Category: HIV

Categories : General Interest HIVTags :

The Good Doctor: Mark Blaylock on Finding Meaning Back at Manguzi

On By ModernMedia
Dr Mark Blaylock, medical manager at Manguzi Hospital. PHOTO: Supplied.

By Sue Segar for Spotlight

There was a time, about 20 years ago, when, at the Manguzi district hospital in Northern KwaZulu-Natal, (and, of course, at hospitals throughout South Africa too) mothers and their babies were dying of AIDS at shockingly high rates.

“We used to get these patients who were slow progressors,” Mark Blaylock, medical manager at Manguzi, tells Spotlight. “Then there were the rapid progressors – babies who were HIV-positive who would get sick very quickly. There wasn’t much we could do for them. We’d give them vitamins and Bactrim, but ultimately they died. Then we had the ones who got sick a bit later, and those were even worse because now mum has had this baby for five years and they’ve bonded, and are a little family and now they are coming in with AIDS. Obviously, a huge number of mums died too. It was heartbreaking.

“It was the pregnancies that knocked their vulnerable immune systems. We’d watch it over and over again. The mums would come in looking ok and then they’d get pregnant and just go downhill. This was in the pre-ARV era. Pregnancy was a death sentence. I think people have forgotten what it was like in those days.”

Blaylock is talking to Spotlight from Northern KwaZulu-Natal, relaying how things have changed for the better since that terrible era. “It’s quite astounding,” he says. Blaylock returned to the hospital ten years ago after having been away for four.

“I was going through the stats recently, and in those days, 40 percent of all mothers who delivered were HIV positive, and about 40 percent of those babies born to HIV- positive mothers ended up with HIV either from birth or breastfeeding. About 20 percent would pick up HIV at birth and another 20 percent would pick it up subsequently through breastfeeding.

“These days, if we have one baby who is delivered HIV-positive or who picks up HIV, we get really upset. Our six-month HIV-positive rate now for babies is less than 0.6 percent and that is a dramatic change. It makes me so happy. Unfortunately, the young girls are still positive, but at least their babies are not becoming positive.”

Blaylock puts the changes down, “purely”, to prevention of mother-to-child transmission (PMCT) using antiretroviral therapy (ART). “Remember how, at one stage, we only gave HIV treatment if a patient was below a certain CD4 count? That was changed to test-and-treat, so regardless of their CD4 count, patients will get HIV treatment which brings the viral load down dramatically,” he says. “And now we have dolutegravir (an ARV), which is the backbone of our current HIV treatment. The success is due to prevention of mother-to-child transmission (PMTC) as well as the test-and-treat policy.”

‘A mixed bag’

It’s Sunday, a day off for Blaylock, and he’s speaking from a place with the best reception near his house on the edge of the Shengeza Lake. He lives here with his wife, Liz and their 13-year-old home-schooled daughter, Una. The sound of birds in the background makes it hard to hear him on the call. “It’s peaceful. There are hippos all around and lots of birds. It’s Eskom-free, which is even better. I love it. We live with three dogs, three cats, a genet, and I can’t tell you how many snakes. It’s paradise.”

It’s taken a long time to clinch this interview, but Blaylock has finally relented and forwarded us the provincial health department’s media protocol he has to adhere to. On problems in KwaZulu-Natal’s health system, he is reticent, saying only that it’s a “mixed bag”. “There’s a lot of dead wood, but there are real areas of excellence,” he says.

His reticence is understandable.

There was a time, also about 15 years ago, amidst the noise and turmoil of the last few years of state-backed AIDS denialism, when Blaylock was going through his own personal trauma. In April 2008, whilst working as chief medical officer at Manguzi, he was suspended for throwing an official photograph of then-Health MEC Peggy Nkonyeni into a dustbin in the hospital’s foyer. He did this out of anger and frustration, after his colleague at the hospital, Colin Pfaff was charged with misconduct for sourcing funding for antiretroviral drugs for pregnant women, and for implementing dual antiretroviral therapy to save babies from HIV – because politicians were not doing so.

He was also furious about comments made by Nkonyeni, questioning the integrity of rural doctors and suggesting they were racist. The South African National AIDS Council soon after asked the Human Rights Commission to probe the ‘racial tone’ of Nkonyeni’s remarks and to curb her ‘harassment’ of Manguzi doctors.

At the time, Blaylock (and Pfaff) were hailed by many working in the health sector as heroes with a deep commitment to their patients. In a letter to the provincial health department at the time, Blaylock said he had given his “heart and soul” to the under-resourced hospital, going beyond the call of duty.

Needing a change

Blaylock was reinstated but, in December 2008, he decided to leave, saying he needed a change and because the KwaZulu-Natal Department of Health was in “absolute disarray”. He says his old colleague Pfaff went to work as a missionary doctor in Malawi.

There was more to Blaylock’s decision to leave Manguzi than just the public disagreement with Nkonyeni. In our interview, he describes those days as “a really tough decade”. “Working in paediatrics, as I did for my first couple of years at Manguzi, I couldn’t take it anymore, emotionally. I just couldn’t do it, so I taught myself surgery. That was easier, as you could fix people. We were also so broken from losing so many friends, colleagues, and patients from HIV at the time. It was definitely traumatising and emotionally exhausting, not just for me but for Liz.

“There’s no doubt most of us were burnt out,” he says. “We kind of knew it, but we pushed on anyway. We were also quite a bit wilder and younger. We’d blow off steam by recklessly taking tiny boats across the lake, in the big waves, with lots of hippos – or we’d go for runs along the beach or naked midnight swims.”

The years outside SA

After leaving Manguzi, Blaylock moved to Ghana, where he took up a position as a general doctor at ABA Hospital in Tarkwa, north-east of Accra. “The hospital was part of the national health system but contracted to a mine, so we would treat people and then try and charge the government, fairly unsuccessfully, for the treatment,” he says. “I’d always fancied the idea of Ghana. I had this fantasy about Kwame Nkrumah and it being the first country to throw off Britain in Africa – but I didn’t enjoy it as much as I’d hoped. Everywhere you went, the police were pulling you over and asking for bribes.”

A defining moment was when Blaylock says he noticed the anti-malaria medication the hospital was giving patients was “just not working”. “Our malaria patients kept coming back full of parasites. I knew there were similar drugs in South Africa which were fantastic, so there was definitely something wrong.” He says he sent a sample to South Africa for testing and realised that “they weren’t as full of the good stuff as they were meant to be”. “I handed in the report and said ‘deal with it.”

From Ghana, where he married Liz and where his daughter Una was born, the family moved to the Kansanshi Mine Hospital in Zambia where they lived on a “beautiful golf estate, surrounded by poverty”.

“It didn’t feel right at all and was quite unfulfilling work,” he recalls. “I did GP work and there was lots of babbalaria – that’s when mostly the expat wives have a hangover on a Monday morning and they think they have malaria.”

Being “medically bored” in Zambia, Blaylock returned to Newcastle in KZN with the aim of specialising in anaesthetics. He worked in Madadeni Hospital’s anaesthetics department, before getting into a registrar’s programme on the anaesthetics circuit at various hospitals in Durban.

‘Like walking back home’

Then, in 2012, his friend and colleague Etienne Immelman, then working as medical manager of Manguzi, suggested that Blaylock should “come home”. “Etienne had been at Manguzi for more than 20 years when he retired six years ago. We’d always had a friendship and a mutual loyalty. He wanted someone to take over.”

Blaylock decided that indeed, it was time. It meant losing the opportunity to specialise, but he says it “felt right”. He went back as medical officer, before becoming manager.

“When I first arrived back, we were a small team, working hard. We all had the same commitment. It gave me a sense of purpose and belonging which hasn’t left.”

