First Injection Approved for VIH-1 Treatment | Salud | La Revista

March 11, 2021 – 09h30

The Medicines and Food Administration (FDA) approves Cabenuva, the inexorable suspension of prolonged cabotegravir and rilpivirine release, used in conjunction with intramuscular use. This is the first inefficiently approved FDA approved regimen for adults infected with VIH-1 that is administered once a month. The FDA also approves Vocabria 30 mg tablets (cabotegravir) that must be taken in combination with oral rilpivirine (Edurant) while taking my antitumor treatment with Cabenuva to ensure that the medicines are well tolerated in the anticoagulant formula.

Vocabria is an inhibitor of the transmission of the virus of human immunodeficiency virus type 1 (VIH-1) (Insti) indicated in combination with Edurant for the treatment of the placenta of infection by VIH-1 in adults with virological suppression (ARN of VIH-1) in a stable antiretroviral regimen without treatment fractures and without resistance to como:

Global initiation to evaluate the tolerability of cabotegravir before the administration of ineffective prolonged release suspensions of Cabenuva.

Oral therapy for patients who delay the planned injection dose with Cabenuva.

Cabenuva is a coenvasive product of 2 pharmacies indicated as a complete regimen for the treatment of VIH-1 infection in adults to replace the current antiretroviral regimen in those that have been virologically suppressed (ARN of VIR-1 is less antecedents of treatment and without known resistance to cabotegravir or rilpivirine.

Dosification and administration

The recommended initial dose of diarrhea is a 30 mg Vocabria tablet and a 25 mg Edurant tablet.

• Dosification of intramuscular injection with Cabenuva.
• Injection injections (Cabenuva kit, 600 mg / 900 mg).

The FDA website (www.fda.gov) indicates that it should initiate injections on the last day of oral introduction. Cabenuva is recommended in adults as a single intramuscular gluteal injection of 600 mg (3 ml) of cabotegravir and a single intramuscular gluteal injection of 900 mg (3 ml) of rilpivirine.

According to the initial injection injections, the recommended monthly continuous injection dose of Cabenuva in adults is a single intramuscular gluteal injection of 400 mg (2 ml) of cabotegravir and a single intramuscular gluteal injection of 600 mg. Administering cabotegravir and rilpivirina in separate gluten injection sites (in open or separated cm 2 cm) during the same visit. Patients can receive Cabenuva up to 7 days before or after the scheduled program to receive monthly injections.

Compliment

“I highly recommend the completion of the monthly injection dosing program. Patients who have had an injection visit scheduled should be clinically re-evaluated to ensure that the treatment is treated properly ”. If it is also indicated that if a patient does not receive an injection scheduled for more than 7 days, you should start oral diarrhea therapy to replace up to 2 consecutive monthly injection visits.

If monthly injections are given or are withdrawn for more than 7 days and oral therapy has not been taken orally, the patient is clinically re-evaluated to determine whether the dose of the injection should be followed up.

Contraindications

Cabenuva is contraindicated in patients:

• With hypersensitivity reaction previa to cabotegravir or rilpivirina
• Receive the following co-administered medicinal products in order to obtain significant reductions in the cabotegravir and / or rilpivirine plasma concentrations due to the induction of the urinary diphosphate enzyme (UDP) – virological:
• Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenitoina
• Antimicobacterianos: rifabutina, rifampicina, rifapentina
• Glucocorticoid (systemic): dexamethasone (more than one dose dose)
• Plant base product: San Juan herb (Hypericum perforatum)

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• He reported hypersensitivity reactions with regimens containing rilpivirine and associated with other inhibitors of integration. Suspension Cabenuva immediately develops signs of hypersensitivity reactions.
• Posterior graft reactions to rilpivirine injection. Monitoring and treatment is clinically indicated.
• Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine. Recommends the monitoring of hepatic chemistry. Cabenuva suspension and hepatotoxicity susceptibility.
• If he notices depressive stressors with Cabenuva. Recommend an immediate medical evaluation for depressive symptoms.
• The residual concentrations of cabotegravir and rilpivirine can be maintained in the systemic circulation of patients up to 12 months or more. It is essential to initiate an antiretroviral regimen altogether suppressor or later 1 month after the final dose of Cabenuva injection. If a virological case is suspected, prescribe an alternative regimen which is possible.

Adverse reactions

Cabenuva’s security evaluation is based on the 48-week aggregate data analysis of 1,182 supremacist virulence subjects infected with VIH-1 in 2 international, multicentric and open-air, FLAIR and ATLAS pathways.

The most common adverse reactions (grades 1 to 4) are observed in ≥2% of subjects receiving Cabenuva, where reactions occur at the injection site, pyrexia, fatiga, cabbage pain, musculoskeletal pain, nausea, and erectile dysfunction.

Local reactions to the injection site (ISR) are also notarized. After 14,682 injections, 3663 ISR was reported. The 1% of subjects interrupted the treatment with Cabenuva debited to the ISR. The majority of ISRs live (grade 1, 75%) or moderate (grade 2, 36%). 4% of the subjects experimenting with ISR graves (grade 3) and no subject ISR experiment with grade 4. The ISR reported with the highest frequency due to the pain / malestar localized (79%) Independently of the parentage. Other ISR manifestations reported in more than 1% of subjects during the analysis period include nodules (14%), induration (12%), hinchazon (8%), erythema (4%), pruritus (4%) hematomas ( 3%), calorie (2%) and hematoma (2%). Abscesses and cellulite are reported at the injection site within 1% of subjects. The median duration of ISR events is 3 days.

The skeletal musculoskeletal pain (3%) and, with less frequency, sciatica, were also more common in subjects who received cibotegravir most rilpivirine compared to current antiretroviral regimens and some uncorial time events.

Vasovagal or preoperative reactions are reported in less than 1% of subjects subject to rilpivirine or cabotegravir injection.

See www.fda.gov for more information.