The evolution of clinical study design in heavily treatment-experienced persons with HIV: A critical review

Aberg, Judith A.; Mills, Anthony; Moreno, Santiago; Slater, Jill; Prakash, Manyu; Clark, Andrew

doi:10.1177/13596535231174774

Cited by 2 publications

(1 citation statement)

References 109 publications

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“…Since the introduction of INSTIs, the prevalence of HTE people living with HIV has decreased from 7.5% in 2006 to <1% in 2012 through 2017 [75]. Though this decreased prevalence likely reflects the improvement of ART regimens and increased options for treatment over the last several decades, HTE people can still harbor multi-class resistance that could potentially include INSTI RAMs [76]. Higher prevalence of RAMs was observed in specific groups, such as those who failed and had virus with RAMs to first-generation INSTIs.…”

Section: Discussionmentioning

confidence: 99%

A Comprehensive Literature Review of Treatment-Emergent Integrase Resistance with Dolutegravir-Based Regimens in Real-World Settings

Henegar,

Letang,

Wang

et al. 2023

Viruses

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After a decade of dolutegravir (DTG) use in various antiretroviral therapy combinations and in diverse populations globally, it is critical to identify HIV strains with reduced drug susceptibility and monitor emergent resistance in people living with HIV who experience virologic failure while on DTG-based regimens. We searched the PubMed, Embase, and Cochrane databases to identify studies that reported DTG resistance-associated mutations (RAMs) emerging under selection pressure. Our review showed that RAMs conferring resistance to DTG were rare in 2-drug and 3-drug regimens used in real-world cohorts, corroborating data from clinical trials. The potency of DTG in maintaining virologic suppression was demonstrated, even in cases of pre-existing resistance to companion drugs in the regimen. Estimates of DTG RAMs depended on the population and certain risk factors, including monotherapy, baseline resistance or lack of genotypic testing, treatment history and prior virologic failure, and suboptimal treatment adherence. The RAMs detected after virologic failure, often in heavily treatment-experienced individuals with prior exposure to integrase strand transfer inhibitors, were G118R, E138K, G140A/C/R/S, Q148H/K/R, N155H, and R263K. Overall, these data highlight the durable effectiveness and high barrier to resistance of DTG as part of combination antiretroviral therapy in a wide variety of settings.

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Section: Discussionmentioning

confidence: 99%

A Comprehensive Literature Review of Treatment-Emergent Integrase Resistance with Dolutegravir-Based Regimens in Real-World Settings

Henegar,

Letang,

Wang

et al. 2023

Viruses

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Current ART, determinants for virologic failure and implications for HIV drug resistance: an umbrella review

SeyedAlinaghi,

Afsahi,

Moradi

et al. 2023

AIDS Res Ther

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Objective The purpose of this study is to investigate the incidence of determinants for virologic failure and to identify predisposing factors to enhance treatment efficacy. Tackling this global public health issue is the key to reducing the rate of virological failure and increasing the success of treatment for those living with HIV. Methods This umbrella review delves into various aspects of current anti-retroviral therapy (ART) which is the primary treatment for human immunodeficiency virus (HIV) infection. Comprehensive searches were conducted in online databases including PubMed, Embase, Scopus, and Web of Science, up to May 26, 2023. Following the screening and selection of relevant articles, eligible articles were included in the data extraction. This study adhered to the PRISMA guideline to report the results and employed the NIH quality and bias risk assessment tool to ensure the quality of included studies. Results In total, 40 review studies published from 2015 to 2023 were included. The bulk of these studies concurred on several major factors contributing to HIV drug resistance and virological failure. Key among these were medication adherence, baseline and therapeutic CD4 levels, the presence of co-infections, and the advanced clinical stage of the infection. Conclusion The resistance to HIV drugs and instances of determinants for virologic failure have a profound impact on the life quality of those infected with HIV. Primary contributors to this scenario include insufficient adherence to treatment, decreased CD4 T-cell count, elevated viral levels, and certain treatment regimens. Implementing appropriate interventions could address these issues. Sub-Saharan Africa exhibits elevated rates of determinants for virologic failure, attributed to the delay in HIV testing and diagnosis, and late initiation of antiretroviral therapy (ART). It is essential to undertake further research aimed at enhancing the detection of resistance in HIV patients and mitigating viral failure by addressing these underlying causes.

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The evolution of clinical study design in heavily treatment-experienced persons with HIV: A critical review

Cited by 2 publications

References 109 publications

A Comprehensive Literature Review of Treatment-Emergent Integrase Resistance with Dolutegravir-Based Regimens in Real-World Settings

A Comprehensive Literature Review of Treatment-Emergent Integrase Resistance with Dolutegravir-Based Regimens in Real-World Settings

Current ART, determinants for virologic failure and implications for HIV drug resistance: an umbrella review

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