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, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced data to be presented at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow). It marks ViiV Healthcare’s largest congress presence of the year, with 39 abstracts covering real-world evidence findings for long-acting injectable medicines, pipeline research and patient perspectives.

Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “The breadth and depth of the data that we’re presenting reinforce the role of ViiV’s long-acting injectables in addressing unmet needs in HIV prevention and treatment, including adherence challenges that can remain with daily oral therapy. This further demonstrates ViiV’s leadership in HIV innovation and its commitment to researching options that fit people’s lives as well as their clinical needs.”

Real-world studies provide new data on adherence, persistence and virologic outcomes with Vocabria + Rekambys

OPTIMIZE, a retrospective U.S. study, evaluating adherence and persistence with long-acting injectable Vocabria + Rekambys (cabotegravir + rilpivirine LA [CAB + RPV LA]) (branded as Cabenuva in the US, Canada and Australia) versus daily oral antiretroviral therapy, found that a higher proportion of people receiving CAB + RPV LA met the study’s adherence threshold: 92% compared with 79% of those receiving daily oral ART (cohort sizes: 2,364 and 41,347, respectively).¹

The adherence threshold was defined as treatment covering at least 90% of days up to discontinuation (proportion of days covered [PDC] ≥0.9) in both groups.

At 24 months, 72% (n=1,518) of those in CAB + RPV LA remained persistent compared with 57% (n=1,273) in daily orals. The adjusted hazard ratio for discontinuation was 0.57 (95% CI 0.52-0.63), corresponding to a lower observed rate of discontinuation in the CAB + RPV LA cohort.

An analysis spanning the first five years of CAB + RPV LA availability in the US OPERA cohort included 6,955 adults who were virally suppressed when starting treatment.² Among those who completed initiation and had follow-up viral load measurements, 94% were suppressed at their last measurement across the age groups (18-49 and 50-64) and 71% for the age group (≥65 years) across Hispanic, non-Hispanic Black and non-Hispanic White people. Confirmed virologic failure (CVF) was rare across all age and race or ethnicity groups, ranging from less than 1% to 2%.

In the European COMBINE-2 cohort of 1,022 treatment-experienced, virologically suppressed adults across seven countries, among 1,007 participants with follow-up viral-load data, 98% (n=986) had a last viral load below 50 copies/mL, while confirmed virologic failure was rare (0.7%; n=7).³ 94% of them received injections on time. CAB + RPV LA achieved high rates of virologic suppression, strong adherence and low CVF.

These findings contribute to the growing evidence showing high and consistent virologic suppression rates with CAB + RPV LA across diverse patient populations.

In addition to these data, interim Patient Perspectives findings across 29 countries included separate analyses of 3,888 people living with HIV (PLWH) and 622 personnel from HIV patient organisations. Higher shared decision-making (SDM) was associated with higher proportions reporting satisfaction, overall adherence, and viral suppression.

• 92% (n=1,512/1,640) of people with high SDM were satisfied with their medication vs. 50% (n=549/1,096) with low SDM.⁴

• In the analysis of HIV patient-organisation personnel, greater integration of peer-support activities was associated with higher estimated adherence (aOR 1.13 per activity). But fewer than half (39.2% [n=174/444]) believed the average person in their community would be comfortable discussing adherence challenges with their provider.⁵

OPERA analysis described injection timing and observed HIV diagnoses among US Apretude (cabotegravir long-acting [CAB LA]) for HIV pre-exposure prophylaxis (PrEP) users

In a real-world US cohort of 3,021 CAB LA for PrEP users, the four-year OPERA prevention analysis found 91% of 16,268 maintenance injections were received on time, and most delays (84%), when they occurred, tended to be short (median 4 days late; IQR: 2,10).⁶

• Despite a high rate of STI diagnoses showing ongoing risk (45.39 per 100 person-years), the rate of HIV acquisition was 0.17 per 100 person-years in this real-world cohort of CAB LA for PrEP users with ongoing HIV prevention needs.

Pipeline data show continued innovation with VH184 and VH499, with the potential for less frequent dosing for HIV treatment

In vitro data showed VH184, an investigational third-generation integrase-strand transfer inhibitor (INSTI), retained activity against the tested HIV variants containing resistance-associated substitutions to first and second generation INSTIs.⁷ These findings support potential for a broader resistance profile, while clinical development is investigating its potential for longer dosing intervals, including twice-yearly dosing.

Interim findings from a phase 1 study of 122 participants without HIV who received injectable VH499 or placebo provided preliminary safety findings, with no VH499-related serious adverse events or withdrawals due to adverse events.⁸ Injection-site pain was common, reported in 84% (n=77/92) of VH499 recipients. VH499, an investigational capsid inhibitor, showed a long half-life following subcutaneous and intramuscular administration supporting further evaluation towards twice-yearly dosing, reflecting ViiV Healthcare’s continued focus on researching approaches aimed at reducing treatment burden and addressing evolving unmet needs.

VH184 and VH499 are investigational and are not approved for use by any regulatory authority.

About Vocabria (cabotegravir)

Vocabria injection is indicated – in combination with rilpivirine injection – for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.

Vocabria tablets are indicated – in combination with rilpivirine tablets – for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class for:

• oral lead-in to assess tolerability of Vocabria and rilpivirine prior to administration of long-acting cabotegravir injection plus long-acting rilpivirine injection.

• oral therapy for adults and adolescents who will miss planned dosing with cabotegravir injection plus rilpivirine injection.

Vocabria tablets are indicated for the short-term treatment of HIV in combination with rilpivirine tablets, therefore, the prescribing information for rilpivirine tablets should be consulted for recommended dosing.

The healthcare provider and patient may decide to use cabotegravir tablets as an oral lead-in prior to the initiation of cabotegravir injection to assess tolerability to cabotegravir or may proceed directly to cabotegravir injections.

Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets

About Rekambys (rilpivirine)

Rekambys is indicated – in combination with cabotegravir injection – for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.

Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).

Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection

About Apretude (cabotegravir long acting)

Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents weighing at least 35kg.

Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection

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 with GSK (LSE: GSK) and Shionogi as current shareholders. The company is dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. ViiV Healthcare’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.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025, and GSK’s Q3 Results for 2026.

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