FDA approves label update to ViiV’s long-acting HIV treatment

HIV-focused pharma company ViiV Healthcare has received the okay from the US Food and Drug Administration (FDA) to make the oral lead-in for Cabenuva (cabotegravir, rilpivirine) optional. While the oral combination drug may be taken for a month to assess tolerability prior to injections, this period is now optional after clinical trial data demonstrated similar safety and efficacy profiles for both initiation methods.

Cabenuva, a drug that can be taken as few as six times a year, received FDA approval in February. To learn more about the drug and recent developments around the treatment, Outsourcing-Pharma spoke with Kimberly Smith, head of research and development at ViiV Healthcare.

OSP: Could you share an overview of the journey ViiV has taken with Cabenuva from discovery to approval?​

KS: There have been incredible advancements in HIV research and development over the past four decades that have made HIV a manageable condition for those with access to antiretroviral treatment. The standard of care has been daily oral medication for some time, but we know from our work with the HIV community that people living with HIV are interested in more choices for treatment, specifically options that offer less frequent dosing.

Alongside our partner, the Janssen Pharmaceutical Companies of Johnson & Johnson, we began our investigational research in long-acting cabotegravir and rilpivirine more than six years ago with the goal of bringing an innovative, long-acting treatment option to the HIV community that gave them choice beyond daily pills. And we are so proud to have delivered on that goal.

Cabenuva was first approved in Canada in March 2020 and since then has been approved in the EU, US, Australia, Switzerland, and the UK. (In the EU, Switzerland, and UK, the product goes by the brand names Vocabria and Rekambys.)

Today, virologically suppressed people living with HIV in the US have the option of once-monthly or every-two-months dosing. When we think of what HIV treatments were like just a couple of decades ago, when people living with HIV had to take handfuls of antiretroviral pills several times a day, compared to now and having a treatment that offers as few as six dosing days a year, the progress is really tremendous.

OSP: The treatment is the first (and still only) long-acting treatment for HIV patients. Could you please talk about some of the reasons why this is good news for patients?​

KS: HIV is a lifelong condition and so it’s important that people living with HIV have choices when it comes to their treatment. We know that one treatment does not fit all. Some people living with HIV face challenges taking daily oral HIV medications, and long-acting therapies provide an option that significantly reduces the frequency of dosing.

With Cabenuva, people living with HIV can receive treatment as few as six days a year and remain virologically suppressed, which is a welcome advancement.

OSP: You spent two decades at Rush as an HIV clinician, and with the AIDS Clinical Trials Group. Could you please share some perspective about the progress in HIV treatments from your time in that role to your leadership position with ViiV?​

KS: I began my career at Rush University at the height of the epidemic and spent those early years caring for patients in the hospital and in the outpatient clinic as well as doing clinical research on HIV. My research focused on gender and racial disparities in HIV and on finding better treatment options that were less difficult for patients to take over the long term.

During my time there, I was able to witness the impact early antiretroviral therapies had on people living with HIV and the transformation in care when more tolerable and effective treatments were discovered. But I knew there was still more that could be accomplished in the field to address the evolving needs of the community.

When I made the switch to industry, I decided to do so because I knew it would give me the opportunity to continue to help the HIV community on a larger scale. Since joining ViiV Healthcare, we have seen incredible therapeutic advancements and have developed innovative treatment and prevention options – including long-acting injectable medicines – to address the unmet needs of people living with HIV.

Reflecting on the earliest days of my career, it’s amazing to see the progress we have made. People living with HIV can now live long and healthy lives and have the ability to choose the treatment option that best suits their lifestyle.

OSP: Could you please share some detail about the optional oral lead-in, and how it might help the patient initiation experience?​

KS: When Cabenuva first was approved by the FDA for once monthly and every-two-months dosing, people living with HIV were required to take cabotegravir and rilpivirine tablets for a month to assess the tolerability of the medicines prior to initiating Cabenuva injections. With this recent FDA approval, that oral lead-in period is now optional, allowing people to start directly with injections.

We have been looking for ways to streamline the initiation experience of Cabenuva for both people living with HIV and healthcare providers, and this milestone does just that.

OSP: Please talk about the FLAIR data and how it supports this approval.​

KS: The recent approval was based on the FLAIR study (NCT02938520) which assessed the safety and efficacy of Cabenuva, with or without an oral lead-in phase. The 124-week findings showed similar outcomes in terms of virologic suppression, safety, and tolerability. We submitted an sNDA based on these data in 2021 and are pleased this label update for Cabenuva will allow people living with HIV the option to start directly on injections.

OSP: Could you tell us anything about what might be on the horizon at ViiV?​

KS: As the leader in long-acting HIV therapies, we’ll continue to focus our research and development efforts around cabotegravir in both the treatment and the prevention space. We’re continuing to innovate and we are exploring new options that provide flexibility for in-clinic or at-home administration.

More broadly, at the portfolio level, our developments plan is responding to the voice of the community and attempting to reduce the impact HIV has on their lives – beginning with dosing frequency, which we are looking to address through regimens that can be dosed even less frequently than every two months.

OSP: Anything to add?​

KS: In the US, the FDA also recently approved an expanded indication for Cabenuva for virologically suppressed adolescents 12 years and older who weigh at least 35kg. This is the first time a long-acting HIV treatment has been available for the adolescent population anywhere in the world. We are extremely proud of this accomplishment because we believe adolescents will gain some of the same benefits we have seen in adults, increased privacy, reduced stress related to daily dosing, and potentially less HIV-related stigma.

At ViiV Healthcare, we will continue to deliver on our commitment to providing innovative treatments that meet the evolving needs of the HIV community and will remain dedicated to our mission of ensuring no one living with HIV is left behind.