Suchergebnisse

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

Purpose of the studyThe primary Week 48 analysis of this ongoing, randomized, double‐blind, double‐dummy, active‐controlled Phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir DF (Quad) in treatment‐naïve patients demonstrated that Quad was non‐inferior to efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF) with a differentiated safety profile. We report the Week 96 interim data.MethodsKey eligibility criteria included HIV‐1 RNA ≥5,000 c/mL and eGFR ≥70 mL/min. Virologic success (HIV‐1 RNA <50 c/mL) at Week 96 was assessed per snapshot algorithm. Adverse events and laboratory data were collected prospectively.Results700 patients (89% male, 63% white, 33% with HIV‐1 RNA >100,000 c/mL) were randomized and treated. At Week 48, Quad was non‐inferior to EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% CI ‐1.6% to 8.8%). High rates of virologic success were maintained at Week 96 (84% vs 82%, difference 2.7%, 95% CI ‐2.9% to 8.3%). Subgroup analysis revealed similar rates of virologic success in patients with baseline HIV‐1 RNA >100,000 c/mL (81% vs 83%). Mean CD4 cell increase (cells/mm3) was 295 vs 273. Emergent resistance was infrequent (3% vs 3%). Rates of study drug discontinuation due to adverse events (AEs) were low and comparable (5% vs 7%). Rates of neuropsychiatric AEs were lower in Quad than in EFV/FTC/TDF (47% vs 66%, P<0.001), as were rates of rash (21% vs 31%, P=0.006). Drug discontinuation due to renal reasons occurred in 7 (2%) vs 0 patients through Week 96; only two patients discontinued Quad since Week 48 due to serum creatinine (Cr) increase without features of proximal renal tubulopathy. Median changes in serum Cr (µmol/L [mg/dL]) at Week 96 in Quad vs EFV/FTC/TDF (11.5 vs 0.9 [0.13 vs 0.01]) were similar to those at Week 48 (12.4 vs 0.9 [0.14 vs 0.01]). Quad had smaller median increases (mmol/L [mg/dL]) in total (0.23 vs 0.47 [9 vs 18], P<0.001) and LDL cholesterol (0.23 vs 0.41 [9 vs16], P=0.011), and similar increase in triglycerides (0.05 vs 0.09 [4 vs 8], P=0.41).ConclusionsAt Week 96, Quad demonstrated high rates of virologic suppression with low rates of resistance and a differentiated safety and tolerability profile relative to EFV/FTC/TDF. These results support the durable efficacy and long‐term safety of Quad in HIV‐1 infected patients.

IntroductionThe HIV pandemic disproportionately impacts young women. Worldwide, young women aged 15–24 are infected with HIV at rates twice that of young men, and young women alone account for nearly a quarter of all new HIV infections. The incommensurate HIV incidence in young – often poor – women underscores how social and economic inequalities shape the HIV epidemic. Confluent social forces, including political and gender violence, poverty, racism, and sexism impede equal access to therapies and effective care, but most of all constrain the agency of women.MethodsHIV prevalence data was compiled from the 2010 UNAIDS Global Report. Gender inequality was assessed using the 2011 United Nations Human Development Report Gender Inequality Index (GII). Logistic regression models were created with predominant mode of transmission (heterosexual vs. MSM/IDU) as the dependent variable and GII, Muslim vs. non‐Muslim, Democracy Index, male circumcision rate, log gross national income (GNI) per capita at purchasing power parity (PPP), and region as independent variables.Results and discussionThere is a significant correlation between having a predominantly heterosexual epidemic and high gender inequality across all models. There is not a significant association between whether a country is predominantly Muslim, has a high/low GNI at PPP, has a high/low circumcision rate, and its primary mode of transmission. In addition, there are only three countries that have had a generalized epidemic in the past but no longer have one: Cambodia, Honduras, and Eritrea. GII data are available only for Cambodia and Honduras, and these countries showed a 37 and 34% improvement, respectively, in their Gender Inequality Indices between 1995 and 2011. During the same period, both countries reduced their HIV prevalence below the 1% threshold of a generalized epidemic. This represents limited but compelling evidence that improvements in gender inequality can lead to the abatement of generalized epidemics.ConclusionsGender inequality is an important factor in the maintenance – and possibly in the establishment of – generalized HIV epidemics. We should view improvements in gender inequality as part of a broader public health strategy.