PharmaShots Interview: In Conversation with ViiV Healthcare's Sr. VP, Kimberly Smith, Where she Shares Insights on the US FDA Approval for Label Update of its Lead Candidate in HIV

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PharmaShots Interview: In Conversation with ViiV Healthcare's Sr. VP, Kimberly Smith, Where she Shares Insights on the US FDA Approval for Label Update of its Lead Candidate in HIV


  • Kimberly talked about the approval for label update of ViiV’s lead candidate in HIV, and how an optional oral lead-in will be efficient for people receiving it
  • Kimberly also spoke about ViiV’s collaboration with Janssen for the commercialization of the product 
  • The interview gives an understanding of the different treatment options for HIV and how injectables show higher efficacy than other formulations

Smriti: Can you shed some light on CABENUVA (cabotegravir and rilpivirine) and its formulation details?

Kimberly: Cabenuva (cabotegravir, rilpivirine) is the first and only complete long-acting HIV treatment, offering virologically suppressed adults and adolescents a regimen that significantly reduces dosing to as few as six times a year. It is comprised of two injectable medicines: cabotegravir (200mg/mL), ViiV Healthcare’s integrase strand transfer inhibitor, and rilpivirine (300mg/mL) a non-nucleoside reverse transcriptase inhibitor from Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Cabenuva is administered intramuscularly as two individual injections in the buttocks by a healthcare provider, either once monthly or every two months. The long-acting injectable formulation allows Cabenuva to stay in the body for longer, so it can be taken less frequently.

On March 24, 2022, ViiV Healthcare received approval from the FDA for a label update for Cabenuva making the oral lead-in with cabotegravir and rilpivirine tablets optional. Previously, the label required that prior to starting Cabenuva, the person had to start with oral cabotegravir and rilpivirine for a month to assess tolerability to the medicines. With this approval, the oral lead-in is now optional, which allows people to start directly with long-acting injections and streamlines the initiation process for people living with HIV.

Smriti: Explain the epidemiology of HIV-1 in the US?

Kimberly: In 2020, around 1.2 million people were living with HIV in the US. While we continue to make incredible strides and advancements in HIV treatment and prevention efforts, certain populations remain disproportionately impacted by the disease, including Black and Latinx communities. In 2019, the CDC reported that 42% of the new HIV diagnoses in the US were among the Black community, and 29% were in the Latinx community.

As the fight against HIV continues, ViiV Healthcare is dedicated to providing resources that go beyond treatment and help disrupt disparities in HIV care by supporting programs that meet the needs of communities most disproportionately impacted.

Smriti: How is the injectables' efficacy superior to other formulations?

Kimberly: In clinical trials, Cabenuva was shown to be a safe and effective alternative to daily oral HIV medicine in virologically suppressed adults and adolescents living with HIV.

When it comes to HIV treatment, we know one size does not fit all. We have heard from the HIV community that many people are interested in alternative dosing options that do not require daily oral therapy. Some people living with HIV face challenges taking daily oral HIV therapy, such as stigma or privacy concerns, and long-acting therapies like Cabenuva that provide an option to significantly reduce frequency of dosing may help address unmet needs.

Cabenuva, as a first-of-its-kind regimen that allows people living with HIV the option to maintain viral suppression with six dosing days a year, is a truly innovative and welcome option within the community. And now that the oral lead-in is optional, people living with HIV can start directly with the injections, which will streamline the initiation process.

We saw in clinical trials that Cabenuva dosed every two months was preferred by approximately nine out of every ten participants compared to daily oral cabotegravir and rilpivirine taken as the oral lead-in.* This preference highlights the meaningful impact long-acting regimens can have on the treatment experience for the HIV community.

*Patient preference data were collected from clinical trial participants who received Cabenuva. In a pooled analysis of this intent-to-treat exposed population with no prior Cabenuva experience, 327 patients completed a single-item question at Week 48 and 92% (300/327) preferred every-two-month Cabenuva compared with one percent (4/327) who preferred oral cabotegravir and rilpivirine that was taken as the required oral lead-in. These results are descriptive and should not be used to infer clinical significance.

Smriti: Are you interested in any future collaboration for the promotion and distribution of CABENUVA?

Kimberly: We already have a collaboration agreement with Janssen for the development and commercialization of Cabenuva. Our agreement with Janssen is one example of ViiV Healthcare’s strategy to collaborate with other companies, institutions and not-for-profit organizations to contribute to the understanding and management of HIV.

Smriti: What will be your commercialization strategy after approval i.e., is it going to be a pan-US launch or a phase-wise launch? Do you already have a salesforce in place to do so?

Kimberly: The FDA approval making the oral lead-in optional gives us the ability to market Cabenuva in the US, with or without an oral lead-in. Since the label update in March, our US sales team has been educating US HCPs about this new streamlined initiation process.

Outside of the US, in October 2021, we received authorization from the European Commission to update the Summary of Product Characteristics for Vocabria (cabotegravir) and Rekambys (rilpivirine) making the oral lead-in optional.

Smriti: Also, tell us something about the etiology of HIV-1.

Kimberly: HIV can be passed from one person to another through bodily fluids; this typically happens through sexual contact, sharing needles, blood transfusions, and/or pregnancy. When HIV comes into the body, it attacks and hides in immune cells; the immune system doesn’t see it as foreign and doesn’t react to it as rapidly as it might another type of virus. The HIV virus also can mutate, which is why finding a cure has been so challenging.

But, there’s good news. First, treatment advancements have allowed people living with HIV who have access to medication to live long and healthy lives, often as long as their peers who don’t have HIV. We also have prevention medications that can help people stay HIV-negative. Second, we now know that people living with HIV who are on treatment and maintain undetectable levels of the virus cannot transmit HIV to their sexual partners; this is known as Undetectable = Untransmittable or U=U. I think both of these points go a long way to helping address some of the outdated thinking and stigma associated with HIV.

Source: Canva

About the Author: 

Dr. Kimberly Y. Smith MD, MPH is the Sr. Vice President, Head of Research and Development at ViiV Healthcare. She oversees the clinical development of the ViiV marketed and pipeline assets. She has 20 years of experience as an HIV clinician and researcher. She earned her MD and MPH from the University of Michigan

Related Post: PharmaShots Interview: ViiV Healthcare's Kimberly Smith Shares Insight on Data of Long-Acting Cabotegravir and Rilpivirine Presented at IDWeek 2020

Senior Editor

Senior Editor at PharmaShots. She is curious and very passionate about recent updates and developments in the life sciences industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.

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