***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND We report data from NEWART , a r and omised phase 4 clinical trial comparing virologic efficacy and safety of nevirapine ( NVP ) vs. ritonavir-boosted atazanavir ( ATV/r ) on a background of tenofovir/emtricitabine ( TDF/FTC ) in HIV-1-infected treatment-naïve patients . This study enrolled patients according to CD4-based initiation criteria for NVP ( < 250 cells/mm(3 ) for women and < 400 cells/mm(3 ) for men ) , to reduce the likelihood of symptomatic hepatic events . NEWART was design ed to support and confirm results from ARTEN , an international trial with similar design and study endpoints . METHODS A total of 152 patients were r and omised 1 : 1 to open-label  NVP 200 mg twice daily or ATV/r ( 300/100 mg ) once daily , plus once daily TDF/FTC ( 300/200 mg ) . All participants met CD4(+ ) guidelines at entry . The primary endpoint for non-inferiority was virologic response prior to and at week 48 ( confirmed HIV plasma viral load < 50 copies/ml , without rebound or change in ARVs ) . Safety data , including plasma lipids , were recorded throughout the study . RESULTS The primary endpoint was achieved in 46/75 ( 61.3 % ) and 50/77 ( 64.9 % ) of patients taking NVP and ATV/r , respectively . Frequency of adverse events ( AEs ) was similar between arms , with 88.0 % of NVP-treated patients and 94.8 % of ATV/r-treated patients experiencing at least one AE . Nine patients ( 12 % ) in each arm experienced an AE that led to discontinuation . At week 48 , a significantly greater increase was seen in mean plasma HDL cholesterol ( HDL-C ) in the NVP arm ( 9.6 mg/dl ) vs. the ATV/r arm ( 3.5 mg/dl ) ; p = 0.016 . Also , total cholesterol (TC):HDL-C ratio on-treatment was -0.38 and -0.02 for the NVP and ATV/r arms , respectively ( p = 0.038 ) . CONCLUSIONS Efficacy results were consistent with the ARTEN study demonstrating that NVP was non-inferior to ATV/r when taken in combination with TDF/FTC . Rates of AEs were similar between the two arms , whereas HDL-C increased and TC : HDL-C decreased significantly more in patients taking NVP than ATV/r Objective : To assess the safety and efficacy of two , single-tablet regimens for the initial treatment of HIV infection . Design : Phase 2 , r and omized , double-blind , double-dummy , multicenter , active-controlled study . Methods : Antiretroviral treatment-naive adults with a screening HIV-1 RNA at least 5000 copies/ml and a CD4 cell count more than 50 cells/μl were r and omized 2 : 1 to receive fixed-dose combination tablets of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate ( EVG/COBI/FTC/TDF ; N = 48 ) or efavirenz/emtricitabine/tenofovir disoproxil fumarate ( EFV/FTC/TDF ; n = 23 ) for 48 weeks . The primary endpoint was proportion of participants with HIV-1 RNA less than 50 copies/ml at week 24 . Results : Participants receiving EVG/COBI/FTC/TDF exhibited a more rapid decline in HIV-1 RNA and a greater proportion suppressed viral load to less than 50 copies/ml than participants receiving EFV/FTC/TDF . Both EVG/COBI/FTC/TDF and EFV/FTC/TDF result ed in high rates of viral suppression and increases in CD4 cell count . Ninety and 83 % of participants suppressed HIV-1 RNA to less than 50 copies/ml both at the 24-week and 48-week visits for EVG/COBI/FTC/TDF and EFV/FTC/TDF , respectively . Once-daily administration of EVG/COBI/FTC/TDF  provided a mean EVG trough concentration 10-fold over its protein binding-adjusted IC95 across study visits . EVG/FTC/TDF/GS-9350 was generally well tolerated with a lower rate of drug-related central nervous system ( 17 % ) and psychiatric ( 10 % ) adverse events versus EFV/FTC/TDF ( 26 and 44 % , respectively ) . Decreases in estimated glomerular filtration rate occurred within the first few weeks of dosing in participants