South Africa to manufacture CAB-LA, an injectable HIV-prevention drug

SOUTH AFRICA— Cipla, one of the world’s largest pharmaceutical companies, has announced its plans to manufacture cabotegravir (CAB-LA), a long-acting prophylaxis, in South Africa.

This ground-breaking development has the potential to provide protection against the HIV virus for millions of people in Africa.

For the first time, an affordable version of this innovative HIV-prevention drug will be produced within South Africa.

This development is significant as it opens the possibility of granting access to a two-monthly injection to millions of individuals at risk of HIV infection in Africa. The drug has been proven to drastically reduce the chances of contracting the virus.

Cipla, an Indian-based pharmaceutical company, has confirmed that it will produce a generic version of CAB-LA at its manufacturing facilities in Benoni, located near Johannesburg.

Cabotegravir works by blocking the entry of HIV into cells, significantly lowering an individual’s risk of contracting the virus through sexual transmission.

Two oral versions of pre‐exposure prophylaxis (PrEP) are already available, both as a daily pill and they have been shown to reduce HIV infection in groups at high risk by up to 99% but only when taken consistently, which many users find hard.

The injectable CAB-LA has shown to be more effective because adherence is much easier and the key ingredient, an antiviral compound prevents the viral genome from integrating into the DNA of host cells.

The bimonthly injections mean less hassle and more discretion for the user than a daily pill.

The confirmation follows an announcement in March that the developers of CAB-LA, ViiV Healthcare, and the UN-backed Medicines Patent Pool (MPP), had granted licenses to three companies, including Cipla.

The other two companies, Aurobindo and Viatris, are also Indian corporations that are already producing antiretroviral drugs for HIV treatment.

The branded version of CAB-LA sells for about US$3,500 for one injection in the US, a price that puts it out of reach for lower-income countries.

Even at a lower, not-for-profit price at which the manufacturer said it would sell the medicine to 90 poorer countries, including South Africa, the brand-name version is probably too expensive for most low and middle-income governments to buy.

On AIDS Day in 2022, celebrities and leading figures in healthcare, including Winnie Byanyima, executive director of UNAIDS, called for ViiV to lower the price of the drug.

To produce a generic version of a medicine, a pharmaceutical company must gain access to the manufacturing technology, which can take up to five years before the product becomes available in the market.

In South Africa, ViiV currently holds the patent for CAB-LA until 2031. This means that unless licenses are granted for other generic manufacturers, ViiV would have a monopoly on the product for at least eight years.

A report from the US FDA’s Center for Drug Evaluation and Research estimated that the entry of one generic manufacturer into the market could reduce the price wholesalers pay to manufacturers for a drug by 39%.

Additionally, the report found that products with six or more generic producers were on average 95% cheaper than when only a single branded option was available.

Importing ready-made and packaged medicines can be costly, while importing raw materials to locally manufacture the medicine is significantly cheaper, as analyzed by the consultancy firm McKinsey.

According to UNAIDS data, in 2020, approximately 680,000 people worldwide died from AIDS-related illnesses, a significant decrease from the 1.9 million deaths recorded in 2004.

New HIV infections have also been reduced by 52% since the peak in 1997.

UNAIDS established the 90-90-90 targets to measure global progress by 2020, aiming for 90% of people with HIV to know their status, 90% of those with a known status to be on treatment, and 90% of those on treatment to achieve viral suppression.

These targets have been revised to 95-95-95, to be achieved by 2030.

In July 2022, the World Health Organization (WHO) released new guidelines recommending the use of long-acting injectable cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP) for HIV.

The WHO urged countries to consider this safe and highly effective prevention option for individuals at significant risk of HIV infection.

The guidelines from WHO also highlight key research gaps related to CAB-LA, including issues such as HIV drug resistance, HIV testing, service delivery models, resource requirements, safety during pregnancy and breastfeeding, and provision of CAB-LA for populations at higher risk of infection.

These research gaps need to be addressed to successfully provide and expand the use of CAB-LA as a prevention strategy.

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