In the RADIANT-TB randomised controlled trial carried out in Khayelitsha, researchers found that tuberculosis (TB) patients with HIV taking a double dose of dolutegravir had similar viral suppression to those taking a single dose plus placebo. The findings, published in The Lancet HIV, suggest that a only once-daily dolutegravir is feasible in patients with HIV-associated tuberculosis.
WHO’s preferred first-line antiretroviral therapy (ART) regimen for adults and adolescents with HIV is dolutegravir, combined with tenofovir and lamivudine or emtricitabine. A disadvantage of dolutegravir is substantial drug–drug interaction with rifampicin, which is important as tuberculosis is the most common cause of hospitalisation and mortality among people living with HIV.
The drug–drug interaction between rifampicin and dolutegravir can be overcome by supplemental dolutegravir dosing, but is a challenge in resource-constrained settings. The researchers sought to investigate whether virological outcomes with standard-dose dolutegravir-based ART are acceptable in people with HIV on rifampicin-based antituberculosis therapy.
RADIANT-TB was a phase 2b, randomised, double-blind, non-comparative, placebo-controlled trial in Khayelitsha, Cape Town, South Africa. Participants were aged over 18 years, with plasma HIV-1 RNA >1000 copies/mL, CD4 count > 100 cells/μL, ART-naive or first-line ART interrupted, and on rifampicin-based antituberculosis therapy for less than three months. Participants were assigned (1:1) to receive either tenofovir disoproxil fumarate, lamivudine, and dolutegravir plus supplemental 50mg dolutegravir 12h later or the same drugs but with placebo in place of the supplemental dolutegravir. Participants received standard antituberculosis therapy (rifampicin, isoniazid, pyrazinamide, and ethambutol for the first two months followed by isoniazid and rifampicin for four months). The primary outcome was the proportion of participants with virological suppression (HIV-1 RNA <50 copies/mL) at week 24 analysed in the modified intention-to-treat population.
No treatment-related dolutegravir resistance emerged in the trial, and though not significant, an increase in insomnia was noted in the supplemental dolutegravir arm. In terms of future research, it is questionable whether a phase 3 trial would be needed given the significant time required for a policy change. Limitations included the study not being powered to compare efficacy.
The authors concluded, “Our findings suggest that twice-daily dolutegravir dosing might be unnecessary in people with HIV-associated tuberculosis. More evidence, from cohort studies or possibly a phase 3 trial, might be necessary to change policy on the need for a supplemental dolutegravir dose with rifampicin-based antituberculosis therapy.”
According to new research findings published in iScience, people living with HIV with a history of pulmonary tuberculosis had broader and more potent HIV antibody responses and differences in HIV sequences predicted to be antibody-resistant as compared to those without tuberculosis. The study suggests that concomitant tuberculosis disease has a significant impact on HIV immune responses and the viruses circulating in people living with HIV.
Tuberculosis infects more than 2 billion people in the world, and although tuberculosis is the most common co-infection in people living with HIV, previous studies have not examined how tuberculosis impacts HIV immune responses and virus characteristics.
This study suggest that tuberculosis may impact the efficacy of antibody based prevention and therapeutic strategies. Vaccines to elicit antibodies and antibodies are also being investigated as a means to treat and cure HIV. Higher prevalence of antibody resistant strains along with tuberculosis disease implies that these antibody-based interventions are more likely to in fail in these individuals.
“Tuberculosis is extremely common, especially in regions of the world with high levels of ongoing HIV transmission, and impacts both the immune responses and the characteristics of the circulating virus in people living with HIV so it is imperative we understand the relationship between the two,” said Manish Sagar, MD, an internist at Boston Medical Center and Professor of Medicine at Boston University Chobanian & Avedisian School of Medicine. “These studies have implications for HIV vaccines and antibody based HIV therapeutics.”
Researchers worked closely with investigators in Uganda and at the AIDS Clinical Trial Group (ACTG) to collect samples from people newly diagnosed with HIV that either did or did not have tuberculosis. From these individuals, they examined samples collected prior to and about 6 months after the start of HIV medications. Researchers compared antibodies, plasma inflammatory markers, and HIV sequences in the baseline and in treatment samples.
