New HIV drug hailed, but can SA afford it?
There is widespread hope for curbing HIV after the United States Food and Drug Administration (FDA) approved an injectable drug for HIV prevention recently. Lenacapavir needs to be injected just twice a year.
Lenacapavir is a medication used to treat and prevent HIV infection. It functions as a capsid inhibitor, meaning it blocks the protein shell (capsid) that HIV requires to replicate.
Lenacapavir is available in both oral tablet form and as subcutaneous injections. It is available as oral tablets and subcutaneous injections, with the injections given every six months after an initial oral and injection phase.
The drug comes as relief as it could help overcome barriers such as having to take pills daily, frequent clinic visits and the stigma associated with HIV prevention.
Clinical trials, conducted in South Africa and Uganda, have demonstrated its 100% efficacy in preventing HIV transmission when administered every six months. This injectable offers a potential alternative for individuals who may not adhere to daily oral PrEP medication.
More than 5 000 participants were involved in the research, according to the Institute of Infectious Diseases and Molecular Medicine.
South Africa has the highest number of people living with HIV globally, with an estimated 8.2 million individuals, or 13.7% of the population, according to recent estimates.
Lenacapavir will come as good news for many people seeking protection from HIV, but they often feel depressed and forget to take their medication daily.
A study done by the Southern African Journal of HIV Medicine pointed out several barriers and one facilitator of adolescents' ART, with adherence as one of them.
The identified barriers to adherence included factors related to school, social situations, health services, treatment, and the individual patient.
Factors related to the school environment, such as commitment to schoolwork, communication with teachers, and negative attitudes from teachers, have been found to discourage access to clinics, disclosure of health status, and adherence to antiretroviral therapy (ART).
Participants frequently expressed feeling torn between their school responsibilities and the need to attend clinic appointments.
Although there was a school located near the clinic, many participants opted to attend a different school.
''It would be nice for us to come at our own time so that we do not have to miss our schoolwork. That way, we can balance our lives. Your school work doesn't suffer because of the clinic appointments, and vice versa,'' said a group of males, aged 18.
While the new drug is generally hailed in the fight against HIV Aids, there could be a stumbling block: the cost.
Although the drug manufacturer Gilead The company has not yet made the price of the drug public, it is estimated that it is likely to be on par with current preventive medications at about $25,000 (£18,400) a year. As a treatment for people already living with HIV, it costs about $39 000 (nearly R700 000) annually.
Research from the University of Liverpool and other institutions suggests it could be produced for only $25 (£18.40) a year, including a 30% profit margin.
Speaking on Newsroom Afrika recently, Sibongile Tshabalala from Treatment Action Campaign said it could take longer for Lenacapavir to be available due to cost and patent laws.
She said that the one jab could cost R500 000. Two injections are needed annually.
''You need to be a millionaire to afford the injection. It's very expensive. And also our government won't be able to buy (it) for us. The projections are showing that we will get this (injection) by around 2035; ten years from now, while the research was done in South Africa and while the breakthrough was found in South Africa.''
But there's renewed hope.
According to AFP, lower-income countries could gain access to a 'game-changing' HIV prevention drug with a new deal signed between US pharmaceutical giant Gilead and the Global Fund, the health financing group said this week.
While details of the deal regarding the cost are not publicly known, Health Minister Aaron Motsoaledi hailed the drug: 'This is a game changer for South Africa.'
Statistics show that Sub-Saharan Africa accounts for 67 percent of global HIV cases. Tshabalala urged governments of the region to get together and start companies to manufacture vaccines for the benefit of their people
But there's renewed hope. Lower-income countries could gain access to a 'game-changing' HIV prevention drug with a new deal signed between US pharmaceutical giant Gilead and the Global Fund, the health financing group said this week.
