ViiV Shows Positive Real-World Results for Long-Acting HIV Treatments

ViiV Healthcare has reported new real-world and pipeline findings for presentation at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2026), including evidence associating long-acting cabotegravir plus rilpivirine (CAB + RPV LA) with higher treatment adherence and persistence than daily oral antiretroviral therapy (ART). The company’s programme includes 39 abstracts covering HIV treatment, prevention, patient perspectives and investigational medicines.

The findings address a persistent challenge in HIV management: maintaining long-term treatment engagement while sustaining viral suppression. Although long-acting injectables reduce the need for daily medication-taking, their effectiveness in practice also depends on timely injection attendance and continued clinical monitoring.

OPTIMIZE Study: Adherence and Persistence

The retrospective US OPTIMIZE study compared long-acting CAB + RPV LA, marketed as Vocabria plus Rekambys in Europe and Cabenuva in the US, Canada and Australia, with daily oral ART.

• Adherence: Among 2,364 individuals receiving CAB + RPV LA, 92% met the study’s adherence threshold, compared with 79% of 41,347 individuals receiving daily oral ART. Adherence was defined as treatment coverage for at least 90% of days up to discontinuation (proportion of days covered [PDC] ≥0.9).
• Persistence: At 24 months, 72% (n=1,518) of the CAB + RPV LA cohort remained on treatment, compared with 57% (n=1,273) of the daily oral ART cohort.
• Discontinuation risk: The adjusted hazard ratio (aHR) for discontinuation was 0.57 (95% CI 0.52–0.63), corresponding to a 43% lower adjusted hazard of discontinuation with injectable therapy compared with daily oral ART.

These observational findings demonstrate an association rather than establishing that injectable treatment alone caused the differences in adherence or persistence.

Sustained Viral Suppression Across Real-World Cohorts

Data from two observational cohorts provide additional evidence on virologic outcomes among people receiving CAB + RPV LA.

• US OPERA cohort: The analysis included 6,955 adults who were virally suppressed when initiating CAB + RPV LA. Among participants who completed treatment initiation and had follow-up viral-load measurements, 94% of those aged 18–49 and 50–64 years were suppressed at their last measurement, compared with 71% among adults aged 65 years or older. Confirmed virologic failure was uncommon, ranging from less than 1% to 2% across age and racial or ethnic groups.
• European COMBINE-2 cohort: The analysis included 1,022 treatment-experienced, virologically suppressed adults across seven European countries. Among 1,007 participants with follow-up viral-load data, 98% (986/1,007) had a last viral load below 50 copies/mL. Confirmed virologic failure occurred in seven participants (0.7%), while 94% received injections on time.

Patient Engagement, Peer Support and HIV Prevention

• Shared decision-making: Interim analyses across 29 countries included 3,888 people living with HIV. Medication satisfaction was reported by 92% (1,512/1,640) of participants reporting high shared decision-making, compared with 50% (549/1,096) reporting low shared decision-making. Higher shared decision-making was also associated with better reported adherence and viral suppression.
• Peer support and communication: Among patient-organisation personnel, greater integration of peer-support activities was associated with higher estimated adherence (adjusted odds ratio [aOR] 1.13 per activity). However, only 39.2% (174/444) believed people in their communities would feel comfortable discussing adherence challenges with healthcare providers.
• PrEP maintenance: A four-year US OPERA analysis of 3,021 users of long-acting cabotegravir for HIV pre-exposure prophylaxis (PrEP) found that 91% of 16,268 maintenance injections were administered on time. Of the injection delays, 84% were short, with a median delay of four days (IQR 2–10). The STI diagnosis rate was 45.39 per 100 person-years, while the observed HIV acquisition rate was 0.17 per 100 person-years.

Early Pipeline: VH184 and VH499

ViiV Healthcare presented early-stage data on two investigational candidates designed to support extended dosing schedules:

• VH184 (Third-Generation INSTI): In in-vitro studies, VH184 retained activity against HIV variants carrying resistance-associated substitutions to first- and second-generation integrase strand transfer inhibitors (INSTIs). Its resistance profile supports further development toward long-acting combinations with dosing intervals up to twice-yearly.
• VH499 (Investigational Capsid Inhibitor): Interim Phase 1 evaluation in 122 participants without HIV showed no drug-related serious adverse events or safety-related withdrawals. Injection-site reactions (primarily mild-to-moderate pain) occurred in 84% () of VH499 recipients. Pharmacokinetic profiles following subcutaneous and intramuscular dosing support evaluation for twice-yearly regimens.

Both candidates remain investigational and have not received regulatory approval.

Clinical interpretation

The OPTIMIZE findings provide evidence of higher adherence and persistence associated with long-acting CAB + RPV LA compared with daily oral ART in a US real-world setting. OPERA and COMBINE-2 further support sustained viral suppression among selected populations receiving injectable treatment.

However, observational evidence cannot establish causal superiority, and treatment selection must consider individual clinical suitability, resistance history, injection attendance and ongoing monitoring. The patient-perspective findings also reinforce that shared decision-making and support systems remain important components of treatment engagement.

Meanwhile, VH184 and VH499 represent potential approaches to reducing treatment frequency, although their clinical utility will depend on further clinical development. Overall, the findings highlight the growing role of long-acting approaches in HIV treatment and prevention while underscoring the importance of patient-centred care.

Reference

Vocabria + Rekambys associated with greater adherence versus daily oral therapy in a us real-world study, as ViiV healthcare presents broader long-acting portfolio and pipeline data at HIV Glasgow, ViiV Healthcare, 09 November 2026