[Article to be found in the summer issue, at your newsstand or by subscription.] It’s a small revolution in HIV prevention. Since February, Apretude, the first injectable PrEP available in France, has been reimbursed by the French Social Security. An injection of cabotegravir every two months, which complements the arsenal of protections against the virus. Who is concerned? How can it be prescribed? We explain everything.
Illustration : Call Me George(s) pour têtu·
Who is eligible for injectable PrEP?
Preventive treatment against HIV infection, PrEP is intended for people who are seronegative and exposed to the virus. The French Haute Autorité de Santé does not reserve its injectable version for specific populations, but recommends it as an alternative when oral PrEP (the so-called “on-demand”) is not suitable. It is particularly for people:
– who have difficulty adhering to a daily treatment: chemsex practitioners, drug users, sex workers, migrants, stigmatized individuals who would need to hide their PrEP pills;
– to whom oral PrEP is not advised due to renal or bone fragilities;
– who have an absorption disorder of oral PrEP, for example after digestive surgery;
– who have trouble swallowing pills. “The aim is to find the best option for each person, in order to broaden PrEP coverage as much as possible”, explains Valérie Grange, Director of Public Affairs at ViiV Healthcare, the company that developed Apretude.
Are there contraindications?
There are few medical contraindications. Apretude cannot be prescribed for people who are HIV-positive or whose HIV status is unknown, nor in cases of known hypersensitivity to the treatment. It is also incompatible with certain tuberculosis medications (rifampicin, rifapentine) and several anticonvulsants (carbamazepine, oxcarbazepine, phenytoin, phenobarbital). Finally, intramuscular injection is not recommended for people on curative anticoagulants, due to the risk of hematoma or hemorrhage, as well as for people with gluteal prostheses.
Is injectable PrEP as effective as oral PrEP?
Yes. When used correctly, both provide the same protection against HIV. In practice, injectable PrEP proves even more effective than the oral version because it avoids possible misses with a daily regimen. However, note that protection is not complete until seven days after the first injection. And PrEP, whether oral or injectable, does not protect against other sexually transmitted infections (STIs), nor against hepatitis B (for which there is a vaccine).
How is the prescription handled? What about follow-up?
Any physician experienced in HIV care, whether a general practitioner or a specialist, can prescribe Apretude. Before starting treatment, a thorough blood test is necessary to rule out any HIV infection, even if recent, because there is a risk of developing resistance to certain HIV treatments in case of injection in an infected person. Possible STIs are also screened for, and kidney and liver functions are checked.
In most cases, injections can begin immediately. For some people, particularly those with a history of allergies, a preliminary oral phase may be offered to verify tolerance to the treatment. The protocol then starts with two injections at one-month intervals, before moving to an injection every eight weeks. Regular biological monitoring remains necessary throughout the treatment, initially every two months, then every four months. Finally, stopping Apretude should be discussed with one’s doctor, as cabotegravir can persist at very low doses in the body for up to nearly a year.
Does it hurt?
This new PrEP is administered by intramuscular injection into the buttock muscle. So it does hurt like a vaccine in the butt: even though the needle is fairly large, the shot is generally very tolerable. Pain may then appear at the injection site for one or two days. “Studies show that these pains fade over time and with repetition”, reassures Valérie Grange. Apretude is generally well tolerated, despite some mild and transient side effects, such as headaches or a bit of fever.
How much does Apretude cost?
Apretude is covered at 100% for beneficiaries of the French Social Security, the Solidarity Health Insurance (CSS) and State Medical Aid (AME). However, the HIV viral load test required before prescription is reimbursed at only 65%, except for AME beneficiaries. Mutual insurance typically covers the rest, and this test costs nothing in free information, screening and diagnostic centers (CeGIDD), as well as in associative health centers such as Spot, Checkpoint or Le Griffon. But for the association Aides, this requirement remains a barrier to access for populations already far from care. “We are hopeful that this obligation will be lifted in Europe thanks to large-scale studies of the treatment, as is already the case in the United States” notes Valérie Grange. A possible reassessment should not occur before at least two years.