Tuberculosis disease is associated with higher prevalence of the some antibody-resistant HIV. High ongoing HIV transmission in areas of the world with frequent tuberculosis disease suggest that a potential vaccine that elicits broad and potent antibodies may not work because these geographic regions are more likely to have antibody resistant strains.
This has implications for HIV vaccine strategies as they aim to generate antibodies that can block the virus after exposure. Generating broad and potent HIV antibodies remains a monumentally difficult goal. Understanding the biological pathways behind the broadly potent antibody responses generated by tuberculosis could provide insight into how tuberculosis enhances HIV antibody responses. This in turn could be leveraged to develop novel strategies for eliciting broad and potent HIV antibodies.
Gene editing therapy aimed at two targets – HIV-1 and CCR5, the co-receptor that helps the virus get into cells – can effectively eliminate HIV infection, report scientists in PNAS. This is the first to combine a dual gene-editing strategy with antiretroviral drugs to cure animals of HIV-1.
“The idea to bring together the excision of HIV-1 DNA with inactivation of CCR5 using gene-editing technology builds on observations from reported cures in human HIV patients,” said Kamel Khalili, PhD, professor at the Lewis Katz School of Medicine. “In the few instances of HIV cures in humans, the patients underwent bone marrow transplantation for leukaemia, and the donor cells that were used carried inactivating CCR5 mutations.”
Dr Khalili and Howard E. Gendelman, MD, professor at UNMC, were senior investigators on the new study from the Lewis Katz School of Medicine at Temple University and the University of Nebraska Medical Center (UNMC). The two researchers have been long-time collaborators and have strategically combined their research strengths to find a cure for HIV.
“We are true partners, and what we achieved here is really spectacular,” Dr Gendelman said. “Dr Khalili’s team generated the essential gene-editing constructs, and we then applied those constructs in our LASER-ART mouse model at Nebraska, figuring out when to administer gene-editing therapy and carrying out analyses to maximise HIV-1 excision, CCR5 inactivation, and suppression of viral growth.”
In previous work, Drs Khalili and Gendelman and their respective teams showed that HIV can be edited out from the genomes of live, humanised HIV-infected mice, leading to a cure in some animals. For that research, CRISPR gene-editing technology for targeting HIV-1 was combined with a therapeutic strategy known as long-acting slow-effective release (LASER) antiretroviral therapy (ART). LASER ART holds HIV replication at low levels for long periods of time, decreasing the frequency of ART administration.
Despite being able to eliminate HIV in LASER-ART mice, the researchers found that HIV could eventually re-emerge from tissue reservoirs and cause rebound infection. This effect is similar to rebound infection in human patients who have been taking ART but suddenly stop or experience a disruption in treatment. HIV integrates its DNA into the genome of host cells, it can lie dormant in tissue reservoirs for long periods of time, out of reach of antiretroviral drugs. As a consequence, when ART is stopped, HIV replication renews, giving rise to AIDS.
To prevent rebound infection, Dr Khalili and colleagues began work on next-generation CRISPR technology for HIV excision, developing a new, dual system aimed at permanently eliminating HIV from the animal model. “From success stories of human HIV patients who have undergone bone marrow transplantation for leukaemia and been cured of HIV, our hypothesis was that the loss of the virus’s receptor, CCR5, is important to permanently eliminating HIV infection,” he explained. They developed a simple and more practical procedure for the inactivation of CCR5 that includes an IV inoculation of the CRISPR gene editing molecule.
Experiments in humanized LASER-ART mice carried out by Dr Gendelman’s team showed that the constructs developed at Temple, when administered together, resulted in viral suppression, restoration of human T-cells, and elimination of replicating HIV-1 in 58% of infected animals. The findings support the idea that CCR5 has a key role in facilitating HIV infection.
The Temple team also anticipates soon testing the dual gene-editing strategy in non-human primates.
The new dual CRISPR gene-editing strategy holds exceptional promise for treating HIV in humans. “It is a simple and relatively inexpensive approach,” Dr Khalili noted. “The type of bone marrow transplant that has brought about cures in humans is reserved for patients who also have leukaemia. It requires multiple rounds of radiation and is not applicable in resource-limited regions, where HIV infection tends to be most common.”
