Abstract
Background
Long-acting cabotegravir plus rilpivirine (CAB+RPV LA) and dolutegravir plus lamivudine (DTG/3TC) are HIV-1 antiretroviral therapy regimens with different administration routes and dosing frequencies, allowing for greater choice.plus
Methods
VOLITION is a phase 3b, multicenter, nonrandomized, parallel-group, open-label implementation–effectiveness study (NCT05917509) evaluating viral suppression on DTG/3TC for up to 16 weeks, followed by a participant-determined optional switch to CAB+RPV LA dosed Q2M or continuation of DTG/3TC through Month (M) 11/12. Co-primary endpoints were the time to virologic suppression with DTG/3TC and the proportion of participants with HIV RNA < 50 copies/mL per the Snapshot algorithm at M11 with CAB+RPV LA. Safety and participant experience were also assessed.
Results
One hundred and seventy-one participants initiated DTG/3TC. Median time to suppression on DTG/3TC was 4.1 weeks (95% confidence interval: 4.1–4.3), with 98% (n = 167/171) achieving virologic suppression and similar rates observed across baseline viral load and CD4+ cell count categories. At Day of Choice (DoC), 85% (n = 129/151) of eligible participants chose to switch to CAB+RPV LA. At M11, 113/129 (88%) participants maintained suppression with CAB+RPV LA; 1 participant had confirmed virologic failure with resistance (integrase strand transfer inhibitor and non-nucleoside reverse transcriptase inhibitor). Both regimens were well tolerated, with no new safety signals observed. Treatment satisfaction improved after DoC and remained high with CAB+RPV LA.
Conclusions
Providing treatment-naive participants with the option to switch to CAB+RPV LA as soon as virologic suppression was achieved on daily oral therapy allowed them to choose a treatment to meet their individualized needs while maintaining virologic suppression, which is essential for long-term treatment success and optimized quality of life.
Clinical Trial Registration
Keywords: cabotegravir, dolutegravir + lamivudine, long acting, randomized clinical trial, rilpivirine
People with HIV require lifelong treatment to keep the virus under control. Long-acting cabotegravir plus rilpivirine is an injectable treatment that is given every 1 or 2 months. Dolutegravir plus lamivudine is an oral tablet taken daily. The VOLITION study explored whether adults who had not received HIV treatment before could first take a daily tablet (dolutegravir plus lamivudine) to quickly reduce the amount of virus in their blood and then choose whether to continue tablets or switch to long-acting injections (cabotegravir plus rilpivirine). Among 171 participants, nearly all (98%) achieved control of the virus quickly with dolutegravir plus lamivudine. Most (85%) participants with the option chose to switch to cabotegravir plus rilpivirine. At Month 11, 88% of participants who switched to cabotegravir plus rilpivirine maintained low levels of the virus. Both treatment options were well tolerated. People who switched to cabotegravir plus rilpivirine reported high and improved satisfaction with their treatment. Giving people the option to switch to cabotegravir plus rilpivirine as soon as control of the virus has been achieved with oral therapy can help people find a treatment that best fits their life while keeping HIV well controlled.
Graphical Abstract
Graphical Abstract.
Shared decision-making (SDM) is essential in managing chronic conditions like HIV, as it encourages patient engagement, adherence, and personalized treatment [1, 2]. Availability of highly efficacious, well-tolerated antiretroviral therapy (ART) has increased the emphasis on SDM and choice, as well as other factors beyond clinical parameters, such as quality of life and convenience. When people with HIV (PWH) are actively involved in choosing their treatment regimen, they are more likely to report optimal self-rated health and satisfaction and have improved health outcomes [1–3]. Despite this, multiple studies have demonstrated that SDM in treatment selection is often lacking in clinical practice, with treatment preference not being discussed [1, 4, 5].
The Positive Perspectives study showed that some participants felt empowered by knowing daily oral therapy would keep their HIV under control; however, many were stressed by daily dosing routines (33%) and were concerned that taking pills every day increased the likelihood of revealing their HIV status to others (38%) [6]. Having the option to switch from daily oral therapy to long-acting (LA) injectable therapy could reduce stigma [7] and deliver greater treatment satisfaction [8], potentially improve long-term health outcomes, and further support person-centered care.
Cabotegravir plus rilpivirine LA (CAB+RPV LA) and dolutegravir plus lamivudine (DTG/3TC) are integrase strand transfer inhibitor-based HIV ART regimens with different modalities and dosing frequencies, allowing for greater choice and the selection of regimens according to lifestyle considerations. DTG/3TC is a single-tablet regimen taken orally once daily that is approved for treatment-naive and virologically suppressed PWH. DTG/3TC has shown rapid and durable virologic suppression regardless of baseline viral load or CD4+ cell count, with rare reports of emergent resistance across numerous clinical trials and real-world studies in both treatment-naive and treatment-experienced individuals [9–13]. However, some treatment guidelines do not recommend DTG/3TC as an initial ART regimen in individuals with HIV RNA >500 000 copies/mL [14–16]. CAB+RPV LA is the first and only complete LA injectable regimen, dosed monthly or every 2 months (Q2M), and it is approved for the treatment of virologically suppressed PWH [17–19]. CAB+RPV LA has demonstrated high, durable efficacy and a low virologic failure rate with rare reports of emergent resistance [20–27], with greater participant-reported treatment satisfaction and preference over daily oral therapy in real-world and clinical studies [8, 21, 28–30]. In real-world cohorts worldwide, more than 39 000 PWH have received CAB+RPV LA (unpublished data). Some treatment guidelines recommend that PWH should be virally suppressed for 3–6 months prior to switching to CAB+RPV LA [14, 16].
