ViiV HEALTHCARE’S CLARITY STUDY SHOWS LONG-ACTING CABOTEGRAVIR MORE ACCEPTABLE THAN LENACAPAVIR INJECTIONS AFTER A SINGLE DOSE, WITH 90% PREFERRING CABOTEGRAVIR

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  • Initial data from the CLARITY study are first to compare acceptability and tolerability of single-dose cabotegravir (CAB) and lenacapavir (LEN) long-acting injections, in 63 HIV-negative adults
  • Sixty-nine percent of individuals found CAB injections to be ‘totally or very acceptable’ versus 48% for LEN injections, and 90% of participants and 86% of healthcare providers preferred CAB injections over LEN
  • Findings could help inform expectations and decision-making when initiating long-acting HIV injectables

London, 15 October 2025 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced data from the phase I CLARITY open-label, crossover study, showing clinically relevant differences in injection site reaction (ISR) acceptability and tolerability, with 69% of HIV-negative adults finding cabotegravir long-acting (CAB LA) injections to be “totally or very acceptable” vs 48% for lenacapavir (LEN) injections. Data presented at the 20th European AIDS Conference (EACS) in Paris, France, also showed 90% of HIV-negative adults and 86% of healthcare providers (HCPs) preferred CAB LA injections over LEN injections after a single dose, and ISR events were more frequent and visible with LEN than with CAB LA.1

Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “We believe long-acting innovations will play a critical role in the global response to ending HIV and AIDS and understanding potential differences in acceptability and tolerability of options is an important consideration when choosing between long-acting injectables. The CLARITY study showed that after receiving a single dose of each, more individuals and healthcare professionals preferred cabotegravir over lenacapavir injections. These early findings provide valuable insights into long-acting injectable options to help empower individuals and their healthcare providers to make fully informed choices.”

In the open-label crossover study, 63 HIV-negative participants were randomised to receive one medicine at Day 1, followed by the other at Day 15 - either CAB LA (a single intramuscular injection) or LEN (two subcutaneous injections). The primary endpoint was local reaction acceptability assessed seven days after each injection, and results showed clinically relevant differences in ISR acceptability. After a single dose of CAB LA and LEN, 69% (n=42/61) of individuals found CAB injections to be “totally or very acceptable” vs 48% (n=29/60) for LEN injections, which was statistically significant in a post hoc analysis (p=0.019). 

Key preference data from the study:

  • Ninety percent (n=54/60) of healthy HIV-negative adults and 86% (n=6/7) of HCPs preferred CAB LA and 10% (n=6/60) and 14% (n=1/7) preferred LEN, respectively.
  • The four most common reasons cited by participants for why they preferred CAB LA (n=54) were less pain during injection administration (n=40/54), less pain or soreness after injection administration (n=33/54), how long the injection nodules or swelling last (n=31/54), and the size of the injection nodules or swelling (n=30/54).
  • The four most common reasons cited by participants for why they preferred LEN (n=6) were less pain or soreness after injection administration (n=5/6), how long the injection nodules or swelling last (n=3/6), the size of the injection nodules or swelling (n=3/6), and fewer number of side effects (n=3/6).
  • The three most common rationales for HCP preference for CAB LA (n=6) included fewer number of reported side effects (5/6), less severe side effects (4/6), and less pain during injection (4/6). One HCP preferred LEN (n=1) due to ease of injection preparation.

Key ISR data from the study:

  • Single doses of CAB LA were administered as one injection and single doses of LEN as two injections per product labeling, therefore 63 participants were administered a total of 124 LEN injections and 61 CAB injections during the study. Three participants received only one of the doses, all due to non drug-related reasons.
  • Following administration of both injectables, 4.4 times more ISR events were observed with LEN (n=538) than with CAB LA (n=123) and more participants experienced visible ISR events with LEN (n=221 LEN; n=36 CAB LA).
  • Pain was the most commonly reported ISR for LEN in 82% (n=51/62) of participants vs 80% (n=49/61) of participants receiving CAB LA (Relative Risk [RR] 0.98 [0.82, 1.16]).
  • There was a significantly higher risk of palpable and/or visible ISRs with LEN versus CAB:
    • Induration 87% (n=54) vs 18% (n=11) (RR 0.21 [0.12, 0.36])
    • Nodules 74% (n=46) vs 33% (n=20) (RR 0.44 [0.30, 0.65])
    • Erythema 57% (n=35) vs 12% (n=7) (RR 0.20 [0.10, 0.42])
    • Swelling 58% (n=35) vs 34% (n=21) (RR 0.59 [0.40, 0.89])
  • No serious adverse events or discontinuations due to drug-related adverse events were reported.

These findings underscore the importance of individual choice and informed decision-making in choice of long-acting injectable HIV therapy or prevention options. Further results and additional analyses from the study will be presented at a future medical congress.

APRETUDE (cabotegravir) extended-release injectable suspension
Professional Indication and Important Safety Information
INDICATION
APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. 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.

IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
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 by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.

CONTRAINDICATIONS

  • Do not use APRETUDE in individuals:
    • with unknown or positive HIV-1 status
    • with previous hypersensitivity reaction to cabotegravir
    • receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine

WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:

  • Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
  • Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
  • When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
  • Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
  • Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE

Potential Risk of Resistance with APRETUDE:

  • There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE

Long-Acting Properties and Potential Associated Risks with APRETUDE:

  • Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance

Hypersensitivity Reactions:

  • Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE
  • Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

  • Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
  • Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated

Depressive Disorders:

  • Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
  • Promptly evaluate patients with depressive symptoms

Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:

  • The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
  • Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%, all grades) with 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.

DRUG INTERACTIONS

  • Refer to the full Prescribing Information for important drug interactions with APRETUDE
  • Drugs that induce UGT1A1 may significantly decrease the 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

For more information, please see full US Prescribing Information for APRETUDE: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.

About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

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References

  1. J. Boles, et al. Cabotegravir Injections Are More Acceptable Than Lenacapavir Injections Following a Single Dose: Results From CLARITY, a Randomized Crossover Study of Long-Acting Injectable Antiretrovirals. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.