Category Archives: South Africa

South Africa: HIV/Aids Vaccine Research Hope

13 November 2013

South Africa is the only country in the world where a large AIDS vaccine trial is being planned, as the global scientific community struggles to find a way to eradicate HIV.

Announced at this week’s international AIDS Vaccine Conference in Barcelona, the South African trial will involve the only vaccine shown to have some effect on the virus when it was tested among 16,000 people in Thailand. Released in 2009, the Thai trial’s results showed that HIV infection rates were 31 percent lower in participants who had received the vaccine than those who had not.

“On the eve of some of the most important vaccine trials, I am proud of the critical role that the people of South Africa will play,” said Ntando Yalo from the Networking AIDS Community Of South Africa, speaking at conference opening.

But the trial’s researchers are cautious.

Glenda Gray is the South African trial’s lead researcher and executive director of the Perinatal HIV Research at the University of the Witwatersrand. She told conference delegates that trial would begin by testing the Thai vaccine on a small group of people to confirm the vaccine worked as well in South African populations as it did in Thai participants.

“It might not show the same efficacy as in Thailand,” Gray said. “For example, South African women are bigger, and have different (levels of) exposure to the virus.”

With a national HIV prevalence rate of about 17 percent, South Africans are likely to have had much more exposure to the HIV than people in Thailand, where just one percent of the population is HIV-positive. The modest protection offered by the Thai vaccine might be too weak for South Africa, Gray added.

If the vaccine is effective within this smaller group, researchers will modify it for use against the predominant strain of HIV found in South Africa. This modified vaccine would be tested on about 240 people and, if successful, move to a larger trial involving about 5,400 people.

Chasing a “Machiavellian” virus

But the virus, described as “Machiavellian” by scientist Dr Scott Hammer at the start of the conference, continues to evade almost all attempts to eradicate it.

Johnson & Johnson Head of Research Dr Jerry Sadoff said he had been involved in creating 11 vaccines, none of which had taken more than seven years to develop. HIV was the exception, he said.

“You can make a career out of the AIDS vaccine – I have been researching it for almost 30 years,” he joked.

Most vaccines train the body to recognise and kill viruses by injecting people with small, non-toxic “deactivated” parts of the virus.

The body learns to make antibodies to fight the deactivated virus, so that when it is faced with infection from the live, dangerous virus, it is able to recognise and fight it.

But HIV’s constant mutation once it is the body makes it a moving target that is hard to pin down.

About two percent of people infected with HIV are able to contain the virus so that they don’t get sick. Scientists have been studying these “elite controllers,” including sex workers in South Africa, for years but still don’t yet know how their immune systems manage to do this.

Unlocking how our immune systems can produce “broadly neutralising antibodies” to fight HIV is “one of the holy grails of vaccine design,” according to Hammer.

But as scientists struggle to unlock the secrets of our immune systems and HIV, AIDS Vaccine Conference organisers have decided to move away from narrow focus on vaccines.

About 13 years after the first AIDS Vaccine Conference was held, the Global HIV Vaccine Enterprise will open next year’s conference to a wider range of scientists working on HIV prevention methods, including antiretroviral (ARV)-based vaginal or rectal gels – or microbicides – as well as other forms of ARV-based prevention and medical male circumcision.

This much larger gathering of HIV prevention experts will convene in Cape Town next year.

Organisers also raised the issue of a therapeutic HIV vaccine for the first time. Unlike the vaccine being tested in South Africa, a therapeutic HIV vaccine would aim to treat HV infections, not prevent them. A small therapeutic HIV vaccine trial is currently underway in the United States.

[Courtesy AllArica News]

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Shortages of new one-a-day ARV pills in South Africa

19 April 2013 – The South African ARV programme, worth about US$672 million, was awarded in November 2012 and introduced a 3-in-1 pill combining tenofovir, emtricitabine and efevarinz.

However just days into the rollout of fixed-dose combination (FDC) antiretrovirals (ARVs) by South Africa’s HIV treatment programme – the world’s largest – activists are raising fears of drug shortages.

Patients on the triple-therapy regimen will be able to take just one pill daily to control the virus. This has the advantages of improving adherence, simplifying regimens so that prescribing errors are reduced, and enabling the introduction of community models of care.

Motsoaledi launched the phased rollout of FDCs on 8 April at a small community health centre north of the country’s capital, Pretoria. New patients and HIV-positive women who are pregnant or breastfeeding will be the first to receive the new medication. They will initially receive a one-month supply of FDCs, while stable patients will be given a three-month supply.