Initial use of DTG/3TC can provide a route for treatment-naive PWH to rapidly achieve virologic suppression to enable an early switch to CAB+RPV LA. The VOLITION study (NCT05917509) was designed to evaluate the efficacy, safety, participant experience, and implementation of starting oral DTG/3TC as a first-line regimen for initial virologic suppression, followed by a participant-determined optional switch to intramuscular CAB+RPV LA Q2M for the maintenance of virologic suppression or continuation of treatment with DTG/3TC. We present efficacy, safety, and participant experience results from the VOLITION study through Month 11/12.
METHODS
Study Design
VOLITION is a phase 3b, multicenter, nonrandomized, parallel-group, open-label implementation–effectiveness study conducted at 45 sites across Europe, North America, and South America.
The screening period of the study was up to 35 days. At the enrollment visit, participants initiated oral ART with DTG/3TC, and they were informed that they would have the choice of continuing daily DTG/3TC or switching to CAB+RPV LA after achieving initial virologic suppression. Participants were given up to 16 weeks to achieve virologic suppression during the Suppression Phase, with quantitative plasma HIV RNA testing performed at Week 4, 8, 12, and 16 visits. Following their first HIV RNA result <50 copies/mL at any time between Weeks 4 and 16, participants were eligible to choose their treatment for the Maintenance Phase at their next study visit 2–4 weeks later (Day of Choice [DoC] visit; Figure 1).
Figure 1.
Study design. VOLITION was conducted at 45 sites across the United States (n = 15), Spain (n = 8), France (n = 5), Italy (n = 4), Argentina (n = 4), Chile (n = 4), Germany (n = 3), and Canada (n = 2). aOr older, if required by local regulations. bParticipants positive for HBsAg were excluded. Participants negative for anti-HBs but positive for anti-HBc were excluded only if HBV DNA was detected. cParticipants proceeded to the Day of Choice at the study visit following their first plasma HIV RNA result <50 copies/mL (Week 4 at the earliest but no later than Week 16). Participants must have been suppressed to <50 copies/mL in order to qualify for the optional switch to CAB+RPV LA. The exclusion criteria for switching included: treatment-emergent ALT ≥ 5×ULN; ALT ≥ 3×ULN and bilirubin ≥1.5×ULN (with >35% direct bilirubin); and pregnancy. 3TC, lamivudine; ALT, alanine aminotransferase; anti-HBs, hepatitis B surface antibody; ART, antiretroviral therapy; CAB, cabotegravir; DTG, dolutegravir; HBc, hepatitis B core antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCV, hepatitis C virus; LA, long-acting; Q2M, every 2 m; RAM, resistance-associated mutation; RPV, rilpivirine; ULN, upper limit of normal.
Provided there were no contraindications for switching treatments, at the DoC visit, participants could receive their first CAB+RPV LA initiation injections or continue taking DTG/3TC (Figure 1). Participants who did not achieve HIV RNA < 50 copies/mL by Week 16 were permitted a single repeat test, and those who remained unsuppressed continued DTG/3TC into the Maintenance Phase. Eligible participants electing to switch to CAB+RPV LA continued treatment in the Maintenance Phase for up to 11 months, with study visits approximately Q2M from Month 1 to 11. Participants who chose to remain on DTG/3TC (or who were ineligible to switch) continued in the Maintenance Phase for up to 12 months, with study visits after the DoC approximately every 3 months from Month 3 to 12. At study completion, participants were expected to exit the study and transition to local commercially available products. Participants who prematurely discontinued CAB+RPV LA for safety reasons or lack of efficacy were followed for up to 12 months after their last dose.
Patient Consent Statement
VOLITION was conducted in accordance with the Declaration of Helsinki. All participants provided written informed consent. The study protocol, amendments, informed consent, and other information that required preapproval were reviewed and approved at the site or regional level by an independent ethics committee (IEC) or institutional review board (IRB; see Supplementary Table 1 for a full list of IECs/IRBs).
Participants
Eligible participants were aged ≥18 years with plasma HIV RNA ≥ 1000 copies/mL at screening and were naive to ART. There were no exclusions based on CD4+ cell count or maximum HIV RNA level. Recruitment targets were 15% aged ≥50 years, 25% women, and 20% persons of color. Key exclusion criteria included hepatitis B co-infection and known or suspected the presence of any major resistance mutations, as defined by the International Antiviral Society–USA resistance guidelines, to DTG, 3TC, CAB, or RPV at screening [31]. During study conduct, eligibility criteria were amended to allow participants to enroll and start treatment before resistance test results were available, in closer alignment with rapid initiation guidelines [15, 16]. If resistance mutations to DTG or 3TC were identified, participants were required to discontinue the study, and if resistance mutations to CAB or RPV were identified, participants were not permitted to switch to CAB+RPV LA. Women who were pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study were excluded.
Procedures and Assessments (HIV RNA Quantification)
HIV RNA was quantified using the cobas 6800 assay (F. Hoffmann-La Roche) for participant virologic management. However, during the study, contemporaneous ViiV Healthcare–sponsored studies using the same assay identified discrepancies between central and local laboratory viral load results, with unexplained patterns of elevated viral load results at the central laboratory. This prompted additional retrospective testing on stored plasma samples for multiple ongoing studies using the RealTime HIV assay (Abbott), which had been employed in previous studies in the DTG/3TC and CAB+RPV LA clinical development programs. Retesting with the RealTime HIV assay was carried out on all samples at DoC and Month 11/12, as well as at any visits at which an HIV RNA ≥ 50–1000 copies/mL was reported using the cobas 6800 assay. Accordingly, all virologic efficacy analyses presented here are based on the results from the RealTime assay. When a RealTime result was missing or nonevaluable, a cobas 6800 assay result was used instead. Substantial discordance was observed between the cobas 6800 and RealTime HIV RNA assays at low viral load thresholds (<50 and <200 copies/mL), consistent with previous observations; full details regarding the consistency and concordance of assay results are presented elsewhere [32]. All participant management decisions during the study, including determining eligibility for switching to CAB+RPV LA and virologic discontinuation criteria, were based on results from the cobas 6800 assay.
Outcomes
Co-primary study endpoints were the time to virologic suppression (HIV RNA < 50 copies/mL) from Day 1 with DTG/3TC and the proportion of participants with HIV RNA < 50 copies/mL per the Snapshot algorithm at Month 11 with CAB+RPV LA.
The secondary outcomes assessed included the proportion of participants with HIV RNA ≥ 50 copies/mL at Month 11 with CAB+RPV LA; Month 12 Snapshot outcomes with DTG/3TC (<50 and ≥50 copies/mL); the proportion of participants with confirmed virologic failure (CVF; defined as 2 consecutive plasma HIV RNA values ≥200 copies/mL after prior suppression to <50 copies/mL); the development of resistance; and the change in CD4+ cell count over time.
Safety and tolerability were evaluated by monitoring the occurrence of adverse events (AEs), serious AEs (SAEs), drug-related AEs, and AEs leading to discontinuation of the study drug.
Participant experience was evaluated using validated and bespoke questionnaires.
Statistical Analysis
As this study was noncomparative, no formal statistical hypotheses were tested. Sample size was based on estimation (see Supplementary Methods, Sample Size for full details). Baseline assessments were from Day 1 for participants who continued DTG/3TC in the Maintenance Phase and from DoC for those who switched to CAB+RPV LA.
Time to virologic suppression was analyzed based on all participants who received ≥1 dose of DTG/3TC in the Suppression Phase. The nonparametric Kaplan–Meier method was used to estimate time to first HIV RNA < 50 copies/mL from Day 1. Maintenance of virologic suppression to HIV RNA < 50 copies/mL over 11 months postswitching to CAB+RPV LA and over 12 months postcontinuation of DTG/3TC was analyzed using a modified Snapshot algorithm (with RealTime HIV RNA results prioritized over the cobas 6800 assay when available and within the Snapshot window) with a 95% confidence interval (CI) using the Wilson score methodology. Observed data, including only the participants with available virologic data in-window, are also presented.
Safety endpoints were analyzed for all participants who received ≥1 dose of study treatment.
RESULTS
Disposition and Participant Baseline Characteristics
Overall, 222 participants were screened, 51 of whom were not enrolled due to ineligibility. A total of 171 participants were enrolled in the Suppression Phase and received ≥1 dose of DTG/3TC (Figure 2).
Figure 2.
Participant flow. aThe most common reasons for not meeting inclusion/exclusion criteria were: HIV RNA < 1000 c/mL at screening (n = 11), the presence of major resistance mutations to 3TC or RPV (n = 9 [3TC, n = 1; RPV, n = 7; one additional participant failed screening under this criterion because resistance could not be evaluated]); had received ART prior to enrollment (n = 6); untreated syphilis infection (n = 5). bPhysician decisions reflected individualized clinical judgment based on safety, feasibility, adherence considerations, and the need for timely clinical management. cGrade 4 SAE of Pneumocystis jirovecii pneumonia. dParticipants completed the Suppression Phase once they achieved plasma HIV RNA < 50 copies/mL or the participant reached the Week 16 visit, whichever was earlier. eReasons for ineligibility for switching were: did not achieve viral suppression (defined as HIV RNA <50 copies/mL; n = 15) and baseline resistance to non-nucleoside reverse transcriptase inhibitors (E138A; n = 1). Higher numbers of nonsuppression are reported here as participant management was based on the cobas 6800 assay, whereas efficacy results are based on the RealTime assay. fIncludes 22 participants eligible to switch who opted to continue DTG/3TC and 16 participants who were not eligible to switch. gAll participants who withdrew from the study under “protocol-defined stopping criteria” had virologic failure or virologic nonresponse. Virologic discontinuation criteria were based on HIV RNA results from the cobas 6800 assay. 3TC, lamivudine; AE, adverse event; CAB, cabotegravir; DoC, Day of Choice; DTG, dolutegravir; LA, long acting; RPV, rilpivirine; SAE, serious adverse event.
Baseline characteristics are shown in Table 1. Overall, 26% of participants self-identified as women, 30% as Black or African American, and 51% as Hispanic/Latinx. At Day 1, median (interquartile range [IQR]) plasma HIV RNA was 57 100 (21 200–174 000) copies/mL, with 9% (n = 15/171) having ≥500 000 copies/mL. Median (IQR) CD4+ cell count was 396 (252–543) cells/mm3, with 16% of participants having a CD4+ cell count <200 cells/mm3.
Table 1.
Participant Demographics and Disease Characteristics
| Parameter | Suppression Phase (Day 1) DTG/3TC (N = 171) |
Maintenance Phase (Day of Choice)a CAB+RPV LA (n = 129) |
|---|---|---|
| Age, years, median (range) | 31 (18–70) | 31 (18–67) |
| <35 y, n (%) | 105 (61) | 79 (61) |
| ≥50 y, n (%) | 18 (11) | 13 (10) |
| Women (self-identified gender), n (%) | 45 (26) | 34 (26) |
| Race, n (%) | ||
| Black or African American | 51 (30) | 42 (33) |
| White | 106 (62) | 77 (60) |
| Other racesb | 7 (4) | 5 (4) |
| Not reported or unknown | 7 (4) | 5 (4) |
| Hispanic/Latinx ethnicity, n (%) | 88 (51) | 66 (51) |
| Region, nc (%) | ||
| North America | 78 (46) | 63 (49) |
| Europe | 47 (27) | 30 (23) |
| South America | 46 (27) | 36 (28) |
| Plasma HIV RNA (copies/mL), median (range)d | 57 100 (781–4 290 000) | … |
| Plasma HIV RNA (copies/mL) category, n (%)d | ||
| <100 000 | 106 (62) | … |
| 100 000 to <500 000 | 50 (29) | … |
| 500 000 to <1 000 000 | 11 (6) | … |
| ≥1 000 000 | 4 (2) | … |
| CD4+ cell count (cells/mm3), median (IQR) | 396 (252–543) | 555 (427–668) |
| CD4+ cell count (cells/mm3) category, n (%)e | ||
| <100 | 8 (5) | 1 (<1) |
| 100 to <200 | 19 (11) | 7 (6) |
| 200 to <350 | 46 (27) | 20 (16) |
| ≥350 | 98 (57) | 101 (78) |
| CDC category, n (%)f | ||
| Stage 0–2 | 137 (80) | N/A |
| Stage 3 | 32 (19) | N/A |
| Stage unknown | 2 (1) | N/A |
| Weight, median (IQR) | 72.5 (63–84) | 77.7 (65–86) |
| BMI category, n (%) | ||
| Overweight (25 to <30 kg/m2) | 46 (27) | 47 (36) |
| Obesity (≥30 kg/m2) | 34 (20) | 27 (21) |
Abbreviations: 3TC, lamivudine; BMI, body mass index; CAB, cabotegravir; CDC, Centers for Disease Control and Prevention; DTG, dolutegravir; IQR, interquartile range; LA, long-acting; N/A, not applicable; RPV, rilpivirine.
aThere were 38 additional participants who continued into the Maintenance Phase but who did not switch to CAB+RPV LA and therefore remained on DTG/3TC; 11% (n = 4/38) were aged ≥50 y, 24% (n = 9/38) were women, and 16% (n = 6/38) had a BMI ≥ 30 kg/m2. Among these 38 participants, the median viral load was 128 500 copies/mL, and the median CD4+ cell count was 370.0 cells/mm3.
bOther race participants: Multiple: DTG/3TC, n = 3; CAB+RPV LA, n = 3; Asian: DTG/3TC, n = 4; CAB+RPV LA, n = 2.
cNorth America included United States (including Puerto Rico; DTG/3TC, n = 69; CAB+RPV LA, n = 54) and Canada (DTG/3TC, n = 9; CAB+RPV LA, n = 9); Europe included France (DTG/3TC, n = 9; CAB+RPV LA, n = 6), Germany (DTG/3TC, n = 5; CAB+RPV LA, n = 4), Italy (DTG/3TC, n = 16; CAB+RPV LA, n = 9), and Spain (DTG/3TC, n = 17; CAB+RPV LA, n = 11); South America included Argentina (DTG/3TC, n = 28; CAB+RPV LA, n = 20) and Chile (DTG/3TC, n = 18; CAB+RPV LA, n = 16).