Colourised scanning electron micrograph of HIV (yellow) infecting a human T9 cell (blue). Credit: NIH
A large randomised controlled trial into using statins in people with HIV and low-to-moderate cardiovascular risk was stopped early due to clear benefits, according to an update posted online in JAMA Network. Participants, who were taking 4mg pitavastatin calcium daily, saw a 35% reduction in risk with no significant difference in adverse events compared to placebo, according to the National Institutes of Health.
This recommendation came after a planned interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study, which enrolled 7769 participants, across 12 countries across Asia, Europe, North America, South America and Africa. Participants were aged 40–75 years, had 100 cells/mm3 of blood at enrollment, and had low-to-moderate traditional cardiovascular disease risk that would not typically be considered for statin treatment.
It was not clear if statins would have the same effect in people living with HIV and who have premature cardiovascular disease despite having low-to-moderate traditional risk. The interim analysis was compelling enough that the study’s independent Data Safety and Monitoring Board recommended at its latest regular meeting that it be halted early given adequate evidence of efficacy.
The study participants are being notified of the findings and will continue to be monitored for several months. Study results from the review are expected to be published in the coming weeks.
HIV testing is essential across the continuum of care but too often unavailable, unaffordable, or inaccessible. Abbott, the global leader in diagnostics and the fight against HIV, is partnering with Population Services International (PSI) and Unitaid to make HIV self-testing (HIVST) available at an affordable and accessible price. An initial 400 000 tests will be distributed within Africa.
This vital partnership serves as an early market access vehicle to enable affordable access to high-quality self-test kits in high HIV burden settings with a dire need for access to healthcare services, while mitigating risks such as increased supply chain costs and custom fees. People who test positive will undergo confirmatory testing and will be linked to antiretroviral treatment, keeping them healthy and helping reduce further transmission to others.
“With millions of people living with HIV worldwide, many of whom who do not know their status, receiving a diagnosis is a vital first step in accessing treatment”, says Bassem Bibi, divisional vice president, for Abbott’s rapid diagnostics business for EEMEA. “This is why this partnership is so important to Abbott as it reinforces our commitment to enabling people in Africa to live healthier, fuller lives, by improving testing capabilities through high quality and affordable blood-based HIV self-tests.”
“Self-testing has shifted the paradigm for HIV testing. The HIV Self-Testing Africa (STAR) Initiative amassed compelling evidence that HIVST can reach more people than traditional diagnostics. It offers an alternative option to people living with HIV to find out about their status and to access anti-retroviral treatment services. Self-testing is a critical entry point to HIV prevention services for those testing negative, including the delivery of Pre-Exposure Prophylaxis (PrEP). It is also useful for screening in health facilities and to keep services going during COVID-19 and any future emergencies. We require more product options to meet the growing demand,” said Dr Karin Hatzold, Director of the STAR Initiative Project and Associate Director of HIV/TB Programs at PSI. “This important partnership under the early market access vehicle will make it easier for countries to acquire products and embed them in health systems. This will ensure that self-test kits are affordable to those who want to access them.”
The Abbott HIV self-test kits will be distributed strategically to communities with inadequate access to healthcare services and will help build capacity to meet the UNAIDS 95-95-95 targets for 2025. The 95-95-95 targets stipulate that 95% of people living with HIV know their status; 95% of people who know their status are on antiretroviral therapy; and 95% of people on treatment have suppressed viral loads.
“Self-testing has helped us reach beyond health centres and make testing easier. This is critically important for vulnerable groups who are often at higher risk of HIV but may also be hesitant to access health services for fear of stigma, discrimination, and violence,” said Dr Philippe Duneton, executive director of Unitaid. “Making quality self-testing kits widely available and affordable is vital to reaching people at risk of HIV with the opportunity to test privately and access life-saving care.”
The investigational HIV ‘Mosaico’ vaccine regimen was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined. Based on the DSMB’s recommendation, the study will be discontinued. This follows the failure of the similar ‘Imbokodo’ vaccine in sub-Saharan Africa.
