Category: HIV

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Interview: “I Used That Anger to Feed My Activist’s Soul,” Says Former TAC General Secretary

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Dr Vuyiseka Dubula-Majola, the former General Secretary of the Treatment Action Campaign, reflects on her journey and new role at the Global Fund. PHOTO: Joyrene Kramer

By Biénne Huisman for Spotlight

Dressed in a dark jacket, rain is pelting Vuyiseka Dubula-Majola’s face as she rushes past bare trees in Geneva, Switzerland. Along with her two children, Dubula-Majola has newly moved into a house in nearby Genthod, from where she commutes to work by train.

In October, the Global Fund to Fight AIDS, Tuberculosis [TB] and Malaria, appointed Dubula-Majola as head of their community, rights and gender department. The Global Fund has allocated tens of billions of dollars around the world to fight HIV since its inception in 2002.

Five weeks into the job, Dubula-Majola tells Spotlight that a big challenge for her will be to hone a new tool – that of diplomacy.

Laughing, the former General Secretary of the Treatment Action Campaign (TAC) says that in the past, diplomacy has not been her greatest strength.

“In this new job, I am required to be diplomatic,” she says. “Basically, diplomacy is being nice in the face of atrocities, and I am not that person. So it will be a huge challenge for me, it’s going to take a shift. I will have to keep asking myself, ‘what value I can add in this position?’ While developing new tools and new ways of fighting, without being the noisy person in the room.”

The power of collective action

Known for not mincing her words, the activist-scholar is talking to Spotlight over Zoom while walking to the Global Fund’s offices in central Geneva. She adds: “Activists don’t like bureaucracies by nature, but you have a voice here. You have political currency to shift things. It’s a tough one, but I’m there.”

In a 2014 TedX talk hosted in London, an inflamed Dubula-Majola told the audience that she is angry – angry with her father, angry with her government, angry at everyone. But that she was using her anger to fuel her work.

Vuyiseka Dubula-Majola was recently appointed at head of the Global Fund’s community, rights and gender department. PHOTO: Supplied

While she is in Switzerland, Dubula-Majola’s heart still brims with African proverbs, such as: “When spider webs unite, they can tie up a lion.” She has experienced the power of such collective action first-hand at the TAC, but now she’ll be applying it on a different stage. Indeed, her new job is “to ensure that the Global Fund strongly engages civil society and promotes human rights and gender equality”, with a particular focus on supporting community led organisations.

As a role model for her new diplomatic duties, Dubula-Majola cites American public health official Loyce Pace. “Loyce Pace who runs the health program in the United States government, she is very effective in what she does while hardly saying anything in public. But she is shifting norms – bringing priority to black and poor people. She uses her allies and many other people similar to her to say things louder than she could…I guess this is another step of growth in my activist journey – to still be as effective, as radical, the very same eagerness and passion, but silently.”

‘There was no time to dream’

Dubla-Majola grew up in a village near Dutywa in the Eastern Cape. Aged 22 in Cape Town in 2001, she spiralled with depression after being diagnosed with HIV. But instead of resigning herself to what was then still a death sentence for most people, she joined the TAC – working night shifts at the McDonalds drive-through in Green Point, while by day she joined the fight to bring antiretrovirals and other medicines to South Africa.

“As a 22-year-old, I did not have fun, there was no time to dream,” she recalls. “I was fighting for my life and the lives of others. I never thought I would have children, I never thought I would get married, I never thought I would love again. Because there was also the issue of who infected me, how did this happen? You start resenting relationships.”

At the forefront of social justice activism for most of South Africa’s young democracy – a role model for people living with HIV, and for those fighting inequality – Dubula-Majola lead the TAC from 2007 to 2013, after which she joined Sonke Gender Justice as director of policy and accountability. She holds an MA in HIV/AIDS management from Stellenbosch University; her PhD from the University of KwaZulu-Natal examined “grassroots policy participation after a movement has succeeded to push for policy change,” using MSF’s [Médecins Sans Frontières] pioneering antiretroviral sites in Khayelitsha and Lusikisiki as samples.

