Rwanda officially introduced a long-acting injectable Cabotegravir (CAB-LA) HIV prevention drug, on January 3. The prescription medication is traded under brand name Apretude.
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CAB-LA is an injectable form of pre-exposure prophylaxis (PrEP) thought to be highly effective at reducing the risk of HIV acquisition, according to the World Health Organization (WHO). PrEP is a medicine that reduces your chances of getting HIV from sex or injection drug use (injection of a drug into one’s bloodstream via a hypodermic needle).
The new drug is currently being piloted at two health centers in Gikondo and Busanza, in Kigali. Depending on the success of the pilot phase, plans for a nationwide rollout are under consideration, according to Rwanda Biomedical Centre.
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In July 2022, WHO released guidelines for the use of the drug as a PrEP, and called for countries to consider this safe and highly effective prevention option for people at substantial risk of HIV infection.
1. Manufacturer
The drug was developed by ViiV Healthcare, a British multinational pharmaceutical company specialising in the research and development of medicines to treat and prevent HIV/AIDS.
The company is majority owned by British multinational pharmaceutical and biotechnology company GSK, with American multinational pharmaceutical and biotechnology corporation Pfizer, and Japanese pharmaceutical company Shionogi, as shareholders.
2. Effectiveness
In October 2024, ViiV Healthcare stated that findings from two real-world evidence studies showed more than 99 per cent effectiveness of the drug in nearly 1,300 individuals.
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The drug is given as few as six times per year and demonstrated superior efficacy [as compared] to a daily oral PrEP option in reducing the risk of HIV acquisition, its maker said.
Harmony Garges, the Chief Medical Officer at ViiV Healthcare, said the findings continue to support the strong and sustained effectiveness of Apretude for people in real life, outside the controlled environment of a clinical trial. He added that the results add to the growing body of evidence generated over the last three years, showing CAB LA is a highly effective option for HIV prevention.
3. Indication: Who should be given the drug?
Apretude is recommended for PrEP to reduce the risk of sexually acquired HIV infection in adults and adolescents weighing at least 35 kilogrammes.
Prior to initiating Apretude for HIV PrEP, individuals must be tested for HIV infection and have a negative test for this immune system-attacking virus.
4. Contraindications
Apretude should not be used in individuals with unknown or positive HIV status, those with previous hypersensitivity reaction to Cabotegravir, and those receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine, the manufacturer advised.
As noted, drug-resistant HIV variants have been identified with its use by individuals with undiagnosed HIV infection.
Do not initiate Apretude for HIV PrEP unless negative infection status is confirmed, the drug maker warned, adding that in case individuals – unfortunately – acquire HIV while receiving the injectable, they must transition to a complete HIV treatment regimen.
5. How it is used
The medicine belongs to a class of drugs called integrase strand transfer inhibitors (INSTIs) which block integrase, an enzyme HIV uses to insert its viral DNA into the DNA of its host, hence preventing it from replicating.
ViiV Healthcare indicated that the medication is given to people in need – intramuscularly – at a dose of 600 mg (3-ml) per injection.
The treatment is initiated with two injections given one month (four weeks) apart. Thereafter, an injection is administered every two months (eight weeks).
6. Adverse effects
The most common adverse reactions observed in at least 1 per cent of subjects receiving Apretude, were injection site reactions, diarrhea, headache, pyrexia (fever), fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia (muscle pain), rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.