The HPX3002/HVTN 706, or ‘Mosaico’ Phase 3 clinical trial began in 2019 and involved 3900 volunteers in Europe, North America and South America. The participants were men who have sex with men (MSM) or transgender people.
The Janssen-developed vaccine was based on ‘mosaic’ immunogens, which are vaccine components featuring elements of multiple HIV subtypes, in order to induce immune responses against a wide variety of global HIV strains. The investigational vaccine regimen consisted of four injections over a year of Ad26.Mos4.HIV, with the mosaic immunogens delivered by a common-cold virus (adenovirus serotype 26, or Ad26). The final two vaccinations were accompanied by a bivalent (two-component) HIV envelope protein formulation, combining clade C gp140 and mosaic gp140 envelope proteins, adjuvanted by aluminium phosphate to boost immune responses. All study vaccinations were completed in October 2022.
In early studies, this vaccine combination induced strong antibody and T-cell responses and protected monkeys exposed to SIV, the simian cousin of HIV. The vaccines however failed to stimulate production of broadly neutralising antibodies (bNAbs) that disable multiple HIV variants, according to aidsmap. In that study, the vaccine conferred a 25.2% effectiveness in protection, but not the 50% necessary for an effective vaccine.
In its scheduled data review, the DSMB determined there were no safety issues with the experimental vaccine regimen. However, the number of HIV infections were equivalent between the vaccine and placebo arms of the study. During the clinical trial, all participants were offered comprehensive HIV prevention tools, including pre-exposure prophylaxis, or PrEP. Study staff ensured that participants who acquired HIV during the trial were promptly referred for medical care and treatment. Participants are being notified of the findings, and further analyses of the study data are planned.
The Mosaico findings track with developments in the Phase 2b ‘Imbokodo’ (HPX2008/HVTN 705) clinical trial, which was testing a similar HIV vaccine regimen in young women in sub-Saharan Africa. A DSMB determined in 2021 that the experimental vaccine regimen in that study was also safe but ineffective in protecting against HIV acquisition.
Antiretroviral drugs almost completely reduce the risk of mothers passing on HIV infection to their children, even in a low-income country with a high HIV incidence such as Tanzania, according to a new study in The Lancet HIV.
UNAIDS estimates that 11% of children born to HIV-positive mothers in Tanzania are infected with HIV, during childbirth or via breast milk. But the new study suggests this figure is actually much lower.
The researchers, from Karolinska Institutet in Sweden, examined more than 13 000 HIV-positive, pregnant women, at several health centres in one of Africa’s largest cities, Dar es Salaam, in Tanzania. The women were offered antiviral treatment through maternity care between 2015 and 2017.
Only 159 infants were infected
The women were followed for 18 months after giving birth when most of them had stopped breastfeeding. When the researchers examined the mothers’ children, they discovered that only 159 of the more than 13 000 infants had been infected with HIV by the age of 1.5 years, translating to a risk of 1.4%, taking into account a margin of error.
The risk of infection was more than twice as high among women who sought care late in pregnancy or had advanced HIV. Conversely, the risk of infection was only 0.9% in those who had already received HIV treatment when they became pregnant.
“HIV transmission from mother to child can in principle be stopped completely with modern antiviral drugs. But so far it has not been demonstrated in low-income countries in Africa with a high incidence of HIV infection,” says Goodluck Willey Lyatuu, physician and postdoctoral researcher, also at the Department of Global Public Health at Karolinska Institutet and first author of the study.
Early diagnostics are important
The study is limited by challenges that may be typical in low-resource health systems, such as incomplete follow-up and missing data, and that risk factors such as stigma linked to HIV are rarely or never routinely investigated.
“But it is one of the largest cohort studies published from Africa on the risk of HIV transmission from mother to child where the baby is followed until the end of the breastfeeding period,” says says Anna Mia Ekström, clinical professor of global infectious disease epidemiology with a focus on HIV at the Department of Global Public Health at Karolinska Institutet and corresponding author of the study.
Both health minister Dr Joe Phaahla and health authorities in the Free State last week denied claims from activists that there are shortages of antiretroviral medicines at health facilities in the province. Authorities did however confirm that some people living with HIV are only given a two-week supply of medicines at a time.