Blaylock said the hospital went through a “wonderful period” with a core team of great doctors. “But I burnt them all out during COVID – we had 164 deaths, but we pulled a lot of people through and many of the doctors have moved on. We have a young team now and they are getting there, but we don’t have the broad skill range we used to have. That is common across most district hospitals nowadays.”

So, is he happy to have come full circle, back to the place that was once a source of deep distress to him? “Yes,” he says. “For me, it’s about the community. This place gives me that, as well as a sense of stability and purpose. If you go into a little shop in Manguzi, everyone knows who you are. You say hallo to each other. You shout at a taxi driver and he says, ‘Hey Mark, don’t be so naughty’. When I came back ten years ago, it was like walking back home. It’s just a nice feeling.”

He says a lot has changed in the area. “People say there’s been no development, but when I first arrived at Manguzi in 2002, we knew every car on the road. Today, the town is overwhelmed with vehicles. There’s more money around. We almost never see malnutrition anymore. A lot of government programmes are working, as much as we like to diss them.”

Taking a stand

Given the toll that taking a stand has taken on doctors like Blaylock and Pfaff, one might be forgiven for wondering whether it was all worth it.

Did it make a difference to how things turned out? “Absolutely,” says Blaylock. “There were people scattered people around South Africa at the time who were doing great things. In our part of the world, it was Victor Friedland at Mseleni Hospital and Colin Pfaff (at Manguzi) who were the big drivers, pushing for the right actions to provide the services that the HIV Clinicians Society at the time thought was the correct one and was affordable. The Western Cape had already started, so we weren’t doing anything that groundbreaking except that it hadn’t been official policy yet,” he says.

“Can you believe that when HIV treatment first came to South Africa, it was going to be done at tertiary hospitals only? Imagine the repercussions for us sending a patient to Durban – in those days the Hluhluwe road was 160 kilometres of dirt road – to go and get their HIV treatment once a month. It was not sustainable.

“The HIV (Clinicians) Society pushed hard to get it decentralised to all hospitals. Then it was just going to be done by doctors and they said we absolutely cannot do it just with doctors. It has to be a nurse-run programme. Their vision became our current system. They weren’t the only people, but they were at the forefront of it at the time.”

‘Keeping it going’

Apart from the many advances in HIV treatment, much else has changed at Manguzi over the last 15 years. Blaylock says these days the hospital’s gastro wards are empty “thanks to the rotavirus vaccine”. “We’ve also seen a turnaround in acute respiratory tract infection,” he says. “The pneumococcal conjugate vaccine has changed that dramatically. We have also seen the pushing out of Continuous Positive Pressure Airway Ventilation (CPAP) for neonatal respiratory distressed newborns to district hospitals. This is a non-invasive way of ventilating babies with immature lungs,” he says.

“Our next great hope is the HPV vaccine, which will be a groundbreaker. It’s been rolled out in the past couple of years, but we’ll only see the effects in ten years or so because cervical cancer takes a few decades to come about. The other thing I really want to get in,” he insists, “is that our therapy department (offers occupational therapy, speech and hearing, and physiotherapy) at Manguzi is astonishingly fantastic. There are a lot of good things happening,” he says. “It is so easy to sit on the things that irritate you, but it is worth trying to remember the wins.”

As with several other rural doctors Spotlight has interviewed over the years, Blaylock seems deeply committed to building on what works at Manguzi and simply getting things done. As he says, “When you’ve invested so much into a hospital, you want to keep going as much as you can.”

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : Healthcare Politics and Regulations HIVTags : 1 Comment

In-depth: The Court Ruling that Gives Qualifying Pharmacists the Green Light to Provide HIV and TB Meds Without a Script

On By ModernMedia
Photo by National Cancer Institute on Unsplash

By Catherine Tomlinson for Spotlight

Specially trained and accredited pharmacists in South Africa will now be allowed to provide people with medicines to prevent HIV and tuberculosis (TB) and to treat uncomplicated HIV without a doctor’s script. This is because the North Gauteng High Court this week ruled against an application by the IPA Foundation (an association of private doctors) attempting to block the implementation of Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART).

PIMART involves the introduction of a legislative framework, a specialised training course, and an accreditation process to allow pharmacists to supply HIV and TB medicines to people visiting pharmacies, under certain conditions, without a doctor’s script.

The ruling in the case of IPA Foundation versus the South African Pharmacy Council (SAPC) was handed down by Judge Elmarie van der Schyff on 14 August 2023 – almost two years to the day exactly after legislation introducing PIMART was published by the SAPC. Board Notice 101 of 2021 was published on 13 August 2021 (at the time, Spotlight published an in-depth article on the case for PIMART).

While PIMART has been delayed for two years by the IPA Foundation’s legal challenge, Judge van der Schyff’s ruling now clears the way for the SAPC to proceed with its implementation.

Steve Letsike, Chair of the SAPC’s Health Committee and PIMART Task Team, said in a media conference on Thursday that the IPA Foundation has until 8 September to appeal the High Court’s decision. Speaking at the same media conference, Mogologolo Phasha, President of the SAPC, indicated that if the IPA Foundation appeals the ruling, the SAPC will continue to fight to preserve the initiative in higher courts.

Spotlight asked the IPA Foundation whether they plan to appeal the decision, but no response was received by time of publication.

The background

The introduction of PIMART was proposed by the SAPC in 2018 in response to a request from the National Department of Health for the SAPC to develop an intervention to enable pharmacists to help get HIV prevention treatment to more people quicker.

Pharmacists trained and accredited under the PIMART initiative will be able to provide preventative therapy for HIV (both post-exposure and pre-exposure prophylaxis – PEP and PrEP), TB preventive therapy, and first-line antiretroviral treatment for uncomplicated HIV.

According to Phasha, around 900 pharmacists, or 5% of pharmacists on the register have already undertaken specialised, supplementary training to enable them to provide PIMART services. He noted, however, that before trained pharmacists would be able to start providing PIMART services they would need to receive accreditation in the form of a permit granted by the National Department of Health under Section 22(A)15 of the Medicines and Related Substances Act.

The court’s response to the IPA Foundation’s arguments

In February 2022, the IPA Foundation filed an affidavit with the North Gauteng High Court seeking review and dismissal of the SAPC’s decision to implement PIMART and related legislation.

In its affidavit, the IPA Foundation argued that the provision of PIMART services falls within the domain of medical doctors and that pharmacists do not have the required training and competencies to provide these services. The IPA Foundation further argued that the SAPC does not have the legislative mandate to introduce PIMART, that the SAPC’s reasons for implementing PIMART were not adequately explained, and that the SAPC’s procedures for implementing PIMART were not procedurally fair and did not provide adequate opportunity for interested parties to comment.

The IPA Foundation warned of a “slippery slope” resulting from PIMART’s introduction, adding “this objection essentially warns of the opening of the floodgates or perhaps an anticipated negative precedent setting occurrence relevant to the provision of medication… without prescription”.

In her ruling, Judge van der Schyff noted that while tension between healthcare cadres regarding their scopes of practice is common, the World Health Organization calls for “a collaborative approach to primary healthcare issues and the embracing of task-shifting”.

She added that “competition, per se, does not limit or curtail the rights of medical practitioners to continue providing the services that they currently provide,” further stating that “even if the assumed competition is regarded to affect family practitioner’s rights adversely, the alleged adverse effect it holds for medical practitioners has to be considered against the need to expand primary healthcare services aimed at preventing and treating HIV”.

Judge van der Schyff dismissed the IPA Foundation’s argument that the SAPC is not mandated to introduce PIMART, stating that “the SAPC is empowered to prescribe the scope of practice of the various categories of persons registered in terms of the Pharmacy Act”. She added, “The development and implementation of PIMART, does not expand the existing scope of practice of pharmacists that generically provides for PIT [pharmacist-initiated therapy] and PCDT [primary care drug therapy]. It introduced a specialised category of PIT and PCDT focused on preventing and treating HIV.”

Judge van der Schyff also rejected the IPA Foundation’s arguments that PIMART’s introduction was procedurally unfair and the decision for its implementation was not properly explained, arbitrary, or capricious. She says that “through its collaboration with the Southern African HIV Clinicians Society, whose members include numerous medical doctors, the development of PIMART was given great exposure”.

“The need to widen access to first-line ART [antiretroviral therapy] and TPT [TB preventative therapy] on a community level is not a figment of SAPC’s imagination, but a dire need that is also evinced in other countries,” held van der Schyff.

Finally, Judge van der Schyff rejected the argument that pharmacists are not adequately trained to provide PIMART services, stating, “The PIMART training course was developed to ensure that pharmacists who successfully completed the training would be ‘suitably qualified to safely and effectively assist in providing ART’.” She adds that the PIMART training course was “developed by suitably qualified experts in the field, which experts include medical practitioners”.

The ruling was welcomed by the SAPC and several HIV groups.

“The superior court yesterday (Wednesday) confirmed what has been our long-held view that PIMART is a necessary and competently designed intervention programme to support South Africa’s efforts in providing access to patients diagnosed with HIV and AIDS,” said Phasha. “The programme may also arrest and lower the ballooning HIV budget, which is nearly half the national health budget, by reducing the rate of new infections.”

Nelson Dlamini, Head of Communications at the South African National AIDS Council (SANAC), told Spotlight that SANAC welcomes the court ruling.

“The magnitude of South Africa’s HIV burden requires innovative ways of accessing HIV treatment, care, and support. PIMART is one such approach that will improve access to antiretroviral therapy for people living with HIV and those requiring PEP & PrEP,” said Dlamini.

Sibongile Tshabalala, Chairperson of the Treatment Action Campaign (TAC), said the organisation also welcomes the ruling. “The challenges that we are facing in the country include one of people queuing for a long time in facilities… and also the attitude of nurses in facilities which chases away so many people from facilities. We also have the issue of key populations that are not comfortable to go in public health facilities to access medication… so if a pharmacist is able to issue and prescribe ARVs and TB medication it will mean that we will be able to cover a lot of people.”

*NOTE: A representative 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 Licence.

Source: Spotlight

Categories : Healthcare Politics and Regulations HIVTags :

Court Ruling Means that Pharmacists can Prescribe to People with HIV

On By ModernMedia
Photo by Miguel Á. Padriñán: https://www.pexels.com/photo/syringe-and-pills-on-blue-background-3936368/

The South African Pharmacy Council (SAPC) has been given judicial go-ahead to introduce its Pharmacy-Initiated Management of Antiretroviral Treatment (PIMART) initiative, which will allow specially trained pharmacists to manage and prescribe medicine to patients with HIV and tuberculosis.

Pretoria High Court Judge Elmarie van der Schyff has dismissed an application brought by a doctors’ organisation – the IPA Foundation – for the setting aside of the programme.

She said the pilot project had emphasised the value of the initiative, which was in line with the World Health Organisation’s vision to promote widely accessible primary health care.

“The untapped value of pharmacists in fighting HIV was also emphasised by the efficient role pharmacies played in meeting health care needs and providing health care services during the Covid-19 pandemic,” she said.

“The need to widen access to first line ART and TPT therapy on a community level is not a figment of SAPC’s imagination but a dire need that is also evinced in other countries.”

Read the judgment here

The IPA Foundation approached the court, under the Promotion of Administrative Justice Act (PAJA), seeking to review and set aside the SAPC’s decision to implement PIMART.

IPA claimed that the SAPC had failed to give interested parties an adequate opportunity to comment before the initiative was implemented. It further contended that PIMART unjustifiably encroached on the domain of medical practitioners and was in conflict with legislation.

IPA also accused SAPC of misleading the Director-General of Health, claiming there had been extensive consultation with stakeholders, which led to the approval and issuing of permits for the initiative.

The SAPC said the application should be dismissed. It said pharmacy-provided primary healthcare was a well known and functional concept in South Africa and PIMART was simply a “widening of this”.

Referring to the background and context, Judge van der Schyff said, in line with WHO recommendations that all people living with HIV must be provided with ART, the department of health had requested the SAPC to consider and implement interventions that would ensure that patients had increased access to medicines.

This led to the SAPC requesting the Director-General in August 2018 to consider issuing permits to pharmacists who had completed supplementary training, to manage patients and to dispense medication under PIMART.

In March 2021, the SAPC published a notice for public comment regarding the adoption of PIMART. The first permits were issued in August that year.

However, IPA submitted objections outside of the timeline for comments. It said this was because its members were struggling with another wave of the Covid-19 pandemic.

“Pharmacists and doctors operate in distinct and separate professional domains, the boundaries of which are closely guarded and some tension exists … IPA’s objection to PIMART seems to be rooted, partially at least, in this professional tension.

“This is evidenced by its fear that the decision to implement PIMART might ‘open the floodgates’ and ‘pave the way for pharmacists to ultimately treat and prescribe other schedule 4 drugs in respect of acute illnesses’,” the Judge said.

She noted, however, that the National Drugs Policy, in line with WHO guidelines, promoted “task shifting” to advance access to medicine and that at primary level, prescribing should be competency based, not occupation based.

Any alleged adverse effect that PIMART held for a medical practitioner had to be considered against the need to expand primary health care services aimed at preventing and treating HIV and providing first-line ART therapy.

Judge van der Schyff said the initiative gave members of the public a choice as to whether they wanted to approach a pharmacist, who had been issued with a permit, or a general practitioner.

In considering procedural fairness, the judge said there was nothing sinister in the timing of the notice calling for comment, that the project was not something hidden in secrecy and “I find it improbable, as alleged, that none of IPA’s members had timeous knowledge of the board notice”.

The decision to implement PIMART also fell within the ambit of the SAPC’s powers.

Evidence also showed that the PIMART training course was developed to ensure that pharmacists who successfully completed the training would be suitably qualified to safely and effectively assist in providing ART.

Judge van der Schyff dismissed the review application and ordered IPA to pay the costs.

Professor Francois Venter, former President of the Southern African HIV Clinicians Society and Director of Ezintsha, an HIV research organisation at Wits University, commented, “I hope this is the end of it. The pharmacies are an essential part of the health system, and pharmacists internationally play a big role in expanding HIV services.”

Republished from GroundUp under a Creative Commons 4.0 Licence.

Source: GroundUp

Categories : HIVTags :

Traditional Healers in Rural Mpumalanga Help Diagnose HIV

On By ModernMedia
Photo by Sergey Mikheev on Unsplash

An initiative of Wits University’s MRC/Wits Agincourt Research Unit, the Traditional Healers Project convened two ‘open houses’ at local primary healthcare facilities – Rolle Clinic and Thulamahashe Community Health Centre in rural Bushbuckridge, Mpumalanga – in March 2023.

An ‘open house’ is a community and stakeholder gathering hosted at a public health facility in partnership with the Department of Health.

The aim of these sessions is to build on the relationship that the MRC/Wits Agincourt Research Unit has established between local traditional healers, community members, and healthcare facility staff to support the end of HIV through regular HIV counselling and testing.

Traditional healers in public health

The sessions supplement research that began almost a decade ago, which focuses on the role of traditional healers in healthcare access and delivery.

Specifically, this research aims to determine:

  • whether traditional healers can conduct HIV counselling and testing (HCT)
  • whether the patients of traditional healers are willing to undergo HCT that is administered by a traditional healer
  • whether traditional healers and biomedical healthcare workers can work together to help link patients to HIV/AIDS diagnosis and care.

The open house sessions form part of this research and provide a platform where traditional healers and biomedical healthcare workers can come together and build mutual understanding and trust, with a view to linking those who test positive for HIV with healthcare providers who can then administer lifesaving antiretroviral treatment (ART) and care.

15 traditional healers certified HIV counsellors and testers

The open houses drew an audience of more than 150 participants, including 15 traditional healers, local indunas [tribal chiefs], community healthcare workers (CHWs), community members, and representatives from Right to Care (a local collaborating partner on HIV) and the Department of Health.

Mr Wonderful Mabuza, Project Manager at the MRC/Wits Agincourt Research Unit, oversees the open houses and says that the successes to date have far surpassed expectations:

“It is exciting to be part of the group that is doing this work, knowing that we have a lot of people who visit traditional healers in our communities. It’s groundbreaking to have traditional healers trained to provide HIV counselling and testing – and amazing to see community members respond, with some never having tested previously.”

Gogo Singabeni, one of the 15 traditional healers who has completed the programme, says: “I was very excited to be invited to the HIV training, and that we would be certified in HIV testing and counselling. It’s important to show people proof that I am certified to do HIV testing.”

She adds: “The first day of testing [a patient] was very difficult for me. I was even shaking as I was conducting the test. I started with the first client, although I was shaking, and I managed to complete the process according to how we were trained. After the client left, I drew strength in seeing that I am able to do it.”

Partnerships imperative

Dr Ryan Wagner, Senior Research Fellow at the MRC/Wits Agincourt Research Unit, leads the traditional healers programme known collectively as Ntirhisano (Shangaan for ‘working together’).

He emphasises the importance of the Ntirhisano team, traditional healers, community healthcare workers, and the Department of Health collaborating to strengthen the referral system. 

“In order to expand coverage and increase uptake of HIV testing – and thereby contribute to ending new HIV cases – we need to embrace innovative approaches, such as traditional healer-initiated HIV counselling and testing,” says Wagner.

“We have recruited and trained 15 traditional healers in the Thulamahashe/Rolle area who, for the past six months, have been successfully testing their patients for HIV/AIDS. Those who tested positive have been referred to a local clinic or community healthcare worker.”

The Department of Health’s Primary Healthcare Supervisor, Sister Mariah Mkhari, says: “The Department of Health alone cannot do it, but with such collaborations between MRC/Wits and other stakeholders we will be able to conquer HIV. We welcome the initiative, and we hope Wits can expand to other areas in Bushbuckridge and train all traditional healers to test for HIV.”

Categories : Genetics HIVTags :

Study of African-ancestry Genomes Reveals Defensive Gene Against HIV

On By ModernMedia
Photo by Ayo Ogunseinde on Unsplash

A study on almost 4000 people of African descent has identified a gene that acts as natural defence against HIV by limiting its replication in certain white blood cells. The findings were published in Nature. An international effort co-led by EPFL, Canada’s National Microbiology Laboratory, and Imperial College London, it paves the way for new treatment strategies.

“We searched for human genetic variation that associates with spontaneous control of HIV and identified a novel region in the genome that is only variable in populations of African ancestries,” says Professor Jacques Fellay at EPFL’s School of Life Sciences. “We used a combination of computational and experimental approaches to explore the biological mechanism behind the genetic association and provide evidence that the gene CHD1L acts to limit HIV replication in a subset of white blood cells.”

HIV is still a problem

Despite significant advances in treatment and access to therapy, the human immunodeficiency virus remains a global health challenge with almost 40 million affected individuals, no vaccine and no cure.

Although annual HIV infections have been declining because of widespread antiretroviral therapies, the trend has slowed substantially since 2005, and there are now alarming increases in the number of newly infected adults in some regions.

Genome-Wide Association Studies, or GWAS, analyse the entire genome of a large number of individuals to identify genetic variants associated with a clinical outcome, such as the ability to naturally control viral replication.

Measuring HIV replication control: not enough in African populations

The degree of viral infection is measured by the virus’ “setpoint viral load” (spVL), which refers to the relatively stable level of HIV replication in the body after the initial, acute phase of infection in untreated individuals.

A critical determinant of HIV infection progression and transmissibility, spVL is expressed as the number of viral copies/mL of plasma. The spVL of HIV varies widely in the infected population, depending on the ability of every individual’s immune system to control viral replication without antiretroviral drugs.

Although there have been large studies of spVL control in populations of European descent, much less has been done in populations of African ancestries, which have both a high genomic diversity and the greater burden of HIV.

A key gene for resistance to HIV replication in people of African ancestries

To address this disparity, a large international collaboration of scientists and clinicians has now performed large-scale GWAS using data from diverse populations of African ancestries. In total, the scientists analyzed the genomes from 3,879 individuals living with HIV-1. Using computational analysis and fine-mapping techniques, they identified a novel region in the genome that shows a strong association with spVL control.

This region corresponds to a gene known as CHD1L (for “Chromodomain Helicase DNA Binding Protein 1 Like”), which encodes a protein that helps DNA unwind after it has been damaged, allowing it to be repaired. But in this study, the CHD1L gene showed genetic variation specific to populations of African ancestries, and that was linked to the spontaneous control of the most common and virulent type of HIV, called HIV-1.

Having identified CHD1L as a potential modulator of HIV-1 infection, the researchers explored the biological mechanism behind the genetic association and determined that CHD1L plays a role in limiting HIV replication in a subset of white blood cells.

The study was co-led by Jacques Fellay at EPFL, Paul McLaren at the Public Health Agency of Canada’s National Microbiology Laboratory, and Manjinder Sandhu at Imperial College London.

The discovery of CHD1L’s role in limiting HIV replication could lead to improved treatment options for infected individuals. “Our findings provide insights into potential therapeutic targets, which are needed to continue the fight against HIV-1,” says Fellay. “In addition, our results underscore the importance of performing genomic studies in diverse ancestral populations to better address their specific medical needs and global health inequities.”

Source: Ecole Polytechnique Fédérale de Lausanne

Categories : Gender HIVTags :

Feature: The Complexities of Traditional and Medical Circumcision in the Eastern Cape

On By ModernMedia
Circumcision rates in South Africa have increased dramatically over the last decade with 62.5% of males aged 15 to 49 who were circumcised as of 2022. PHOTO: Rodger Bosch

By Siyabonga Kamnqa for Spotlight

There is compelling scientific evidence that Voluntary Male Medical Circumcision (VMMC) is both safe and significantly reduces a man’s risk of becoming infected with HIV. While there can also be some protection from traditional circumcision, the protective effect of medical circumcision is thought to be much greater. The World Health Organization (WHO) has recommended medical circumcision for HIV prevention since 2007.

Circumcision rates in South Africa have increased dramatically over the last decade. According to estimates from Thembisa, the leading mathematical model of HIV in South Africa, 62.5% of males aged 15 to 49 were circumcised as of 2022. In 2012, this number stood at 38.8%. Experts ascribe some of the reduction in the country’s rate of new HIV infections to the massive circumcision drive over the last decade.

But the choice between medical, traditional, or no circumcision is often about much more than HIV risk. For one thing, traditional circumcision has great cultural meaning for some groups.

‘From boyhood to manhood’

Spotlight visited Lwazi Mfeka* at his ibhoma (traditional hut) during his last week at an initiate school in the Eastern Cape this winter. The first-year Walter Sisulu University student asked to remain anonymous for fear of victimisation, as talking openly about initiation is taboo in many rural communities.