dIn order to progress to the Day of Choice, participants were required to have achieved plasma HIV RNA result of <50 copies/mL in the Suppression Phase. For the participants who switched to CAB+RPV LA, Day 1 median (range) HIV RNA was 53 400 (781–4 280 000) copies/mL. Plasma HIV RNA categories (copies/mL) at Day 1 were: <100 000, n = 86/127 (68%); 100 000 to <500 000, n = 36/127 (28%); ≥500 000, n = 5/127 (4%).
eFor the participants who switched to CAB+RPV LA, Day 1 median (range) CD4+ cell count was 412 (19–1522) cells/mm3. CD4+ cell count categories (cells/mm3) at Day 1 were: <100, n = 4/125 (3%); 100 to <200, n = 14/125 (11%); 200 to <350, n = 35/125 (28%); ≥350, n = 72/125 (58%).
fFor the participants who switched to CAB+RPV LA, Day 1 CDC categories were: stage 0–2, n = 105 (81%); stage 3, n = 22 (17%); stage unknown, n = 2 (2%).
Most participants (98%, n = 167/171) completed the Suppression Phase. Reasons for premature discontinuation were physician decision (n = 2), lost to follow-up (n = 1), and an AE (n = 1; not considered related to the study treatment).
At DoC, 151 (88%) participants were eligible and were offered the choice to switch to CAB+RPV LA. The majority (85%, n = 129/151) chose to switch to CAB+RPV LA for the Maintenance Phase; 22 (15%) participants chose to remain on DTG/3TC.
Efficacy
DTG/3TC
Median time to suppression with DTG/3TC was 4.1 weeks (95% CI 4.1–4.3); 98% (n = 167/171) of participants achieved virologic suppression (Figure 3), and suppression rates were similar across baseline viral load (92%–98%) and CD4+ cell count categories (83%–98%; Supplementary Figure 1). At Month 12, of the participants who remained on DTG/3TC (n = 38), 29 (76%) had HIV RNA < 50 copies/mL, 4 (11%) had HIV RNA ≥ 50 copies/mL, and 5 (13%) had no virologic data in the Snapshot analysis window per the modified Snapshot algorithm (Supplementary Table 2). The observed virologic suppression rate at Month 12 was 88% (n = 29/33; participants with available virologic data in window). CD4+ cell count increased during the DTG/3TC Suppression Phase, with a median (IQR) initial increase from Day 1 to DoC of 142 (42–248) cells/mm3 (n = 159/171). For those who remained on DTG/3TC (n = 33/38), median (IQR) increase from Day 1 to Month 12 was 263 (112–411) cells/mm3, with a median absolute (IQR) CD4+ cell count of 735 (458–876) cells/mm3 at Month 12. Median CD4+/CD8+ ratios are presented in Supplementary Table 3.
Figure 3.
Time to virologic suppression on DTG/3TC. 3TC, lamivudine; CI, confidence interval; DTG, dolutegravir.
No participants on DTG/3TC developed treatment-emergent resistance. One participant on DTG/3TC (during the Suppression Phase) was withdrawn from the study after meeting the CVF criteria; this participant did not meet the CVF criteria based on retrospective retesting with the RealTime assay. Viral load over time assessed with the RealTime and cobas 6800 assays for this participant is presented in Supplementary Figure 2.
CAB+RPV LA
At Month 11, of the participants who switched to CAB+RPV LA (n = 129), 113 (88%) participants had HIV RNA < 50 copies/mL, 6 (5%) participants had HIV RNA ≥ 50 copies/mL, and 10 (8%) participants had no virologic data in the analysis window per the modified Snapshot algorithm (Table 2). The observed virologic suppression rate at Month 11 was 95% (n = 113/119; participants with available virologic data in window). Median (IQR) CD4+ cell count increased from DoC to Month 11 by 78 (−10 to 182) cells/mm3 (n = 118/129), with a median absolute (IQR) CD4+ cell count of 624 (431–826) cells/mm3 at Month 11. Median CD4+/CD8+ ratios are presented in Supplementary Table 3. Of the 729 injection visits in the Maintenance Phase, 643 (88%) were administered on time (within the ±7-day dosing window), or earlier (1%, n = 9/729; >7 days before the target injection date). The median (IQR) number of days after the target date for late injections was 9 (8–10) days. Most CAB LA and RPV LA injections were administered with needles that were 1.5 to 2 inches in length (125 participants [97%]); 8% (n = 10) and 2% (n = 3) of participants received CAB LA or RPV LA injections with needles ≥2 inches and <1.5 inches in length, respectively.
Table 2.
