ViiV Healthcare presents continued positive findings from first-ever implementation science study on integrating an investigational once-monthly injectable HIV treatment into US healthcare practices

For media and investors only

Issued: London, UK

• Interim data presented at IDWeek 2020 showed the majority of patient participants continue to find once-monthly injectable cabotegravir plus rilpivirine to be acceptable for treating their HIV and appropriate for their daily lives
• Further findings from interviews with healthcare providers and clinical staff revealed key recommendations for clinic set-up, injection administration, and appointment management to facilitate the implementation of the once-monthly regimen into practice

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive findings from people living with HIV (PLHIV) who are participating in the CUSTOMIZE trial (Cabotegravir plus Rilpivirine in the US To Optimize and Measure Implementation and Experience). CUSTOMIZE is the first-ever implementation science study that aims to identify successful methods of integrating the investigational once-monthly, long-acting regimen of cabotegravir and rilpivirine for the treatment of HIV-1 into clinical practices in the US. These findings build on recently presented healthcare provider and clinical staff survey perspectives and were presented today at the 2020 Infectious Diseases Society of America (IDSA) IDWeek™.

The CUSTOMIZE study was launched in July 2019 to find the most practical and efficient ways to implement a monthly injectable treatment regimen in the US which, if approved, has the potential to create a paradigm shift in HIV treatment. Since the study began, a team from ViiV Healthcare has worked with healthcare providers, clinical staff, and patients across a range of medical practices, including federally qualified health centers, academic medical centers, and private physician offices.

As part of a survey given to patient participants after the first four months of the study, the majority (91%) said they continued to perceive the once-monthly injectable regimen as highly acceptable for treating their HIV and an appropriate treatment option for their life. Healthcare providers and clinical staff outlined several key recommendations to best facilitate the implementation of the injectable regimen across a number of criteria, including clinic set-up, injection administration, and appointment management.

Paul Benson, D.O., CUSTOMIZE Investigator and Director of the Be Well Medical Center, said: “Options to replace daily oral therapy have the potential to change the treatment landscape and it’s promising to see strong acceptance of this once-monthly injectable treatment among people living with HIV who participated in the CUSTOMIZE study. By incorporating their voices, we help ensure their perspectives about long-acting treatment are heard and build on the acceptance of the regimen’s implementation among healthcare providers and clinical staff from the study. If this investigational regimen is approved, the findings of CUSTOMIZE will be instrumental in helping to ensure that healthcare providers in the US can successfully deliver this innovative, once-monthly treatment option to people living with HIV.”

Patient perspectives from CUSTOMIZE

During the study, 105 virologically suppressed adults living with HIV at eight participating clinical sites received once-monthly cabotegravir and rilpivirine and were surveyed on the regimen’s acceptability for treating their HIV and appropriateness for their life. The perspectives of these participants were positive overall, with a large proportion (>91%) indicating they agreed or completely agreed at the beginning of the study and after four months of treatment that the once-monthly regimen was both appropriate and acceptable.

Prior to initiating treatment with once-monthly cabotegravir and rilpivirine, participants were asked a series of questions about their current antiretroviral therapy (ART). At the study start, one-third of participants (33%) reported hiding their oral ART from others, and one in five participants (22%) reported they had difficulty remembering to take their daily ART. Interest in a “more convenient treatment option” (83%) was a top reason among trial participants for choosing to enrol in the CUSTOMIZE study.

Access to care was assessed after four months, with the majority of participants (84%) reporting that monthly clinic visits were very or extremely acceptable and 66% of participants reporting no logistical challenges to their clinic administered once-monthly injection. Although pain or soreness from their injection was cited by 58% of participants as their most common worry at the start of the trial, only 28% of participants continued to report injection pain or soreness as a concern after four months of treatment. Adherence to treatment among trial participants remained high over the course of four months with nearly all injections (95%) received within a +/- 7-day treatment window around the target treatment date, further supporting patient acceptance of monthly visits.

Healthcare provider and clinical staff perspectives from CUSTOMIZE

Interviews were conducted at study initiation and after four months with 24 physicians, nurses, and administrators to evaluate barriers and facilitators to the implementation of once-monthly cabotegravir and rilpivirine. After four months of implementation, interviews with staff study participants revealed key recommendations on best practices to facilitate clinic set-up, injection administration, and appointment management. While some staff had initial concerns about implementation, at the interim analysis these concerns were perceived as surmountable, requiring minor purchases or minimal practical changes to clinical practice.  Overall, study participants viewed operationalizing this injectable regimen as an important and achievable goal that will facilitate patient preferences and treatment adherence.

When planning to implement once-monthly cabotegravir and rilpivirine, staff study participants recommended that clinics create a process for managing the flow of patients that included identifying designated rooms for administering injections, establishing proper refrigeration space, identifying a person to track appointment schedules, and creating a system for rescheduling and reminders. To alleviate the potential impact of missed appointments and facilitate implementation, participants recommended that administrators explore ways to improve transportation support through public transit vouchers and ride-sharing programs, explore the flexibility of allowing walk-in appointments, and modifying the working hours of nurses to increase coverage for injection administration. Lastly, as administering injections may be new for HIV practitioners, participants recommended face-to-face injection trainings among staff as well as administering initial injections during such trainings to increase confidence among new adopters.

Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: “The perspectives of people living with HIV and the insightful recommendations of healthcare providers and clinical staff who have successfully implemented this once-monthly regimen will be invaluable in helping integrate once-monthly injectable treatment, if approved, into US healthcare practices. By combining the findings of this regimen’s clinical development program with the real-world experience supporting its implementation through CUSTOMIZE, healthcare providers and administrators now have evidence and tools to help bring this treatment to people living with HIV in the US.”

The full 12-month results from the CUSTOMIZE study will be presented at an upcoming medical meeting. The corresponding CARISEL study, which will examine the implementation of the long-acting regimen of cabotegravir and rilpivirine in certain European healthcare settings, started in September 2020 and initial results are expected in 2021.

The long-acting regimen of cabotegravir and rilpivirine was approved by Health Canada in March 2020 and is currently under review by the US Food and Drug Administration and other global regulatory authorities. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) recently issued a positive opinion recommending marketing authorisation for long-acting cabotegravir and rilpivirine in both injectable and tablet formulations. The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, which has the authority to approve medicines for use throughout the European Union.

About CUSTOMIZE (NCT04001803)

CUSTOMIZE is a single-arm, multicenter, one-year evaluation of the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinic practices to deliver the investigational once-monthly, injectable regimen of cabotegravir and rilpivirine to appropriate patients living with HIV. The study evaluates both qualitative and quantitative measures across a range of clinic types, including university hospitals as well as private and public clinics, with varied geographic and demographic representation.

A suite of educational items, training aids, treatment and resource planning tools, appointment reminders and patient-directed support items were made available as part of this study. Staff study participants from each site (physician/primary care practitioner, nurse/medication administration personnel, administrator/clinic manager) took part in the study through participation in surveys and interviews. Sustainment of implementation strategies was assessed via surveys and semi-structured interviews of staff study participants as well as patient study participants. The primary endpoint was change from baseline to Month 12 in site survey responses for acceptability, appropriateness and feasibility.

For further information please see https://www.clinicaltrials.gov/ct2/show/NCT04001803

About the long-acting regimen of cabotegravir and rilpivirine

The long-acting regimen of cabotegravir and rilpivirine is an investigational regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL). The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.

CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is currently only approved in Canada.

Important Safety Information for CABENUVA
Indications and clinical use:
CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA <50 copies/mL).

VOCABRIA (cabotegravir tablets) is indicated, in combination with EDURANT (rilpivirine tablets), as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 RNA <50 copies/mL) as: An oral lead-in to assess tolerability of cabotegravir prior to initiating CABENUVA

• Oral bridging therapy for missed CABENUVA injections

Geriatrics (>65 years of age): Not sufficiently studied to determine if they respond differently than patients <65 years of age

Pediatrics (<18 years of age): Safety and efficacy not established

Contraindications:

In combination with:

• Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, and phenytoin
• Antimycobacterials: Rifabutin, rifampin, rifapentine
• Glucocorticoid: Systemic dexamethasone (more than a single dose)
• St John’s wort (Hypericum perforatum)

Relevant warnings and precautions:

• Should not be used in patients with known or suspected resistance to cabotegravir or rilpivirine
• Patients may still develop opportunistic infections and other complications of HIV infection
• Risk of transmission: precautions should be taken
• Depressive disorders
• Hepatotoxicity (serum transaminase elevations)
• Hepatic adverse events; increased risk for worsening or development of transaminase elevations in patients with hepatitis B or C co-infection or marked elevations in transaminases prior to treatment; monitoring of liver chemistries is recommended
• Loss of virologic response due to drug interactions; review concomitant medications during therapy
• Caution when used in combination with drugs that have a risk of Torsade de Pointes
• Skin and hypersensitivity reactions; discontinue immediately if signs or symptoms develop
• Administer the oral lead-in dosing prior to administration of CABENUVA to help identify patients who may be at risk of a hypersensitivity reaction
• Residual concentrations of cabotegravir and rilpivirine injections may remain in the systemic circulation of patients for up to 12 months or longer
• Risk of resistance due to treatment discontinuation
• Post-injection reactions within minutes after the injection of rilpivirine, including dyspnea, agitation, abdominal cramping, flushing, sweating, oral numbness, and changes in blood pressure. Reported in <0.5% of subjects and began to resolve minutes after the injection, and may have been associated with inadvertent (partial) IV administration
• Insufficient data in pregnant women; should not be used unless the potential benefits outweigh the potential risks
• HIV-1-infected mothers should not breastfeed their infants if receiving CABENUVA

For more information:

Please consult the Product Monograph at cabenuvapm.viivhealthcare.ca for additional important information relating to adverse reactions, drug interactions, and dosing. The Product Monograph is also available by calling 1-877-393-8448. To report an adverse event, please call 1-877-393-8448.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/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 www.viivhealthcare.com.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.