquiline and linezolid are part of the standard treatment for DR-TB, but not for DS-TB).

When asked how well monitoring participants in the TRUNCATE arms after they stopped treatment was able to detect those who still had active TB disease, Paton tells Spotlight that further analysis of the sputum smears samples will be able to tell us more. The trial used a relatively low-technology approach where a symptom screening and a sputum smear test were used to determine if a participant still had active TB and needed to be re-treated.

“We need to run additional biomarkers, interrogate the data set in more detail to figure out who was cured, who wasn’t cured, over what duration and how well do these other things [sputum smear test and symptom screening] pick it [TB] up,” he says.

He adds that this was a starting point, “but we are likely to be able to do better if we use some of the new biomarker technologies for monitoring”.

Implications of findings

“These results are very exciting as proof of concept – they show it’s possible to shorten treatment for drug-sensitive TB even further,” says Lindsay McKenna, TB Project Co-Director at New York-based Treatment Action Group (TAG). “But we need to optimise the regimen and study this treatment strategy in broader populations, including people living with HIV – none were enrolled in the study – and [in] programme contexts,” she says.

“There are other trials that are being planned that look to proactively (for example, at time of treatment initiation) determine who might benefit from shorter versus longer treatment based on available indicators or risk factors known to be correlated with treatment outcomes, such as disease severity, BMI, and HIV status (called a stratified medicine approach), and to tailor the duration of treatment accordingly,” she adds. “If the latter stratified medicine approach is proven, it will be very interesting to see how these two approaches compare and are viewed by programmes and affected communities.”

Feasibility of shortened regimens

Nerissa Donato the site co-investigator for the Truncate TB trial from the Lung Centre in the Philippines outlined the feasibility and acceptability of the TRUNCATE strategy at last week’s conference. This was based on participant questionnaires, clinician surveys, description data from the trial, and observations from Donato.

“The TRUNCATE strategies were acceptable and feasible in the context of the clinical trial. It can be successfully implemented provided that it is supported by the NTP (national treatment programme) and embraced by trained clinicians,” she says.

She explains the main challenges to implementing the strategy were patients’ concerns about potential side effects and the greater pill burden, but after some discussion participants were comfortable with the regimen due to the possibility of a much shorter treatment regimen. The close following up of participants and follow-up visits required was different from the normal procedure of treating for six months and being discharged from care. But she says participants were generally happy to come back for the follow-up visits.

Clinicians who participated were initially sceptical of whether the regimen was safe and would work but after the trial, they had a more positive view, according to Donato.

She says that in order to implement the strategy in the real world, it would need to be adopted by the NTPs, which will likely require more data on cost-effectiveness.

Need better treatment approaches and regimens

Paton tells Spotlight that somewhere between the two extremes of overtreating TB patients and personalised medicine as seen in high-income countries, there can lie a better treatment option for TB patients. An approach that is less monolithic and instead based on reacting to individual patient needs and responses.

“We need to look at how do we personalise it [TB treatment], but in a way that’s not so high tech so it becomes impossible for programmes,” he says.  “At least if you’re monitoring [patients] you’ve got a safety net. If you get it wrong, you just make sure you pick the person up early and re-treat and there shouldn’t be serious harm from that.”

Additional data from the trial will be released in the coming months.

Republished from Spotlight under a Creative Commons 4.0 Licence.

Read the original article here.

Categories : COVIDTags :

GroundUp: Vaccine drive is Running out of Steam

On By ModernMedia
Covid vaccines
Photo by Mat Napo on Unsplash

By Daniel Steyn

Daily COVID vaccinations have more or less plateaued since July. At the peak of the vaccination drive, South Africa was administering up to 240 000 vaccine doses a day. But this number has dropped to just over 5000 a day. Less than half of these are first doses and a third are booster shots.

The government still hasn’t reached its target of 67% adult vaccination, which it wanted to achieve by the end of 2021. Half of the adult population in South Africa is currently vaccinated. Among adults 60 years or older, nearly 73% have been fully vaccinated.

GroundUp visited the District Six Community Day Centre, a government clinic, in Cape Town. We asked for a COVID vaccine and were directed to a small room on the first floor, where one of us waited over 1.5 hours to get a vaccine (though two of us were vaccinated considerably quicker – about 30 minutes). This wasn’t because there was a long queue.

The nurse administering the vaccines was busy treating patients elsewhere in the clinic. The person logging the vaccines on the computer system told GroundUp that on average, 12 people a day come to the clinic for vaccines.

GroundUp visited a Clicks store in Cape Town where, three months ago, vaccines were still being administered. But they no longer do COVID vaccines.

The government’s dedicated Coronavirus website has a list of “active vaccination sites”, many of which are no longer active, and the “Find My Jab” page has completely different information.

Meanwhile, people are still getting ill from the virus. About 2000 new cases are reported each week, but according to the National Institute for Communicable Diseases (NICD) only 16% of cases are being detected. Testing sites are also few and far between.

Professor Glenda Gray says that the vaccine has done a good job at reducing deaths, serious illness and hospitalisations. Official daily deaths and hospitalisation rates are low in relation to previous waves. In the past four weeks, 125 deaths from COVID were reported.

The real number of deaths is likely much more than this. A weekly report published by the Medical Research Council and the University of Cape Town calculates the number of excess deaths – the deaths above the historical average before COVID: there have been close to 50 000 excess deaths so far this year. While in earlier waves the researchers were able to estimate that 85% to 95% of these excess deaths were due to COVID, the changing nature of the epidemic has made it much harder to estimate how many of this year’s excess deaths are due to COVID.

More than 85% of COVID infections in the country are from the Omicron BA.5 variant, which is widespread and infectious but usually causes very mild illness.

To prevent serious illness and death, getting the vaccine and booster shots are still recommended. Gray says that it is especially important for immunocompromised people, such as people living with HIV, to get vaccinated.

“Sadly, the virus has done a far better job of generating immunity than our government, which continues to be maddeningly slow at getting the vaccine out,” says Professor Francois Venter, infectious diseases clinician and head of Ezintsha at Wits University.

Although being infected by and recovering from the virus does provide a level of immunity, getting a vaccine still greatly improves one’s protection against the virus.

“I think we were all hoping once we had immunity from either infection or a vaccine or two, it would be enough. But from what we are seeing internationally, new waves of COVID, while not killing people in the numbers we saw in 2020 and 2021, are still making people very sick,” Venter says.

Dr Nicholas Crisp, Deputy Director-General of the National Department of Health, is the coordinator of the national vaccination drive. He agrees the current status of the vaccination drive is “very disappointing”.

He says the vaccination program is being integrated into primary health care, targeting areas geographically where communities or segments of a community are not vaccinated.

To monitor and manage the pandemic, Crisp says the government is continuing with daily testing, gene sequencing and wastewater sampling. Crisp says that the government is preparing for the future of COVID as well as other potential pandemics.

Future variants of the virus could be more dangerous. “As long as there is transmission, there is going to be mutation,” Gray told GroundUp. How the virus mutates in the future is yet to be seen.

In the US, new bivalent vaccines designed to target the Omicron variant are already available. But, Gray says, there is not yet sufficient evidence that these work better than the current vaccines.

According to Crisp, the government is not considering any new vaccines. “We are not buying vaccines this year and may not buy vaccines next year,” he says.

South Africa still has 8 million doses of the Pfizer vaccine and 10 million doses of the Johnson and Johnson vaccine. He says paediatric Pfizer vaccines will be purchased with some of the credit that South Africa has with the Covax facility. These will be given to children who are immunocompromised.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp