Outcomes according to study group.

<p>Groups: ____ No OI; …. TB; –– Other OIs.</p

Selected baseline characteristics by study groups.

<p>^a TB = tuberculosis; PTB = pulmonary tuberculosis; ETB = extrapulmonary tuberculosis.</p><p>^b p-values for categorical variables were obtained with the use of the chi-square test, while ANOVA test was used for continuous variables.</p><p>^c ZDV = zidovudine; 3TC = lamivudine; EFV = efavirenz; DDI = didanosine; TDF = tenofovir; FTC = emtricitabine.</p

Risk Factors of Time to Treatment Failure.

1<p>All adjusted models include treatment condition.</p><p>Table Legend:</p><p>QOL_health: general health perceptions.</p><p>QOL_mental: mental health.</p

Baseline Participant Characteristics.

<p>Table Legend:</p><p>QOL_health: general health perceptions.</p><p>QOL_mental: mental health.</p><p>Treatment: Once daily protease inhibitor + nucleoside reverse transcriptase inhibitors: atazanavir + didanosine-EC and emtricitabine.</p><p>Treatment: Once daily non-nucleoside reverse transcriptase inhibitor + nucleoside reverse transcriptase inhibitors: efavirenz + co-formulated emtricitabine-tenofovir-DF.</p><p>Standard of care: efavirenz plus co-formulated lamivudine-zidovudine.</p

ACTG A5175/Pearls trial – Survival probability estimate from randomization to treatment failure by pill count non-adherence (solid line = did not miss any pills; dashed line = missed any pills).

<p>ACTG A5175/Pearls trial – Survival probability estimate from randomization to treatment failure by pill count non-adherence (solid line  =  did not miss any pills; dashed line  =  missed any pills).</p

Primary and secondary time-to-event outcomes for comparison of efavirenz plus emtricitabine-tenofovir-DF to efavirenz plus lamivudine-zidovudine using data collected through 31-May-2010.

a<p>Also known as relative risk. Estimated from Cox regression model stratified by both country and RNA stratum and including randomized treatment group as sole covariate.</p>b<p><i>p</i>-Value calculated from stratified log-rank test between arms. Not applicable (NA) because no formal hypothesis testing was performed based on DSMB recommendations.</p>c<p>The five most common causes of death were infection (17 deaths) and unknown cause (five deaths) followed by suicide, trauma, and stroke (three deaths each).</p>d<p>Disease progression diagnoses are in <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s012" target="_blank">Table S7</a>; grade 3 and 4 laboratory adverse events in <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s013" target="_blank">Table S8</a>; and signs and symptoms in <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s014" target="_blank">Table S9</a>.</p>e<p>All events meeting these criteria are reported; some participants met criteria for multiple endpoints.</p>f<p>Confirmed plasma HIV RNA≥1,000 copies/ml at study week 16 or later.</p>g<p>Change in any component of initial randomized antiretroviral regimen.</p>h<p>The following antiretroviral substitutions were prespecified and were not included in this endpoint: stavudine or TDF for ZDV, nevirapine for EFV, or didansoine for TDF.</p>i<p>CD4+ lymphocytes <100/µl at week 48 or later.</p

Primary and secondary time-to-event outcomes for the comparison of atazanavir plus didanosine-EC and emtricitabine to efavirenz plus lamivudine-zidovudine using data collected through 22 May 2008.

a<p>Also known as relative risk. Estimated from Cox regression model stratified by both country and RNA stratum and including randomized treatment group as sole covariate.</p>b<p><i>p</i>-Value calculated from stratified log-rank test between arms.</p>c<p>The five most common causes of death were infection (six deaths), liver disease (three deaths), malignancy (two deaths), suicide (two deaths), and unknown cause (two deaths).</p>d<p>Disease progression diagnoses are in <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s007" target="_blank">Table S2</a>; grade 3 and 4 laboratory events in <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s008" target="_blank">Table S3</a>; and signs and symptoms in <a href="http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001290#pmed.1001290.s009" target="_blank">Table S4</a>.</p>e<p>All events meeting these criteria are reported; some participants met criteria for multiple endpoints.</p>f<p>Confirmed plasma HIV RNA≥1,000 copies/ml at study week 16 or later.</p>g<p>Elevated bilirubin concentration not included.</p>h<p>Change in any component of initial randomized antiretroviral regimen.</p>i<p>The following antiretroviral substitutions were prespecified and were not included in this endpoint: TDF for DDI, stavudine or TDF for ZDV, or nevirapine for EFV.</p>j<p>CD4+ lymphocytes <100/µl at week 48 or later.</p

Subgroup analysis for primary efficacy and safety endpoints by randomly assigned antiretroviral treatment.

<p>Subgroup analyses were conducted for the baseline covariates self-reported sex and race/ethnicity and the countries in which the participating research sites were located. The relative risk and 95% CIs are provided for all participants (overall) and for each subgroup. <i>p</i>-Value represents interaction test between baseline covariate and randomized treatment group. Comparisons between ATV plus DDI and FTC and EFV plus 3TC-ZDV are in red. Comparisons between EFV plus FTC-TDF and EFV plus 3TC-ZDV are in green. (A) Treatment failure (efficacy) composite endpoint. (B) Safety events composite endpoint.</p

Efficacy and safety of randomized study treatment over time.

<p>(A–H) black circles, EFV plus 3TC-ZDV; red triangles, ATV plus DDI-EC and FTC; green squares, EFV plus FTC-TDF. (A–B) Estimated cumulative probability of antiretroviral regimen failure defined by the protocol-specified primary efficacy endpoint: comparison of EFV plus 3TC-ZDV to ATV plus FTC and DDI (A) and EFV plus FTC-TDF (B). (C–D) Proportion of participants with plasma HIV-1 RNA less than 400 copies/ml for comparison of EFV plus 3TC-ZDV to ATV plus FTC and DDI (C) and EFV plus FTC-TDF (D). These comparisons included all randomized study participants according to assigned study treatment. The analysis that counted missing values as greater than 400 copies/ml (open symbols) is truncated at the maximum potential duration of study follow-up for participants who entered the study at the end of the enrollment period (144 wk). (E–F) Median change in CD4+ lymphocyte count from screening value over time for comparison of EFV plus 3TC-ZDV to ATV plus FTC and DDI (E) and EFV plus FTC-TDF (F). (G–H) Estimated cumulative probability a safety endpoint over time for comparison of EFV plus 3TC-ZDV to ATV plus FTC and DDI (G) and EFV plus FTC-TDF (H). For (A–D, G and H), bars represent the 95% CI for the estimate. For (E–F), bars represent the interquartile range. (A–H) The number of evaluable participants at each time point is provided for each randomized treatment assignment.</p