‘Build and regain the dignity of poor people’

In 2018, when Stellenbosch University offered her a job as director of its Africa Centre for HIV/AIDS Management, Dubula-Majola was circumspect. Why take up appointment at a white male-dominated institution shackled by slow transformation, in an elitist town? But she took on the challenge to become the transformation she wanted to see.

Dubula-Majola tells Spotlight that while relishing the privilege of academia – a space to reflect – it saw her away from “the heat of the activist fire” for too long. Five years later, a new challenge awaits.

Reflecting on Stellenbosch, she says: “This [job at the Global Fund] is even harder, because it’s not just one country, one university. This is all the continents of the world. All of them facing the same thing, the struggle here is to build and regain the dignity of poor people around the globe.”

Despite her early misgivings about relationships, Dubula-Majola married fellow TAC activist, Mandla Majola. Their children, now aged 10 and 16, are HIV-negative. Presently Majola is helping with their friend Zackie Achmat’s independent campaign for the 2024 general elections, after which he will join his wife in Geneva. The family will unite in Switzerland for Christmas though – “which will be the most miserable and cold Christmas,” says Dubula-Majola, laughing. “It will be our first winter Christmas and our last. As we just arrived a month ago, it doesn’t make sense to travel back to South Africa for the holidays.”

Overall she says she remains hopeful, adding that movements like #MeTo are lessons in global solidarity.

Her thoughts on continuing the fight against HIV: “It is up to HIV positive people, and those who want to remain HIV negative, to steer towards an AIDS-free generation. We must stop complaining, thinking politicians will do everything for us, and do it ourselves.”

Meanwhile, Global Fund representatives have voiced confidence in Dubula-Majola’s ability to lead. Marijke Wijnroks, head of the organisation’s strategic investment and impact division, said in a statement: “Following an extensive search process, I am delighted to say that we found the ideal person for this role. As a person living with HIV, Vuyiseka’s lived experience and leadership style are well aligned to what we need from this critical role.”

Note: Dubula-Majola is a former General Secretary of the TAC. 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

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Treating Newborns with HIV in 1st 48 Hours may Result in Medication-free Remission

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Photo by Christian Bowen on Unsplash

An unexpectedly high percentage of children, who were born with HIV and started treatment within 48 hours of life, exhibit biomarkers by two years of age that may make them eligible to test for medication-free remission, according to a multinational study published in The Lancet HIV.

“Moving away from reliance on daily antiretroviral therapy (ART) to control HIV would be a huge improvement to the quality of life of these children,” said Protocol Co-Chair and senior author Ellen Chadwick, MD, at Ann & Robert H. Lurie Children’s Hospital.

Conducted in 11 countries including South Africa, the proof-of-concept study was charged with replicating the case of HIV remission as seen in the “Mississippi baby” that was reported in 2013. In that case, the infant started ART at 30 hours of life, was treated for 18 months, and achieved 27 months of ART-free remission before the virus rebounded. Typically, if ART is stopped, the virus rebounds within a month.

The study included a three-drug ART regimen initiated within 48 hours of life, with the fourth drug added within 2-4 weeks. This is very early treatment compared to the standard of care where three-drug ART may not begin until 2-3 months of age.

In the US, however, based on earlier findings from this study, very early treatment is now the norm for infants at high risk of acquiring HIV infection from their mother.

“With earlier treatment, we hope to limit or prevent the establishment of viral reservoirs in the body. These viral reservoirs hold small amounts of hidden virus which are hard to reach with ART. By shrinking these reservoirs, we expect to increase the amount of time that patients can be in remission, without needing daily ART,” said co-author and Protocol Co-Chair Jennifer Jao, MD, MPH, from Lurie Children’s.

Dr Chadwick adds: “Another benefit of smaller viral reservoirs might be that newer treatments such as long-acting antibody therapies or therapeutic vaccines could potentially be used instead of daily ART.”

“Our results show a higher percentage of children might be eligible to interrupt therapy than we expected, and the next step is to stop ART and see how many children actually achieve remission,” said Dr Chadwick.

“If even one child achieves remission, that would be considered a success. Today, newer more effective and better tolerated HIV medications are available for infants than when the study began, strengthening the prospect of limiting viral reservoirs and testing for possible remission in infants and children with HIV. Overall, this is an exciting advancement and an opportunity to change the course of pediatric HIV infection.”