He said leaving his ibhoma on the last day of his tenure as an initiate is a moment that will forever be etched in his mind. Not only did this signal the end of a “challenging” three-week period at the school, but it was also a symbolic moment where he says he has graduated from boyhood to manhood.

Mfeka said he was supposed to have undergone the ritual in December last year, but due to a bereavement in his family, he couldn’t. “At varsity, I was often mocked and isolated because I was still a ‘boy’. This bothered me a lot and I couldn’t wait to come here (to the mountain) and finally become a man,” he said.

He admits he was gripped by fear in the months leading up to his initiation.

“For starters, many young boys die while undergoing the custom and I didn’t want to add to the numbers. But, fortunately, my dad chose an ingcibi (traditional surgeon) with a good track record. I first had to go and get tested by a doctor for chronic illnesses such as HIV and TB as I had to present a medical certificate to the ingcibi before being circumcised. At the initiation school, everything was done according to the rules. After each cut, the spear gets sanitised to avoid any spread of infections,” Mfeka said.

Botched circumcisions

Mfeka’s fears are not without merit. In recent years, traditional male circumcision has often made headlines for all the wrong reasons, with the lives of young men lost due to botched or unhygienic circumcisions.

According to Mamnkeli Ngam, spokesperson for the Eastern Cape Department of Cooperative Governance and Traditional Affairs, in the 2022 winter initiation season, 11 of 10 794 boys who underwent traditional circumcision in the province died, while in the summer initiation season, 23  of 51 601 died. Ngam says around 20 000 boys went into the mountains to undergo traditional circumcision this winter (2023).

He told Spotlight that some fly-by-night ingcibis, desperate to make a quick buck, are the ones giving the custom a bad name. He says that assisted by the local chiefs and the police, they have been clamping down on illegal initiation schools and arresting bogus traditional surgeons.

“During the period between 1 June to 20 July, nine bogus traditional surgeons have been arrested in the Eastern Cape,” Ngam said.” We have been conducting safety campaigns ahead of the winter circumcision season to educate communities. Circumcising boys without parental consent [and] not having undergone medical examination to perform the procedure is against the law.”

Nkosi Mpumalanga Gwadiso, the Eastern Cape House of Traditional and Khoisan Leaders’ chair, told Spotlight that parents need to be involved throughout the process. “Often, parents leave everything to the amakhankatha (traditional nurses). That’s where things go wrong. As chiefs, we always emphasise the importance of parental involvement from day one until the initiates come back home safely. Some traditional nurses are the reason things go wrong because they neglect the initiates and go drinking. It is therefore the responsibility of the fathers to ensure that they visit the initiation schools regularly and monitor everything,” Gwadiso said.

While numbers vary widely and we haven’t been able to get a full picture, we understand that initiation schools can admit around 100 initiates during each of the winter and summer circumcision seasons. Our informal survey of several initiation camps in the former Transkei suggests the cost is typically around R300.

The medical alternative

While medical male circumcision is a generally available alternative to traditional circumcision, its provision in the Eastern Cape is influenced by cultural factors. For example, according to Eastern Cape Provincial Health Department spokesperson, Yonela Dekeda, the department does not conduct open marketing or demand creation in the communities/public “due to cultural dynamics within the province”.

“Medical Male Circumcision services are actually confined within the health facility level. Therefore, intake depends on the walk-ins, not on demand creation or promoting of the MMC services,” Dekeda said. “MMC is the choice of individual families. However, as the department, we are ensuring that all the designated MMC sites are well equipped with necessary MMC equipment, including training of clinicians such as medical doctors, clinical associates, and professional nurses to provide quality voluntary medical male circumcision services.”

Despite the lack of promotion, some young men, such as Bandile Macetywa*, have opted to go the medical route. He asked that we not use his real name for fear of victimisation from people who disapprove of his decision not to be circumcised in the traditional manner.

Speaking to Spotlight, the 20-year-old from Cofimvaba in the Eastern Cape said he pleaded with his parents, who are staunch traditionalists, to do the custom the medical way. “I know I disappointed my parents, especially my father, but at the end of the day, it was about my safety. I was happy when they respected my decision,” he said.

However, Mecatywa says he is all too aware of the discrimination that awaits him in society. “There are already naysayers. But I’m just glad the whole process went well. For Pete’s sake, we are in 2023. People are free to choose where they get circumcised. Some people had the guts to tell me to my face that I deserved to be abducted and circumcised again the traditional way?” he said.

Mecetywa believes many lives will be saved if rural communities can be educated to accept medical male circumcision. “It is much safer with [fewer] risks of getting infected while undergoing it. I am not saying traditional male circumcision is wrong. But why do initiates continue to die or have botched operations if things are done the right way,” he asked.

While the department does not actively promote medical circumcision, and while Mecetywa is clearly very aware of being in a minority, there are in fact significant numbers of medical circumcisions being conducted in the Eastern Cape. According to Dekeda, 14 637 were performed in the province in 2022, while 14 300 have been performed so far this year.

Medical male circumcision is an elective procedure that is widely available in the public sector, often provided via NGOs. The process typically involves counselling, a pre-assessment to check for anything that may hamper a client’s ability to be circumcised, post-operative care, and follow-up visits. Clients will typically also be offered an HIV test.

VMMC in the Western Cape

Meanwhile, in the Western Cape, the Department of Health and Wellness in collaboration with the City of Cape Town and the Department of Cultural Affairs and Sport has implemented an initiation consent form as a mechanism to uphold ethics. It includes medical screening that helps minimise and mitigate potential risks.

Western Cape Department of Health spokesman Mark Van der Heever told Spotlight, “The initiation consent form is further reviewed to enable alignment to developments as these emerge. Training and capacitation of traditional surgeons is a key element to strengthening partnership following a whole of government and whole of society approach.”

Van der Heever says since 2020, 274 circumcisions were performed by a Medical Officer invited by the traditional healers to perform the circumcisions.  A total of 131 977 medical male circumcisions, according to Van der Heever, were performed at the Western Cape health facilities since 2013, with 13 105 performed just last year.

The rest of the stats are as follows:

2013 – 12 581

2014 – 15 990

2015 – 14 131

2016 – 11 982

2017 – 15 127

2018 – 14 557

2019 – 18 000

2020 – 5 750 (COVID)

2021 – 10 754 (COVID)

2022 – 13 105

Van der Heever adds that between April and March 2023, Medical Male Circumcision was reported at 130 public health sites and a total of 12 259 circumcisions were performed across the province.

“The province also has two Men’s Health Clinics (in Karl Bremer and Elsies River). With the intention of increasing access to services, we are in discussions to upskill clinicians to enable service provision at health facilities. Current service provision is based on roving teams in both the metro and rural districts, which limit access to availability of the team.”

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : HIVTags :

Opinion: HIV Investments Remain No-brainers, but Some Things Need to Change

On By ModernMedia
Photo by Miguel Á. Padriñán

By Marcus Louw for Spotlight

Making the case for governments and donors to pump money into the HIV response has become more difficult over the last decade. This is partly a result of the notable successes we’ve had – for example, in 2022, HIV-related deaths in South Africa were down to less than a fifth of what it was in 2005. There is clearly some justification for the point of view that HIV simply isn’t the crisis it used to be.

That said, it is also true that about 8 million people in South Africa are living with HIV. This number will continue to rise in the coming years as the rate of new HIV infections is much higher than the rate of HIV-related deaths. Barring a major scientific breakthrough, all these millions of people will require antiretroviral medicines for the rest of their lives, both for their own health and to reduce onward transmission of the virus. In this context, a failure to maintain and improve HIV treatment and prevention programmes will have catastrophic consequences.

