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Background: Increased eligibility guidelines of antiretroviral therapy (ART) may lead to greater routine viral load monitoring. However, in resource-constrained settings, the additional resources required by greater routine viral load monitoring may impair ability to comply with expanded eligibility guidelines for ART., Objective: We use a published validated computer simulation of the HIV epidemic in East African countries (expanded to include transmission as well as disease progression) to evaluate the cost-effectiveness of routine viral load monitoring., Methods: We explored alternative scenarios regarding cost, frequency, and switching threshold of routine viral load monitoring (including every 6 or every 12 months; and switching thresholds of 1000, or 10 000 copies/ml), as well as alternative scenarios regarding ART initiation (200, 350, 500  cells/μl, and no CD4 cell threshold). For each ART initiation strategy, we sought to identify the viral load monitoring strategy at which the incremental cost-effectiveness ratio (ICER) of more frequent routine viral load testing became more favorable than the ICER of more expansive ART eligibility. Cost inputs were based on data provided by the Academic Model Providing Access to Healthcare (AMPATH), and disease progression inputs were based on prior published work. We used a discount rate of 3%, a time horizon of 20 years, and a payer perspective., Results: Across a wide range of scenarios, and even when considering the beneficial effect of virological monitoring at reducing HIV transmission, earlier ART initiation conferred far greater health benefits for resources spent than routine virological testing, with ICERs of approximately $1000 to $2000 for earlier ART initiation, versus ICERs of approximately $5000 to $25 000 for routine virological monitoring. ICERs of viral load testing were insensitive to the cost of the viral load test, because most of the costs originated from the downstream higher costs of later regimens. ICERs of viral load testing were very sensitive to the relative cost of second-line compared with first-line regimens, assuming favorable value when the costs of these regimens were equal., Conclusion: If all HIV patients are not yet treated with ART starting at 500  cells/μl and costs of second regimens remain substantially more expensive than first-line regimens, resources would buy more population health if they are spent on earlier ART rather than being spent on routine virological testing.

Background: A study of a comprehensive HIV Care Coordination Program (CCP) showed effectiveness in increasing viral load suppression (VLS) among PLWH in New York City (NYC). We evaluated the cost-effectiveness of a scale-up of the CCP in NYC. Methods: We incorporated observed effects and costs of the CCP into a computer simulation of HIV in NYC, comparing strategy scale-up with no implementation. The simulation combined a deterministic compartmental model of HIV transmission with a stochastic microsimulation of HIV progression, and was calibrated to NYC HIV epidemiological data from 1997 to 2009. We assessed incremental cost-effectiveness from a health sector perspective using 2017 $US, a 20-year time horizon, and a 3% annual discount rate. We explored two scenarios: (1) two-year average enrollment and (2) continuous enrollment. Results: In scenario 1, scale-up resulted in a cost-per-infection-averted of $898,104 and a cost-per-QALY-gained of $423,721. In sensitivity analyses, scale-up achieved cost-effectiveness if effectiveness increased from RR1.11 to RR1.37 or costs decreased by 41.7%. Limiting the intervention to persons with unsuppressed viral load prior to enrollment (RR1.32) attenuated the cost reduction necessary to 11.5%. In scenario 2, scale-up resulted in a cost-per-infection-averted of $705,171 and cost-per-QALY-gained of $720,970. In sensitivity analyses, scale-up achieved cost-effectiveness if effectiveness increased from RR1.11 to RR1.46 or program costs decreased by 71.3%. Limiting the intervention to persons with unsuppressed viral load attenuated the cost reduction necessary to 38.7%. Conclusion: Cost-effective CCP scale-up would require reduced costs and/or focused enrollment within NYC, but may be more readily achieved in cities with lower background VLS levels. [ABSTRACT FROM AUTHOR]

Background: Many analyses of HIV treatment decisions assume a fixed formulary of HIV drugs. However, new drugs are approved nearly twice a year, and the rate of availability of new drugs may affect treatment decisions, particularly when to initiate antiretroviral therapy (ART). Objectives: To determine the impact of considering the availability of new drugs on the optimal initiation criteria for ART and outcomes in patients with HIV/AIDS. Methods: We enhanced a previously described simulation model of the optimal time to initiate ART to incorporate the rate of availability of new antiviral drugs. We assumed that the future rate of availability of new drugs would be similar to the past rate of availability of new drugs, and we estimated the past rate by fitting a statistical model to actual HIV drug approval data from 1982–2010. We then tested whether or not the future availability of new drugs affected the model-predicted optimal time to initiate ART based on clinical outcomes, considering treatment initiation thresholds of 200, 350, and 500 cells/mm3. We also quantified the impact of the future availability of new drugs on life expectancy (LE) and quality-adjusted life expectancy (QALE). Results: In base case analysis, considering the availability of new drugs raised the optimal starting CD4 threshold for most patients to 500 cells/mm3. The predicted gains in outcomes due to availability of pipeline drugs were generally small (less than 1%), but for young patients with a high viral load could add as much as a 4.9% (1.73 years) increase in LE and a 8% (2.43 QALY) increase in QALE, because these patients were particularly likely to exhaust currently available ART regimens before they died. In sensitivity analysis, increasing the rate of availability of new drugs did not substantially alter the results. Lowering the toxicity of future ART drugs had greater potential to increase benefit for many patient groups, increasing QALE by as much as 10%. Conclusions: The future availability of new ART drugs without lower toxicity raises optimal treatment initiation for most patients, and improves clinical outcomes, especially for younger patients with higher viral loads. Reductions in toxicity of future ART drugs could impact optimal treatment initiation and improve clinical outcomes for all HIV patients. [ABSTRACT FROM AUTHOR]

Background: The optimal threshold for initiating HIV treatment is unclear. Objective: To compare different thresholds for initiating HIV treatment. Design: A validated computer simulation was used to weigh important harms from earlier initiation of antiretroviral therapy (toxicity, side effects, and resistance accumulation) against important benefits (decreased HIV-related mortality). Data Sources: Veterans Aging Cohort Study (5742 HIV-infected patients and 11 484 matched uninfected controls) and published reports. Target Population: Individuals with newly diagnosed chronic HIV infection and varying viral loads (10 000, 30 000, 100 000, and 300 000 copies/mL) and ages (30, 40, and 50 years). Time Horizon: Unlimited. Perspective: Societal. Intervention: Alternative thresholds for initiating antiretroviral therapy(CD4 counts of 200, 350, and 500 cells/mm3). Outcome Measures: Life-years and quality-adjusted life-years (QALYs). Results of Base-Case Analysis: Although the simulation was biased against earlier treatment initiation because it used an upperbound assumption for therapy-related toxicity, earlier treatment increased life expectancy and QALYs at age 30 years regardless of viral load (life expectancies with CD4 initiation thresholds of 500, 350, and 200 cells/mm3 were 18.2 years, 17.6 years, and 17.2 years, respectively, for a viral load of 10 000 copies/mL and 17.3 years, 15.9 years, and 14.5 years, respectively, for a viral load of 300 000 copies/mL), and increased life expectancies at age 40 years if viral loads were greater than 30 000 copies/mL (life expectancies were 12.5 years, 12.0 years, and 11.4 years, respectively, for a viral load of 300 000 copies/mL). Results of Sensitivity Analysis: Findings favoring early treatment were generally robust. Limitations: Results favoring later treatment may not be valid. The findings may not be generalizable to women. Conclusion: This simulation suggests that earlier initiation of combination antiretroviral therapy is often favored compared with current recommendations. [ABSTRACT FROM AUTHOR]