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Virologically suppressed switch to Dolutegravir/Lamivudine 2-Drug regimen versus switch to commonly prescribed 3-Drug regimens in the United States

AIDS Research and Therapy volume 21, Article number: 76 (2024) Cite this article

Abstract

Background

Two-drug regimens (2DRs) have been introduced in recent years to potentially reduce antiretroviral therapy (ART) toxicities and drug-drug interactions while demonstrating comparable efficacy to three-drug regimens (3DRs) for people with HIV (PWH). The objective of this study was to compare the real-world effectiveness and durability of a single-tablet 2DR of dolutegravir/lamivudine (DTG/3TC) with that of commonly prescribed 3DRs in ART-experienced, virologically suppressed PWH during the first 24 months of DTG/3TC availability in the United States.

Methods

Virologically suppressed (viral load [VL] < 200 copies/mL) adult PWH initiating DTG/3TC 2DR, bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), or a DTG-based 3DR between 01MAY2019 and 31OCT2020 were identified in the OPERA® cohort and followed through 30APR2021. Univariate Poisson regression (incidence rates) and marginal structural Cox proportional hazards models with inverse probability of treatment weights (hazard ratios) were used to quantify relationships between regimen type and confirmed virologic failure (2 consecutive VLs ≥ 200 copies/mL) or regimen discontinuation. Reasons for discontinuation were examined.

Results

A total of 8,037 ART-experienced, virologically suppressed PWH met the inclusion criteria and switched to DTG/3TC (n = 1,450), BIC/FTC/TAF (n = 5,691), or a DTG-based 3DR (n = 896). Incidence rates of confirmed virologic failure were low for all groups, at 0.66 (DTG/3TC), 0.84 (BIC/FTC/TAF), and 1.78 (DTG 3DR) per 100 person-years (py). Compared to DTG/3TC, only the DTG 3DRs were associated with a statistically significant increased hazard of confirmed virologic failure (hazard ratio: 5.21, 95% confidence interval: 1.85, 14.67). Discontinuation rates per 100 py were highest in the DTG 3DR group (24.90), followed by the DTG/3TC group (17.69) and the BIC/FTC/TAF group (8.30). Regardless of regimen, discontinuations were infrequently attributed to effectiveness (VL ≥ 200 copies/mL; 4%) or tolerability (adverse diagnoses, side effects, or lab abnormalities; 6%).

Conclusions

Among virologically suppressed PWH initiating a new regimen, few individuals experienced virologic failure in real-world clinical care. While rates of regimen discontinuation were high, most discontinuations could not be attributed to a lack of virologic control or poor tolerability. These findings suggest that DTG/3TC is an effective option for ART-experienced, virologically suppressed PWH.

Background

The use of three-drug regimens (3DRs), most frequently consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent from either the non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), or integrase strand transfer inhibitor (INSTI) class, has long been the standard of care for HIV treatment. Since their approval, INSTI-based 3DRs have been among the preferred regimens, especially those containing dolutegravir (US Food and Drug Administration [FDA] approval in August 2013) and bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF; FDA approval in February 2018) [1, 2].

As effective ART has increased life expectancy for people with HIV (PWH) [3, 4], concerns about long-term ART toxicities, polypharmacy and drug-drug interaction have been raised [5, 6]. Two-drug regimens (2DRs) have been introduced in recent years to address these concerns [7, 8]. In late 2017, dolutegravir/rilpivirine (DTG/RPV) was the first single-tablet 2DR to be approved in the US for the treatment of ART-experienced, virologically suppressed adult PWH [9]. Dolutegravir/lamivudine (DTG/3TC) was the first once-daily single-tablet 2DR without a food requirement; it was approved for ART-naïve PWH in April 2019 and for ART-experienced, virologically suppressed PWH in August 2020 [10].

Clinical trials have established the efficacy, safety, and tolerability of DTG/3TC [11,12,13,14,15]. Real-world evidence on DTG 2DRs has been promising but often limited by relatively small sample sizes or the use of retrospectively collected data [16,17,18,19,20]. Notably, real-world evidence in North American settings is particularly sparse but has been generally favorable [9, 21]. Given the potential value of single-tablet 2DRs, the objectives of this study were to evaluate the effectiveness and durability of DTG/3TC 2DR compared to other commonly prescribed 3DRs in ART-experienced, virologically suppressed PWH during the first 24 months of DTG/3TC availability in a large clinical cohort in the US.

