Category Archives: Antiretrovirals

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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Africa: 7 Million on HIV/Aids Antiretroviral Treatment

23 May 2013:

The number of people in Africa receiving antiretroviral treatment increased from less than 1 million to 7.1 million over seven years, according to a United Nations report which documents the progress in the AIDS response in the world’s second largest continent.

“Africa has been relentless in its quest to turn the AIDS epidemic around,” said the Executive Director of the Joint UN Programme on HIV/AIDS (UNAIDS), Michel Sidibé.

Antiretroviral treatment increased from less than 1 million in 2005 to 7.1 million in 2012, with nearly 1 million added in the last year alone. AIDS-related deaths were also reduced by 32 per cent from 2005 to 2011.

The UNAIDS Update on Africa, which was released to coincide with the beginning of the African Union’s (AU) 21st summit in Addis Ababa, which began Sunday and runs through 27 May, attributes this success to strong leadership and shared responsibility in Africa and among the global community. It also urges sustained commitment to ensure Africa achieves zero new HIV infections, zero discrimination and zero AIDS-related deaths.

“As we celebrate 50 years of African unity, let us also celebrate the achievements Africa has made in responding to HIV–and recommit to pushing forward so that future generations can grow up free from AIDS,” Mr. Sidibé said.

The report states that 16 countries–Botswana, Ghana, Gambia, Gabon, Mauritius, Mozambique, Namibia, Rwanda, São Tomé and Principe, Seychelles, Sierra Leone, South Africa, Swaziland, Tanzania, Zambia, and Zimbabwe–now ensure that more than three-quarters of pregnant women living with HIV receive antiretroviral medicine to prevent transmission to their child.

Despite positive trends, Africa continues to be more affected by HIV than any other region of the world, and accounts for 69 per cent of people living with HIV globally. In 2011 there were still 1.8 million new HIV infections across the continent, and 1.2 million people died of AIDS-related illnesses.

In the report, entitled Update, Mr. Sidibé emphasizes that sustained attention to the AIDS response post-2015 will enhance progress on other global health priorities. He also identifies five lessons in the AIDS response that will improve the world’s approach to global health. These are: focusing on people, not diseases; leveraging the strength of culture and communities; building strong, accountable global heath institutions; mobilizing both domestic and international financial commitments; and elevating health as a force for social transformation.

“These strategies have been fundamental to Africa’s success at halting and reversing the AIDS epidemic and will support the next 50 years of better health, across borders and across diseases,” he said.

The report also stresses AU leadership is essential to reverse the epidemic. At this year’s Summit, AIDS Watch Africa, a platform for advocacy and accountability for the responses to AIDS, tuberculosis and malaria founded by African leaders in 2001, will review progress on health governance, financing, and access to quality medicines, among other areas, and measure whether national, regional, continental and global stakeholders have met their commitments.

The AU, UNAIDS and the New Partnership for Africa’s Development (NEPAD) will also launch the first accountability report on the AU-G8 partnership, focusing on progress towards ending AIDS, Tuberculosis and Malaria in Africa.

[Courtesy AllAfrica News]

Zimbabwe: HIV Wreaks Havoc in Prisons

HARARE: 13 May 2013

THE HIV prevalence rate in Zimbabwe prisons stands at 27%, a figure almost double the national prevalence rate, a health official revealed.

Aids and TB Unit director in the Ministry of Health and Child Welfare, Owen Mugurungi, said women prisoners were the worst affected by HIV.

“The prevalence rate for prisons was found to be double the national prevalence. It was around 27%, but when you look at gender, women were more affected at around 39%,” Mugurungi said.

The Zimbabwe Prisons Services is on record saying that they would not allow HIV and Aids preventative measures such as condoms, claiming this was tantamount to legalising illicit behaviour. This is despite the known existence of homosexuality in jails.

According to the Prisons Act, homosexuality is viewed as sodomy and if there are witnesses to the act, the offenders would be punished. According to the 2010-11 Zimbabwe Demographic and Health Survey (ZDHS), the HIV prevalence rate in the country is now 15%, down from 18% in 2006.

HIV prevalence continues to be higher among women than men; 18% of women are HIV-positive compared to 12% of men.

Mugurungi said the ministry of health was cooperating with prison officials to come up with strategies to strengthen both prevention and treatment of HIV patients.

“I must say that this is not just for prisoners but also prison workers and communities living around prisons,” he said.

Mugurungi added that the ministry together with prison authorities, trained staff to work within prisons, so that they could start providing anti-retroviral therapy within the correctional facilities.

“But the decision of where and when is really within the ambit of prison authorities. We as ministry can only train them and capacitate them,” he said

[Courtesy of AllAfrica News]

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]