Cost and cost-effectiveness of dolutegravir-based antiretroviral regimens: an economic evaluation of a clinical trial

Jamieson, Lise; Serenata, Celicia; Makhubele, Lebogang; Sokhela, Simiso; Mashabane, Nkuli; Akpomiemie, Godspower; Lf, Johnson; Venter, W D Francois; Meyer‐Rath, Gesine

doi:10.1097/qad.0000000000003068

Cited by 7 publications

(6 citation statements)

References 28 publications

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“…In SSA, DTG was also shown to be cost-effective compared with EFV (either 600 mg or low dose, ie, 400 mg; EFV400). [6][7][8][9][10] Moreover, studies from the DolPHIN-2 trial in South Africa and Uganda alleviated concerns over the safety of DTG during preconception and pregnancy. 11,12 Nevertheless, concerns have been raised about the effects of lifelong DTG-based ART, especially given increasing evidence in Europe, North America, and SSA that DTG leads to excessive weight gain and a higher incidence of obesity.…”

Section: Introductionmentioning

confidence: 99%

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Improvements in Patient-Reported Outcomes Following Initiation of Dolutegravir-Based or Low-Dose Efavirenz-Based First-Line Antiretroviral Therapy: A Four-Year Longitudinal Analysis in Cameroon (NAMSAL ANRS 12313 Trial)

Bousmah,

Protopopescu,

Mpoudi-Etame

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background: We provide new and comprehensive evidence on the evolution of a wide range of patient-reported outcomes (PROs) in the NAMSAL ANRS 12313 trial in Cameroon (2016–2021)—the first randomized comparison of dolutegravir 50 mg (DTG) and low-dose efavirenz (ie, 400 mg; EFV400) in treatment-naive adults living with HIV-1 in sub-Saharan Africa. Methods: We first described the evolution of PROs between baseline and week 192. Then, we used random-effects models to measure the effect of time since the initiation of antiretroviral therapy and the differential effect of DTG versus EFV400 on each PRO, adjusting for clinical, demographic, and socioeconomic factors, while accounting for unobserved heterogeneity and missing data. Results: Among the 613 patients randomized (DTG arm, n = 310; EFV400 arm, n = 303), (1) physical and mental health-related quality of life improved by 13.3% and 6.8%, respectively, (2) the percentage of patients with depression, anxiety, and stress decreased from 23.3%, 23.0%, and 7.7% to 3.1%, 3.5%, and 0.4%, respectively, and (3) the mean number of HIV-related symptoms decreased from 7.2 to 3.0 (P < 0.001). For most PROs, no significant difference was found between both arms, even when accounting for the effect of DTG on weight gain. Nevertheless, our results suggest smaller improvements in mental health outcomes in the DTG arm, with a 5 percentage point higher adjusted probability of having anxiety at week 192 (P < 0.01). Conclusions: Although supporting the current World Health Organization guidelines recommending DTG-based and EFV400-based regimens as preferred and alternative first-line antiretroviral therapy, further studies should investigate medium-term mental health outcomes in patients on DTG. Trial Registration: ClinicalTrials.gov: NCT02777229.

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Section: Introductionmentioning

confidence: 99%

“…In SSA, DTG was also shown to be cost-effective compared with EFV (either 600 mg or low dose, ie, 400 mg; EFV400). 6–10 Moreover, studies from the DolPHIN-2 trial in South Africa and Uganda alleviated concerns over the safety of DTG during preconception and pregnancy. 11,12…”

Section: Introductionmentioning

confidence: 99%

Improvements in Patient-Reported Outcomes Following Initiation of Dolutegravir-Based or Low-Dose Efavirenz-Based First-Line Antiretroviral Therapy: A Four-Year Longitudinal Analysis in Cameroon (NAMSAL ANRS 12313 Trial)

Bousmah,

Protopopescu,

Mpoudi-Etame

et al. 2023

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…In 2021, the global HIV program was making decisions regarding new antiretroviral therapy (ART) regimens with fewer side effects and higher resistance barriers, which may improve adherence and viral suppression. 14 A fixed-dose combination of DTG, lamivudine, and tenofovir was available for over 18 million adults and 100,000 children in 60 countries, as reported in 2022. 30 Affordable antiretrovirals have played a significant role in increasing global antiretroviral therapy coverage.…”

Section: Discussionmentioning

confidence: 99%

“…7 According to previous studies, DTG may result in lower costs for HIV treatment and be the most efficacious core agents belonging to integrase strand transfer inhibitors (INSTIs). 14 , 15 This study aims to review evidence of the cost-effectiveness of DTG in combination with tenofovir and lamivudine compared with the standard of care for HIV therapy.…”

Section: Introductionmentioning

confidence: 99%

The Cost-Effectiveness of Dolutegravir in Combination with Tenofovir and Lamivudine for HIV Therapy: A Systematic Review