There is also increasing competition with other areas of urgent need. In recent years, climate change and COVID-19 have understandably made the headlines much more frequently than HIV. There is also a slow shift underway in South Africa’s disease burden, away from HIV and tuberculosis toward non-communicable diseases (NCDs) such as diabetes and hypertension.

Still a no-brainer

Despite these shifts, there is good reason to think that spending money on HIV continues to offer excellent value for money. For example, according to a recent report by Economist Impact (part of the Economist group that also publishes the Economist magazine), for every dollar spent on HIV in South Africa from 2022 to 2030, it is estimated the country will see GDP gains of over $7.

We also have a good idea of the impact and cost-effectiveness of specific HIV-related interventions. According to the most recent version of the South Africa HIV investment case, published in December 2021, condom provision continues to be the most cost-effective intervention in South Africa, followed by antiretroviral treatment, infant testing, pre-exposure prophylaxis for men who have sex with men, and general population testing. Voluntary medical male circumcision has become less cost-effective as coverage levels have risen in recent years, but remains worth it. In fact, the investment case leaves no doubt that most of the key interventions needed to combat HIV in South Africa are both worth it and affordable.

Despite all this, according to a recent UNAIDS report, global investment in HIV has taken a knock in recent years, and in 2022 we were essentially back down to the same level as in 2013. Such reductions constitute a crisis in HIV funding, especially in poor countries that are heavily reliant on donor funds. In South Africa, key interventions like antiretroviral treatment and condoms generally remain funded, but public sector health budgets have been shrinking in real terms, something that is no doubt impacting the HIV programme.

Time to leverage HIV investments

This brings us back to the knotty problem with which we started – while HIV remains a large and serious problem and most investments in combatting HIV remain excellent value for money, making the case for these investments has become more difficult due to competing priorities and the fact that, in South Africa at least, people are not dying of AIDS at nearly the rate they did 20 years ago. How to best make the case in a way that convinces governments and donors to put up the money in this context is a devilishly hard problem.

There are certainly no simple solutions.

What there is, though, is some indications that a too narrow focus on HIV is becoming a harder sell. There is also a risk that as funds for HIV get harder to come by, and the clamour for funding NCDs becomes more pronounced, we may end up pitting diseases against each other in a way that benefits no one.

Given the incredible acuteness of our HIV crisis ten and 20 years ago, a laser focus on HIV was right and necessary. Today, however, the reality is that many people living with HIV are also living with NCDs like diabetes or hypertension, something that will become only more so as the population of people living with HIV grow older. It is clear that we need to start doing a better job of integrating care and treatment for all the different diseases one person might have – the key is to do so in a way that doesn’t drop the ball when it comes to HIV.

In some areas progress is already clear – medicines distribution via pickup points closer to people’s homes were fuelled by the need to get ARVs to people, but is now also being used to distribute medicines for some NCDs. In other areas, such as data systems, integration however remains limited and the systems available for HIV and TB remain superior to those for NCDs.

There appears to be a broader policy shift along these lines. As recently reported on Devex, the Global Fund to Fight HIV, TB, and Malaria’s current five-year strategy explicitly endorses and promises funding for integrating non-communicable disease services with TB and HIV programmes. UNAIDS’s new ‘The path to end AIDS’ report also makes the right noises on the “deeper integration of HIV and other health services”, as does South Africa’s National Strategic Plan for HIV, TB, and STIs 2023 – 2028.

Of course, the road from policy-level ambitions such as these and change on the ground can be a long one – to some extent such integration has been on the cards for over a decade. But, rising NCD rates, an ageing population of people living with HIV and comorbidities, and funding pressures mean that getting integration right is now more urgent than ever.

One of the arguments for HIV-specific funding has always been that HIV investments have benefited healthcare systems more generally, even if that was not the primary intention. Maybe in this next act of the HIV response then, the key will be to stop thinking of health system improvement as a side effect of HIV investments and instead lean into the idea of explicitly leveraging what we’ve done and will continue to do in HIV to improve health systems more generally.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : Cardiovascular Disease HIVTags :

Daily Statin Reduces Risk of Major Cardiovascular Events in People Living with HIV

On By ModernMedia
Photo by Towfiqu Barbhuiya on Unsplash

A new study published in the New England Journal of Medicine found that statins, a class of cholesterol-lowering medications, may offset the high risk of cardiovascular disease in people living with HIV by more than a third, potentially preventing one in five major cardiovascular events or premature deaths in this population. People living with HIV can have a 50–100% increased risk for cardiovascular disease.

“This research suggests that statins may provide an accessible, cost-effective measure to improve the cardiovascular health and quality of life for people living with HIV,” said Gary H. Gibbons, MD, director of the National Heart, Lung, and Blood Institute (NHLBI), a study funder. “Additional research can further expand on this effect, while providing a roadmap to rapidly translate research findings into clinical practice.”

For the double-blinded phase 3 trial, known as Randomised Trial to Prevent Vascular Events in HIV (REPRIEVE) study, researchers randomised participants into either a treatment group, where they received pitavastatin calcium daily or a control group receiving placebo. The researchers followed participants for about five years, but ended the trial early when they discovered the treatment benefits outweighed potential risks.

To understand the benefits, the researchers compared how often participants in each group experienced major cardiovascular events, including heart attacks, strokes, or surgery to open a blocked artery. They found participants who took daily pitavastatin had 35% fewer major cardiovascular events than those who took a placebo. The researchers also measured the number of deaths in combination with major cardiovascular events during the study period and found participants in the treatment group were 21% less likely than those in the placebo group to experience these events. Additionally, those taking pitavastatin had a 30% reduction in their low-density lipoprotein (LDL) cholesterol levels.

“Lowering LDL cholesterol levels reduces risks for cardiovascular events, like having a heart attack and stroke, but these findings suggest there may be additional effects of statin therapy that explain these reduced risks among people living with HIV,” said Steven K. Grinspoon, MD, the study chair. “Ongoing research about how statin therapy may affect inflammation and increased immune activation among people with HIV may help us better understand the additional benefits we’re seeing with this treatment approach.” 

To support optimal health outcomes among the study participants, normal liver and kidney function were an enrolment criteria. They were also required to take antiretroviral therapy, which itself is critical to reducing the risk of HIV complications and related comorbidities, including cardiovascular disease.

Beginning in 2015, REPRIEVE enrolled 7769 adults, ages 40–75, from 145 sites in 12 countries. Adults in the study were an average age of 50 and had low-to-moderate risks for cardiovascular disease, which meant they normally would not have been prescribed statins. Women accounted for 31% of participants. Approximately 41% of study participants identified as Black, 35% as white, 15% as Asian, and 9% as another race.

Source: National Insitutes of Health

Categories : HIVTags :

Over 4.7m People in SA Placed on New HIV Med in Four Years

On By ModernMedia
Photo by Sergey Mikheev on Unsplash

By Elri Voigt for Spotlight

In what is likely one of the largest treatment rollouts in South African history, well over four million people living with HIV have started taking the antiretroviral dolutegravir since its introduction around four years ago. Now, according to a recent study published in the Lancet medical journal, use of dolutegravir in South Africa is associated with more people staying on treatment and higher rates of viral suppression.

The use of a three-in-one combination of the antiretroviral drugs tenofovir, lamivudine and dolutegravir (TLD for short) for the treatment of HIV was first recommended by the World Health Organization (WHO) in 2018. A year later it was recommended in the South African treatment guidelines as first line treatment for HIV and a three-year tender was awarded. Since then, dolutegravir has largely replaced another antiretroviral called efavirenz.

