ViiV Healthcare announces US FDA approval of Apretude (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention
- Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (
FTC/TDF tablets) in reducing the risk of HIV acquisition
- Approved in the US for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV, including men who have sex with men as well as women and transgender women who have sex with men
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Apretude (cabotegravir extended-release injectable suspension) (Photo: Business Wire)
Cabotegravir long-acting for PrEP is provided as an injection given as few as six times per year and is initiated with a single 600 mg (3-ml) injection given one month apart for two consecutive months. After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3-ml) injection given every two months. Vocabria (cabotegravir oral tablets) may be administered for approximately one month before initiating the first injection to assess the tolerability of the medicine.
The most common adverse reactions (all grades) observed in at least 1% of clinical trial participants receiving cabotegravir long-acting for PrEP were injection site reactions, diarrhoea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection. Adverse events led to discontinuation in 6% of participants in HPTN 083 and 1% of participants in HPTN 084.
In HPTN 083, participants in the US were inclusive of the Black/
HIV continues to be a global public health crisis, with an estimated 38 million people living with HIV worldwide and 1.7 million new cases annually. PrEP represents an effective tool to reduce new cases of HIV, which in addition to successful HIV antiretroviral treatment, will help efforts to end the HIV epidemic. However, fewer than 25% of the people who could benefit from PrEP in the US are currently taking it. Despite the wide availability of daily oral PrEP, it can be limited by inconsistent adherence as well as structural and cultural barriers that lead to underutilisation in key populations.
About Apretude (cabotegravir extended-release injectable suspension)
Apretude is the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option proven superior to daily oral
Apretude is an integrase strand transfer inhibitor (INSTI). INSTIs, like cabotegravir extended-release injectable suspension, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease.
About HPTN 083 (NCT02720094)
The HPTN 083 trial is a phase IIb/III double-blind non-inferiority trial designed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral
Long-acting cabotegravir was found to be superior to daily oral
About HPTN 084 (NCT03164564)
The HPTN 084 trial is a phase IIb/III double-blind superiority trial designed to evaluate the safety and efficacy of the long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral
Long-acting cabotegravir was found to be superior to daily oral
Indication and Important Safety Information for Apretude (cabotegravir 200 mg/mL extended-release injectable suspension)
Apretude is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. Apretude is administered as a single 600-mg (3-mL) intramuscular (IM) injection of cabotegravir in the muscle of the buttock by a health care professional once every 2 months.
WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
See full prescribing information for complete boxed warning.
Individuals must be tested for HIV-1 infection prior to initiating Apretude or oral cabotegravir, and with each subsequent injection of Apretude, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Apretude for HIV-1 PrEP by individuals with undiagnosed HIV-1 infection. Do not initiate Apretude for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving Apretude for PrEP must transition to a complete HIV-1 treatment regimen.
- Unknown or positive HIV-1 status.
- Previous hypersensitivity reaction to cabotegravir.
- Coadministration with drugs where significant decrease in cabotegravir plasma concentrations may occur.
WARNINGS AND PRECAUTIONS
- Use APRETUDE for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of comprehensive management to reduce the risk of HIV-1 acquisition.
- Potential risk of developing resistance to Apretude if an individual acquires HIV-1 either before or while taking Apretude or following discontinuation of Apretude. Reassess risk of HIV-1 acquisition and test before each injection to confirm HIV-1 negative status.
- Residual concentrations of cabotegravir may remain in the systemic circulation of individuals up to 12 months or longer.
- Hypersensitivity reactions have been reported in association with other integrase inhibitors. Discontinue Apretude immediately if signs or symptoms of hypersensitivity reactions develop.
- Hepatotoxicity has been reported in patients receiving cabotegravir. Clinical and laboratory monitoring should be considered. Discontinue Apretude if hepatotoxicity is suspected.
- Depressive disorders have been reported with Apretude. Prompt evaluation is recommended for depressive symptoms.
The most common adverse reactions (all grades) observed in at least 1% of subjects receiving Apretude were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact
- Refer to the full prescribing information for important drug interactions with Apretude.
- Drugs that induce uridine diphosphate glucuronosyltransferase (UGT1A1) may significantly decrease plasma concentrations of cabotegravir.
USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using Apretude to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation.
- Pediatrics: Not recommended in individuals weighing less than 35 kg.
Please see full Prescribing Information.
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