Aprilianti,

Utami,

Suwantika

et al. 2024

CEOR

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The World Health Organization (WHO) recommends dolutegravir (DTG), a human immunodeficiency virus (HIV) medicine, as the first- and second-line treatment for all populations because, when compared to an efavirenz (EFV) regimen, plus two nucleoside reverse transcriptase inhibitors (NRTIs) has demonstrated significant effectiveness in HIV suppression in persons. This study aims to review evidence of the cost-effectiveness of DTG in combination with tenofovir and lamivudine compared with the standard of care for HIV therapy. The systematic review involved searching electronic databases for articles published between January 2018 and May 2022. Electronic database sources include PubMed, ScienceDirect, and EBSCO for articles on DTG in combination with tenofovir and lamivudine as subjects with cost-effectiveness outcomes. The inclusion criteria in this systematic review were studies about the cost-effectiveness analysis (CEA) of DTG in combination with tenofovir and lamivudine, written in English. A total of 145 articles were identified from three databases. After removing nine duplicates, 142 articles were screened by title and abstract, excluding 123 articles. After a full-text screening of 19 articles, five articles were selected for further analysis. Five articles reviewed in sub-Saharan Africa, India, and China implemented different modelling methods for CEA but produced similar results. The results of these studies demonstrate that it is more cost-effective than standard care for HIV treatment. The study conducted in sub-Saharan Africa from 2018 to 2020 showed a cost-effective result with disability-adjusted life years averted (DALY averted) by 83%; in India, it resulted in incremental cost-effectiveness ratio (ICER) $130 per year of live-saved (YLS); and a study in China found that dolutegravir plus tenofovir and lamivudine led to 0.006 incremental quality-adjusted life years (QALYs) with cost savings of $64. The DTG regimen is cost-effective and recommended for HIV therapy in all studies that provide results.

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“…In the context of rising pre-treatment NNRTI drug resistance 1,2 , the World Health Organisation (WHO) recommended dolutegravir (DTG) as the preferred antiretroviral therapy (ART) drug of choice for both newly diagnosed and individuals transitioning from previous regimens 3 . Safety, potency, tolerability and cost-effective characteristics of dolutegravir (DTG) supported this change 4 subsequently, countries across sub-Saharan Africa (SSA) have consequently rolled-out dolutegravir as part of standard treatment. Roll out across the region started in 2019 and is expected to continue, aided by the availability of a low-cost, generic fixed-dose co-formulation of tenofovir, lamivudine and dolutegravir (TLD) 5 .…”

Section: Introductionmentioning

confidence: 99%

Limited emergence of resistance to Integrase strand transfer inhibitors (INSTIs) in HIV-experienced patients failing dolutegravir-based antiretroviral therapy: Cross-sectional analysis from a Northeast Nigerian cohort

Abdullahi

Kida

Maina

et al. 2022

Preprint

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Background: Owing to high levels of resistance to previous first-line NNRTI-based antiretroviral therapy (ART), consolidated recommendations since 2019, from the WHO and others, have indicated that dolutegravir (DTG) is the preferred drug of choice for HIV treatment, globally. There is a paucity of resistance outcome data from non-B HIV subtypes circulating across West Africa. Aim: We aimed to characterise the mutational profiles of HIV-positive patients from a small North-East Nigeria cohort, failing a DTG-based ART regimen. Methods: Plasma samples were collected and stored from 61 HIV-1 infected participants. Following failure of DTG-based ART, all samples were sequenced by Illumina whole-genome, ultra-deep sequencing. Sequencing was successful in (n=33) participants with median age of 40 years and median time on ART of 9 years. HIV-1 subtyping was performed using SNAPPy. Haplotype reconstruction and transmission were inferred using standard phylogenetic methods. Result: Most patients had mutational profiles that were reflective of prior exposure to first- and second-line ART including exposure to thymidine analogues, efavirenz and nevirapine. One patient had evidence of major INSTI DRMs (T66A, G118R, E138K and R263K), reducing efficacy of DTG and CAB by 5-10x. The participant was aged 18, infected with a subtype G virus and likely vertically infected. Conclusion: This study found low level resistance to DTG in the cohort, with one patient having high-level resistance to DTG and other INSTIs. Critical population level and long-term data on DTG outcomes are required to guide implementation and policy action across the region.

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Cost and cost-effectiveness of dolutegravir-based antiretroviral regimens: an economic evaluation of a clinical trial

Cited by 7 publications

References 28 publications

Improvements in Patient-Reported Outcomes Following Initiation of Dolutegravir-Based or Low-Dose Efavirenz-Based First-Line Antiretroviral Therapy: A Four-Year Longitudinal Analysis in Cameroon (NAMSAL ANRS 12313 Trial)

Improvements in Patient-Reported Outcomes Following Initiation of Dolutegravir-Based or Low-Dose Efavirenz-Based First-Line Antiretroviral Therapy: A Four-Year Longitudinal Analysis in Cameroon (NAMSAL ANRS 12313 Trial)

The Cost-Effectiveness of Dolutegravir in Combination with Tenofovir and Lamivudine for HIV Therapy: A Systematic Review

Limited emergence of resistance to Integrase strand transfer inhibitors (INSTIs) in HIV-experienced patients failing dolutegravir-based antiretroviral therapy: Cross-sectional analysis from a Northeast Nigerian cohort

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