ViiV Healthcare is a global leader focused on innovative medicines for HIV treatment and prevention. Majority owned by GSK, the HIV specialist company has Pfizer Inc and Shionogi as shareholders.
ViiV’s current treatment pipeline comprises long-acting injectables and drug candidates with unique mechanisms of action at various stages of development. In November, the firm entered into a licensing agreement with NIH to develop investigational bNAb N6LS for the treatment and prevention of HIV-1.
Dr Harmony P Garges, Chief Medical Officer at ViiV Healthcare, leads the global medical team. As CMO, she is accountable for all aspects of human safety and medical governance for the company, including strategic planning for investigator-sponsored and collaborative studies. Edited excerpts from an interview:
Treatment approaches using novel regimes like Dovato have helped bring down the drug burden and improve compliance levels in people living with HIV. How does ViiV look to tackle drug resistance, which continues to be a major challenge?
As we work to develop new medicines for HIV, we are acutely aware that we need to remain vigilant over how the virus evolves to be resistant to treatment. Any new treatment will need to be at least as effective as existing ones, and especially so in treating patients who have limited options due to treatment resistance. The World Health Organization (WHO) published a report in 2019 which showed that resistance to two NNRTIs, efavirenz and nevirapine, exceeded 10% in 12 of the 18 countries reporting data for the report. This is clearly of concern, and further support the WHO’s 2018 recommendation of rapid adoption of dolutegravir-based regimens which, if implemented, will help avert the effects of NNRTI resistance.
Fostemsavir, a first-in-class investigational attachment inhibitor with a unique MOA and one of our pipeline treatments, has been specifically studied in the heavily treatment experienced (HTE) patient population in the BRIGHTE study. This study has allowed ViiV Healthcare to further understand the safety and efficacy of fostemsavir through 96 weeks of therapy, which demonstrated continued improvement in virologic suppression and clinically significant CD4 T cell recovery in HTE PLHIV.
The first-ever injectable, cabotegravir + rilpivirine, can change the current HIV treatment paradigm. At the same time, the effective implementation of monthly injections may pose practical hurdles to both healthcare facilities as well as people living with HIV. In what ways can implementation issues can be overcome?
As part of our efforts to help medical practices prepare for the first and only once-monthly, complete long-acting regimen, ViiV Healthcare initiated the first-ever pre-approval implementation study in HIV – CUSTOMIZE – to identify and evaluate approaches to implementing the treatment regimen into clinical practice. This study was launched in partnership with diverse medical practices, providers, and patients across nine US states to identify the most practical and efficient ways to implement this therapy.
Although implementation trials are usually run after a medicine is made available, we are conducting this trial now, because we recognize that a long-acting injectable treatment for HIV will require a shift in the traditional care model currently in place.
How does ViiV Healthcare seek to address the mental health impact of HIV?
To address the mental health impact of HIV, it is vital that we have a strong understanding of the experiences and perspectives of PLHIV. To achieve this, ViiV Healthcare runs an international survey that seeks to understand the experiences of people living with HIV. According to the international Positive Perspectives 1 survey, despite high overall satisfaction with current antiretroviral (ARV) therapies, considerable challenges and daily impact of treatment persist.
We are also leading Patient Reported Outcomes (PRO) research to comprehend what is happening in the ‘real world.’
Looking to the immediate future, the insights gained through this research demonstrate that improvements in long-term quality of life (QoL) and emotional wellbeing can be best achieved if PLHIV’s lives are ‘de-medicalised’. By developing treatment strategies and regimens that reduce the daily intrusion of medical treatments in their lives, PLHIV can be liberated from daily HIV medication and in turn, improve mental wellbeing.
With an ageing HIV population, healthcare providers need to take a more holistic approach and have a greater understanding of the evolving healthcare needs over an entire lifetime. PLHIV need to be offered choices and [we should] appreciate how those options fit and impact their current lifestyle and long-term plans. It is no longer enough to aim for an undetectable viral load. We must now strive for a life where PLHIV thrive and achieve a ‘self-perceived’ optimal QoL and improved mental health.
Can you share the key insights gained by ViiV Healthcare in working towards its goal to end the HIV epidemic in the US?
At ViiV Healthcare, we recognize that we can’t end the epidemic in the US without involving, collaborating and empowering people living with and at risk of acquiring HIV. That’s why working with the worldwide HIV community has been a key part of our approach.
We engage with key stakeholders and organizations at the national, regional, and local levels to gain insights, increase collaboration and deliver innovative approaches to accelerate the HIV response. We develop and fund innovative, community-based programmes that seek to eliminate disparities in HIV care, as evidenced by our ACCELERATE! programme and Positive Action for Women, Positive Action for Youth, Positive Action for Latinx Men and Positive Action Southern Initiative – programmes focused on key populations disproportionately impacted by HIV. This has allowed us to develop and support sustainable initiatives to ensure everyone benefits from the promise of modern HIV treatment to extend life, improve outcomes and eliminate transmission.
We also take an innovative approach to HIV management that explores the gaps in the real-world delivery of HIV care. As part of this commitment, we’ve established an Implementation Science programme, focused on improving the delivery of HIV care and treatment in the often-complicated ‘real-world’. Through these Implementation Science efforts, we’re striving to improve everything from initial testing and diagnosis, access to treatment, identifying solutions, to improved treatment adherence for PLHIV; ensuring no individual is left behind in our goal of ending the HIV epidemic.
What strategies does ViiV have to extend the benefits of these therapeutic advances to the developing world where the prevalence of HIV is higher?
Making our medicines widely available to those affected by HIV, regardless of income or where they live, is central to both our access-to-medicines strategy and a core element of our corporate mission. Making our medicines available at an affordable price is also an essential part of our access approach.
We support people and communities most affected by HIV through our global Positive Action programme. Working closely with PLHIV and other priority populations, Positive Action provides grants to community-based organisations to address many of the structural and systemic drivers of HIV, and overcome barriers to HIV prevention, treatment and care access.
Additionally, our innovative public-private partnership initiative between the Clinton Health Access Initiative (CHAI) and ViiV Healthcare with financial support from Unitaid is designed to accelerate the development of optimal paediatric formulations of our antiretroviral medicine dolutegravir and was launched in July 2018. The partnership aims to expedite development and introduction by providing generic partners with financial and technical incentives to manufacture dolutegravir for the treatment of HIV in children and infants across resource-limited settings.