Modelling the budget impact of darunavir in the treatment of highly treatment-experienced, HIV-infected adults in France.

BACKGROUND: A key element for payers in the assessment of the economic profile of a medication is its anticipated impact on the evolution of healthcare budgets. OBJECTIVES: To forecast the impact of the use of darunavir with low-dose ritonavir 600/100 mg twice a day (bid) in highly treatment-experienced, HIV-infected adults who have failed one or more protease inhibitor (PI)-containing regimen on the budget of the French Sickness Fund (French healthcare system) over a 3-year time horizon. METHODS: A transition state model based on disease severity was developed that compared the evolution of antiretroviral and non-antiretroviral-related direct costs of care in the target population over 3 years (2007-2009) under two scenarios: (1) darunavir enters the French market in year 1; (2) darunavir is not available to the target population during 2007-2009. Model inputs were derived from a targeted analysis of the French hospital database in HIV, the darunavir POWER 1 and 2 trials and other relevant clinical studies. RESULTS: In the scenario where darunavir was available from year 1, the proportion of patients in the lower, more costly CD4 cell count strata (≤ 100 cells per mm³) was consistently lower than in the scenario without darunavir in each year of the model (17.0% vs 19.2%, 13.9% vs 18.3% and 10.8% vs 16.8% for years 1, 2 and 3, respectively). As a result, over the entire 3-year period, the net increase of antiretroviral drug costs (+ 5.6 million Euros; €), resulting from the substitution of older, cheaper PIs by darunavir, is expected to be fully compensated by savings in hospitalization costs (€-9.7 million) and expenditures for other HIV-related (non-antiretroviral) medications (€-7.3 million), leading to a net saving of €11.4 million or 2.9% of the total budget in the scenario without darunavir. Various sensitivity analyses confirmed these projected savings. CONCLUSION: The use of darunavir/ritonavir (DRV/r) 600/100 mg bid, in combination with other antiretroviral agents, in highly pre-treated, HIV-infected adults who have failed one or more PI-containing highly active antiretroviral therapy regimen is not expected to increase the budget of the French healthcare system, in comparison with a scenario without darunavir. Further research is needed to estimate the budget impact of the use of DRV/r in less treatment-experienced, HIV-infected individuals in France.

Food insecurity is associated with incomplete HIV RNA suppression among homeless and marginally housed HIV-infected individuals in San Francisco.

BACKGROUND AND OBJECTIVES: There is growing international concern that food insecurity may negatively impact antiretroviral (ARV) treatment outcomes, but no studies have directly evaluated the effect of food insecurity on viral load suppression and antiretroviral adherence. We hypothesized that food insecurity would be associated with poor virologic response among homeless and marginally housed HIV-positive ARV-treated patients. DESIGN: This is a cross-sectional study. PARTICIPANTS AND SETTING: Participants were ARV-treated homeless and marginally housed persons receiving adherence monitoring with unannounced pill counts in the Research on Access to Care in the Homeless (REACH) Cohort. MEASUREMENTS: Food insecurity was measured by the Household Food Insecurity Access Scale (HFIAS). The primary outcome was suppression of HIV viral RNA to <50 copies/ml. We used multivariate logistic regression to assess whether food insecurity was associated with viral suppression. RESULTS: Among 104 participants, 51% were food secure, 24% were mildly or moderately food insecure and 25% were severely food insecure. Severely food insecure participants were less likely to have adherence > or =80%. In adjusted analyses, severe food insecurity was associated with a 77% lower odds of viral suppression (95% CI = 0.06-0.82) when controlling for all covariates. In analyses stratified by adherence level, severe food insecurity was associated with an 85% lower odds of viral suppression (95% CI = 0.02-0.99) among those with < or =80% adherence and a 66% lower odds among those with >80% adherence (95% CI = 0.06-1.81). CONCLUSIONS: Food insecurity is present in half of the HIV-positive urban poor in San Francisco, one of the best resourced settings for HIV-positive individuals in the United States, and is associated with incomplete viral suppression. These findings suggest that ensuring access to food should be an integral component of public health HIV programs serving impoverished populations.