By VETTAPHARMA reporter, 19th February 2026: London, UK — ViiV Healthcare, the HIV-focused company majority owned by GSK with Pfizer and Shionogi as shareholders, announced that its long-acting injectable regimen Cabenuva (cabotegravir + rilpivirine) demonstrated superior efficacy compared to daily oral antiretroviral therapy (ART) in people living with HIV who face adherence challenges. The results from the Phase III LATITUDE study were published in The New England Journal of Medicine.
The randomized, open-label LATITUDE trial enrolled 453 participants and evaluated whether switching to long-acting injectable cabotegravir plus rilpivirine administered every four weeks could reduce the risk of regimen failure versus continuing daily oral ART.
At Week 48, the cumulative probability of regimen failure was 22.8% (29/152) in the long-acting arm compared with 41.2% (55/154) in the daily oral therapy arm — representing nearly a 50% reduction in regimen failure among participants receiving Cabenuva.
Breaking down the data:
In the long-acting arm, 19% (29/152) experienced regimen failure
- 3% (5) due to virologic failure
- 16% (24) due to permanent treatment discontinuation
In the daily oral ART arm, 36% (55/154) experienced regimen failure
- 21% (32) due to virologic failure
- 15% (23) due to permanent discontinuation
The overall safety profile was comparable between the two groups. As expected, injection site reactions were the most common adverse events in the long-acting treatment arm.
According to the company, this marks the first randomized study demonstrating superiority of a long-acting injectable HIV regimen over daily oral therapy specifically in individuals with adherence difficulties — a population at increased risk of virologic rebound and treatment failure.
The findings reinforce the clinical value of long-acting antiretroviral therapy as an alternative to daily pills, particularly for patients who struggle with consistent medication adherence — a major barrier to sustained viral suppression.
Strategic Implications for GSK and Pfizer
For majority stakeholder GSK, the positive Phase III data strengthen its leadership position in long-acting HIV therapies and reinforce the commercial durability of Cabenuva within its specialty medicines portfolio. Superior efficacy data in a high-risk adherence population may expand physician confidence, support broader guideline inclusion, and potentially drive increased uptake in global markets. For Pfizer, which holds an equity stake in ViiV Healthcare, the results support continued value generation from its HIV collaboration and provide indirect portfolio strength without requiring standalone commercialization infrastructure. Strong clinical differentiation may enhance revenue visibility within the long-acting HIV segment and solidify the competitive positioning of the ViiV partnership model.
Cabenuva is currently approved in multiple countries as a complete long-acting regimen for the treatment of HIV-1 infection in adults who are virologically suppressed.
Source credit:
- ViiV Healthcare. (2026, February 18). ViiV Healthcare’s long-acting Cabenuva (cabotegravir + rilpivirine) for HIV demonstrates superior efficacy compared to daily oral therapy for people with adherence challenges; results published in NEJM. Click here
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