Despite headlines about a new once-a-month drug for HIV prevention, global experts warn that the medication is still in clinical trials and is not yet available for widespread use.
Access Expansion Agreement
This information emerged following an agreement between Aspen Pharmacare and the American pharmaceutical company MSD. This partnership aims to increase the availability of the investigational drug, known as alimatravir, across the entire African continent, pending regulatory approval. Aspen stated plans to manufacture, market, and distribute this medicine on the African continent, thereby supporting efforts to improve access to HIV prevention technologies.
Characteristics of the New Drug
Alimatravir is an investigational oral agent being studied as a form of pre-exposure prophylaxis (PrEP). PrEP refers to medications taken by HIV-negative individuals to reduce the risk of infection. The difference between alimatravir and the existing oral PrEP in South Africa is that the new drug is designed to be taken only once a month, whereas the current oral PrEP requires daily intake.
Availability in South Africa
Currently, Alimatravir is not sold in South Africa. The drug is still being evaluated within Phase III clinical trials to determine its safety and efficacy. For it to be approved for use in South Africa, it requires authorization from the country's national drug regulator—the South African Health Products Regulatory Authority (SAHPRA). Until such approval is obtained, residents of South Africa are advised to continue using established HIV prevention methods recommended by healthcare professionals.
The Drug's Place in Prevention Systems
At this stage, alimatravir does not replace existing prevention methods. Daily oral PrEP remains one of the most effective forms of protection for people at high risk of HIV infection when adherence to the regimen is maintained. Other prevention methods mentioned include condom use, post-exposure prophylaxis (PEP), male circumcision, and regular HIV testing. Internationally, long-acting injectable PrEP has also emerged, although access to it varies by country. If the drug is approved, it will add another option rather than replacing current prevention methods.
Significance for South Africa
South Africa faces one of the world's largest HIV epidemics. According to UNAIDS data, millions of South Africans live with HIV, and thousands of new infections are recorded annually. Health experts consistently emphasize that expanding the range of preventive options is critical, as different medications suit different people and lifestyles. A once-monthly drug could make HIV prevention more convenient for some individuals who find it difficult to take pills daily. Nevertheless, specialists caution that additional evidence is required for this drug to be included in standard HIV prevention programs.
Role of Aspen
Aspen noted that this agreement could strengthen Africa's capacity to produce advanced medicines closer to where they are needed. The COVID-19 pandemic highlighted the continent's dependence on imported vaccines and medicines, which spurred renewed efforts to build up pharmaceutical manufacturing capacity in Africa. Localizing the production of HIV prevention drugs can contribute to increasing the long-term reliability of supplies and ensuring faster access if regulatory approvals are granted.
Next Steps
The results of the ongoing Phase III clinical trials will determine the possibility of submitting alimatravir to regulatory bodies for approval. If successful, regulatory authorities, including SAHPRA, will evaluate the presented evidence before deciding on the drug's usability in South Africa. Until then, health authorities urge people at risk of HIV to continue using proven prevention methods and consult with medical specialists regarding the suitability of existing PrEP options for them.