ABSTRACT
Forty-eight-week results from a randomized, multicentre, part-blinded, phase IIb clinical trial assessing the efficacy and safety of 400 and 800 mg etravirine twice daily (phase IIb formulation) and optimized background regimen versus standard-of-care regimen are presented. Both etravirine doses demonstrated sustained virological suppression at 48 weeks and a favourable tolerability profile. Etravirine demonstrated higher efficacy than control, irrespective of the number of detectable nonnucleoside reverse transcriptase inhibitor-resistance-associated mutations at baseline or active background antiretrovirals.
Subject(s)
Anti-HIV Agents/administration & dosage , HIV Infections/drug therapy , HIV-1/isolation & purification , Pyridazines/administration & dosage , Anti-HIV Agents/adverse effects , Anti-HIV Agents/therapeutic use , Dose-Response Relationship, Drug , HIV Infections/virology , Humans , Nitriles , Pyridazines/adverse effects , Pyridazines/therapeutic use , Pyrimidines , Single-Blind Method , Treatment Outcome , Viral LoadABSTRACT
HIV medicine is a complex and rapidly changing field that requires experienced care providers. Clinical research has shown what has always been intuitive: providers with more experience have patients with better outcomes, and the resultant decrease in morbidity, mortality, and inpatient costs of expert care are cost-effective. As a result, there is a need to identify providers who can give the best quality care to persons living with HIV/AIDS. The American Academy of HIV Medicine has established a credentialing process to identify HIV specialists who demonstrate continuing competency in key aspects of HIV medicine from among a broad range of HIV health care providers. Several other organizations have attempted to identify qualified HIV medical providers but differ in key aspects of their definition of an HIV expert, with differing effects on the quality of health care delivered to persons living with HIV/AIDS. There is a need for all interested parties to come together to find solutions; to address the need for, and barriers to, increasing the number of HIV specialists; and to come to a consensus about the best way to ensure quality care for all those living with HIV/AIDS.
Subject(s)
Credentialing , Education, Medical , HIV Infections , Specialization , Clinical Competence , Education, Medical, Continuing/standards , Humans , Medicine/standards , Needs Assessment , Specialty Boards , United StatesABSTRACT
BACKGROUND: Anemia is prevalent in HIV-positive patients despite lower doses of zidovudine used in highly active antiretroviral therapy. Previously, epoetin alfa has been administered 3 times weekly (TIW). We compared the hematologic and quality of life (QOL) effects and tolerability of the more convenient once-weekly (QW) regimen with TIW epoetin alfa in anemic HIV-positive patients. METHODS: Two hundred eighty-five anemic (hemoglobin [Hb] <12 g/dL) HIV-positive adults receiving stable antiretroviral therapy were enrolled in this 16-week, randomized, multicenter study. Enrolled patients were randomized to receive epoetin alfa doses of 40,000 to 60,000 U QW or 100 to 300 U/kg TIW. RESULTS: Two hundred seventy-two patients were evaluable for efficacy. Both epoetin alfa dosing schedules produced significant Hb level increases by week 2 (mean Hb increase of 1.3 g/dL [QW] and 1.0 g/dL [TIW]; P < 0.0001) that continued to increase until week 8 and were maintained until study completion, with no significant difference between treatment groups at final Hb measurement (mean Hb increase of 2.9 g/dL [QW] and 2.5 g/dL [TIW]). All QOL parameters improved significantly (P < 0.05) from baseline by week 8 in both groups, with no significant differences between groups at week 16. Both dosing schedules were well tolerated. CONCLUSIONS: QW dosing of epoetin alfa is as effective as TIW dosing in increasing Hb levels, which was associated with improved QOL in anemic HIV-positive patients. QW dosing should also offer added convenience for patients and caregivers.
Subject(s)
Anemia/drug therapy , Erythropoietin/administration & dosage , HIV Infections/blood , HIV-1 , Hematinics/administration & dosage , Adult , Anemia/virology , Drug Administration Schedule , Epoetin Alfa , Female , HIV Infections/virology , Hemoglobins/metabolism , Humans , Male , Prospective Studies , Quality of Life , Recombinant ProteinsABSTRACT
Routine clinical assessment of health-related quality of life in persons with HIV infection has the potential to improve care by assessing and monitoring treatment effects, enhancing communication between patient and provider, and tracking changes in functional status over time. Currently available research-based assessment tools may be inadequate for routine clinical use because of the lack of inclusion of HIV-relevant aspects of quality of life and the impracticality of the use of such tools in the clinical setting. There may be a need for a new, clinically relevant, HIV-specific assessment tool that would be easy to incorporate into clinical practice to briefly, yet comprehensively, assess characteristics frequently found in HIV-infected persons, such as fatigue, pain, nausea and vomiting, sleep disturbances, sexual dysfunction, and body image issues. Until such a tool is developed, the Linear Analogue Self-Assessment questionnaire and the Medical Outcomes Study Short Form-12 (MOS SF-12) are short enough for routine use in a clinical setting. Slightly longer measures, such as the MOS-HIV Health Survey (MOS-HIV), can provide information in a greater number of domains.