“I can confidently say that there are no stockouts or shortages of ARVs in the Free State,” Phaahla told Spotlight at the World AIDS Day commemoration event in Mangaung.
This was reiterated by spokesperson for the Free State Department of Health, Mondli Mvambi saying, “We do not have shortages of HIV medicines in the province.”
He says allegations of patients not receiving their medication are very serious and cannot be taken lightly. He says should the department hear from patients who are not receiving their HIV medicine, they will investigate.
But Makhosazana Mkhatshwa, a research officer at the Treatment Action Campaign (TAC), says in the past three months, nine clinics in the province indicated that patients have left their facility without the medicine that they needed and of these nine clinics, three of them had sent people home because there was a stockout of HIV medication. She says impacted clinics include Poly Clinic and MUCPP in Mangaung, and Namahadi Clinic in Thabo Mofutsanyana District.
According to community-led monitoring group Ritshidze’s latest report on clinic services in the Free State, there were 40 patient reports this year of shortages of HIV medication compared to 13 patient reports last year. The report states that the most commonly reported medicine shortages by public healthcare users were contraceptives, HIV, and TB medicines. The report was based on monitoring at 28 clinics. TAC is a Ritshidze partner organisation.
Only 7 or 14-day supply for some
One woman Spotlight spoke to at the World AIDS Day commemoration event held in Mangaung last week says she is a patient at Pule Sefatsa Clinic in Botshabelo, Mangaung. “I am forced to go to clinic every week because they only give me a supply for eight days. This is an inconvenience for me because I have to skip work every week just to get my medication.”
Another public healthcare user from Bloemfontein tells Spotlight that for two weeks in October he was stranded without ARVs. He says that he is usually given a 14-day supply at a time. When he requested a full month’s supply to last him through a work-related trip to Cape Town he says his request was declined at the Poly Clinic at Pelenomi Hospital. He says he ended up going without medication.
Aron Malete, District Health Manager for Mangaung, told Spotlight there are no ARV shortages in the district, but asked for details of the above cases so that he could investigate.
The problem is not stockouts per se, but a shortage of medication, says Sello Mokhalipi, Secretary General of Positive Action Campaign. “You will find that there is a shortage of ARVs for seven days, then the next week it will be available,” he says.
Mokhalipi, like other activists Spotlight spoke to, is opposed to giving people only a seven or 14-day supply of medication at a time. He says people should be given enough for three to six months.
When Spotlight put the concerns and calls for multi-month dispensing to Mvambi he says, “We have identified people who are clinic hoppers who steal medicine. They get three months and thereafter run to another clinic to get another three months’ supply. To curb this practice,” Mvambi says, “we keep people on seven and 14 days’ supply The idea is to give them a few days because they claim to have forgotten their clinic cards.”
According to him, people get three months’ supply when they have their clinic card because clinic staff can verify who they are and what medicine they have been receiving.
Doing ‘exceptionally well’ but there are concerns
According to Phaahla who delivered a speech at the World AIDS Day commemoration event, the province has done “exceptionally well in terms of testing, having already surpassed the 94 percent threshold”. Phaahla said 94 percent of people who are living with HIV in the province know their status, 86 percent of those who know their status are on antiretroviral treatment, and 92 percent of those who are on treatment are virally suppressed.
He, however, singled out some districts such as Xhariep and Lejweleputswa where he says the “number of people with HIV and on treatment fare poorly on the target of being virally suppressed”. “This,” Phaahla says, “is very concerning and we must urgently intervene to create a balance among the targets in order to achieve zero new infections by 2030. This includes ensuring that services are brought closer to the people and that our health facilities are adequately resourced with medicine and related necessities.”
“Results for each of the sub-populations vary with adult females at 95 – 91 – 93, adult males at 93 – 77 – 93, and children at 82 – 65 – 68,” says Mvambi. “To achieve the 95 – 95 -95 targets the Free State must increase the number of adult men on ART by 25 745, adult women on ART by 9 744, and children on ART by 5 138.”
“As you can see,” says Mvambi, “the women are more likely to get tested, be initiated on ART, and have their viral load suppressed than their counterparts.”
