Search

Background: A prospective study was extended to the new antiretroviral and monitoring strategies in HIV-infected adults in low-income countries (NAMSAL-ANRS)-12313 trial, a 96-week open-label, multicenter, randomized phase 3 trial comparing dolutegravir (DTG) 50 mg with efavirenz 400 mg (EFV400), both administered with tenofovir disoproxil fumarate and lamivudine (TDF/3TC) as first-line treatment for antiretroviral therapy (ART)-naive people living with human immunodeficiency virus type 1 (HIV). Noninferiority of DTG to EFV400 was demonstrated at 48-week and sustained at 96 weeks. Here, we present results at 192-week., Methods: Previous trial participants were reconsented and followed up on their initial randomization arm (1:1 DTG/TDF/3TC:EFV400/TDF/3TC). Assessments included changes in viral suppression, biological parameters, and new serious adverse events (SAEs)., Results: Among the participants enrolled in the trial, 81% (499/613) were analyzed at week 192: 84% (261/310) on DTG/TDF/3TC and 78% (238/303) on EFV400/TDF/3TC. HIV RNA suppression was maintained in 69% (214/310) on DTG/TDF/3TC-based and 62% (187/303) on EFV400/TDF/3TC-based regimens (difference, 7.3% [95% confidence interval, -.20 to 14.83]; P = .057). Five (DTG/TDF/3TC = 2; EFV400/TDF/3TC = 3) new viral failures (World Health Organization definition) without related resistance DTG mutations and 24 new SAEs were observed (DTG/TDF/3TC = 13; EFV400/TDF/3TC = 11). Mean weight gain was +9.4 kg on DTG/TDF/3TC and +5.9 kg on EFV400/TDF/3TC. The percentage of participants with obesity increased from 6.9% to 27.7% on DTG/TDF/3TC ( P < .0001) and from 8.3% to 16.7% on EFV400/TDF/3TC ( P = .0033)., Conclusions: Four-year follow-up of people with HIV on DTG- and EFV400-based regimens showed long-term efficacy and safety of both ARTs, markedly among participants on DTG/TDF/3TC with high baseline viral load. However, unexpected substantial weight gain over time was prominent among participants on DTG/TDF/3TC, which should be closely monitored. Clinical Trials Registration.  NCT02777229., Competing Interests: Potential conflicts of interest. A. C. was a member of the WHO guideline panel in 2018 and 2019. The HIV Unit of Geneva University Hospitals (HUG) received unrestricted educational grants from ViiV, AbbVie, Gilead, and MSD, all of which also provided financial support to the LIPO group and metabolism (day hospital) in the HIV/AIDS Unit of HUG. J. R. has received personal fees and grants from Gilead, MSD, Pfizer, Tibotec-Janssen, and ViiV Healthcare for participation in advisory boards, educational programs, and conferences. All other authors report no potential conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: We provide new and comprehensive evidence on the evolution of a wide range of patient-reported outcomes (PROs) in the NAMSAL ANRS 12313 trial in Cameroon (2016-2021)-the first randomized comparison of dolutegravir 50 mg (DTG) and low-dose efavirenz (ie, 400 mg; EFV400) in treatment-naive adults living with HIV-1 in sub-Saharan Africa., Methods: We first described the evolution of PROs between baseline and week 192. Then, we used random-effects models to measure the effect of time since the initiation of antiretroviral therapy and the differential effect of DTG versus EFV400 on each PRO, adjusting for clinical, demographic, and socioeconomic factors, while accounting for unobserved heterogeneity and missing data., Results: Among the 613 patients randomized (DTG arm, n = 310; EFV400 arm, n = 303), (1) physical and mental health-related quality of life improved by 13.3% and 6.8%, respectively, (2) the percentage of patients with depression, anxiety, and stress decreased from 23.3%, 23.0%, and 7.7% to 3.1%, 3.5%, and 0.4%, respectively, and (3) the mean number of HIV-related symptoms decreased from 7.2 to 3.0 ( P < 0.001). For most PROs, no significant difference was found between both arms, even when accounting for the effect of DTG on weight gain. Nevertheless, our results suggest smaller improvements in mental health outcomes in the DTG arm, with a 5 percentage point higher adjusted probability of having anxiety at week 192 ( P < 0.01)., Conclusions: Although supporting the current World Health Organization guidelines recommending DTG-based and EFV400-based regimens as preferred and