In a recent interview with PharmaShots, Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare shared information on the positive findings presented at the 2020 Infectious Diseases Society of America (IDWeek) and the impact of COVID-19 on the development of long-acting cabotegravir and rilpivirine.

Shots:

• The company reported the positive findings of a pooled analysis of six ongoing clinical studies which includes P-IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE studies evaluating long-acting cabotegravir and rilpivirine regimen in 1,744 patients with HIV-1 infection across 16 countries
• The positive findings showed 93% of participants maintained their injection visits amid the COVID-19 with no instances of virologic failure or development of resistance and showed good tolerability
• Long-acting regimen of cabotegravir and rilpivirine is indicated as a complete 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 <50 copies/mL) and has received Health Canada's approval in Mar'2020

Tuba:  Showcase the ViiV's positive findings presented at the 2020 Infectious Diseases Society of America (IDSA) IDWeek.

Kimberly: At IDWeek 2020, we presented data across our innovative portfolio, showcasing meaningful advancements and scientific breakthroughs that are currently challenging the treatment paradigm. We shared positive findings across our development program for long-acting cabotegravir and rilpivirine, including five-year findings from LATTE-2 and 48-week findings from POLAR that further established the durable efficacy and safety of long-acting cabotegravir and rilpivirine. Findings from the implementation science CUSTOMIZE study showed that long-acting cabotegravir and rilpivirine was both acceptable and appropriate among people living with HIV and their providers, and provided best practices to integrate the investigational regimen in US healthcare settings. Lastly, positive findings from an analysis of the entire long-acting cabotegravir and rilpivirine development program confirmed there were no antiretroviral therapy interruptions in spite of COVID-19, demonstrating strong implementation fidelity for this potential HIV treatment option.

Tuba:  What are the impacts of global pandemic COVID-19 on the development of the dual regimen?

Kimberly: The analysis showed that no antiretroviral therapy interruptions were found across the entirety of the ongoing clinical development program for long-acting cabotegravir and rilpivirine. When missed visits occurred due to the pandemic, they were manageable and successfully mitigated, primarily by switching patients onto short periods of daily oral therapy of cabotegravir and rilpivirine, with no resulting virologic failure or emerging resistance. These findings speak to how the regimen of cabotegravir and rilpivirine may be adapted to meet the needs of people living with HIV who have events in their lives that could cause them to miss an injection appointment.

Tuba:  As the approval in the EU is on track, when can we expect the availability of a combination regimen in the EU?  What are your other geographical targets for seeking approval?

Kimberly: The long-acting regimen of cabotegravir and rilpivirine 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) has issued a positive opinion recommending marketing authorization for long-acting cabotegravir and rilpivirine in both injectable and tablet formulations. The CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission, which has the authority to approve medicines for use throughout the European Union.

Further regulatory authority submissions are planned in the coming months. We look forward to working with these regulatory authorities as part of our continued commitment to developing new and innovative treatment options for people living with HIV.

Tuba:  When can we expect the NDA submission of Cabotegravir and Rilpivirine complete long-acting regimen to the US FDA?

Kimberly: The long-acting regimen of cabotegravir and rilpivirine was resubmitted to the US Food and Drug Administration earlier this year and is currently under review. The PDUFA date is set for Jan. 28, 2021.

Tuba:  Is ViiV Healthcare working on any digital tool or planning to work on any digital initiative for changing the experience of people living with HIV?

Kimberly: ViiV Healthcare recently announced a new weekly podcast, Being Seen, which is an in-depth exploration of the role culture plays in resolving how we see ourselves and how we are seen by others. The first season explores current cultural representations of the queer and gay Black male experience and the impact on their lives and society.

Hosted and narrated by Darnell Moore, award-winning writer and activist, we hope that Being Seen can encourage more culturally accurate portrayals of the queer and gay Black male experience to reduce stigma and change perception. The podcast expands on insights and findings from our landmark ethnographic research conducted among Black gay men in Baltimore, Maryland and Jackson, Mississippi. We hope that this initiative will raise awareness to the impact of stigma on every aspect of these individual's lives and underscore the collective responsibility to end discrimination among marginalized communities, including those living with HIV.

Tuba:  As ViiV Healthcare has a broad portfolio of medicines targeting HIV in adults, what are your efforts in pediatric HIV infection which is the most invisible population in HIV?

Kimberly: Age-appropriate formulations are essential to close the gap between treatment options available for adults and children and ensure children have access to life-saving medicines that give them the potential to be healthy, just like any other child.

On June 12, the FDA approved Tivicay PD tablets for oral suspension, which are used in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least four weeks and weighing at least 3kg. The FDA also approved the extended indication of already approved Tivicay 50mg film-coated tablet in pediatric HIV patients weighing 20kg and above.

In addition, we have worked in collaboration with the HIV community and our partners, DAIDS, NIH, IMPAACT, Penta, and MRC at UCL, who have been instrumental to our progress in generating and analyzing clinical data to optimize pediatric formulations and help improve the lives of children living with HIV.

About Kimberly Smith:

Dr. Kimberly Y. Smith MD, MPH is the Vice President for Global Medical Strategy and Head of Research and Development for ViiV Healthcare. She oversees the clinical development of the ViiV marketed and pipeline assets and works closely with the development teams in both GSK and Pfizer.

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