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ViiV Healthcare to present first head-to-head data for long-acting HIV treatment Cabenuva against daily oral Biktarvy at CROI 2023
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Other key data to be presented from ViiV Healthcare's innovative pipeline and portfolio include new HIV prevention findings for long-acting cabotegravir and predictors of response to broadly neutralising antibody N6LS
London, 14 February 2023 - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of key abstracts from the company's diverse portfolio of industry-leading innovative HIV treatment and prevention options alongside next-generation pipeline advancements at the Conference on Retroviruses and Opportunistic Infections (CROI 2023) being held in Seattle, Washington from 19 - 22 February 2023.
Key data to be presented includes the first head-to-head study for the complete long-acting HIV treatment regimen,Cabenuva (cabotegravir, rilpivirine [CAB+RPV LA]) compared against complete daily oral Biktarvy(bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]). Additionally, there will be new findings from the HIV Prevention Trials Network (HPTN) 083 and 084 trials of cabotegravir for PrEP.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: "The exciting findings in HIV treatment and prevention to be presented at CROI 2023 underscore ViiV Healthcare's position as the industry leaders in 2-drug and long-acting regimens. We believe long-acting is both the present and future of HIV, and providing an option beyond daily pills is why we chose to do a head-to-head study with a commonly prescribed, daily, oral medicine. The treatment satisfaction and preference findings for the individuals who were part of this trial demonstrate an important unmet need to address the burden of daily pills for a significant proportion of people living with HIV. We will also be presenting data showing HIV incidence and prevention efficacy of cabotegravir long-acting for PrEP among Black men having sex with men and transgender women in the US, communities frequently underrepresented in clinical trials. ViiV Healthcare will continue to bring forward ground-breaking advances in HIV treatment and prevention and looks forward to sharing these data with the scientific and HIV communities."
Key abstracts to be presented at CROI 2023 by ViiV Healthcare and its study partners will include:
Advancing innovative long-acting HIV treatment: At CROI 2023, ViiV Healthcare will share findings from the SOLAR study, the first, head-to-head, phase IIIb study of the complete long-acting injectable regimen Cabenuva compared against complete daily oral BIC/FTC/TAF. The noninferiority study assessed virologically suppressed adults who had been taking BIC/FTC/TAF and were then randomised to switch to treatment with CAB+RPV LA or continue with BIC/FTC/TAF. Researchers will share 12-month findings on treatment satisfaction and patient preference for the two regimens along withhead-to-head efficacy and safety results.[i] Additional findings from SOLAR to be presented at CROI 2023 will also include the results of an analysis observing weight and metabolic changes when switching to CAB + RPV LA or continuing on BIC/FTC/TAF.[ii]
New scientific data from HPTN 084 on cabotegravir long-acting for HIV prevention: New findings from the HPTN 084 trial that assess the impact of less frequent dosing of cabotegravir LA for PrEP pharmacology in women will be presented. Findings to be presented at CROI will focus on participants with delayed injections during the blinded phase of the study.[iii]Additional findings on cabotegravir LA for PrEP from HPTN 084 to be presented at CROI 2023 will also include the results of an analysis observing safety, tolerability, and acceptability of the long-acting prevention medicine in a substudy that enrolled adolescent girls in sub-Saharan Africa, a population that is among the most disproportionately impacted by the HIV epidemic.[iv]
Advancing new mechanisms of action in HIV research: Phase IIa proof-of-concept data will be presented from the BANNER study of N6LS (VH3810109), a novel, investigational, broadly neutralising antibody (bNAb) that is being investigated in adults living with HIV at two dosing levels - a high dose and ten-fold lower dose (40 mg/kg and ∼4 mg/kg (280 mg), respectively). Researchers will share how baseline viral and participant factors impact virologic response following infusion of VH3810109, and will demonstrate the utility of using a phenotypic test to determine sensitivity of pre-treatment virus to N6LS.[v]
Strengthening clinical and real-world evidence for dolutegravir and 2-drug regimens: New findings for dolutegravir (DTG) will be presented at CROI, including 48-week metabolic health results from RUMBA, the first, open-label, randomised clinical trial comparing the effects of switching from a second-generation integrase inhibitor based triple antiretroviral therapy (BIC/FTC/TAF) to the 2-drug regimen Dovato (dolutegravir, lamivudine [DTG/3TC]).[vi]
Results from the D2EFT study, an international randomised open-label trial that compared DTG with ritonavir boosted darunavir (DRV/r) versus DTG with fixed tenofovir and lamivudine or emtricitabine (TDF/XTC) versus standard of care in adults whose first-line therapy has failed, will be presented. Data from Eswatini will also be presented, evaluating the prevalence of neural tube defects (NTDs) among women on DTG at the time of conception.[vii] Previous findings from the Tsepamo study showed that NTD prevalence in infants born to women on DTG at the time of conception were not significantly different from women living with HIV or women on other antiretroviral therapy.[viii]
Understanding patients' experience to best meet the needs of people living with HIV: Additional findings underscoring the importance of patient preference and experience to be shared at CROI 2023 include data on the HPTN 083 study of cabotegravir LA for PrEP, evaluating participant choice of long-acting PrEP versus daily oral PrEP after study unblinding.[ix]Further, results among participants from the HPTN 083 study looks at experiences among US Black men and transgender women.[x]
Here is a list of ViiV Healthcare sponsored and supported studies to be presented at CROI 2023:
APRETUDE (cabotegravir) extended-release injectable suspensions
INDICATION
APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
Link to full press release
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2023/february/viiv-healthcare-to-present-first-head-to-head/
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