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In response, the health department began negotiations with Treasury to get emergency funding to restore some of these services. As part of its application, the health department submitted proposals for each province, which specified how much money was needed and how it would be used. (Though this only took place after significant delay and confusion). Since Treasury couldn't afford to plug the entire gap left by the US funding cuts, the provincial-level proposals only requested money for some of the services that had been terminated. For instance, funding was not requested for the key populations health centres. Instead, the priority was to secure the jobs that had been lost at government health facilities. As such, the total amount that was requested from Treasury for each province was largely calculated by taking the total number of health workers that NGOs had hired at clinics and working out how much it would cost to rehire them for 12 months. Rather than paying the NGOs a grant to deploy these workers as was done by USAID, the health department proposed hiring them directly. This meant that they calculated their wages according to standard government pay scales which is less than what these workers would have earned from the NGOs. The total came to just under R1.2 billion for all the provinces combined. Treasury awarded roughly half of this on the basis that the money would be used to finance these wages for six months, rather than 12. This amounts to the R590-million for provinces that was announced by Motsoaledi. If all goes smoothly and this money is used effectively to hire these staff over the next six months, then a new tranche of Section 16 funding could be released in order to continue hiring them. Funds might also be released to fund the key populations health sites. A concern, however, is that the money may just be used by provinces to augment their ordinary budgets. If the funds aren't actually earmarked to respond to the US cuts, then it is much less likely that more emergency funding will be released. At this stage, it is too early to tell how provinces will use the money, particularly given that it appears that at least some of them haven't gotten it yet. Spotlight and GroundUp sent questions to several provincial health departments. Only the Western Cape responded. The province's MEC for Health and Wellness, Mireille Wenger, said that the funds have not yet been received by her department, but that once they were, they would be directed to several key priority areas, including digitisation of health records, and the strengthening of the primary healthcare system. It's thus not clear whether the province will be earmarking any of the funds to employ health staff axed by US-funded NGOs. In response to a question about this, Wenger stated that 'further clarity is still required from the National Department of Health and National Treasury regarding the precise provincial allocations and conditions tied to the additional funding'. WHAT ABOUT RESEARCH? Of the R753-million that's been released for this year, R132-million has been allocated to mitigate the funding cuts for research by US federal institutions, primarily the National Institutes for Health (NIH). Unlike USAID, the NIH is not an aid body. It provides grants to researchers who are testing new treatments and medical interventions that ultimately benefit everyone. These grants can be awarded to researchers in the US or abroad as part of a highly competitive application process. Researchers in South Africa are awarded a few billion rands worth of grants from the NIH each year, largely due to their expertise in HIV and TB. But over the last few months, much of this funding has been terminated or left in limbo. (See a detailed explanation of the situation here). The R132-million issued by Treasury is supposed to assist some of these researchers. It will be followed by another R268-million over the following two years. The Gates Foundation and Wellcome Trust are chipping in an additional R100-million each – though in their case, the funds are being provided upfront. All of this money – R600 million in total – is being channelled to the SAMRC, which will release it to researchers via a competitive grant allocation system. According to SAMRC spokesperson Tendani Tsedu, they have already received the R132-million from Treasury, though they are still 'finalizing the processes with the Gates Foundation and Wellcome Trust for receipt of [their donations]'. The SAMRC is also in negotiation with a French research body about securing more funds, though these talks are ongoing. In the meantime, the SAMRC has sent out a request for grant applications from researchers who have lost their US money. The memo states: 'Applicants may apply for funding support for up to 12 months to continue, wind down or complete critical research activities and sustain the projects until U.S. funding is resumed or alternative funds are sourced.' 'The plan,' Tsedu said, 'is to award these grants as soon as possible this year.' Professor Linda-Gail Bekker, CEO of the Desmond Tutu Health Foundation, told us that the hope is that the grants could fill some of the gaps. 'This is a bridge and it is certainly going to save some people's jobs, and some research,' she said, but 'it isn't going to completely fill the gap'. Indeed, the SAMRC has made clear that its grants aren't intended to replace the US funding awards entirely. This is unsurprising given that the money that's being made available is a tiny fraction of the total grant funding awarded by the NIH. It's unlikely that research projects will continue to operate as before, and will instead be pared down, said Bekker. 'It's going to be about getting the absolute minimum done so you either save the outcome, or get an outcome rather than no outcome,' she said. In other cases, the funds may simply 'allow you to more ethically close [the research project] down,' Bekker added. For some, this funding may also have come too late. Many researchers have already had to lay off staff. Additionally, patients who had been on experimental treatments may have already been transitioned back into routine care. It's unclear how such projects could be resumed months later. In response, Tsedu stated: 'For projects that have already closed as a result of the funding cuts, the principal investigator will need to motivate whether the study can be appropriately resurrected if new funds are secured.' The SAMRC has established a steering committee which will adjudicate bids. They will be considering a range of criteria, Tsedu said, including how beneficial the research might be for the South African health system, and how heavily the project was impacted by the US funding cuts. They will also consider how an SAMRC grant could 'be leveraged for future sustainability of the project, personnel or unit,' he said. AN ENDLESS BACK AND FORTH The job of the SAMRC steering committee will likely be made a lot more complicated by the erratic policy changes within the NIH. On 25 March, the body sent a memo to staff, – leaked to Nature and Bhekisisa – instructing them to hold all funding awards to researchers in South Africa. After this, numerous researchers in the country said they couldn't renew their grants. However, last month, Science reported that a new memo had been sent to NIH staff which said that while South African researchers still couldn't get new grants, active awards could be resumed. Since then, some funds appear to be trickling back into the country, but certainly not all. For instance, Spotlight and GroundUp spoke to one researcher who had two active NIH awards before the cuts. He stated that one of these was resumed last month, while the other is still paused. Bekker also told us that she had heard of one or two research grants being resumed in the last week, though she said the bulk of active awards to South Africa are still pending. 'Where people are the prime recipients [of an NIH grant] without a subawardee, there seems to be a queue and backlog but some [of those awards] are coming through,' said Bekker. 'But how long this is going to take and when it might come through we're waiting to hear.' She said a strategy might be to apply for the SAMRC bridging funding and 'if by some miracle the [NIH funding is resumed]' then researchers could then presumably retract their SAMRC application. In the meantime, health researchers will have to continue spending their time working out how to respond to the abrupt and increasingly confusing changes to funding guidelines that have dogged them since Trump assumed office. 'It's such a dreadful waste of energy,' said Bekker. 'If we were just getting on with the research, it would be so much better.' Co-published by Spotlight and GroundUp