“The central procurement unit in the national department of health has worked tirelessly with suppliers, provincial medical depots as well as facilities, to ensure that depots placed orders with suppliers, and health facilities placed orders with depots,” Health Minister Dr Aaron Motsoaledi said. “We are confident that we have sufficient supplies of ARVs for all patients who are eligible for the FDCs.”

But stock shortages have already been reported in Western Cape Province and more are thought to be occurring in other provinces, according to activists. In March, the Western Cape Department of Health told AIDS lobby group the Treatment Action Campaign (TAC) and Médecins Sans Frontières (MSF) / Doctors Without Borders that it had received significantly smaller stocks of the FDCs than had been ordered from suppliers.

Dr Lynne Wilkinson, the MSF project coordinator in Khayelitsha, a township on the outskirts of Cape Town, said this meant the depot could not maintain the usual two- or three-month buffer stock.

Researcher Simonia Mashangoane said TAC continues to receive reports from health facilities in Mpumalanga and Gauteng provinces, with some saying they have received insufficient supplies of the FDCs. Recent shortages of the ARV, lamivudine, have also been reported. In a joint statement with the National Association of People Living with HIV and AIDS (NAPWA), TAC criticised the health department’s communications and called for clear timelines regarding the introduction of FDC drugs.

“Public announcements created the expectation that the pills will be widely available from 1 April, but non-priority groups might have to wait many more months before being switched to the FDCs,” TAC and NAPWA said in their statement. “Patients have not been given any indication as to when the various phases will be initiated, and how long they will have to wait.”

Wilkinson said there are also concerns that because new ARV patients have been prioritized to receive the FDC, they could be especially vulnerable if FDC stockouts force clinicians to switch them to the old regimen of three separate ARVs.

“Newly initiated patients are counselled about the treatment that they are about to receive,” Wilkinson told IRIN. “The problem is if they are counselled on how to take one pill a day, and in a few months that stock runs out and they have to be put on three separate pills, the clinic has to re-counsel them. If that doesn’t happen, then there’s a chance patients won’t take the treatment properly.”

According to Western Cape Department of Health spokesperson Hélène Rossouw, the problem lies with the National Department of Health. “The problem is that the national government procures the medicines, so it’s all centralized at the national level in accordance with treasury regulations,” Rossouw told IRIN. “The awarding of the tenders… the signing of contracts… takes time.”

“What’s happening in the Western Cape is a domino effect of [those delays],” she added. “The Western Cape Minister of Health Theuns Botha is looking at the possibility of procuring our own stocks separately because we have had too many problems with national government delays, and our patients go without.”

Supply and demand

The inability of pharmaceutical companies to ramp up production to meet demand after winning a tender has at times been seen as contributing to the threat of drug shortages.

Stavros Nicolaou, Senior Executive at Aspen Pharmacare, one of three companies to be given the FDC tender, said the latest award had sought to avoid stockouts at dispensing level by introducing a grace period for suppliers. Aspen is the largest supplier of generic medicines to the public and private health sectors in South Africa, he said, and is also the only local company producing the FDCs.

“Historically, what happened was that a tender was awarded on 15 December, and on 1 January… you’d be expected to supply,” Nicolaou told IRIN. “If it was the first time you were going to supply, you had to have anticipated winning the tender to be ready to go out with product on the first of January.”

Drug companies need about three months of lead-time to order, ship, receive and assure the quality of the active pharmaceutical ingredients needed for manufacturing drugs. In the case of FDCs, Aspen had also had to make structural alterations to its manufacturing facilities to accommodate the special technology required to manufacture a pill that combines three drugs.

Nicolaou said he did not believe that any possible FDC shortage was attributable to the inability of drug companies to supply. He noted that Aspen and other drug companies had met with the Department of Health in June 2012, before the tender was opened, to devise feasible timelines for ramped up production of the FDCs, develop plans for a phased rollout, and discuss the requirements of the tender, which hinged largely on projections of how many patients would make the switch to FDCs.

Stopping stockouts

An estimated 70 to 80 percent of patients on the triple regimen are expected to make the switch by the end of the year. To combat stockouts, data is being collected on a weekly basis from provincial depots to identify weaknesses in the supply chain, and the department has also instituted monthly meetings with suppliers, at which three-month forecasts are presented.

Recent stockouts of regularly prescribed ARVs in Gauteng Province have been attributed to financial management problems, including corruption, in the provincial department of health, rather than to supply-chain issues. The Gauteng provincial treasury intervened in December 2012.

“We’ve been told that some of the drug shortages in Gauteng are due to poor budgeting and financial management,” said TAC provincial coordinator Stephen Ngcobo. “We did our own research and found that… the budget was not covering the need, and that the [ARV] budget had been cut in half over the past two or three years, and this was having an effect… [now].”