According to the Free State Department of Health’s latest annual report for the financial year 2021/2022, the number of patients initiated on ARV treatment dropped from 36 776 in 2019/2020 to 26 364 in 2021/2022. In the report, the department states that it failed to meet its target for retaining adults on ART in care. The ART adult remain-in-care rate in 2019/20 was 68%. In 2020/21, it dropped to 52.8% and picked up in 2020/21 at 67.3%. Among the reasons the department cites are the high number of loss to follow-up of clients and “poor tracing by community healthcare workers due to poor supervision”.
NOTE: An employee 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.
In 2020, pharmaceutical company ViiV Healthcare announced that a bimonthly injection of its new drug, cabotegravir, prevents HIV infection. More than two years later, the drug is still unaffordable in countries where HIV is highly prevalent.
Local medicines manufacturer Aspen Pharmacare says that licences should be given to African producers so that cabotegravir can be made more affordable and accessible.
Cabotegravir can be used to prevent HIV infection. This is known as Pre-Exposure Prophylaxis, or PreP. Currently, PrEP is only available in pill form and has to be taken daily. A bimonthly injection is an appealing alternative that, if made widely available, can make a big dent in the HIV infection rate.
Globally, 1.5-million people are infected with HIV and about 650,000 people die of AIDS every year. UNAIDS’s target of reducing annual infections to fewer than 500,000 by 2020 was not reached. It is widely accepted among experts that prevention as well as treatment is necessary to end the epidemic.
Although the World Health Organisation has recommended cabotegravir for PrEP, it is unaffordable, especially in developing countries where HIV is most prevalent. The Clinton Health Access Initiative (CHAI) has estimated that cabotegravir could be manufactured for just over $65 (R1100) a year.
According to The Guardian, ViiV’s not-for-profit price for cabotegravir is estimated to be $240-$270 (R4,059-R4,567) for a full year’s supply for one patient.
But in the United States, a full year’s supply for one person of cabotegravir is sold for more than $22,000 (R370,000). In the UK a year’s supply is $9,275.
In comparison, oral PrEP costs about R686 for a full year’s supply for one patient in South Africa. Cabotegravir is not yet approved by the South African Health Products Regulatory Authority.
Stavros Nicolaou, group senior executive strategic trade at Aspen Pharmacare, says that there is local capability to manufacture cabotegravir but licences have not yet been granted. The company invested heavily in sterile equipment, needed to produce injections, during the Covid-19 pandemic. This can be used to produce cabotegravir.
Aspen is the biggest producer of antiretrovirals (ARVs) in Africa. Nicolaou says that giving licences to African producers is crucial to ensuring the equitable supply of medication.
ViiV has committed to allowing generic versions of the drug to be manufactured but has said that the process is complicated. Cabotegravir is currently only manufactured at one site in the UK.
In July, activists interrupted presentations during the AIDS 2022 conference in Montreal, calling on ViiV to lower the price of cabotegravir. Doctors Without Borders (Médecins Sans Frontières) has urged ViiV to make the drug available in high-prevalence countries and to be more transparent about its pricing and manufacturing process.
ViiV has come to an agreement with the Medicines Patent Pool (MPP), a nonprofit organisation that will facilitate the process of awarding licences to manufacturers.
But Dr Andrew Hill from the Department of Pharmacology at the University of Liverpool says that the agreement is highly restrictive.
Hill says that many countries have been excluded from the list, particularly those in South America and Asia, including those with high HIV infection rates.
He says that most of the world’s population could be reached if cabotegravir was made available at the CHAI price of $65 (R1100) per patient per year. That it is not yet widely available is a “failure of public health”, he told GroundUp.
In South Africa, where just under 14% of the population has HIV, the announcement of cabotegravir two years ago was widely celebrated among clinicians.
The researchers we spoke to suggest that the uptake of cabotegravir would be higher than that of PreP tablets and so it would be more effective. Most new infections in Sub-Saharan Africa are among women and adolescent girls. Cabotegravir offers them a discreet alternative and one that doesn’t require daily adherence.
“It’s very frustrating,” says Juliet Houghton, CEO of the Southern African HIV Clinicians Society. Houghton says that if cabotegravir can be rolled out in pharmacies across the country, with pharmacists allowed to administer it, it will greatly increase the uptake of PrEP and reduce infections.