Today, TLD is the recommended treatment option for most people living with HIV in the country. The 2023 National antiretroviral (ARV) guidelines also include recommendations for the use of child-friendly formulations of dolutegravir and dolutegravir containing regimens in kids. Spotlight reported on these here.

Around 4.7m people in SA taking dolutegravir

According to Foster Mohale, spokesperson for the National Department of Health, in 2019 the HIV clinical guidelines were revised to include a fixed combination dose of TLD “for all eligible people for use as the first line regimen.”

Based on this, the department set a goal that 90% of those eligible for it should receive TLD as a first line regimen. In terms of meeting this goal, Mohale says that by March 2023, just over four million (4 127 427) people were on TLD. Additionally, about 650 000 (653 884) people were on other dolutegravir based regimens. Altogether, there are thus now over 4.7 million people in the country on treatment combinations that include dolutegravir.

“Based on the March 2023 data, 90% of clients on first line regimen were on TLD. However, performance varies by province,” he says.

Of the total number of people on ART in the public health sector, 75.8% are on TLD, according to Mohale.

Trends in the roll out

While on paper the country’s transition from efavirenz to dolutegravir-based regimens seems to have been smooth, the reality on the ground has been more complex. A study published in the Lancet earlier this year looked at real-world rollout data from 2019 to 2022. The study was conducted in 59 clinics across the country and collected data from two cohorts-one cohort were first time initiators of ART and the other were transitioning from regimens that did not include dolutegravir to ones that did.

In the initiator cohort, just over 45 000 people were initiated on ART between December 2019 and February 2022. Of those, 68.9% were initiated on dolutegravir-based regimens, 31.1% on efavirenz-based regimens, and 0.1% on nevirapine-based regimens.

Those initiated on dolutegravir-based regimens were more likely to still be on treatment a year later and were also more likely to be virally suppressed than those who were initiated on the other regimens.

In December 2019, in the transition cohort, just over 180 000 people were on a non-dolutegravir first line regimen. By February 2022, 67% of them had transitioned to a dolutegravir-based regimen. These people were also more likely to be retained in care at 12 months and be virologically suppressed than those who had not switched to a dolutegravir-based regimen.

“That’s good for a number of reasons. It means that the treatment’s working, people are less likely to get unwell and also, they can’t transmit the virus onto other people,” explains Dr Jienchi Dorward, one of the study authors and an academic clinical lecturer at the University of Oxford and honorary associate scientist at the Centre for the AIDS Programme of Research in South Africa (CAPRISA).

‘Bumpy transition’

Dr Yukteshwar Sookrajh, a Senior Medical Practitioner at the eThekwini Municipality Health Unit who was also involved in the study, tells Spotlight that the rollout quickly gathered momentum.

“But initially there were some issues to navigate around drug interactions; concurrent TB infection and the use of dolutegravir in women of childbearing potential,” he says. “Once those concerns were addressed, the comfort of switching to dolutegravir was increased and we find that the majority of our patients have now safely transitioned across to dolutegravir-based regimens.”

In many ways South Africa was slow in rolling out dolutegravir compared to other African countries, according to Professor Francois Venter, the head of Ezintsha at Wits University. Reasons for this, he says, include an initial concern around the safety of dolutegravir use among pregnant women, and disruption in training due to the COVID-19 pandemic.

He says that the South African Clinicians society was alerted during the COVID-19 pandemic that many patients in the public health sector had still not been transitioned to dolutegravir. An education campaign was then launched to encourage clinicians to start or switch patients to dolutegravir.

However, as it stands now the rollout of the drug in the public sector has been a huge success, despite what Venter calls a “bumpy transition”.

Initial safety concerns

One important reason to conduct the study reported in the Lancet, according to Dorward, was a safety concern regarding the use of dolutegravir by pregnant women. An earlier study conducted in Botswana called Tsepamo found a higher prevalence of neural-tube defects (a type of birth defect) associated with dolutegravir exposure at conception than with other types of antiretroviral exposure. As more data has been gathered since, it has however become clear that dolutegravir does not in fact increase the risk of neural-tube defects.

But the Tsepamo scare did impact who was initiated and transitioned onto dolutegravir in first two years of the rollout.

“The initial concerns around neural-tube defects and the use of dolutegravir in women of childbearing potential clearly hampered rollout of dolutegravir in women – and this has been clearly demonstrated in this study,” says Sookrajh.

The Lancet study found that pregnant women and non-pregnant women were less likely to be initiated on dolutegravir than men early in the rollout, with the biggest difference between women and men aged 15 to 24 years old. This difference decreased with age and by age 55 there was no difference between men and women receiving dolutegravir.

But this changed over time and by September 2021 women were as likely to get initiated on dolutegravir as men. Spotlight previously reported that the rollout was done in two stages. In the first stage men, adolescent boys, women on reliable contraception, and older women were prioritised.

Of those who started treatment during the study period, 46.9% of the pregnant women in the cohort were initiated on dolutegravir-based regimens, while 63.9% of the non-pregnant women and 82.3% of the men in the cohort were initiated on dolutegravir-based regimens.

“In both those groups [cohorts] we found that women were less likely than men to get dolutegravir, but interestingly, this was particularly in younger women,” Dorward explains. “As time went on, the difference between men and women became much less…around June to September 2021 was a time period where we found that women and men pretty much began to equally get dolutegravir.”

Dorward says the data showed an uptick in women in the study being given dolutegravir once the South African guidelines changed to reflect that there was no longer a concern around neural-tube defects.  It is thus likely that the safety concern was responsible for the lower initial uptake among young women.

He adds that the messaging around this potential risk was based on the evidence available at the time and was clearly outlined in the guideline document and training for dolutegravir use, but these did not appear to adequately allay these concerns among healthcare workers.

“The risks versus benefits needed to be messaged in a more effective way such that healthcare workers were more comfortable and confident in offering dolutegravir to women,” he says. Based on this experience Sookrajh adds that in future there needs to be more engagement with “practitioners on the ground to determine what type of messaging and supportive materials are required to facilitate better understanding of guidelines at the coal face.”

Another concern for some healthcare workers has been that dolutegravir-based regimens have been associated with greater weight gain than efavirenz-based regimens. But, as argued in a recent editorial in the Southern African Journal of HIV medicine, association is not the same as causation and it may well be that efavirenz inhibits weight gain rather than dolutegravir promoting it. People living with HIV who start taking antiretroviral medicines often gain weight as their health recovers.

New guidelines should further boost uptake

Sookrajh says that the National Department of Health’s antiretroviral (ARV) 2023 guidelines will further improve the uptake of dolutegravir in the public healthcare system.

“With the April 2023 National Department of Health ARV Guidelines, we actually find that further barriers to switching to dolutegravir have been removed and dolutegravir is clearly placed as the preferred drug of choice in almost all scenarios for both first- and second-line antiretrovirals,” he says.

“I think the new [ARV] guidelines hopefully will be a big improvement for people who are on treatment, and part of that is possible because we’re using the drug that is better. You’re less likely to get resistance with dolutegravir so we’re less worried if people don’t take treatment properly that they might get drug resistance, although we still need more research to be sure about that,” Dorward says. “And it’s still very important for people to take treatment consistently to suppress the virus and maintain their own health and prevent onward transmission.”

According to Venter, there needs to be proper resistance surveillance to detect potential dolutegravir resistance.

“We can’t take for granted we’ll never have resistance [to dolutegravir]…eventually there will be the occasional patient that does have resistance, but we need proper surveillance there,” he says. “And then we need to keep an eye on things. There are still patients getting HIV…there’s still a lot of new infections…we need to make that stop…we’ve got amazing PrEP and way too few people getting it. So, we do need to start addressing that.” (PrEP, or pre-exposure prophylaxis, refers to antiretrovirals taken to prevent HIV infection.)

