Cost-Utility Analysis of a Dolutegravir-Based Versus Low-Dose Efavirenz-Based Regimen for the Initial Treatment of HIV-Infected Patients in Cameroon (NAMSAL ANRS 12313 Trial)

Abstract

Objectives Evidence comparing the economic and patient values of the World Health Organization’s preferred (dolutegravir 50 mg [DTG]-based) and alternative (low-dose [400 mg] efavirenz [EFV400]-based) first-line antiretroviral regimens is limited. We compared patient-reported outcomes (PROs), costs, and the cost-utility of DTG- versus EFV400-based regimens in treatment-naive HIV-1 adults in the randomised NAMSAL ANRS 12313 trial in Yaoundé, Cameroon. Methods We used clinical data, PROs, and health resource use data collected in the trial’s first 96 weeks (2016–2019). Quality-adjusted life-years (QALYs) were computed using utility scores obtained from the 12-item Short Form (SF-12) generic health scale. Other PROs included perceived symptoms, depression, anxiety, and stress. In the 96-week base-case analysis, we estimated the unadjusted and multivariate-adjusted (1) mean costs (in US$, 2016 values) and QALYs/patient, (2) incremental costs and QALYs/patient, and (3) net health benefit (NHB). Outcomes were extrapolated over 5 and 10 years. Uncertainty was assessed using the cost-effectiveness acceptability curve and scenario and cost-effective price threshold analyses. Results In the base-case analysis, the NHB (95% confidence interval) for the DTG-based regimen relative to the EFV400-based regimen was 0.056 (− 0.037 to 0.153), corresponding to an 88% probability of DTG being cost-effective. A 10% decrease in this regimen’s price (from $5.2 to $4.7/month) would increase its cost-effectiveness probability to 95%. When extrapolating outcomes over 5 and 10 years, the DTG-based regimen had a 100% probability of being cost-effective for a large range of cost-effectiveness thresholds. Conclusions At 2020 antiretroviral drug prices, a DTG-based first-line regimen should be preferred over an EFV400-based regimen in sub-Saharan Africa. Trial Registration ClinicalTrials.gov Identifier: NCT02777229. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-020-00987-3.

Dolutegravir in real life: Self‐reported mental and physical health outcomes after transitioning from efavirenz‐ to dolutegravir‐based antiretroviral therapy in a prospective cohort study in Lesotho

“…In NAMSAL, the SF-12 PCS and MCS increased over time in both arms, with the PCS reaching levels comparable to those reported here, whereas the MCS remained lower in NAMSAL through week 48 [2]. In NAMSAL, the baseline prevalence of at least mild depression was over 23% at enrolment but had dropped to below 10% in both arms by 48 weeks, with the latter result being comparable to the prevalence in DO-REAL at baseline and 16-week follow-up, albeit using a different screening tool [2,33].…”

“…Among randomized trials comparing DTG and EFV [2][3][4][5][6][7]33], only the NAMSAL trial (conducted in Cameroon) comparing DTG and low-dose EFV provided information on mental and self-reported physical health scores. Similar to this study, NAMSAL reported no difference in the prevalence of at least mild depression, the overall number of symptoms, and the PCS or MCS assessed by the SF-12 among individuals treated with DTG versus low-dose EFV [2,33].…”

“…At enrolment and follow-up, participants were interviewed using the Patient Health Questionnaire-9 (PHQ-9) for depression screening [23], a modified HIV symptom index (mHSI; original version [24]; modified by adding one question as detailed in the 'Measures' section below) questionnaire on pre-specified HIV-/ART-related symptoms, the 12-Item Short-Form health survey (SF-12) general health screening tool [25], and a short studyspecific questionnaire. The PHQ-9 [26][27][28][29][30][31][32], SF-12 [2,[33][34][35][36], and variations of the HIV symptom index [2,33,35,[37][38][39][40][41][42] have been used in the context of HIV in a wide variety of populations in sub-Saharan Africa, including validation of the PHQ-9 [30][31][32] and SF-12 [34] among people living with HIV in African settings. Questionnaires were translated to Sesotho, the local language.…”

Cost-effectiveness analysis of nivolumab plus ipilimumab versus chemotherapy as the first-line treatment for unresectable malignant pleural mesothelioma

“…Cost and utility were discounted at the rate of 3%. 16 In this study, $150,000 was used as the willingness-to-pay (WTP) threshold. 17 …”

“…The discount rate was 0%–6%. 16 Probabilistic sensitivity analyses were performed through Monte-Carlo simulation and were repeated 1000 times, and the results were presented in the form of cost-effectiveness acceptability curves and incremental cost-effectiveness scatter plots.…”