In an interview with PharmaShots, Max Lataillade, Vice President, Head of Global Research Strategy, ViiV Healthcare shared his views on the development of Rukobia and the story of its development. He also shed light on what this approval means to the patients.

Shots:

• MA for Rukobia marks a critical breakthrough for this select group of adults who have cycled through several different antiretrovirals, sometimes from birth, and until now, have had little to no treatment options left to maintain viral suppression
• In the study, Rukobia maintained viral suppression over the long-term in 60% of HTE adults in the randomized cohort (a unique finding in multidrug-resistant trials with 96 weeks of data), and in 37% of HTE adults in the nonrandomized cohort
• Rukobia is a first-in-class attachment inhibitor and targets the first step of the HIV lifecycle. It works by attaching directly to the glycoprotein 120 (gp120) subunit on the surface of the virus

Tuba: Discuss the development of Rukobia and how it works for patients with HIV.

Max: Rukobia is a first-in-class attachment inhibitor and targets the first step of the HIV lifecycle. It works by attaching directly to the glycoprotein 120 (gp120) subunit on the surface of the virus, thereby blocking HIV from attaching to the host immune system CD4+ T-cells and preventing the virus from infecting those cells and multiplying. I often say that with this novel mechanism of action (MOA), we are attacking HIV first instead of waiting for HIV to attack our immune cells and immune system. Rukobia shows no cross-resistance to other currently licensed antiretroviral classes, offering a new option to a specific group of people who have multidrug-resistant HIV and are at risk of disease progression and death. Rukobia comes in tablet form; the recommended dose is 600mg of fostemsavir, twice daily. 

Fostemsavir is manufactured in Parma, Italy, and by Piramal in the United Kingdom. During certain stages of production, fostemsavir is sensitive to light and, to ensure appropriate manufacturing, ViiV Healthcare built two new facilities in record time to solely accommodate the drug's complex manufacturing process.

Source: HIV.gov

Tuba: Highlight the clinical data supporting the approval of Rukobia (fostemsavir) in HIV.

Max: The Marketing Authorisation Application (MAA) for Rukobia is supported by Week 96 data from the pivotal phase III BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimized background therapy (OBT) in heavily treatment-experienced (HTE) adults living with multidrug-resistant HIV, many of whom had advanced HIV disease, and were severely immunocompromised at study entry.

In the study, Rukobia maintained viral suppression over the long-term in 60% of HTE adults in the randomized cohort (a unique finding in multidrug-resistant trials with 96 weeks of data), and in 37% of HTE adults in the nonrandomized cohort. The primary endpoint of the study was the mean change in log10 HIV-1 RNA between Day 1 and Day 8 for the randomized cohort.

The proportion of participants who discontinued treatment with Rukobia due to an adverse event was 7% at Week 96 (randomized: 5% and nonrandomized: 12%). The most common adverse reactions (all grades) observed in =5% of randomized and nonrandomized participants were nausea, fatigue, and diarrhea. The most common adverse events leading to discontinuation were related to infections (3%). Serious adverse reactions occurred in 3% of people taking Rukobia and included three cases of severe immune reconstitution inflammatory syndrome, which is not uncommon in this heavy treatment-experienced population.    

Tuba: What makes Rukobia unique from other HIV treatments available?

Max: Rukobia is the first HIV attachment inhibitor and targets the first step of the HIV lifecycle. It has no cross-resistance to other currently approved ARV classes, has shown sustained rates of virologic suppression in patients unable to otherwise construct a viable regimen, and has demonstrated clinically meaningful CD4+ T-cell recovery in this specific patient population.

Tuba: What are the other targeted geographies (Ex-US & EU) for seeking approval of Rukobia?

Max: ViiV Healthcare's access to medicines strategy considers the specific challenges faced by countries in terms of local HIV epidemic burden and economic status. ViiV Healthcare expands and accelerates access to our medicines to benefit people living with HIV who need them regardless of their income, location, status, age, or gender. We are committed to enabling access to our medicines where we believe there is a medical need. In line with this commitment, we will be seeking needs-driven registration of our products, including Rukobia.

Tuba: As the company is dedicatedly working in HIV, is ViiV planning to push its boundaries besides HIV?

Max: We are the only company set up to specifically combat, prevent, cure and end HIV. We go to extraordinary lengths to achieve our vision and are 100% dedicated to addressing the challenges of the HIV epidemic. Our focus is on researching and delivering innovative HIV medicines that make a difference to people living with, and at risk of, HIV and AIDS. In addition, we work on a wide range of community programmes and initiatives to serve every community affected by the virus.

We are fully committed to push through every challenge until HIV/AIDS is eradicated, and as such, our focus will remain 100% on HIV and AIDS.

Tuba: What does this approval mean for the company?

Max: Rukobia addresses a critical unmet need in HIV care for those with little or no treatment options left; through our pioneering research, we aim to meet the diverse needs of the HIV community and we won't stop until our research offers more ways to treat, and hopefully one day, cure HIV. Marketing Authorisation for Rukobia further embodies our mission to ensure no person living with HIV is left behind and continues to reinforce our commitment and drive to be here until HIV is not.

Tuba: What challenges did you face in the development of Rukobia?

Max: We have overcome many barriers to bring this important medicine to a small subset of people living with HIV. In 2016, ViiV Healthcare decided to continue the Rukobia clinical program after it was acquired from Bristol Myers Squibb. At that time, this complex but unique medicine had already been in the development space for over 15 years.

Because of the unique properties of Rukobia (in particular, its sensitivity to light during certain stages of its production), manufacturing has been extremely complex. To address these challenges and ensure that we could sustainably develop Rukobia, we have invested tens of millions to construct two manufacturing facilities just to make Rukobia. The development of Rukobia, in particular, is one of many examples highlighting how ViiV Healthcare fulfills its mission of leaving no person living with HIV behind.  

Image Source: University of Toronto

About Author:

Max Lataillade is the Vice President and Head of Global Research Strategy at ViiV Healthcare. He joined the company in 2016 and leads several programs and HIV teams with a focused approach on developing new antiretroviral agents that are safe and well-tolerated, with novel mechanisms of action that target key unmet medical needs in treatment-naïve and experienced people living with HIV.

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