“We can’t just keep treating people for HIV,” Houghton says. “Prevention has to be the way forward.”
“We need to look at PreP closer to the way we look at contraception,” says Andy Gray, senior lecturer in Pharmacology at the University of KwaZulu-Natal. Offering more choices that fit into a variety of lifestyles is likely to improve the uptake of PrEP, he says.
Dr Yogan Pillay, country director for CHAI, says that governments and civil organisations need to pressure ViiV and MPP to increase the availability of cabotegravir.
“That 82% of the 250 000 adolescent girls and women that acquired HIV in 2021 are in Sub-Saharan Africa makes it imperative that cabotegravir is made available at an affordable price as soon as possible,” Pillay says.
“We need this drug, we need it now, and we need truckloads,” says Professor Francois Venter, executive director of Ezintsha at Wits. “It works very well. It is safe. And while we still have to figure out how to use it best, we can’t do that with nothing in hand.”
A spokesperson for ViiV Healthcare told GroundUp: “We believe cabotegravir long-acting (LA) for PrEP has the potential to change the shape of the HIV epidemic and we are ambitious for the impact we can have together with global health partners to bring this medicine to those who need it.”
ViiV says that at first, three generic manufacturers will be selected by MPP.
“Enabling up to three generics in the first instance allows for competition but avoids a fractured market with too many manufacturers and a risk of there not being enough demand to sustain the long-term manufacturing commitments to be made by licensees,” ViiV said.
ViiV also said they are working with various partners to ensure that Cabotogrevir is accessible to countries in Sub-Sarahan Africa.
“We know that affordability is a real challenge in these countries, and we are working with our partners to look at affordable pricing, demand and innovative funding mechanisms to help enable access for people who could benefit from PrEP,” ViiV said.
ViiV says that CHAI’s price estimation is unrealistic because of the complexity of the manufacturing process.
The South African Health Products Regulatory Authority (SAHPRA) has authorised an injection containing the antiretroviral cabotegravir for use to prevent HIV infection, according to drugmaker ViiV Healthcare.
“We are very pleased that this week, SAHPRA granted regulatory approval of Apretude or cabotegravir long-acting injectable,” ViiV Healthcare spokesperson Catherine Hartley told Spotlight. “It brings a much-needed innovative HIV prevention option to the communities that need it most, including women and adolescent girls where challenges with adherence, limited efficacy, and stigma have hindered the impact of current PrEP options.”
At the time of publication, SAHPRA had not yet confirmed the registration, although Spotlight understands a media statement on the issue is imminent. The regulator received ViiV Healthcare’s initial application for approval in November 2021.
ViiV Healthcare has not disclosed at what price it will offer the shot in South Africa or other African countries. The company has, through a deal with the Geneva-based Medicines Patent Pool, agreed to grant voluntary licenses to at least three generic producers that could potentially supply the injection to South Africa. It is however expected to take three to five years before any of the generics will be ready.
Executive Director of the HIV prevention organisation AVAC confirmed news of the authorisation late Wednesday in a social media post, calling it a critical step in making the injection available to millions that could benefit from the shot.
The bi-monthly shot likely outperformed the pill, the World Health Organization explains in new guidelines, mainly because it was easier for people to get an injection every two months than to take the pills every day.
Previously, Spotlight reported that pilot projects are slated to begin providing access to the HIV prevention shot early next year. Demonstration projects run in partnership with the national health department and research organisations the Wits Reproductive Health and HIV Institute and Ezintsha are expected to offer patients a choice of the HIV prevention shot, pill, or monthly vaginal ring.
The pilot projects, sometimes called “demonstration” projects, will be looking to help answer major questions about an eventual national rollout, including how to create national awareness campaigns about the HIV prevention injection and how to provide it outside of hospitals and clinics and closer to communities.
SAHPRA authorisation marks the first step toward an eventual national rollout, according to national health department HIV prevention technical advisor Hasina Subedar. Subedar spoke to Spotlight in July at the International AIDS Conference. In particular, the finer details of the registration – which are still not public – will guide who can and can’t receive the shot, for instance.