The study was conducted in 11 countries – Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, USA, Zambia and Zimbabwe.

Source: Ann & Robert H. Lurie Children’s Hospital of Chicago

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In-depth: How do Long-acting HIV Treatments Work?

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Photo by Miguel Á. Padriñán

By Elri Voigt for Spotlight

Researchers have been trying to develop antiretroviral medicines that can last for weeks, months or even years per dose. It is thought that such long-acting therapies may eventually end up replacing the daily pills taken by most people living with HIV today.

As pointed out by Dr Anushka Naidoo, a Clinical Pharmacologist and Principal Investigator and Scientist at the Centre for AIDS Programme of Research in South Africa (CAPRISA), three such long-acting HIV medicines have made it to market so far. They are the injectables cabotegravir (CAB-LA) and rilpivirine (RPV-LA) and the dapivirine vaginal ring (DPV-VR). Of these only CAB-LA (two-monthly) and DPV-VR (monthly) have so far been approved by the South African Health Products Regulatory Authority (SAHPRA) for HIV prevention. CAB-LA and RPV-LA have been approved for HIV treatment in the United States, but not yet by SAHPRA.

Image: DOH

CAB-LA and DPV-VR are being rolled out as HIV pre-exposure prophylaxis (PrEP) in pilot studies in South Africa. Spotlight earlier this year provided an update on these pilots here.

How do long-acting formulations work?

Dr Sindiswa Maphumulo, a Specialist Virologist and lecturer at the University of the Free State, tells Spotlight that designing long-acting formulations is a very complex and costly process. She explains that when designing any drug, whether it is long-acting or not you need to look at two things – pharmacodynamics and pharmacokinetics. Basically, she says, pharmacokinetics refers to what the body does with the drug in question while pharmacodynamics refers to what the drug does to the body.

“So you’re going to have to know what is the human body going to do to this drug once you’ve administered it and also what is the drug targeting or aiming to do in the human body once it has been given,” she says. For long-acting drugs, studies need to determine what the half-life (how long it lasts in the body) of the drug is so the doses can be timed correctly. It is also essential that different populations are studied to determine how individual’s bodies react to the drug.

“You want to make sure that there is a steady release of that specific drug, which depends on the drug class that you’ve chosen because we target different sites of HIV [with different drug classes],” she adds.

Naidoo tells Spotlight that: “Long-acting drug delivery formulations enable slow drug release after administering a single dose over the course of days, weeks, months or even years, and can maintain a steady pharmacokinetics profile.”

Naidoo says that long-acting drugs are formulated so that they form a “depot” of the drug, either through the way the drug is released into the body or the way device that contains the drug is designed to slowly release it over time. Several ways of achieving this has been investigated, including long-acting injectables, implants, infusion pumps, and patches. Long-acting injections and implants, for example, are already widely used in South Africa as contraceptives.

For HIV this means that ARVs can either be stored in the body and slowly absorbed or be stored in a device that is placed in the body which releases consistent drug levels over time. For example, “long-acting injectables are usually the same medication that is taken in pill form but when injected they allow for the slow release of medication into the blood over a longer period of time,” says Naidoo.

How CAB-LA works

Maphumulo explains that CAB-LA and DPV-VR fall under different drug classes which target different stages of the HIV viral replication cycle inside the human body. Cabotegravir is an Integrase Strand Transfer Inhibitor (INSTI) – which is to say it targets the integrase enzyme that allow HIV to integrate itself into a cell’s DNA.

“Cabotegravir’s unique physiochemical and pharmacokinetic properties have permitted its formulation and delivery both as an oral tablet for daily administration and as a long-acting nanosuspension for monthly to quarterly intramuscular injection,” Naidoo says.

“Cabotegravir LA is made from the free acid form of cabotegravir, which has a low water solubility, a long systemic half-life and high antiviral potency,” says Emmanuella Chinonso Osuala, a Research fellow and PhD student based at CAPRISA.

She explains that the properties of this drug make it suitable for a so-called nanosuspension delivery system and allows for high levels of the drug be contained in a small volume that can be administered through an intramuscular injection. This is achieved by manufacturing cabotegravir, through a process called wet-bead milling, to form nanocrystals – approximately 200nm in size. These have a large surface which allows for “a slower and controlled release of the drug over time”.

