ViiV Healthcare presents real-world evidence at EACS 2021 reinforcing the use of its 2-drug regimens Dovato (dolutegravir/lamivudine) and Juluca▼ (dolutegravir/rilpivirine) for the treatment of people living with HIV
Real-world evidence (RWE) is an essential component of evidence-based medicine, building a bridge between clinical trials and clinical practice. Today, ViiV Healthcare is presenting three real-world evidence studies at the 18th European AIDS Conference (EACS 2021), which evaluate the effectiveness, safety and tolerability of these antiretroviral treatment (ART) regimens in real-world clinical settings.
Vani Vannappagari, Global Head of Epidemiology and Real World Evidence at ViiV Healthcare, said: “ViiV Healthcare is dedicated to developing medicines that meet the evolving needs of people living with HIV and the findings presented today further highlight the important role of dolutegravir-based 2-drug regimens as viable, long-term treatment options demonstrated in both clinical trials and real-world clinical practice. These valuable data strengthen the compelling case for introducing dolutegravir/lamivudine to treatment-naïve people living with HIV, in addition to switching those who are already virologically suppressed.”
The COMBINE-2 study evaluated 283 participants who were virally suppressed and switched to an integrase inhibitor (INI) + reverse transcriptase inhibitor (RTI) 2-drug regimen (2DR), of which the majority were dolutegravir-based. Findings showed that the regimens were tolerable and highly effective in maintaining long-term virologic suppression at 96 weeks, with 99.2% (n=274/276) of participants remaining virally suppressed as of their last viral load. In the study, which included a representative proportion of black (15.9%, n=45) and female (29.3%, n=83) participants, 98% of participants were on a dolutegravir-based 2DR; 62% (n=175) on dolutegravir/lamivudine and 36% (n=101) on dolutegravir/rilpivirine. Two serious adverse events (AEs) were reported, one relating to weight gain and the other to anxiety/depression. Weight gain was the most commonly reported AE (n=8; IR: 5.0, 95% CI: 3.4-7.3).1
Findings from the URBAN study showed high rates of virologic suppression for dolutegravir/lamivudine at one year, at 93.3% (n=28/30) in treatment naïve study participants, and 92.9% (n=303/326) in those who were virally suppressed, with zero cases of resistance development. Safety findings showed a low number of discontinuations for virologic reasons (0.8%, n=3). No serious AEs were reported. The most common AEs in the study were depression (n=3), sleep disorders (n=2) and headache (n=2). Median weight change from baseline was +2.0 kg (IQR,1.0 ‒ 6.0; n=15) in treatment-naïve, and +1.4 kg (IQR, -1.0‒4.0; n=122) in treatment experienced people living with HIV.2
The JUNGLE study showed that the 2DR dolutegravir/rilpivirine is highly effective in maintaining virologic suppression at two years, with a viral suppression rate of 75% (n= 137/182). There were no discontinuations for virologic reasons. The most common AEs seen in the study were sleep disorder (n=9), depression (n=4) and diarrhoea (n=3). In 20 participants, (10.6%), AEs led to discontinuation of dolutegravir/rilpivirine. No serious AEs were reported.3
Dr Cristina Mussini, Professor of Infectious Diseases at University of Modena and Reggio Emilia, Policlinico Hospital, Italy and lead author of COMBINE-2 said: "Real-world evidence gathered by clinicians in their everyday practice has long been recognised as a valuable adjuvant to randomised controlled trials (RCTs). RCTs have an essential role in evidence-based medicine, and real-world evidence builds on that by providing insights into how medicines work for real patients in their day-to-day lives. The real-world evidence on dolutegravir-based dual therapy at EACS and in particular, dolutegravir/lamivudine (DTG/3TC), reinforces what we have previously seen in numerous RCTs, demonstrating that DTG/3TC is effective and well tolerated, while maintaining long-term virologic suppression and offering a high barrier to resistance.”
1 Mussini C, Henegar C, Assoumou L, et al. Highly Effective Two-drug Regimens of an Integrase Inhibitor and Reverse Transcriptase Inhibitor in Real-World Setting -Data from COMBINE-2 Study. Poster PE2/48. Presented at EACS, October 2021.
2 Scholten S, Noe S, Wyen C, et al. 12-month outcomes of Dolutegravir (DTG) + Lamivudine (3TC) in ART-naïve and pre-treated PLHIV in Germany: Real-world data from the German URBAN cohort. Poster PE2/52. Presented at EACS, October 2021
3 Ummard-Berger K, Wyen C, Schabaz F, et al. 2-year outcomes of dolutegravir/rilpivirine in virologically suppressed HIV-infected PLHIV: Real-world data from the German JUNGLE cohort. Poster PE2/2. Presented at EACS, October 2-21.