receiving EVG/COBI/FTC/TDF , remained within the normal range and did not progress at week 24 or 48 ; no participant experienced a clinical adverse event or discontinued study drug due to changes in serum creatinine or renal function . Conclusion : Once-daily EVG/COBI/FTC/TDF achieved and maintained a high rate of virologic suppression with fewer central nervous system and psychiatric adverse events compared to a current st and ard-of-care regimen of EFV/FTC/TDF ABSTRACT Background Patients infected with HIV-1 initiating antiretroviral therapy ( ART ) containing a non-nucleoside reverse transcriptase inhibitor ( NNRTI )  show presumably fewer atherogenic lipid changes than those initiating most ARTs containing a protease inhibitor . We analysed whether lipid changes differed between the two most commonly used NNRTIs , nevirapine ( NVP ) and efavirenz ( EFV ) . Methods and Findings Prospect i ve analysis of lipids and lipoproteins was performed in patients enrolled in the NVP and EFV treatment groups of the 2NN study who remained on allocated treatment during 48 wk of follow-up . Patients were allocated to  NVP ( n = 417 ) , or EFV ( n = 289 ) in combination with stavudine and lamivudine . The primary endpoint was percentage change over 48 wk in high-density lipoprotein cholesterol ( HDL-c ) , total cholesterol ( TC ) , TC : HDL-c ratio , non-HDL-c , low-density lipoprotein cholesterol , and triglycerides . The increase of HDL-c was significantly larger for patients receiving NVP ( 42.5 % ) than for patients receiving EFV ( 33.7 % ; p = 0.036 ) , while the increase in TC was lower ( 26.9 % and 31.1 % , respectively ; p = 0.073 ) , result ing in a decrease of the TC : HDL-c ratio for patients receiving NVP ( −4.1 % ) and an increase for patients receiving EFV ( + 5.9 % ; p < 0.001 ) . The increase of non-HDL-c was smaller for patients receiving NVP ( 24.7 % ) than for patients receiving EFV ( 33.6 % ; p = 0.007 ) , as were the increases of triglycerides ( 20.1 % and 49.0 % , respectively ; p < 0.001 ) and low-density lipoprotein cholesterol ( 35.0 % and 40.0 % , respectively ; p = 0.378 ) . These differences remained , or even increased , after adjusting for changes in HIV-1 RNA and CD4 + cell levels , indicating an effect of the drugs on lipids over and above that which may be explained by suppression of HIV-1 infection . The increases in HDL-c were of the same order of magnitude as those seen with the use of the investigational HDL-c-increasing drugs . Conclusion NVP-containing ART shows larger increases in HDL-c and decreases in TC : HDL-c ratio than an EFV-containing regimen . Based on these findings , protease-inhibitor-sparing regimens based on non-nucleoside reverse transcriptase inhibitor , particularly those containing NVP , may be expected to result in a reduced risk of coronary heart disease Introduction : Direct comparison of the efficacy and safety of different agents is needed to guide selection of optimal treatment regimens for therapy-naive HIV-1-infected patients . Methods : Gemini was a 48-week , multicenter , open-label , noninferiority trial in treatment-naive HIV-1-infected adults r and omized to either saquinavir/ritonavir ( SQV/r ) 1000 mg/100 mg twice a day or lopinavir/ritonavir ( LPV/r ) 400 mg/100 mg twice a day , each with emtricitabine/tenofovir 200 mg/300 mg every day . Results : A similar proportion of participants in the SQV/r ( n = 167 ) and LPV/r ( n = 170 ) arms had HIV-1 RNA levels < 50 copies per milliliter at week 48 : 64.7 % vs 63.5 % and estimated difference in proportion for noninferiority : 1.14 % , 96 % confidence interval : −9.6 to11.9 ( P < 0.012 ) , confirming that SQV/r was noninferior to LPV/r treatment . There were no significant differences in week 48 CD4 counts between arms . The rate and severity of adverse events were similar in both groups . There were no significant differences in the median change from baseline between arms in plasma lipids except for triglyceride levels , which were significantly higher in the LPV/r at week 48 . Conclusions : In treatment-naive , HIV-1-infected patients , SQV/r treatment was noninferior in virologic suppression at 48 weeks to LPV/r treatment and offered a better triglyceride profile Background Rates of cardiovascular disease are higher among HIV-infected patients as a result of the complex interplay between traditional risk factors , HIV-related inflammatory and immunologic changes , and effects of antiretroviral therapy ( ART ) . This study prospect ively evaluated changes in cardiovascular biomarkers in an underrepresented , racially diverse , HIV-1-infected population receiving abacavir/lamivudine as backbone therapy . Methods This 96-week , open-label , r and omized , multicenter study compared once-daily fosamprenavir/ritonavir 1400/100 mg and efavirenz 600 mg , both with ABC/3TC 600 mg/300 mg , in antiretroviral-naïve , HLA-B*5701-negative adults without major resistance mutations to study drugs . We evaluated changes from baseline to weeks 4 , 12 , 24 , 48 , and 96 in interleukin-6 ( IL-6 ) , high-sensitivity C-reactive protein ( hs-CRP ) , soluble vascular adhesion molecule-1 ( sVCAM-1 ) , d-dimer , plasminogen , and fibrinogen . Biomarker data were log-transformed before analysis , and changes from baseline were described using geometric mean ratios . Results This study enrolled 101 patients ( 51 receiving fosamprenavir/ritonavir ; 50 receiving efavirenz ) : 32 % female , 60 % African American , and 38 % Hispanic/Latino ; 66 % ( 67/101 ) completed 96 weeks on study . At week 96 , levels of IL-6 , sVCAM-1 , d-dimer , fibrinogen , and plasminogen were lower than baseline in both treatment groups , and the decrease was statistically significant for sVCAM-1 ( fosamprenavir/ritonavir and efavirenz ) , d-dimer ( fosamprenavir/ritonavir and efavirenz ) , fibrinogen ( efavirenz ) , and plasminogen ( efavirenz ) . Values of hs-CRP varied over time in both groups , with a significant increase over baseline at Weeks 4 and 24 in the efavirenz group . At week 96 , there was no difference between the groups in the percentage of patients with HIV-1 RNA < 50 copies/mL ( fosamprenavir/ritonavir 63 % ; efavirenz 66 % ) by ITT missing-equals-failure analysis . Treatment-related grade 2–4 adverse events were more common with efavirenz ( 32 % ) compared with fosamprenavir/ritonavir ( 20 % ) , and median lipid concentrations increased in both groups over 96 weeks of treatment . Conclusions In this study of underrepresented patients , treatment with abacavir/lamivudine combined with either fosamprenavir/ritonavir or efavirenz over 96 weeks , produced stable or declining biomarker levels except for hs-CRP , including significant and favorable decreases in thrombotic activity ( reflected by d-dimer ) and endothelial activation ( reflected by sVCAM-1 ) . Our study adds to the emerging data that some cardiovascular biomarkers are decreased with initiation of ART and control of HIV viremia . Trial registration Clinical Trials.gov identifier CONTEXT Abacavir , a nucleoside analogue , has demonstrated suppression of human immunodeficiency virus ( HIV ) replication alone 
    Output:
    
For viral suppression at 48 weeks , compared with efavirenz , the odds ratio ( OR ) for viral suppression was 1·87 ( 95 % credible interval [ CrI ] 1·34 - 2·64 ) with dolutegravir and 1·40 ( 1·02 - 1·96 ) with raltegravir ; with respect to viral suppression , low-dose efavirenz was similar to all other treatments .
Both low-dose efavirenz and integrase str and transfer inhibitors tended to be protective of discontinuations due to adverse events relative to normal-dose efavirenz .