Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.

Treatment response is defined as a VL <50 copies/mL measured at two consecutive visits up to Week 48 and without subsequent rebound or change of ARV therapy up to Week 48, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.

VL <50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient

VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)

Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT

Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.

Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.

QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.

Cost effectiveness assessment by number of patients hospitalized

Cost effectiveness assessment by number of patients with non-scheduled physician visits

Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations.

Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment

Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.

Number of patients with AE lipodystrophy

Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)

Number of patients with AE elevated serum glucose

Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96.

Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144.

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response

Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response.

Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count < 50 copies/mL up to Visit 10 (week 48) or loss of virologic response

Calculations based on the MDRD algorithm.

Proportion of Patients reporting rash of any severity

Proportion of Patients reporting hepatic events of any severity

Proportion of Patients reporting CNS (central nervous system) side effects of any severity

Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL

Changes frombaseline apolipoprotein A1 & B

Change of hsCRP from baseline to week 48, 96, 144

Change of total triglycerides from baseline to week 48, 96, 144

Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144