Methods

Study design and population

This study used prospectively collected electronic health record (EHR) data from the Observational Pharmaco-Epidemiology Research and Analysis (OPERA®) cohort. OPERA includes data from rural clinics, wellness centers, sexual health clinics, health departments, federally qualified health centers, and large metropolitan multidisciplinary health centers across 19 US states and Puerto Rico. At the time of the study, PWH in OPERA represented approximately 12% of all PWH linked to care in the US [22]. The OPERA cohort obtains annual institutional review board (IRB) approval from Advarra IRB, including a waiver of informed consent and authorization for the use of protected health information. OPERA complies with all HIPAA and HITECH requirements.

Individuals who switched to the single-tablet formulation of DTG/3TC, BIC/FTC/TAF, or a DTG 3DR (i.e., dolutegravir/abacavir/lamivudine [DTG/ABC/3TC], dolutegravir + tenofovir disoproxil fumarate/emtricitabine [DTG + TDF/FTC], or dolutegravir + tenofovir alafenamide/emtricitabine [DTG + TAF/FTC]) were eligible for the study. Of note, twice daily DTG was allowed in the DTG 3DR group and any formulation of these DTG 3DRs was included. The study population included ART-experienced people with HIV-1 infection who were aged 18 years or older and were virologically suppressed (last HIV RNA viral load [VL] < 200 copies/mL within 12 months before/at regimen initiation). The window of eligibility was from 01MAY2019 to 31OCT2020. PWH with any prior exposure to the ART regimens of interest were excluded. Included individuals contributed person-time from initiation of the regimen of interest until the first occurrence of the outcome of interest (virologic failure or regimen discontinuation) or one of the following censoring events: (a) loss to follow-up (i.e., 12 months of follow-up with no contact), (b) death, (c) study end (30APR2021), or (d) regimen discontinuation (analyses of virologic failure only).

Measurements

Demographic and clinical characteristics were described for each group. Confirmed virologic failure was defined as two consecutive VLs ≥ 200 copies/mL. Regimen discontinuation occurred when any component of the ART regimen was changed (i.e., adding and/or removing any ARV agent). Switching from a DTG/3TC single-tablet 2DR to a multi-tablet DTG + 3TC regimen was considered as a discontinuation in this analysis.

Reasons for discontinuation were identified from provider notes, lab results, and diagnoses. These reasons were categorized as treatment-related, non-treatment related, or no reason identified. Treatment-related reasons included last VL ≥ 200 copies/mL, adverse diagnosis/side effect (i.e., new mental health, liver, renal, or bone comorbidity diagnosed within 21 days before discontinuation), or lab abnormality (i.e., alkaline phosphatase [ALP]; alanine transaminase [ALT]; aspartate transaminase [AST]; or bilirubin > 3 times the upper limits of normal within 21 days of discontinuation). Non-treatment-related reasons included regimen simplification, access issues, non-adherence, treatment gaps, or patient/provider choice.

Statistical analyses

Baseline was defined as the initiation date of the ART regimen of interest. Descriptive statistics for baseline demographic and clinical characteristics consisted of medians with interquartile range (IQR) for continuous variables and absolute and relative frequencies for categorical variables. Incidence rates and 95% confidence intervals (CI) for the first occurrence of confirmed virologic failure or regimen discontinuation were estimated using univariable Poisson regression.

Marginal structural Cox proportional hazards models with stabilized inverse probability of treatment weights (IPTW) were used to evaluate the association between ART regimen and time to virologic failure or regimen discontinuation. IPTWs were constructed with multinomial logistic regression including potential confounders identified a priori based on the literature. These were measured at baseline and included age (linear and quadratic terms), number of ART classes experienced prior to initiation of the regimen of interest (linear and quadratic terms), female sex, Black race, Hispanic ethnicity, receiving care in the Southern US, core agent class of regimen immediately prior to initiation of the regimen of interest (INSTI, NNRTI, PI, other/unknown), CD4 cell count (linear and quadratic terms) at baseline, and an interaction term between sex and region of care.

Sensitivity analyses

The study period included both time before (01MAY2019–29FEB2020) and during (01MAR2020–30APR2021) the COVID-19 pandemic, an era during which provider-patient interactions, prescribing practices (of all medicines, including ART), and lab testing (e.g., viral load monitoring) were impacted [23,24,25]. Sensitivity analyses explored its potential impact by assessing incidence rates of visits with healthcare providers (in-person and telehealth), viral load measurements, regimen discontinuations, and virologic failures both before and during the COVID-19 pandemic.

