Retrospective study on the outcome of two-drug regimens based on dolutegravir plus one reverse transcriptase inhibitor in virologically-suppressed HIV-infected patients

Galizzi, Nadia; Poli, Andrea; Galli, Laura; Muccini, Camilla; Mastrángelo, Andrea; Dell’Acqua, Raffaele; Maillard, Myriam; Bossolasco, Simona; Cinque, Paola; Lazzarin, Adriano; Castagna, Antonella; Gianotti, Nicola

doi:10.1016/j.ijantimicag.2020.105893

Cited by 30 publications

(53 citation statements)

References 32 publications

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“…The mean age of PLHIV ranged from 48.5 to 59 years and all PLHIV were treatment-experienced suppressed. Most PLHIV switched from triple therapy [33][34][35]. Some populations also had PLHIV with resistance mutations including the M184I/V mutation for 3TC resistance [33][34][35][36].…”

Section: Dual Therapy With Dtg + 3tcmentioning

confidence: 99%

“…Most PLHIV switched from triple therapy [33][34][35]. Some populations also had PLHIV with resistance mutations including the M184I/V mutation for 3TC resistance [33][34][35][36]. PLHIV in Reynes et al [36] were considered heavily pre-treated, whereas Hidalgo-Tenorio et al [35] and Gagliardini et al [37] included a population with no history of VF.…”

Section: Dual Therapy With Dtg + 3tcmentioning

confidence: 99%

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Effectiveness and safety of dolutegravir two‐drug regimens in virologically suppressed people living with HIV: a systematic literature review and meta‐analysis of real‐world evidence

et al. 2021

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Dolutegravir (DTG) is widely recommended within three-drug regimens. However, similar efficacy and tolerability have also been achieved with DTG within two-drug regimens in clinical trials. This study evaluated the real-world effectiveness and discontinuations in people living with HIV-1 (PLHIV) switching to DTG with lamivudine (3TC) or rilpivirine (RPV). MethodsThis was a one-arm meta-analysis utilizing data from a systematic literature review. Data from real-world evidence studies of DTG + RPV and DTG + 3TC were extracted, pooled and analysed. The primary outcome was the proportion of patients with viral failure (VF; ≥ 50 copies/mL in two consecutive measurements and/or ≥ 1000 copies/mL in a single measurement) at week 48 (W48) and week 96 (W96). Other outcomes included virological suppression (VS; < 50 copies/mL) and discontinuations (W48 and W96). Estimates were calculated for VF, VS as per snapshot (VSS) and on treatment analysis (VSOT), and discontinuations. ResultsPooled mean estimates of VF for DTG + 3TC and DTG + RPV were 0.8% [95% confidence interval (CI): 0.4-1.3] and 0.6% (95% CI: 0.0-1.6), respectively, at W48. VSS rate at W48 was 85.0% (95% CI: 82.3-87.5) for DTG + 3TC regimen and 92.4% (95% CI: 85.0-97.7) in the DTG + RPV regimen. The DTG + 3TC and DTG + RPV regimens led to discontinuations in 13.6% (95% CI: 11.1-16.2) and 7.2% (95% CI: 2.1-14.4) of patients, respectively, at W48. Similar results were observed at W96. ConclusionsTreatment with DTG + 3TC or DTG + RPV in clinical practice provides a low rate of VF and a high rate of VS when initiated in virologically suppressed PLHIV with diverse backgrounds.

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Section: Dual Therapy With Dtg + 3tcmentioning

confidence: 99%

Section: Dual Therapy With Dtg + 3tcmentioning

confidence: 99%

Effectiveness and safety of dolutegravir two‐drug regimens in virologically suppressed people living with HIV: a systematic literature review and meta‐analysis of real‐world evidence

et al. 2021

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“…DTG uniformly shows a high genetic barrier to resistance in both 3DR and 2DR, and resistance-associated mutations (RAMs) are rarely observed. In vitro, DTG-resistance was found to develop much more slowly than for raltegravir (RAL), cabotegravir (CAB) and elvitegravir (EVG) [ 21 ], and resistance development during the failure of a DTG-containing 2DR was reported only for isolated clinical cases [ 16 , 22 , 23 ].…”

Section: Diagnostic Framework For Dolutegravir Plus Lamivudine Two-drug Regimens Use In Cart-naïve Patientsmentioning

confidence: 99%

“…When it comes to the physician’s decision of whether to switch from a fully effective 3DR to a 2DR or not, the main reason we consider is the possibility of reducing long-term side effects (i.e., a pro-active switch) and, therefore, the frequency of medical visits. In our daily clinical activity, however, we also know that one of the main reasons for the success of 2DR in real-life, especially in single-pill regimens, is the patients’ desire to use an easy, manageable regimen, which has the least impact on their daily routine [ 15 , 23 , 62 , 63 ]. This is a need that transversally affects a wide variety (and heterogeneity) of clinical and social conditions, and is felt now more than ever.…”

Section: Diagnostic Framework For Dolutegravir Plus Lamivudine Two-drug Regimens In Virologically Suppressed Patientsmentioning

confidence: 99%

“…A recent meta-analysis reported random-effects pooled estimates for a viral suppression of 98.6% and 97.5% at 48-weeks and 96-weeks of DTG/3TC, respectively, by combining the results of 11 real-world studies [ 72 ]. In fact, all the real-life studies available today, including the most recent, report on the excellent and sustained efficacy of this 2DR when used as a switch regimen ( Table 5 ) [ 15 , 23 , 62 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 ]. These results are consistently maintained in both patients with a previous history of VF and resistance [ 23 , 62 , 74 , 75 , 76 , 80 , 82 ], and over longer observation periods [ 75 , 76 , 84 ].…”

Section: Diagnostic Framework For Dolutegravir Plus Lamivudine Two-drug Regimens In Virologically Suppressed Patientsmentioning

confidence: 99%

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Dolutegravir Plus Lamivudine Two-Drug Regimen: Safety, Efficacy and Diagnostic Considerations for Its Use in Real-Life Clinical Practice—A Refined Approach in the COVID-19 Era

Cento

Perno

2021

Diagnostics

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The diagnostic and therapeutic management of the Coronavirus Disease 2019 (COVID-19) pandemic in the HIV population brought some known criticalities (and opportunities) to the forefront, for both those who are facing their first therapeutic line today, and for those already well viro-suppressed. The clinical, socioeconomic, and psychological impact of the COVID-19 pandemic should not affect the long-term care of people living with HIV, which creates an urgent need to optimize the diagnostic and treatment approach to the first-line or switch regimens. The use of dolutegravir plus a lamivudine two-drug regimen is one of the most promising solutions to ease the management of HIV treatment in this difficult period. In this review, we report the most salient features related to the use of this regimen from real-life cohorts, meta-analyses, randomized clinical trials, and studies presented at international conferences up to March 2021. We focused on the diagnostic and clinical-management implications of its use in real life, and how these comply with the contingent historical situation. The issue of the timing and type of diagnostic procedures and the relevance of classical diagnostic tests (such as genotype for resistance detection) is also discussed. According to the currently available results, dolutegravir plus a lamivudine two-drug regimen represents an outstanding tool, whose expected advantages fulfill the current requirements for optimal daily care of our HIV patients.

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Efficacy and tolerability of dolutegravir/lamivudine versus dolutegravir/rilpivirine in switching from a three‐drug regimen based on nonnucleoside reverse transcriptase inhibitors: A retrospective cohort study

Lagi,

Giacomelli,

Borghi

et al. 2023

Journal of Medical Virology

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Real‐life comparisons of dolutegravir/rilpivirine (DTG/RPV) and DTG/lamivudine (3TC) regimens in people living with human immunodeficiency virus (PLWHIV) who switched from a standard three‐drug regimen based on nonnucleoside reverse transcriptase inhibitors (NNRTIs) are missing. This study aimed to compare DTG/3TC and DTG/RPV in virologically suppressed patients (HIV‐RNA < 50 copies/mL) coming from any NNRTI‐based regimen in terms of discontinuation due to virologic failure (VF) discontinuation rates due to all causes, and adverse events. As a secondary outcome, we evaluated the difference in creatinine, total cholesterol, CD4, and triglycerides from baseline to weeks 48 after the switch. Of the 415 PLWHs included in the study, 278 (66.9%) switched to DTG/3TC, and 137 (33.1%) switched to DTG/RPV. Overall, 48 PLWHs (11.6%) discontinued the treatment:38 with DTG/3TC and 10 with DTG/RPV with similar discontinuation rates: 5.01 × 100 py (95% confidence interval [CI] 3.64–6.94) and 4.66 × 100 py (95% CI 2.51–8.67), respectively. The most common reason for discontinuation was toxicity (26 patients, 22/278 [7.9%] in the DTG/3TC group and 4/137 [2.9%] in the DTG/RPV group), mainly neurologic toxicity (never above grade 2). We found no differences in discontinuation rates due to treatment adverse events. Two study participants experienced virological failure in the DTG/3TC arm. We observed no significant difference in CD4 cell counts, lipid parameters, or renal function between the two groups at 48 weeks. This study demonstrated that, in clinical practice, a two‐drug regimen with DTG/3TC or DTG/RPV is characterized by a low discontinuation rate and VF in virologically suppressed PLWHs switched from an NNRTI‐based three antiretroviral drugs regimen.

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Retrospective study on the outcome of two-drug regimens based on dolutegravir plus one reverse transcriptase inhibitor in virologically-suppressed HIV-infected patients

Cited by 30 publications

References 32 publications

Effectiveness and safety of dolutegravir two‐drug regimens in virologically suppressed people living with HIV: a systematic literature review and meta‐analysis of real‐world evidence

Effectiveness and safety of dolutegravir two‐drug regimens in virologically suppressed people living with HIV: a systematic literature review and meta‐analysis of real‐world evidence

Dolutegravir Plus Lamivudine Two-Drug Regimen: Safety, Efficacy and Diagnostic Considerations for Its Use in Real-Life Clinical Practice—A Refined Approach in the COVID-19 Era

Efficacy and tolerability of dolutegravir/lamivudine versus dolutegravir/rilpivirine in switching from a three‐drug regimen based on nonnucleoside reverse transcriptase inhibitors: A retrospective cohort study

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