alternative first-line antiretroviral therapy, further studies should investigate medium-term mental health outcomes in patients on DTG., Trial Registration: ClinicalTrials.gov : NCT02777229., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: Coronary dissection is a rarely reported complication of cocaine use for which there are no specific guidelines on management despite the widespread use of the drug., Methods: We report a case of a 26-year-old otherwise fit and healthy Caucasian male smoker who presented to our facility with an infero-lateral ST elevation myocardial infarction (STEMI) following nasal inhalation of 1 gram of cocaine. Coronary angiography showed a mid left anterior descending (LAD) artery dissection with distal occlusive embolism and another dissection of the distal right coronary artery (RCA) with embolism and occlusion of the distal posterolateral branch., Outcome: Wiring of both vessels with a High-Torque Floppy wire successfully re-established TIMI 3 flow with relief of pain and resolution of his ST-segment elevation. Given the absence of any flow-limiting lesions, stenting was avoided. He was subsequently put on a combination of therapeutic dose enoxaparin, aspirin, ticagrelor, atorvastatin and metoprolol. A repeat angiogram eight days later showed complete healing of the dissections., Conclusion: This case shows that percutaneous management without stenting coupled with aggressive anti-coagulation of cocaine induced coronary dissection may result in an acceptable outcome especially in a young otherwise fit and healthy patient., (Copyright © 2015 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Prevalence of skin and eye disorders in African onchocerciasis (river blindness) is well documented. However, less is known about their joint occurrence. Information on concurrence may improve our understanding of disease pathogenesis and is required to estimate the disease burden of onchocerciasis. We analysed data from 765 individuals from forest villages in the Kumba and Ngambe Health districts, Cameroon. These data were collected in 1998, as baseline data for the evaluation of the African Programme for Onchocerciasis Control. Concurrence of symptoms was assessed using logistic regression. Onchocerciasis was highly endemic in the study population (63% nodule prevalence among males aged ≥20). Considerable overall prevalences of onchocercal visual impairment (low vision or blindness: 4%), troublesome itch (15%), reactive skin disease (19%), and skin depigmentation (25%) were observed. The association between onchocercal visual impairment and skin depigmentation (OR 9.0, 95% CI 3.9-20.8) was partly explained by age and exposure to infection (OR 3.0, 95% CI 1.2-7.7). The association between troublesome itch and reactive skin disease was hardly affected by adjustment (adjusted OR 6.9, 95% CI 4.2-11.1). Concluding, there is significant concurrence of morbidities within onchocerciasis. Our results suggest a possible role of host characteristics in the pathogenesis of depigmentation and visual impairment. Further, we propose a method to deal with concurrence when estimating the burden of disease., (Copyright © 2011 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.)

The African Programme for Onchocerciasis Control (APOC) has implemented a series of surveys aimed at evaluating the long-term impact of its activities. The region of Lastourville (Gabon) is one of the selected sites for this study. A total of 886 persons was examined for skin lesions, and 459 out of them participated in detailed ocular examinations. Blackflies were collected during one year and dissected. Although the focus was found to be hypoendemic (prevalence of nodules: 7.7%), the frequency of onchodermatitis was relatively high. The lesions of the anterior segment of the eye were rare, but the prevalence of optic nerve disease, and of choroido-retinal lesions reached 5.2 and 2.7%, respectively. The annual transmission potential (2,171 infective larvae per man) was high, when compared with the results recorded in the human population. This may be due to the presence of Onchocerca spp. of animal origin in the blackflies. These results indicate that in the area of Lastourville, though regarded as the main focus of onchocerciasis in Gabon, the disease is relatively mild.