Results

Study Population

A total of 8,037 ART-experienced, virologically suppressed PWH met the inclusion criteria and switched to DTG/3TC (n = 1,450), BIC/FTC/TAF (n = 5,691), or a DTG 3DR (n = 896). Baseline demographic and clinical characteristics varied across groups (Table 1). Individuals who switched to DTG/3TC were slightly older, less likely to be Black or to receive care in the US South, and more likely to have comorbid conditions than individuals initiating BIC/FTC/TAF or a DTG 3DR. PWH initiating a DTG 3DR were most likely to be new to an OPERA provider and therefore, to be missing information about their prior ART experiences (Table 1). There were 13 PWH taking a DTG 3DR that were prescribed DTG twice daily, suggesting that they were heavily treatment experienced.

Table 1 Baseline demographic and clinical characteristics of ART-experienced, virologically suppressed PWH switching to DTG/3TC, BIC/FTC/TAF, or a DTG 3DR between 01MAY2019 and 31OCT2020 (N = 8,037)
Full size table

Effectiveness: confirmed Virologic failure

Overall, only 88 PWH (1%) experienced virologic failure over a total of 9,696 py. Incidence rates for confirmed virologic failure were < 2 per 100 py in each of the three ART regimen groups. After adjustment for confounding, those in the DTG 3DR group were over five times more likely to experience virologic failure compared to the DTG/3TC group (Fig. 1). There was no statistically significant difference in incidence rate of virologic failure between the DTG/3TC and BIC/FTC/TAF groups.

Fig. 1
figure 1

Incidence rates of confirmed virologic failure and association between ART regimen and confirmed virologic failure, by ART regimen (DTG/3TC, BIC/FTC/TAF, DTG 3DR) 3DR, 3-drug regimen; 3TC, lamivudine; ART, antiretroviral therapy; BIC, bictegravir; CI, confidence interval; DTG, dolutegravir; FTC, emtricitabine; HR, hazard ratio; IR, incidence rate; py, person-years; TAF, tenofovir alafenamide. a Marginal structural Cox proportional hazards models with stabilized inverse probability of treatment weights controlling for baseline age (linear & quadratic), number of ART classes (linear & quadratic), female, Black race, Hispanic ethnicity, Southern US, core agent class of prior regimen, CD4 cell count (linear & quadratic)

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Durability: Follow-Up and Regimen Discontinuation

The median duration of follow-up on the regimen of interest exceeded a year in all groups; PWH on BIC/FTC/TAF were followed the longest (Table 2). The incidence rates for regimen discontinuation varied considerably across groups (11–27%) and confidence intervals did not overlap. In adjusted analyses, compared to DTG/3TC, those on BIC/FTC/TAF were half as likely to discontinue the regimen than those on DTG/3TC. Individuals on DTG 3DRs had a 69% higher hazard of regimen discontinuation than those on DTG/3TC.

Table 2 Duration of follow up and regimen discontinuation among virologically suppressed PWH switching to DTG/3TC, BIC/FTC/TAF, or a DTG 3DR between 01MAY2019 and 31OCT2020 (N = 8,037)
Full size table

While the reasons for regimen discontinuation were often unknown, only 7 to 11% of discontinuations were related to the effectiveness (VL ≥ 200 copies/mL) or tolerability (adverse diagnoses, side effects or lab abnormalities) of the ART regimen (Fig. 2). Notably, regardless of regimen, nearly all PWH who discontinued their regimen were suppressed (VL < 200 copies/mL) at the time of discontinuation (DTG/3TC: 97%; BIC/FTC/TAF: 94%; DTG 3DR: 93%). The most common non-treatment related reasons for discontinuation included provider choice (all groups), access issues related to cost, formulary, or availability (DTG/3TC), and a reduction of pill count (DTG 3DR).

Fig. 2
figure 2

Reasons for ART regimen discontinuation identified from healthcare provider notes, lab results, and diagnoses, by ART regimen (DTG/3TC, BIC/FTC/TAF, DTG 3DR). 3DR, 3-drug regimen; 3TC, lamivudine; ART, antiretroviral therapy; BIC, bictegravir; DTG, dolutegravir; Dx, diagnosis; FTC, emtricitabine; mL, milliliter; TAF, tenofovir alafenamide; VL, viral load. a Last VL > 200 copies/mL, adverse diagnosis/side effect (i.e., new mental health, liver, renal or bone comorbidity diagnosed within 21 days before discontinuation, or as noted), lab abnormality (i.e., alkaline phosphatase [ALP], alanine transaminase [ALT], aspartate transaminase [AST] or bilirubin > 3 times the upper limits of normal within 21 days of discontinuation). b Simplification; access issues; non-adherence; treatment gap; patient/provider choice; any other reason noted

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Sensitivity analyses: impact of the COVID-19 pandemic

The median follow-up time in this study was considerably longer during the COVID-19 pandemic (14.0 months; IQR: 9.4, 14.0) than before it (4.9 months; IQR: 2.4, 7.4). Overall, the incidence rate of in-person visits with healthcare providers decreased from 7.55 per py (95% CI: 7.44, 7.66) before COVID-19 to 5.04 per py (95% CI: 4.99, 5.09) during COVID-19, while incidence rates of telehealth visits increased from 0.21 per py (95% CI: 0.19, 0.23) to 1.65 per py (95% CI: 1.62, 1.68). There was also a small decrease in both viral load measurements (2.94 to 2.17 per py) and regimen discontinuations (0.15 to 0.10 per py). Virologic failures were infrequent in both periods. Results were mostly consistent across the three regimen groups. However, individuals on DTG/3TC experienced an increase in visits during COVID-19, driven by a much larger increase in telehealth visits and a smaller reduction in in-person visits than those in either of the 3DR groups (Table 3).

Table 3 Clinical follow-up measures before and during the COVID-19 pandemica among virologically suppressed PWH switching to DTG/3TC, BIC/FTC/TAF, or a DTG 3DR between 01MAY2019 and 31OCT2020 (N = 8,037)
Full size table

Discussion

In this observational study evaluating the effectiveness and durability of a single-tablet DTG/3TC 2DR compared to commonly prescribed 3DRs among 8,037 ART-experienced, virologically suppressed PWH, rates of virologic failure were low across all regimens. This is noteworthy given that use of a 2DR may alleviate issues relating to tolerance and drug-drug interactions. Rates of discontinuation differed between groups and were high, especially in the DTG/3TC and DTG 3DR groups.

The effectiveness of DTG/3TC is consistent with results from clinical trials and observational studies [11,12,13]. A meta-analysis of real-world evidence studies reported that only 1% of ART-experienced, suppressed individuals experienced virologic failure defined as two consecutive viral loads ≥ 50 copies/mL or a single viral load > 1000 copies/mL [16]. Incidence rates of virologic failure ranged from 0.9 per 100 py to 3.3 per 100 py in European observational studies [26,27,28,29]. In this study, only DTG 3DRs were significantly associated with virologic failure compared to DTG/3TC (adjusted HR: 5.21; 95% CI: 1.85, 14.67). Notably, none of the 13 PWH prescribed twice-daily DTG as part of a DTG 3DR experienced confirmed virologic failure.

Rates of discontinuation varied across regimens, from 8.3 per 100 py with BIC/FTC/TAF, to 17.7 per 100 py with DTG/3TC, and 24.9 per 100 py with DTG 3DR. These rates are elevated compared to rates of discontinuation reported by other cohorts, which ranged from 4.7 per 100 py to 11.1 per 100 py [28,29,30,31]. Compared to DTG/3TC, hazard of regimen discontinuation was lower with BIC/FTC/TAF (adjusted HR: 0.51; 95% CI: 0.42, 0.62), but higher with DTG 3DRs (adjusted HR: 1.69; 95% CI: 1.30, 2.19). Most PWH remained virologically suppressed at discontinuation and only 7 to 11% of discontinuations appeared related to effectiveness or tolerability. This finding is in line with clinical trials and observational studies, which reported between 1% and 8% of discontinuations linked to adverse events, intolerance, or toxicity [11, 30, 32, 33]. Although most discontinuations had no reason listed in the EHR, other discontinuations not associated with elevated VL or toxicity were frequently attributed to provider choice (17–37% of discontinuations).

The higher rates of regimen discontinuation among DTG/3TC and DTG 3DR users may be explained in part by the fact that comorbidities were more common in these groups than in BIC/FTC/TAF users, and management of comorbidities could have an impact on HIV treatment decisions. Moreover, high discontinuation rates for DTG 3DRs may be associated to the fact that DTG 3DRs are the oldest ART options in the study. Regimen selection and discontinuation decisions may also have been influenced by the staggered FDA approval for DTG/3TC 2DR in the US (April 2019 for ART-naïve, August 2020 for ART-experienced, suppressed PWH). Most included PWH (79%) switched to DTG/3TC between April 2019 and July 2020, representing off-label prescribing. The remaining 21% of PWH switched to DTG/3TC after FDA approval for ART-experienced, suppressed individuals [10]. In a post-hoc analysis, the proportion of individuals who discontinued their DTG/3TC regimen during follow-up was larger before FDA approval (20%) than after (12%). Surveys of healthcare providers highlight due caution when treating PWH [34], especially when switching to a new treatment paradigm [35]; precautionary decision-making may have been applied to the off-label prescribing of this new 2DR during the study.

The timing of this study may have also contributed to its limitations. Disruptions to HIV care during the beginning of the COVID-19 pandemic impacted the frequency and type of care received, as demonstrated by the sensitivity analysis. During the COVID-19 pandemic, there was a reduction in the rates of overall visits, in-person visits, and viral load monitoring among PWH who switched to BIC/FTC/TAF or a DTG 3DR, compared to rates observed before the pandemic; the increase in telehealth visits did not completely offset the decrease in in-person visits. In the DTG/3TC group, however, there was an overall increase in visits; the decrease in in-person visits was minimal and the increase in telehealth visits was more substantial than in the 3DR groups.

Missing data were also a challenge in this study. DTG 3DRs were more likely to be prescribed to PWH who were new to an OPERA provider and thus had missing or incomplete clinical history, including their prior ART experiences and comorbidities. Missingness was also an issue when considering reasons for regimen discontinuation as they are poorly documented in EHRs. While efforts were made to identify potential reasons by harnessing the richness of EHR data to evaluate not only provider notes but also diagnoses and lab results around the time of discontinuation, no reason could be attributed to 49–72% of discontinuations.

An additional limitation of the study is its short duration of two years, resulting in limited time to observe virologic outcomes and discontinuations. Further, despite the large sample size, the number of virologic failures was small across all three groups, leading to wide confidence intervals for the associated hazard ratios. This limits the ability to determine if clinically and/or statistically significant differences were truly present.

Key strengths of this study included the use of prospectively captured clinical data from the US-based OPERA cohort, representing a diverse group of approximately 12% of PWH in the US at the time of this study (June 2021) [36]. Even after applying the study’s inclusion and exclusion criteria, the study sample size was over 8,000 PWH with 1,450 PWH initiating DTG/3TC. One previous study evaluated 966 PWH on DTG/3TC 2DR while all others were much smaller, ranging from 117 to 566 PWH on DTG/3TC in retrospective studies predominantly conducted in European countries [16, 18, 20, 27, 31, 37, 38]. The present study provided an opportunity to compare DTG/3TC 2DR in its first 24 months of availability in the US with commonly prescribed 3DRs in the US and to identify the rare outcome of virologic failure, even during the COVID-19 pandemic. The large sample size and rich EHR data also allowed for the adjustment through IPTWs of several potential confounders identified a priori. Our findings that DTG/3TC is likely an effective and durable treatment option for suppressed PWH were consistent with prior studies based in Europe and elsewhere, despite differences in sample sizes, geographic settings, and methodologic rigor of those studies.

Conclusions

Given the potential value of 2DRs in situations where complex polypharmacy, drug-drug interaction, and long-term ARV toxicity may be of concern, it is notable that virologic failure was rare among ART-experienced, virologically suppressed PWH in the US-based OPERA cohort who newly switched to DTG/3TC, BIC/FTC/TAF, or a DTG 3DR. Though regimen discontinuations were slightly higher than expected, only a small percentage was attributed to effectiveness or tolerability. The findings of this study suggest that DTG/3TC, a single-tablet 2DR, is an effective option for ART-experienced, virologically suppressed PWH. Continued study of 2DRs is needed to evaluate longer-term effectiveness and durability of these ART regimens for PWH.

Data availability

The datasets used in this study are not publicly available due to privacy concerns and the proprietary nature of the database but can be accessed upon reasonable request through the corresponding author to the OPERA Epidemiological and Clinical Advisory Board. Access to codes may be granted upon request with parties agreeing to privacy restrictions and technological specifications and requirements.

Abbreviations

2DR:

2-drug regimen

3DR:

3-drug regimen

3TC:

Lamivudine

ABC:

Abacavir

ALP:

Alkaline phosphatase

ALT:

Alanine transaminase

ART:

Antiretroviral therapy

AST:

Aspartate transaminase

ARV:

Antiretroviral

BIC:

Bictegravir

CI:

Confidence interval

DTG:

Dolutegravir

HER:

Electronic health record

FDA:

Food and Drug Administration

FTC:

Emtricitabine

HIV:

Human immunodeficiency virus

HR:

Hazard ratio

INSTI:

Integrase strand transfer inhibitor

IPTW:

Inverse probability of treatment weights

IQR:

Interquartile range

IRB:

Institutional review board

mL:

Milliliter

NNRTI:

Non-nucleoside reverse transcriptase inhibitor

NRTI:

Nucleoside reverse transcriptase inhibitor

OPERA®:

Observational Pharmaco-Epidemiology Research and Analysis

PI:

Protease inhibitor

PWH:

People with HIV

Py:

Person-years

RPV:

Rilpivirine

STR:

Single-tablet regimen

TAF:

Tenofovir alafenamide

TDF:

Tenofovir disoproxil fumarate

US:

United States

VL:

Viral load

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Acknowledgements

This research would not be possible without the generosity of people living with HIV, their families, and their OPERA caregivers. Additionally, we are grateful for the following individuals: Rachel Palmieri Weber & Michael Osterman (manuscript preparation), Lito Torres (SAS programming), Robin Beckerman (QA), Bernie Stooks & Lisa Lutzi (database management/quality), and Judy Johnson (medical terminology classification).

Funding

This research was funded by ViiV Healthcare.

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Authors and Affiliations

  1. Whole Family Health Center, Vero Beach, FL, USA

    Gerald Pierone

  2. Epividian, Inc, 150 Fayetteville Street Suite 2300, Raleigh, NC, 27601, USA

    Jennifer S. Fusco, Laurence Brunet & Gregory P. Fusco

  3. ViiV Healthcare, Durham, NC, USA

    Vani Vannappagari, Supriya Sarkar & Cassidy E. Henegar

  4. ViiV Healthcare, London, UK

    Jean van Wyk

  5. AIDS Healthcare Foundation, Miami, FL, USA

    Michael B. Wohlfeiler

  6. Men’s Health Foundation, Los Angeles, CA, USA

    Anthony Mills

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  1. Gerald Pierone
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Contributions

GP and JSF share the responsibility for the design of this study and protocol development. GP, JSF, MBW, and GPF contributed to the acquisition of data. JSF and LB are responsible for all analyses which were conducted according to the protocol. GP, JSF, LB, MBW, and GPF contributed to the interpretation of results. JSF and LB drafted the manuscript. All authors have critically reviewed and approved the manuscript and have participated sufficiently in the work to take public responsibility for its content. It is Epividian’s policy to publish the results of all studies, regardless of the results, for full transparency; the sponsor of this study did not direct the study design, analysis, or submission of this manuscript for publication.

Corresponding author

Correspondence to Jennifer S. Fusco.

Ethics declarations

Ethics approval and consent to participate

Institutional review board (IRB) approval covering patient data contained in the OPERA database was received from Advarra IRB; a waiver of informed consent and authorization for the use of protected health information for patient data was granted (Pro00023648). The study was conducted in accordance with HIPAA and HITECH requirements, which expand upon the ethical principles detailed in the 1964 Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interests

GP, MBW, and AM are members of the Epidemiology and Clinical Advisory Board for Epividian. MBW has participated in post-conference advisory boards for the Conference on Retroviruses and Opportunistic Infections and International AIDS Conference and serves as a principal investigator on ViiV Healthcare clinical trials but does not receive personal compensation for this work, which goes directly to the AIDS Healthcare Foundation. AM receives research funding from Gilead, ViiV, GSK, Abbott, Roche, and Merck. He has attended advisory boards for Gilead, ViiV, and Epividian. JSF, LB, and GPF are employed by Epividian, Inc.; Epividian has had research funded by ViiV Healthcare, Merck & Co., Janssen, Gilead Sciences, Theratechnologies, EMD Serono, and AIDS Healthcare Foundation. VV, SS, CEH, and JvW are employed by ViiV Healthcare and hold stock in GSK as part of their employment.

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Pierone, G., Fusco, J.S., Brunet, L. et al. Virologically suppressed switch to Dolutegravir/Lamivudine 2-Drug regimen versus switch to commonly prescribed 3-Drug regimens in the United States. AIDS Res Ther 21, 76 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12981-024-00668-7

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Keywords

AIDS Research and Therapy

ISSN: 1742-6405

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