That a Johannesburg company – Kiara Health – will start manufacturing affordable and flexible silicone rings to protect women from HIV is a crucial step to making the continent self-reliant, writes Catherine Tomlinson for Spotlight.
Although studies show that the ring, containing the antiretroviral drug dapivirine, and which provides protection for a month, is less effective than HIV prevention pills and injections, it has benefits over other tools, leading the World Health Organisation (WHO) to recommend its inclusion in the package of sexual health services for women.
Its major advantage over pills is that it can be used discreetly, allowing women to use it without having to negotiate or discuss its use and purpose with their sexual partners.
However, despite the WHO’s recommendations, its current price is a barrier to broad roll-out in South Africa.
The only dapivirine vaginal ring approved by the South African Health Products Regulatory Authority (SAHPRC) currently available in the country is the DapiRing, made by Swedish company Sever Pharma Solutions, under a licence from the Population Council (formerly the International Partnership for Microbicides).
It can be bought privately in SA for R320, excluding dispensing fees, but is not available to the public outside study and pilot sites, as the National Essential Medicines List Committee deemed it unaffordable. The committee said the product would be affordable at a threshold price of R52 per ring.
Local company will boost access
The Population Council, which owns the intellectual property on the dapivirine ring, selected South African pharmaceutical company Kiara Health to manufacture and supply the ring across Africa, its decision being noteworthy, as holders of intellectual property protections on HIV health technologies typically seek out companies in Asia, and India in particular, as manufacturing partners.
Kiara Health’s CEO Dr Skhumbuzo Ngozwana told Spotlight that while it is not yet known what the ring’s price would be, it is expected to be cheaper than the DapiRing.
The Council said the initial focus of the licence and partnership would be to develop manufacturing capacity at Kiara Health to supply the ring across Africa – and to serve markets outside Africa.
Professor Linda-Gail Bekker, CEO of the Desmond Tutu HIV Foundation, said: “If the pandemic taught us anything, it is the value of being self-reliant as a region – being able to manufacture the vaginal ring is a step closer to southern African self-reliance.”
Exclusive supply licence
The Council plans to pursue an exclusive supply licence with Kiara for the sole supply of the ring in Africa. This is a strong vote of confidence by the Council in the company’s ability supply the ring at adequate scale and affordable prices.
Since Kiara Health’s exclusivity is for the supply of the ring, if there is a need, the company will be able to supply a dapivirine vaginal ring made by the Council’s Swedish manufacturing partner Sever Pharma Solutions, which is already widely authorised for use in African countries.
This would also guard against supply shortfalls that sometimes occur when only one manufacturer supplies a market, said Dr Brid Devlin, the Population Council’s chief scientific officer.
Would this boost domestic manufacturing?
Vaginal rings have multiple potential applications. Although those that prevent pregnancy have been available since the early 2000s and work is under way to develop a ring that is effective in combating both HIV and pregnancy, one that reduces the risk of contracting HIV for three months – as opposed to one month – is also under development.
Ngozwana said in the long-term, Kiara Health hoped the partnership with the Population Council would expand, to allow for local manufacturing of other sexual and reproductive health technologies in their product portfolio.
Spotlight article – SA company set to manufacture HIV prevention ring (Creative Commons Licence)
See more from MedicalBrief archives:
SA firm to produce contraceptive anti-HIV vaginal rings
Why SA pilots of HIV prevention shots and vaginal rings have been delayed
Study finds vaginal ring safe in late pregnancy and while breastfeeding
Dapivirine vaginal ring receives WHO prequalification for HIV prevention