“[The] drug is released from the injectable suspension over several months due to the slow dissolution of crystals from the suspension,” Osuala explains.

How DPV-VR works

Naidoo explains that DPV-VR is a ring made of “a flexible silicone polymer” and contains the drug dapivirine, which is slowly released over the course of a month and can be inserted and replaced by the women themselves each month. A three-month ring is also currently in development.

“The ring delivers dapivirine directly at the site of potential infection, with low systemic exposure (it acts at the site of action in the vagina and is not released in significant amounts into the blood circulation), which could minimise side effects…and reduce the risk of developing HIV (drug) resistance,” she says.

Dapivirine, according to Maphumulo is part of a drug class called Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs), which block the reverse transcriptase enzyme on the HIV virus that allows for the transcription of HIV – which is an RNA virus into DNA. It is this transcription which would allow HIV to enter the human cell nucleus and replicate there.

Making current treatments long-acting

While long-acting forms of cabotegravir and dapivirine are clearly useful, these are far from the most widely used ARVs. Most HIV treatment in South Africa today is with a combination of three drugs, with the key one being dolutegravir. Earlier this year we reported on how more than 4.7 million people in the country have started or switched to dolutegravir-based HIV treatment in the last five years.

One group of researchers are trying to develop long-acting formulations of these commonly used ARVs. Using so-called drug combination nanoparticles (DcNP) they have developed a long-acting formulation of the ARVs tenofovir, lamivudine, and dolutegravir (LA-TLD) that shows some promise as a monthly injection. Early findings presented at this year’s International AIDS Society (IAS) conference in Australia and published in the journal AIDS suggest that the formulation achieves sufficient drug concentrations in non-human primates to allow for monthly dosing.

Dr Rodney Ho, an expert in biomedical science and pharmacology based at the University of Washington in the United States who led the research, tells Spotlight the study wanted to address a seemingly impossible question.

“Can we make three incompatible oral antivirals – tenofovir, lamivudine (which are water soluble) and dolutegravir (which is oil soluble and water-insoluble) – compatible and create a long-acting drug combination injectable product? With creativity and hard work, our team finally found a way to make this happen,” he says.

He explains that the three drugs were bound to lipid (fatty) nanoparticles using DcNP technology, which stabilises them so that the combination of drugs do not get released at the injection site immediately. Instead, the drugs are taken up by the body’s lymph and lymph nodes, which allows the drug to be metabolised within the body’s cells, which host the HIV virus, before it is taken up in the blood stream.

“As a result of this intentional design, LA-TLD has now provided data verifying that we are able to provide the necessary long-acting drug profile while achieving targeted drug exposure in cells and tissues of interest for an extended time,” Ho says.

“These results verified that a stable and scalable long-acting product, previously considered impossible, is now proven to be possible. This novel LA-TLD product can be administered via subcutaneous injection and will reach therapeutic drug levels within hours (not days which is needed for CABENUVA – LA-CAB and LA-RPV taken as HIV treatment). Thus, two-month oral leading doses may not be necessary,” he says.

Challenges around long-acting formulations

Osuala says there are several scientific challenges when it comes to long-acting formulations. This includes ensuring that: the drugs remain stable when released over long periods of time; sustained drug release is maintained; and the biocompatibility of the materials used in the product. Other challenges include issues around drug potency, as the amount of drug required for the formulation depends on its potency; as well as the cost and access to the formulations, as it is currently expensive to develop and manufacture which may hinder the accessibility of these products in low-and-middle-income (LMIC) countries.

Further challenges, according to Naidoo include the added complication that if adverse events occur for long-acting injectables, “one cannot simply stop taking the medication like one can with daily pills” since the drug will continue to be released into the body. One way to reduce this risk is through having an oral lead-in period where the drugs, like cabotegravir and rilpivirine that are set to be injected are first taken in pill form for four weeks, which can be stopped if an adverse event like hypersensitivity, an allergy or a severe side effect occurs.

Other challenges include the cold-chain storage requirements that some long-acting formulations and injections have, Naidoo says, “which can be challenging in LMIC settings so formulations without cold chain needs are needed.”