Virologic Outcomes (Modified Snapshot Algorithm) at Month 11 With CAB+RPV LA
| n (%) | CAB+RPV LA (n = 129) |
|---|---|
| Virologic suppression (<50 copies/mL) [95% CI] | 113 (87.6) [80.0–92.2] |
| No virologic suppression (≥50 copies/mL) [95% CI] | 6 (4.7) [1.7–9.8] |
| Data in window not below threshold | 5 (3.9)a |
| Discontinued for lack of efficacy | 1 (<1)b |
| Discontinued for other reason while not below threshold | 0 |
| Change in background therapy | 0 |
| No virologic data in window | 10 (7.8) |
| Discontinued study due to AE or death | 0 |
| Discontinued study for other reason | 10 (7.8)c |
| On study but missing data in window | 0 |
All participant management decisions during the study, including determining eligibility for switching to CAB+RPV LA and virologic discontinuation criteria, were based on results from the cobas 6800 assay; efficacy results are based on the RealTime assay.
Abbreviations: AE, adverse event; CAB, cabotegravir; CI, confidence interval; CVF, confirmed virologic failure; LA, long-acting; RPV, rilpivirine.
aParticipants had viral blips (51, 69, 79, 93, and 121 copies/mL).
bMet CVF criteria using the cobas 6800 assay but did not meet the CVF criteria based on the retrospective retesting with the RealTime assay.
cLost to follow-up (n = 6), withdrawal by participant (n = 2), and participant reached protocol-defined stopping criteria (n = 2).
One participant (0.8%) in the CAB+RPV LA group met the CVF criteria with emergent resistance (see Supplementary Figure 2, footnote A, for a full summary). Three additional participants in the CAB+RPV LA group were withdrawn from the study after meeting the CVF criteria with the cobas 6800 assay; these participants did not meet the CVF criteria based on retrospective retesting with the RealTime assay, and none of these participants had resistance mutations detected at the suspected virologic failure visit. Viral loads over time assessed with the RealTime and cobas 6800 assays for each participant are presented in Supplementary Figure 2.
Safety
Drug-related AEs with DTG/3TC were reported by 17 (10%) participants during the Suppression Phase and 2 (5%) participants during the Maintenance Phase; none were grade ≥3 (Supplementary Table 4) or led to study discontinuation. In the CAB+RPV LA group, 66 (51%) participants had drug-related AEs, the majority of which were grade 1 or 2 injection site reactions (ISRs; Supplementary Table 5). Excluding ISRs, 13 (10%) participants in the CAB+RPV LA group had drug-related AEs, all of which were grade 1 or 2. Four drug-related grade 3 AEs were reported across 3 participants (injection site pain [n = 2], injection site swelling [n = 2]). injection site reactions were reported in 49% (n = 63/129) of participants, most of which were grade 1 or 2 (98%), with a median (IQR) duration of 3 (2–6) days. There were no drug-related SAEs, drug-related withdrawals, or deaths reported during the study.
Participant Experience
On Day 1, when asked whether they had considered what treatment they would choose at DoC, 72% (n = 119/165) of participants who completed the questionnaire had considered an option, 85% (n = 101/119) of whom expressed an interest in switching to CAB+RPV LA. At DoC, 85% (n = 129/151) of eligible participants chose to switch to CAB+RPV LA. Reasons for switching to CAB+RPV LA at DoC, and the perceived advantages of CAB+RPV LA at Day 1 and DoC, are presented in Supplementary Figures 3 and 4. At Month 11, 89% (n = 93/105) of participants who responded to the question stated that they planned to continue CAB+RPV LA after the study, 5% (n = 5/105) planned to switch back to DTG/3TC, and 7% (n = 7/105) were unsure.
Overall, participants reported high levels of treatment satisfaction with DTG/3TC at Week 4, with mean (standard deviation [SD]) HIV Treatment Satisfaction Questionnaire status version (HIVTSQs) scores of 57.6 (9.21) out of 66, which were maintained at DoC (mean [SD] score: 57.8 [10.70]). Among those choosing CAB+RPV LA, treatment satisfaction improved after DoC (mean [SD] score: 57.6 [10.36]) and remained high through Month 11 (mean [SD] score: 62.5 [6.74]) (Supplementary Figure 5). Participants continuing DTG/3TC maintained high satisfaction from Week 4 (mean [SD] score: 57.4 [9.97]) through Month 12 (mean [SD] score: 60.0 [7.36]).
DISCUSSION
The VOLITION study integrates early SDM by offering ART-naive PWH the option to choose between LA injectable and oral regimens after achieving virologic suppression, enabling treatment selection aligned with individual preferences and needs while maintaining virologic suppression.
Once-daily DTG/3TC enabled rapid virologic suppression in 4.1 weeks across this diverse population of treatment-naive adults with HIV, confirming its high potency, including for those with a high viral load and low CD4+ cell count at baseline, consistent with previous reports [33–35]. Notably, transmitted resistance compromising rapid initiation with DTG/3TC was uncommon in this study population and was similar to previous observations seen in GEMINI and STAT [35, 36]. Among the participants who continued DTG/3TC, most remained suppressed at Month 12 (88%, n = 29/33 participants with available virologic data in window). The small sample size and higher proportion of participants with no virologic data during the window should be considered in the overall interpretation of Month 12 efficacy outcomes for DTG/3TC and limit the generalizability of the results for this subset of participants.
VOLITION provided the option to switch to CAB+RPV LA following attainment of virologic suppression (median: 4.1 weeks), which was earlier than previous clinical trials (eg, the phase 3 FLAIR study [switch at 20 weeks] [23]) and substantially earlier than the timeframe recommended by some current treatment guidelines (following 3–6 months of suppression). Importantly, there is no recommended timeframe for suppression in the labeled indication [17–19]. This provides proof of concept for modern potent oral ART regimens to be employed similarly, allowing newly suppressed PWH to be given the choice to switch to CAB+RPV LA immediately following rapid suppression, supporting greater choice and selection of regimens according to lifestyle considerations.
In VOLITION, there was a high interest in switching to CAB+RPV LA at Day 1, which was reflected in the high proportion of participants who chose to switch to CAB+RPV LA at DoC. Perceived advantages of switching to CAB+RPV LA reported at DoC centered around convenience, fit with life, and autonomy. These advantages highlight the importance of factors beyond routine clinical parameters when considering treatment decisions. Notably, one-third of participants cited collaborating with healthcare providers on treatment as an advantage of having the option to switch, emphasizing the value of PWH being actively involved in treatment decisions. Previous research on CAB+RPV LA found high levels of treatment acceptance among stably suppressed PWH, with the vast majority preferring it to oral therapy and planning to continue treatment [8, 28, 29]. Data from VOLITION establish these findings among newly suppressed PWH, with treatment satisfaction improving after switching and remaining high through Month 11, despite the already high levels reported at Week 4 with DTG/3TC, and the vast majority of participants planning to continue CAB+RPV LA after the study. The high HIVTSQs scores observed for both CAB+RPV LA and DTG/3TC suggest that these findings may be partly attributable to the person-centered approach used in treatment selection; however, the nonrandomized, participant-choice design limits generalizability of findings to wider populations.
At Month 11, newly suppressed PWH maintained high rates of virologic suppression with CAB+RPV LA after an early switch from oral ART (95%, n = 113/119 participants with available virologic data in window), consistent with prior phase 3/3b and real-world studies in stably suppressed PWH [23–27, 36]. One participant in the CAB+RPV LA group experienced CVF with resistance, similar to results observed within the SOLAR study among stably suppressed participants switching to CAB+RPV LA from bictegravir/emtricitabine/tenofovir alafenamide [25].
Many participants entered the study with a pre-existing inclination toward switching to LA therapy, as shown by Day 1 data indicating considerable interest in CAB+RPV LA among treatment-naive individuals. This should be considered when interpreting findings on participants’ intentions to switch and perceptions of CAB+RPV LA. The high durability and persistence seen with CAB+RPV LA suggest that this preference was not undermined by tolerability issues or injection burden; otherwise, higher rates of discontinuation or switching back to oral ART would be expected.
Both DTG/3TC and CAB+RPV LA were well tolerated, with no new safety signals identified. There was only one AE leading to withdrawal from the study (Suppression Phase), which was not considered related to the study drug, and there were no drug-related SAEs.
Several limitations should be considered. First, the participant-choice, nonrandomized design introduces important considerations for interpretation. Because treatment selection was determined by participant preference, selection bias is inherent and should be considered in the interpretation of the results. Second, not all plasma samples were retested with the RealTime assay, necessitating a modified Snapshot algorithm comprising both RealTime and cobas 6800 assays, which may limit comparison to other clinical trials. Assay discordance is evaluated in a separate publication that is in development.
VOLITION demonstrates that offering an early switch to CAB+RPV LA immediately following rapid virologic suppression in ART-naive PWH, without waiting for stable suppression of 3–6 months, can be facilitated when using DTG/3TC or other oral regimens that achieve rapid virologic suppression. Rapid initiation and immediate suppression were achieved with DTG/3TC, irrespective of baseline viral load or CD4+ cell count. This enabled an early switch to CAB+RPV LA while maintaining virologic suppression, alongside high treatment satisfaction and a preference for continuing CAB+RPV LA. The opportunity to switch to CAB+RPV LA immediately after achieving virologic suppression with oral therapy empowers ART-naive PWH to choose a treatment option that best meets their individualized needs. Quality of life is an important goal of therapy alongside viral suppression [37, 38], which is essential for treatment success and ending the HIV epidemic.
Elevator Pitch
VOLITION demonstrates that rapid virologic suppression with DTG/3TC can facilitate an early, optional switch to CAB+RPV LA in treatment-naive people with HIV while maintaining high rates of virologic suppression and treatment satisfaction. Notably, the option to switch to CAB+RPV LA following attainment of virologic suppression (median: 4.1 weeks) was assessed earlier than previous clinical trials and substantially earlier than the timeframe recommended by some current treatment guidelines (following 3–6 months of suppression). These findings support a more individualized, person-centered approach to HIV care that expands treatment choice and may help inform future clinical practice around SDM in treatment selection.
Supplementary Material
Notes
Acknowledgments. The authors thank everyone who has contributed to the VOLITION study, including all participants and their families, the VOLITION clinical investigators, and participating clinic staff. Employees of ViiV Healthcare were involved in the design of the study, data analysis, and the preparation of this manuscript. Professional medical writing and editorial assistance were provided by Poppy Mashilo and Daniel Williams of Nucleus Global and funded by ViiV Healthcare.
Author contributions. All authors were involved in the conception and design of the study, data acquisition or analysis and interpretation, critically reviewing the manuscript, and approving the final version for submission.
Protocol availability. The protocol used for this trial is available online at https://clinicaltrials.gov/study/NCT05917509.
Data availability. Data sharing requests will be considered by the management group upon written request to the corresponding author. Deidentified participant data or other prespecified data will be available subject to a written proposal and a signed data sharing agreement.
Financial support. VOLITION was funded by ViiV Healthcare.
Contributor Information
Ezequiel Córdova, IDEAA Foundation, Buenos Aires, Argentina.
Charlotte-Paige Rolle, Orlando Immunology Center, Orlando, Florida, USA.
Kai Hove, ViiV Healthcare, London, UK.
Franco Felizarta, Private Practice, Bakersfield, California, USA.
Marc Johnson, Atrium Health Carolinas Medical Center, Charlotte, North Carolina, USA.
Guillermo Cuevas Tascón, Department of Internal Medicine, Hospital Universitario Infanta Leonor, Madrid, Spain.
Jean-Michel Molina, Paris Cité University, INSERM UMR1342 Biology and Pathogenesis of Viral Infections, IRSL, Paris, France; Department of Infectious Diseases, St-Louis and Lariboisière Hospitals, Assistance Publique Hopitaux de Paris, Paris, France.
Joaquin Bravo Urbieta, Infectious Diseases Unit, Internal Medicine Department, Morales Meseguer General University Hospital, Murcia, Spain; Infectious Diseases and Artificial Intelligence Group, Biomedical Research Institute of Murcia Pascual Parrilla-IMIB, Murcia, Spain; Department of Internal Medicine, Faculty of Medicine, University of Murcia, Murcia, Spain.
Laurent Hocqueloux, Centre Hospitalier Universitaire D’Orléans, Orléans, France.
Sergio Lupo, Instituto Centralizado de Asistencia e Investigación Clinica Integral, Rosario, Argentina.
Carlos M Perez, Faculty of Medicine, Universidad San Sebastián, Concepción, Chile.
Björn-Erik Ole Jensen, Department of Gastroenterology, Hepatology, and Infectious Diseases, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University, Düsseldorf, Germany.
Celia Jonsson-Oldenbüttel, MVZ München am Goetheplatz, Munich, Germany.
Francisco Xavier Zamora Vargas, Espacio Eme, Santiago Metropolitan Region, Chile.
Jason Szabo, Clinical Department, L’Actuel Medical Clinic, Montreal, Quebec, Canada.
Pedro Cahn, Fundación Huésped, Buenos Aires, Argentina.
Andrea Antinori, Clinical Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.
Juan Carlos López Bernaldo de Quirós, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERINFEC, Madrid, Spain.
Antonella Castagna, Infectious Diseases Unit, IRCCS, San Raffaele Scientific Institute, Milan, Italy.
Monika Bui, GSK, London, UK.
Richard Grove, GSK, London, UK.
Kehui Wang, GSK, Collegeville, Pennsylvania, USA.
Marty St Clair, ViiV Healthcare, Durham, North Carolina, USA.
Riya Moodley, ViiV Healthcare, London, UK.
Jacob Radford, ViiV Healthcare, London, UK.
Julie Priest, ViiV Healthcare, Durham, North Carolina, USA.
Cassidy A Gutner, ViiV Healthcare, Durham, North Carolina, USA.
Ian Jacob, ViiV Healthcare, London, UK.
Avishek Chatterjee, GSK, Bengaluru, Karnataka, India.
Suryakant Somvanshi, GSK, Pune, Maharashtra, India.
Irina Kolobova, ViiV Healthcare, Durham, North Carolina, USA.
Rekha Trehan, ViiV Healthcare, London, UK.
Christopher Polk, ViiV Healthcare, Durham, North Carolina, USA.
Parul Patel, ViiV Healthcare, Durham, North Carolina, USA.
Patricia de los Rios, ViiV Healthcare, Durham, North Carolina, USA.
Paul DiMondi, GSK, Durham, North Carolina, USA.
Lori A Gordon, ViiV Healthcare, Durham, North Carolina, USA.
Kimberley Brown, ViiV Healthcare, Durham, North Carolina, USA.
Harmony P Garges, ViiV Healthcare, Durham, North Carolina, USA.
Bryn Jones, ViiV Healthcare, London, UK.
Jean van Wyk, ViiV Healthcare, London, UK.
Supplementary Data
Supplementary materials are available at Open Forum Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author.
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