RESUMO
Cancer is a high incidence disease, forcing healthcare systems to assign a significant amount of resources to its treatment. New developments have arisen recently: development of new agents that act at specific steps of cellular differentiation and proliferation and identification of predictive genetic markers which allow sub-groups of patients that will benefit from these agents, alone or in combination with chemotherapy, to be targeted. The majority of new drugs coming to the market combine greater clinical benefit and higher costs. Constraints on healthcare budgets worldwide make it necessary to rationalise the expense by prioritising allocation of available resources to the most efficient interventions, so that the best possible clinical result can be obtained at a reasonable cost and with the best quality of life for the patient. Economic evaluation studies represent the only tool available to scientifically determine the cost-effectiveness of new treatments and the budgetary impact of their introduction to the therapeutic arsenal available for the treatment of cancer.
Assuntos
Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Custos de Cuidados de Saúde , Neoplasias/tratamento farmacológico , Neoplasias/economia , Humanos , EspanhaRESUMO
BACKGROUND: Non-nucleoside reverse transcriptase inhibitor-containing regimens may be a valid alternative to protease inhibitor-containing regimens for initial antiretroviral therapy, but to date few studies comparing these two strategies have been performed. OBJECTIVE: To evaluate the efficacy and safety of nelfinavir or nevirapine associated to zidovudine/lamivudine in HIV-infected naive patients. DESIGN: Randomized, open-label, multicentre trial. SETTING: Twelve centres in Spain (9) and Argentina (3). PATIENTS: One hundred and forty-two HIV-infected naive patients without AIDS. INTERVENTIONS: Patients received combivir (zidovudine 300 mg/lamivudine 150 mg, twice-daily) plus either nelfinavir (1250 mg) twice-daily (zidovudine/lamivudine/nelfinavir, n=70) or nevirapine (200 mg) twice-daily (zidovudine/lamivudine/nevirapine, n=72), and were followed for 12 months. The primary endpoint was the proportion of patients with a plasma HIV-1 RNA (pVL) of less than 200 copies/ml by PCR at 12 months. pVL of less than 20 copies/ml (PCR), changes in CD4 counts, clinical progression and adverse events were also evaluated. Efficacy was assessed using intent-to-treat (ITT) (missing=failure) and on-treatment analysis. RESULTS: At 12 months in the ITT analysis the proportion of patients with pVL below 200 copies/ml was 60% (95% CI 48.5-71.5) in the zidovudine/lamivudine/nelfinavir arm and 75% (95% CI 65-85) in the zidovudine/lamivudine/nevirapine arm (P=0.06), and the proportion below 20 copies/ml was 50% (95% CI 38.3-61.7) and 65% (95% CI 54.2-76.2), respectively (P=0.06). No differences were found when comparing the subgroup of patients with baseline pVL of more than 100,000 copies/ml. A gain of +173 and +162 CD4 cells/mm3, respectively, was observed. Zidovudine/lamivudine/nelfinavir was discontinued in 21% of patients, and zidovudine/lamivudine/nevirapine in 25%, due to toxicity (P>0.2). CONCLUSIONS: Our results suggest that zidovudine/lamivudine/nevirapine is at least as effective as zidovudine/lamivudine/nelfinavir as first-line therapy for HIV disease.