“The development of long-acting injectable formulations are a complex, time-consuming, and costly process. One of the challenges in the development of long-acting injectable formulations is the limited selection of ‘polymers’ and ’excipients’ (materials used to formulate the long-acting injectables that are available). As a result, some innovator companies develop proprietary excipients for use in long-acting injectable formulations, which can delay the development of generic long-acting injectable products,” she adds.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : Antibiotics HIVTags : Leave a comment

New Drug Offers Hope against Untreatable Gonorrhoea

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Photo by Myriam Zilles on Unsplash

By Catherine Tomlinson for Spotlight

Newly announced results of a pivotal phase 3 trial have demonstrated the effectiveness of a new one-dose treatment for gonorrhoea. The medicine, called zoliflodacin, is the first new drug developed to treat gonorrhoea in over 30 years. More than half of the 930 patients included in the trial were from South Africa, including women, adolescents, and people living with HIV.

Zoliflodacin, which was shown to be non-inferior to (as good as) the currently used treatment in treating uncomplicated gonorrhoea, provides an important new tool to combat rising rates of drug resistant gonorrhoea. It was found to be generally well tolerated and there were no serious adverse events or deaths recorded in the trial. So far, only top line results have been shared in a media release and the findings have not yet been published in a medical journal. (You can see some technical details of the study design on ClinicalTrials.gov)

The World Health Organization raised the alarm about increasing rates of drug resistant gonorrhoea in 2017, noting the emergence of cases of untreatable gonorrhoea resistant to all available antibiotics. According to the United States Centers for Disease Control and Prevention “medication to treat gonorrhoea has been around for decades, but the bacteria has grown resistant to nearly every drug ever used to treat it”. They say: “only one class of antibiotics known as cephalosporins remains to treat the infection”.

As a drug from a new class of antibiotics, zoliflodacin, offers a new potential treatment for patients whose gonorrhoea was previously untreatable, as well as a new tool for safeguarding the ongoing effectiveness of currently available antibiotics.

How zoliflodacin may change gonorrhoea treatment

Professor Sinead Delany-Moretlwe, Director of Research for Wits RHI and the National Principal Investigator for the trial in South Africa, told Spotlight that while zoliflodacin may be used to treat drug resistant gonorrhoea, it also provides an attractive new treatment option for first-line treatment of gonorrhoea in some countries (in other words, gonorrhoea that is not resistant to other treatments).

Zoliflodacin, which is taken as a single oral dose, is simpler to administer than the current standard of care, which involves a combination of injectable ceftriaxone and oral azithromycin. Removing the need for an injection could simplify the administration of gonorrhoea treatment and improve its uptake.

Using zoliflodacin as first-line gonorrhoea treatment can also help safeguard the ongoing effectiveness of cephalosporins (including ceftriaxone), according to Delany-Moretlwe, which she adds are needed not just for treatment of gonorrhoea, but also other infections.

According to Delany-Moretlwe, because zoliflodacin is the first of a new class of antibiotics with novel mechanisms of action and without existing cross resistance, the hope is that widespread use of zoliflodacin as first-line gonorrhoea treatment will slow the emergence of resistance compared with the medicines currently being used.

The Global Antibiotic Research and Development Partnership (GARDP), a non-profit that sponsored the trial, points out that: “Antimicrobial resistance [AMR] has been around for millions of years, long before the first man-made antibiotics. So, drug-resistant bacteria are inevitable and will eventually affect all antibiotics”. They state: “to beat AMR we need a steady supply of new antibiotics to be developed that are effective against drug-resistant bacteria, particularly for priority pathogens that have the greatest public health impact.”

Gonorrhoea in South Africa

South Africa has incredibly high rates of gonorrhoea, with an estimated 2 million new cases annually. While data on rates of drug resistance in the country is limited, the data that is available indicates that ceftriaxone resistance in the country is low, but azithromycin resistance is concerningly high in some parts of the country.

As there is no routine screening for gonorrhoea in South Africa, linkage to treatment remains a challenge. Currently, diagnosis is largely done through symptomatic reporting by patients. But this approach misses many cases as some patients do not self-report symptoms and some cases of gonorrhoea are asymptomatic.

In 2022, the Southern African HIV Clinicians Society released new guidelines for the management of sexually transmitted infections which called for provider-initiated symptomatic screening and provider-initiated diagnostic screening in high-risk populations.

The country’s new National Strategic Plan on HIV, TB and STIs has set a target to increase the number of pregnant women tested for gonorrhoea from 10% in 2023 to 80% by 2028 and has committed to implementing diagnostic testing in other priority populations, including adolescent girls and young women.

How will new gonorrhoea treatments be commercialised?

Zoliflodacin was developed by GARDP in collaboration with the company Innoviva Specialty Therapeutics. According to GARDP, it holds the rights to register and commercialise zoliflodacin in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. While, Entasis Therapeutics Limited, an affiliate of Innoviva Specialty Therapeutics, “retains the commercial rights for zoliflodacin in the major markets in North America, Europe, Asia-Pacific, and Latin America”.

South Africa is one of the countries in which GARDP holds the rights to register and commercialise zoliflodacin. It is anticipated that this will be done through selection and licensing of companies to manufacture and supply zoliflodacin in South Africa and other countries where GARDP holds commercialisation rights.

GARDP recently launched a request for proposals from partners that are interested in commercialising zoliflodacin. GARDP has also signed a memorandum of understanding with two generic producers to explore opportunities to commercialise the medicine in low-and-middle-income countries.

While the price that will be offered by commercial partners for the product remains to be seen, it is anticipated that products will be made available at affordable prices in line with GARDP’s goal to ensure that “all GARDP products are available, affordable, and appropriately used across populations that need them”.

“This is the first study to address a World Health Organization priority pathogen that has been sponsored and led by a non-profit organization,” says GARDP.

“This demonstrates that GARDP’s model can play a crucial role in helping to fix the public health failure at the heart of the global AMR crisis,” says Professor Glenda Gray, GARDP board member and President of the South African Medical Research Council.

SA involvement

According to GARDP, South Africa had the highest number of participants in the global trial, across six sites in four provinces: Wits RHI in Hillbrow, Johannesburg; the Desmond Tutu HIV Foundation in Masiphumelele, Cape Town; Setshaba Research Centre in Soshanguve, Gauteng; the SAMRC’s clinical research sites in Botha’s Hill and Tongaat in KwaZulu-Natal; and Ndlovu Research Centre in Groblersdal, Limpopo.

“We have also been able to leverage our HIV experience to build capacity for trials of novel STI technologies, a previously neglected area. Undertaking this vital work on a new treatment for gonorrhoea has also given us the opportunity to focus sharply on the local situation in South Africa,” says Delany-Moretlwe.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

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An Injectable Hydrogel could Deliver Long-term ART for HIV Patients

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Photo by Raghavendra V Konkathi on Unsplash

A new injectable solution that self-assembles into a gel under the right conditions could help manage HIV unlike any currently available methods, researchers report in the Journal of the American Chemical Society. Developed by John Hopkins University researchers, the new gel releases a steady dose of the antiretroviral lamivudine over six weeks, suggesting people living with HIV could have an alternative to the daily pill regimen.

“The primary challenge in HIV treatment is the need for lifelong management of the virus, and one way to address this is to reduce dosing frequencies to help patients stick to medical regimens,” said lead researcher Honggang Cui, a chemical and biomolecular engineer. “This new molecular design shows us a future in which drug hydrogelation can do that to improve HIV treatment.”

In plasma-like conditions, Cui’s team showed the gel quickly separates into molecules of lamivudine. By injecting the gel in the backs of mice, the researchers found one injection was sufficient to maintain effective and lasting drug concentrations for 42 days with nearly no side effects.

“Our goal is to help improve people’s quality of life,” Cui said. “The antiviral substance can be injected under the skin and remain in place over an extended period, releasing the therapeutic compound slowly and consistently – a critical need for individuals with HIV.”

For people living with HIV, the key is maintaining bloodstream drug levels at concentrations that suppress virus load in the body. But that can be difficult with traditional approaches because the body naturally rids itself of these chemicals, Cui said, which is why different treatments require different dosages and dosing frequencies to work.

Most antiretroviral therapies use a combination of drugs, so the researchers plan to include other drugs in tests. Because lamivudine is an FDA-approved drug to treat HIV and hepatitis B, the researchers said the hydrogel could also help manage hepatitis B.

