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

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 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.

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.