Activists have begun a civil disobedience campaign in the province to draw attention to ARV and other drug stockouts, and civil society organizations will soon be launching a project to monitor supply problems.

[Courtesy of IRIN]

HIV Drug Test to Slash Costs by 80 Percent

9 April Cape Town — Researchers in South Africa have developed a low-cost tool to test for HIV drug resistance, potentially opening the door to improved treatment for users of antiretroviral drugs (ARVs).

The researchers, based at the University of Western Cape’s South African National Bioinformatics Institute (SANBI), have developed a computer-based tool – Seq2Res – that vastly reduces the costs and time involved in analysing data about viral DNA compared to conventional methods.

Simon Travers, bioinformatics associate professor and project leader at SANBI, says the tool allows HIV drug resistance testing of samples from almost 50 patients pooled together, which makes it significantly cheaper. Conventional method can only assess one patient’s data at a time.

“Our tool makes this analysis easy,” Travers tells SciDev.Net.

It is also expected to be five times cheaper than the average conventional testing system.

Travers says that the tool offers a more sensitive HIV drug resistance test by identifying drug resistant viral variants circulating at low levels in individuals. Viral sequences are listed and compared to a reference virus to identify the presence of mutations that are known to cause drug resistance.

“The software will allow for more manageable processing and interpretation of sequence data obtained using next generation sequencing platforms for HIV resistance surveillance,” Gillian Hunt, a researcher from South Africa’s National Institute for Communicable Diseases, tells SciDev.Net.

Travers says the new tool will enable researchers and clinicians to easily process their drug resistance testing data without needing expert bioinformatics assistance.

The data will be collected and stored in a large database, which will be accessible to researchers at no charge as a service to the academic research community.

Travers explains that the researchers are three months into the development of the web application and that tests will start by end of June, with a final roll-out of the Seq2Res tool set for September this year.

The tool currently used in the research laboratory at SANBI is being developed into a web-based application with US$120,000 of funding from the South African government’s Department of Science and Technology (DST).

SOUTH AFRICA: 55% of HIV Patients Go Missing Before Treatment

A study has found that about 55 percent of HIV patients in South Africa who are not eligible for treatment at the time of diagnosis will disappear from clinics within a year of initial monitoring, leaving a serious gap in HIV care and prevention, say researchers.
Most patients in South Africa must have a CD4 count – a measure of the immune system’s strength – of 200 or less to be eligible for antiretrovirals (ARVs), but previous research has shown that about two-thirds of people will not meet ARV treatment criteria at diagnosis.

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South Africa : ARV Drug Myth

Media in South Africa recently erupted into a frenzy of coverage of an allegedly new illegal drug, ‘whoonga’, said to contain life-prolonging antiretrovirals (ARVs), but experts say the drug is actually an old foe, heroin, and does not include ARVs.

The South African AIDS lobby group, the Treatment Action Campaign (TAC), has expressed concern that misreporting in the media may fuel a craze of its own and put HIV patients and ARV drug stocks in jeopardy.

Traditionally, the term ‘whoonga’ in South Africa referred to low grade heroin, which was often mixed with substances like rat poison and detergent to increase its volume prior to sale. Recent media reports have alleged that ‘whoonga’ now contains crushed ARVs and that the use of the combination of heroin and HIV treatment is widespread among the country’s townships, particularly those surrounding the port city of Durban in South Africa’s KwaZulu-Natal Province.

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SOUTH AFRICA: HIV School Testing Controversy

South Africa is preparing to take HIV testing into the classroom as part of its national voluntary HIV testing and counselling (VCT) campaign, but testing kids is controversial and implementing the programme is fraught with challenges – just ask those already doing it.

Government departments, together with the South African National AIDS Council, are holding nationwide consultative meetings with members of the education, children’s rights and HIV sectors to formulate a national policy for school-based HIV testing, as well as guidelines and recommendations for the country’s nine provinces.

Activists from the Durban-based Yezingane Network of children’s organizations met with national Health Minister Aaron Motsoaledi and identified consent and confidentiality as two of the main challenges.

however some student and teacher unions are opposed to school-based testing, arguing that children as young as 12 years old may not be psychologically or emotionally prepared to deal with an HIV-positive diagnosis.

Launched in April 2010, South Africa’s VCT campaign is seeking to test 15 million South Africans by April 2011. A schools-based component was included from the outset, but public debate did not erupt until the Department of Health (DoH) announced it had pushed back the February 2011 start date for student testing to allow it and the Ministry of Basic Education to formulate a child-sensitive VCT strategy.

About 3 percent of South African children 18 years and younger are HIV-positive, according to a 2010 report by South African research body, the Human Sciences Research Council.

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