“This is a novel way to deliver anti-HIV meds, and this platform has the advantage that a single polymer can be programmed to deliver several different drugs simultaneously,” said co-author Charles W. Flexner, a professor of medicine, pharmacology, and molecular sciences in the Johns Hopkins School of Medicine. “One of the drawbacks of the approved injectable HIV treatments is that none have activity against hepatitis B virus, which is a common co-infection with HIV, especially in Asia and Africa. This formulation delivers lamivudine, a drug active against both HIV and HBV, but can also be modified to deliver tenofovir, which is the current standard of care for HBV treatment.”

The team envisions their hydrogel working as a preventive measure, similar to how some people take anti-HIV drugs to avoid infection.

“Keeping the high drug levels in plasma for 42 days is very impressive,” Cui said. “But in the future, we hope it will be even longer.”

Hydrogels have unique water-absorbing properties that give them a jellylike consistency resembling biological tissue. The new gel undergoes self-formulation, stays close to the site of injection, and separates into molecules that can fend off the virus without the need for additional carriers or delivery materials.

“The most exciting aspect of these gel filaments is that they consist entirely of the therapeutic agent itself,” Cui said. “Everything originates from the same compound after injection, and this simplest drug formulation could streamline the regulatory approval process once clinical efficacy is demonstrated.”

The team tweaked the molecular properties of lamivudine to act as the building blocks of a supramolecular polymer, a large chain of repeating molecules that can either stick together tightly or come apart, depending on temperature, pH, and other external conditions.

Source: Johns Hopkins University

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Free State Bottom of the List when it Comes to Multi-month Dispensing of ARVs, Survey Finds

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Photo by Miguel Á. Padriñán

By Refilwe Mochoari for Spotlight

The percentage of people living with HIV receiving a three to six-month supply of ARVs at a time in the Free State has dropped from 13% last year to 3% this year, making the province the worst performer in multi-month dispensing of ARVs in the country. This while in Mpumalanga, 64% of people living with HIV receive a three to six-month refill as per national guidelines.

This is according to the latest figures from community-led clinic monitoring group, Ritshidze. In its third Free State report, released on 30 August, the group notes several challenges faced by people living with HIV, key populations that include men who have sex with men and sex workers, among others, and other public healthcare users in the province. Among these are a lack of multi-month dispensing of ARVs and long waiting times at clinics, two factors that can make it harder to take treatment as prescribed.

The report notes that multi-month dispensing often allows people living with HIV to collect their treatment at pick-up points situated at healthcare facilities or externally in the community, making it quicker and easier to collect ARVs. Yet the monitoring data shows that 41% of people using facility pick-up points said they still have to collect files, take vitals, and see a clinician before getting their parcel, which adds to unnecessary delays. “Overall, these shortcomings contribute to slow progress towards getting everyone to start and stay on HIV treatment,” the report states.

Monitoring for the new report was done in April and May this year at 21 facilities and included interviews with 1 095 public healthcare users across four districts in the province. Of the public healthcare users interviewed, 47% (516) were people living with HIV (PLHIV) and 16% (180) were younger than 25.

The recommendations

The report stresses that multi-month dispensing of antiretroviral treatment is just one of several ways to help reduce the burden on the healthcare system, and to reduce the pressure manifesting in long waiting times, overcrowded clinics, and overworked clinic staff. Ritshidze recommends – as it did in its two previous Free State reports – that “the department extends and implements refills up to three months by end of December 2023, and six months by end of September 2024”. It is also recommended that the department, “Ensures that all people living with HIV are offered a range of repeat prescription collection strategy options”, “that facility pick-up points are one-stop very quick ART collection-only, that clinic visits are under 30 minutes and there is no need to go to the clinic registry, collect folders, and to see a clinician.

“Multi-month dispensing and repeat prescription collection strategies can simplify and adapt HIV services across the cascade in ways that both serve the needs of people living with HIV better and reduce unnecessary burdens on the health system,” the report notes.