Venter adds that while successful in the public health sector, the uptake of dolutegravir has been extremely slow in the private health sector for reasons unknown to him.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : HIV PaediatricsTags :

SA AIDS 2023: New Treatments and Guidelines to Benefit Kids, with More Advances on The Horizon

On By ModernMedia
Photo by Sergey Mikheev on Unsplash

By Elri Voigt for Spotlight

Several sessions at the 11th SA AIDS conference, recently held in Durban, highlighted the worrying fact that key HIV numbers such as treatment coverage are much lower in children than in adults. There is hope, however, that new treatments and new treatment guidelines might help close the gap.

In a plenary session, Dr Sandile Buthelezi, Director General of the National Department of Health, told delegates that on UNAIDS’ 95-95-95 targets, children in South Africa are at 81-65-68. This means that 81% of children living with HIV have been diagnosed, 65% of those diagnosed are on antiretroviral treatment, and 68% of those on treatment are virally suppressed. For the South African population as a whole, the numbers are at 94-76-92.

Throughout the conference, various speakers highlighted the fact that only 65% of children who have been diagnosed are on treatment as a particular concern. To close the gap and reach UNAIDS’ target of 95%, just over an additional 88 000 children would need to be initiated on treatment.

Professor Lee Fairlie, Director of Maternal and Child Health at Wits RHI, said in a presentation that only 52% of children younger than 14 living with HIV are on treatment. Fairlie also pointed out that children lagged behind substantially when it comes to viral suppression, and this is particularly challenging in the youngest age groups.

Not all bad news

But it was not all bad news at this year’s conference. One piece of good news is that new and better child-friendly antiretroviral formulations are being rolled out in South Africa. These new treatments should make it easier for children to start and stay on treatment – children often find it difficult to take medicines formulated for adults, due to factors like incorrect dosing, large pills, and bad taste.

The National Department of Health recently updated the country’s antiretroviral treatment guidelines to allow for the use of several of these new formulations and better HIV treatment regimens for children. Most notable is the introduction of a new regimen consisting of the medicines abacavir, lamivudine and dolutegravir (ALD for short).

Speaking at the conference, Dr Leon Levin, a paediatrician who has been treating infants, children, and adolescents living with HIV for almost three decades, pointed out that the availability of new paediatric formulations had a major impact on the new treatment guidelines. (Spotlight previously reported on the registration of some of these new formulations here.) Levin is also the Senior Technical Advisor in Paediatrics at the NGO Right to Care.

One such child-friendly formulation is a 120/60mg scored, dispersible tablet of abacavir and lamivudine that can be taken in patients who weigh between 3 and 25kg. It is given once daily and two generics are registered with the South African Regulatory Authority (SAHPRA). “It’s going to literally replace all the other paediatric Abacavir+3TC formulations. You can swallow it, chew it, crush it, or dissolve it in water. So [it’s] very versatile,” he said.

Also important is a paediatric formulation of the antiretroviral dolutegravir – a medicine that forms the backbone of HIV treatment in adults. According to Levin, the child-friendly version of dolutegravir is not available to everyone yet, and many clinicians still need to undergo training on how to use it. It is a 10mg dispersible, scored tablet given once daily that can be used at 3kg and higher and from four weeks of age onward. There are two generic versions of this product registered with SAHPRA.

The introduction of paediatric dolutegravir is likely to overshadow the introduction of a four-in-one formulation of abacavir, lamivudine, lopinavir/ritonavir. The four-in-one combination has to be taken twice daily, is strawberry flavoured and comes in a powder form. “Unfortunately, this product to nobody’s fault was launched at the same time as paediatric dolutegravir. Which means paediatric dolutegravir is going to take centre stage and this product unfortunately is not going to be used much,” Levin said.

Updated guidelines

Levin explained that the changes to South Africa’s treatment guidelines focused on doing two main things when it comes to children living with HIV, the first is to implement an optimised regimen – the ALD regimen and the second is to create an “enabling environment to support engagement in care and adherence”. He said that with the new guidelines, we can expect “much improved [viral] suppression, optimised regimens, improved synchronisation of clinic visits, happier patients and their families and clinicians as well”.

A big change to the guidelines is that now children who weigh 3kg and are four weeks of age should be started on the ALD regimen, instead of the abacavir, lamivudine, and lopinavir/ritonavir regimen that was previously recommended. “This is a major change. It’s a fantastic, well-tolerated regimen. It’s potent and you’re going to get around a lot of the issues you had with these younger children,” Levin said.

Once the children on this regimen get to 30kg, they will be switched to a regimen containing tenofovir, dolutegravir, and lamivudine (TLD for short). TLD is also the regimen adults living with HIV in South Africa are offered when starting treatment for the first time.

For children who are already on treatment, the new guidelines recommend that all children who are four weeks of age and older and weigh 3kg or more should be transitioned to a dolutegravir-containing regimen. For children with suppressed viral loads, the switch to ALD or TLD is straightforward, while for children without viral suppression, it can get more complicated.

Another important change is that children over five years of age are now eligible for Repeat Prescription Collection Strategies (RPCs) if they are virally suppressed and had an age-appropriate disclosure, which means that their HIV status has been explained to them in a way that is appropriate for their age, as outlined in the guidelines. For children under five, they can be given a three months supply at a time, providing they are at least six months old. Levin pointed out that whenever RCPs or a three months supply is considered for children, it is essential to look at where and how the parents may be receiving their own antiretroviral treatment so that it can be co-ordinated, and parents don’t have to go to two different places to collect the medications.

New options in the pipeline

While the paediatric formulations included in the new guidelines are a step forward, there are experimental treatments in the pipeline that may make treatment yet more convenient for children.

“There’s a rich pipeline of new combinations and drug delivery developments. Hopefully, this will further improve access, clinical and virological outcomes,” Fairlie said in a conference presentation. “Obviously, the paediatric market is extremely small and then one has to maintain enthusiasm for manufacturers to actually continue to look at the paediatric population. And so, merging of treatments and prophylaxis regimens is really what would work going forwards.”

In her presentation, she specifically referred to long-acting formulations of cabotegravir (CAB-LA) and rilpivirine (RPV). CAB-LA has already been approved by SAHPRA for HIV prevention in adults and, as Spotlight reported last week, pilot projects evaluating how to best provide the CAB-LA injection in South Africa are set to start soon. The combination of CAB-LA and rilpivirine injections has been approved for the treatment of HIV in adults by the United States Food and Drug Administration, but not yet by SAHPRA. The injections are administered every two months.

Fairlie says that currently there are several studies either ongoing or set to start soon for the use of these agents in the paediatric and adolescent age groups. In addition, there are also trials planned to test another long-acting medication called lenacapavir in adolescents and broadly neutralising antibodies (bNAbs) in children.

She also highlighted several improved delivery methods that are in the pipeline for paediatrics. These include a mechanism that doesn’t require water, like oro-dispersible tablets, also known as fast melts, which disintegrate in the mouth as well as oral films that stick to the mouth, disintegrate there, and dissolve. There are also various tablet options that are small enough for children to swallow easily. Like multi-particulates, which are small and solid, multiple-unit dosages that can take the form of granules, pellets, or beads. Mini-tablets are also a prospect – these are compressed tablets no larger than 4ml. Finally, there are novel mechanisms like long-acting oral drug delivery systems and micro-array patches. Fairlie explained that long-acting oral drugs are where a drug is stored in the centre of a capsule that has a number of “arms”, which are able to keep the capsule in the stomach and slowly dissolve and release the drug into the stomach. This allows for slow-release dosing. The “arms” tend to break down after about seven days.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight