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

Abstract

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.

Realizing the Promise of Dolutegravir in Effectively Treating Children and Adolescents Living With HIV in Real-world Settings in 6 Countries in Eastern and Southern Africa

“… 33 Further, DTG plus lamivudine as dual therapy has demonstrated success in achieving VLS and cost-effectiveness in numerous studies. 37 , 38 Clinician hesitancy to changing ART can have dire consequences to patients, 39 and these findings will help to quell concerns that preexisting NRTI RAMs may adversely affect the ability of DTG to achieve VLS in CALHIV, and empower providers in LMICs to confidently switch their pediatric and adolescent patients to DTG.…”

DOLAMA 200: Effectiveness and Safety of a Dual Therapy with Dolutegravir Plus Lamivudine in Treatment-Experienced HIV-1 Infected Real World Participants in Spain

“…Our data support the DTG + 3TC combination, in appropriate patients, as the most cost-effective treatment, reducing the cost per patient/year. These are the expected results of a combination that has effectively demonstrated its virological efficacy in multiple scenarios, and that has demonstrated a minimal toxic potential [24][25][26].…”

“…Regarding the long-term toxicity of ART and its impact on HIV-dependent residual inflammation, aging and the emergence of comorbidities, INSTIs (such as DTG) and 3TC have shown a favorable profile in comparison with other antiretrovirals [ 5 , 11 , 14 , 25 , 26 , 27 ]. Considering the need to monitor the long-term toxicity of ART throughout chronic treatment, it should also be noted that the use of DTG, which theoretically offers a better toxicity profile [ 28 ] and a possible favorable (or neutral) effect of INSTIs against the underlying chronic inflammation associated with HIV infection, [ 3 ], may offer a great advantage for these patients as demonstrated by various clinical trials [ 9 , 12 ] and our study.…”

“…These are the expected results of a combination that has effectively demonstrated its virological efficacy in multiple scenarios, and that has demonstrated a minimal toxic potential [ 24 , 25 , 26 ].…”

Real-world efficacy and safety of dolutegravir plus lamivudine versus tenofovir plus lamivudine and efavirenz in ART-naïve HIV-1-infected adults

“…[9,10] Similar results were reported in studies including some real-world data about 2-drug regimen (2DR) of DTG + 3TC supporting dolutegravir-based 2DRs as good therapeutic options for HIV-1 infection, either ART-naïve or virologically suppressed on previous antiretroviral regimen. [16][17][18][19][20][21][22][23][24][25][26] In China, DTG + 3TC was recently recommended as a first-line regimen for ART-naïve individuals in 2021. [2] Its real-world data for efficacy and safety was limited but have attracted extensive attention.…”