As people living with HIV often report that healthcare workers send them to the back of the queue when they miss appointments, Ritshidze recommends that staff acknowledge and understand the importance of ART continuity, that it is normal to miss appointments, and that no person living with HIV should be sent to the back of the queue if they miss an appointment as per the welcome back campaign strategy. Ritshidze also recommends that clinics must not require transfer letters to restart or continue with ART and any reports where treatment is delayed by healthcare workers requiring a transfer letter should be urgently investigated and disciplinary action taken where appropriate.

The value of multi-month dispensing

The value of multi-month dispensing is well established. Study findings on the HIV programme in Ethiopia released in May this year, for example, stressed that multi-month dispensing of antiretroviral therapy is “an integral component of differentiated HIV service delivery for people living with HIV”. Ethiopia was the first African country to implement six-month dispensing at scale.

The benefits cited by study participants included “time and cost-savings, fewer work disruptions, reduced stigma due to fewer clinic visits, better medication adherence, and improved overall health”. The perceived health system-level benefits included “improved quality of care, decongested facilities, reduced provider workloads, and improved record-keeping”.

According to Clinical Director at the Southern African HIV Clinicians Society, Camilla Wattrus, requiring people to visit healthcare facilities monthly to collect routine medication, can place a huge strain on the available resources in these facilities.

“Multi-month dispensing for eligible, stable patients on chronic medications, including ARVs can help to alleviate some of this burden, easing up the staff’s available time towards those with acute conditions and unstable patients, says Wattrus.

She says multi-month dispensing is also one way to increase access for stable patients to their medication by reducing potential adherence barriers leading to poor health and loss of income due to transport costs and time away from work – all factors identified by Ritshidze through its monitoring. External pick-up points can also help alleviate congestion at facilities and reduce waiting times.

When asked what the Free State health department can do to improve its performance on multi-month dispensing, Wattrus says establishing clear eligibility criteria will work because not all patients may be suitable. She says that patient education is vital so that they understand the importance of adherence.

“Knowing how to take and store medication, knowing where and when to collect medication, when to return for appointments, and understanding that they can return to the facility at any time they feel unwell or in the case of an emergency is very important. Adequate supply chain management to ensure an uninterrupted supply of medication along with accurate record-keeping and communication is vital,” she says. “Pharmacists, prescribers, and other staff members involved must also be adequately trained on how to deliver multi-month dispensing.”

Wattrus says in order for the Free State to do well, there needs to be an improved supply chain management system, adequate training for all involved staff, and a well-functioning pick-up point system implemented.

The reality on the ground

However, founder of the lesbian, gay, bisexual, and transgender (LGBT) organisation, Free State Rainbow Seeds, Thabiso Chaka says the Free State can do better in expanding external pickup points. “Once a person has shown interest and is also adhering to their medication, it is a bonus to say now you don’t have to come to the facility every month and every day. You can come after every three to six months. “I believe it is a good strategy to ensure that people adhere to their treatment. The reason why the Free State is doing poorly is because there is also not enough treatment viral load literacy and this creates a serious challenge and the level of care is often compromised because facilities are congested,” says Chaka.

“As the Free State Rainbow seed, we also want to become a CCMD point where we can be able to issue three to six months because by so doing our people will be comfortable.” CCMD (Central Chronic Medicines Dispensing and Distribution) is a government programme that enables stable patients to collect chronic medicines dispensed centrally from designated pick-up points. Chaka says multi-month dispensing of ARVs “is a good approach to limit issues of defaulting because the stigma attached to HIV-positive people is still there”.

According to Judy Mokoena from the Treatment Action Campaign (TAC) in the Free State, there are many reasons why the provincial department is struggling with multi-month dispensing of ARVs.

“The first one is that most facility managers and pharmacists order medication too late. Another reason is that they do not have an actual database of people living with HIV who come to their facilities. What I have noticed is that most people in the province still receive their medication inside the facilities. As TAC, we have been emphasising the issue of giving patients a supply of three to six months, but they are failing dismally,” she says. “Every year we ask the same questions when it comes to the multi-month dispensing, but there has not been a clear answer from government.”

“ARV shortage and ARV theft also play a role and could be another reason why the government is struggling to provide three to six months’ supply,” says Mokoena. “In the past, we have had challenges of stockouts in the Free State.”

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : General Interest HIVTags : Leave a comment

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 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 HIVTags : Leave a comment

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 : Leave a comment

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.”