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Objective This paper presents the final analysis of once-daily darunavir/ritonavir ( DRV/r) vs. lopinavir/ritonavir ( LPV/r) in treatment-naïve HIV-1-infected adults. Methods ARTEMIS ( AntiRetroviral Therapy with TMC114 ExaMined In naïve Subjects; NCT00258557) was a randomized, open-label, phase- III, 192-week trial. Patients were stratified by baseline HIV-1 RNA and CD4 count, and randomized to once-daily DRV/r 800/100 mg or LPV/r 800/200 mg total daily dose (either once or twice daily) plus tenofovir/emtricitabine. Results Of 689 randomized patients receiving treatment ( DRV/r: 343; LPV/r: 346), 85 and 114 patients in the DRV/r and LPV/r arms, respectively, had discontinued by week 192. Noninferiority was shown in the primary endpoint of virological response ( HIV-1 RNA < 50 copies/ mL) [ DRV/r: 68.8%; LPV/r: 57.2%; P < 0.001; intent to treat ( ITT)/time to loss of virological response; estimated difference in response 11.6% (95% confidence interval 4.4-18.8%)]. Statistical superiority in virological response of DRV/r over LPV/r was demonstrated for the primary endpoint ( P = 0.002) and for the ITT non-virological-failure-censored analysis (87.4% vs. 80.8%, respectively; P = 0.040). No protease inhibitor ( PI) primary mutations developed and only low levels of nucleoside reverse transcriptase inhibitor ( NRTI) resistance developed in virological failures in both groups. Significantly fewer discontinuations because of adverse events were observed with DRV/r (4.7%) than with LPV/r (12.7%; P = 0.005). Grade 2-4 treatment-related diarrhoea was significantly less frequent with DRV/r than with LPV/r (5.0% vs. 11.3%, respectively; P = 0.003). DRV/r was associated with smaller median increases in total cholesterol and triglyceride levels than LPV/r. Changes in low- and high-density lipoprotein cholesterol were similar between groups. Similar increases in aspartate aminotransferase and alanine aminotransferase for DRV/r and LPV/r were observed. Conclusion Over 192 weeks, once-daily DRV/r was noninferior and statistically superior in virological response to LPV/r, with a more favourable gastrointestinal profile, demonstrating its suitability for long-term use in treatment-naïve patients. [ABSTRACT FROM AUTHOR]

Background: We investigated the effect of HIV on COVID‐19 outcomes with attention to selection bias due to differential testing and comorbidity burden. Methods: This was a retrospective cohort analysis using four hierarchical outcomes: positive SARS‐CoV‐2 test, COVID‐19 hospitalization, intensive care unit (ICU) admission and hospital mortality. The effect of HIV status was assessed using traditional covariate‐adjusted, inverse probability‐weighted (IPW) analysis based on covariate distributions for testing bias (testing IPWs), HIV infection status (HIV‐IPWs) and combined models. Among people living with HIV (PWH), we evaluated whether CD4 count and HIV plasma viral load (pVL) discriminated between those who did and those who did not develop study outcomes using receiver operating characteristic analysis. Results: Between March and November 2020, 63 319 people were receiving primary care services at the University of California San Diego (UCSD), of whom 4017 were PWH. The PWH had 2.1 times the odds of a positive SARS‐CoV‐2 test compared with those without HIV after weighting for potential testing bias, comorbidity burden and HIV‐IPW [95% confidence interval (CI): 1.6–2.8]. Relative to people without HIV, PWH did not have an increased rate of COVID‐19 hospitalization after controlling for comorbidities and testing bias [adjusted incidence rate ratio (aIRR) = 0.5, 95% CI: 0.1–1.4]. PWH did not have a different rate of ICU admission (aIRR = 1.08, 95% CI: 0.31–3.80) or of in‐hospital death (aIRR = 0.92, 95% CI: 0.08–10.94) in any examined model. Neither CD4 count nor pVL predicted any of the hierarchical outcomes among PWH. Conclusions: People living with HIV have a higher risk of COVID‐19 diagnosis than those without HIV but the outcomes are similar in both groups. [ABSTRACT FROM AUTHOR]

Objectives: HIV‐1 genetic diversity is increasing among men who have sex with men (MSM) in China, but the association of HIV‐1 genotype with disease progression remains to be elucidated. Methods: We collected data in an observational longitudinal cohort study of 860 HIV‐1‐infected MSM in Guangzhou, China between January 2008 and March 2017. Kaplan‐Meier analysis and Cox proportional hazard model were used to predict the time from HIV‐1 diagnosis to immunodeficiency progression (CD4 cell count < 200 cells/μl) as well as adjusted hazard ratio (aHR). Results: CRF01_AE and HIV‐1 subtype B infection were associated with higher percentage of patients progressed to immunodeficiency and higher incidence of immunodeficiency than infection with CRF07_BC or CRF55_01B. Compared with CRF07_BC, the time from HIV‐1 diagnosis to immunodeficiency were different among the major HIV‐1 genotypes, which ranked as follows, in descending order: CRF07_BC (7.03 years) > CRF55_01B (5.71 years, P = 0.014; aHR 3.752, P = 0.0923) > CRF01_AE (5.18 years, P < 0.001; aHR 4.733, P = 0.0152). HIV‐1 genotype, viral load and baseline CD4 T‐cell count were three independent variables associated with disease progression. Conclusions: Our results confirm differential rates of immunodeficiency progression as a function of HIV‐1 genotype. The impact of HIV‐1 genotype on HIV epidemics, patient management and prevention should be further investigated. [ABSTRACT FROM AUTHOR]