222 pubs · 6,193 cites · h-index 45
BACKGROUND: We evaluated the efficacy and safety of a once-daily oral two-drug regimen (2DR) combining doravirine and raltegravir in virologically suppressed people with HIV (PWH). METHODS: DORAL is a multicentre, open-label, randomized phase II trial conducted in France, Italy, and Spain. Virologically suppressed adults receiving stable antiretroviral therapy (ART), naïve to doravirine and without raltegravir resistance, were randomized (2:1) either to switch immediately to doravirine (100 mg) plus raltegravir (1200 mg) or to continue baseline ART until week 48 before switching to doravirine plus raltegravir. The primary endpoint was virological failure (VF; confirmed plasma HIV-1-RNA ≥50 copies/mL) at week 48. Secondary endpoints included maintenance of virological suppression through W96, immunological outcomes, safety, and pharmacokinetics in a genital sub-study. RESULTS: Among 114 participants (median age, 57 years; median CD4 count, 700 cells/mm3; median duration of virological suppression, 10 years), one VF occurred by week 48 in the immediate-switch group (1.3%; 95% CI, 0.0-6.9); none occurred in the delayed-switch group. No additional VF was observed through week 96. Immunological parameters remained stable during follow-up. Three adverse events considered related to doravirine and raltegravir led to treatment discontinuation. One grade 3 adverse event (anxiety), considered related to study treatment, was reported. In the genital sub-study, drug concentrations exceeded inhibitory thresholds in most samples, with infrequent detection of low-level seminal HIV-1-RNA. CONCLUSIONS: This proof-of-concept phase II switch trial supports the feasibility of a once-daily doravirine plus raltegravir 2DR in selected PWH, particularly when minimizing drug-drug interactions or avoiding NRTI exposure is a priority.
Background: The LENAddOn study aimed to characterize people with HIV (PWH) initiating injectable lenacapavir (LEN) post-early access program in France, assess LEN continuation rates at W26 and W52, and describe reasons for LEN discontinuation. Methods: Observational, retrospective study across 19 centers, including people with HIV-1 who initiated LEN between 20 June 2023 and 30 June 2024. Sociodemographic, clinical, and laboratory data were extracted from medical records. The primary outcome was the proportion of PWH receiving a second and third set of LEN injections at W26 and W52. Results: Seventy-seven PWH were included (median age, 57 years [IQR, 44-63]; duration of antiretroviral therapy (ART), 25 years [17-29]), with a history of frequent adherence issues and vulnerability factors. At LEN initiation, 22 (28.6%) had a plasma HIV-1 viral load (pVL) ≥200 copies/mL, and 43 (55.8%) had a pVL <50 copies/mL; 42 (54.6%) had viral resistance to ≥2 drugs in ≥3 classes. Twenty-one participants (27.3%) received injectable ART associating LEN plus cabotegravir ± rilpivirine. Lenacapavir continuation rate was 94.8% (95% CI, 87.2-98.6) at W26 and 81.8% (71.4-89.7) at W52, with 4 LEN discontinuations between D0 and W26 and 10 between W26 and W52. Main reasons for LEN discontinuation were death unrelated to LEN/lost-to-follow-up (n = 5), persistence of viral replication (n = 3), and injection site reactions (n = 2). Last measured pVL during the study period was <200 cp/mL in 72/77 participants (93.5%) and <50 cp/mL in 61/77 (79.2%). Conclusions: Lenacapavir use allowed simplification of antiretroviral regimens, with the maintenance or achievement of virological suppression. Continuation of LEN at W26 and W52 remained high among a population with extensive treatment history.
Evaluates lenacapavir efficacy in multidrug-resistant HIV patients, indicating strong results for certain groups.
BACKGROUND: Doravirine, the most recent NNRTI, may advantageously replace etravirine in virally suppressed PWH. We evaluated the tolerance and efficacy of doravirine-based ART following a switch from etravirine-based ART. METHODS: SWEED is a national, multicentre, retrospective, observational study including adults with HIV-1 and plasma viral load (pVL) <50 copies/mL on etravirine-based ART, who switched to doravirine-based ART (same number of associated drugs) from 09/01/2019 in 10 French hospitals. The primary outcome was virological failure (VF: confirmed pVL ≥50 copies/mL or single pVL ≥50 with ART change) at week 48 (W48). Secondary outcomes included rates of strategy success (pVL <50 copies/mL with no ART change) and treatment discontinuations due to side effects, and changes in CD4 counts and weight. RESULTS: Among 109 participants (79% men; median age 59 years), median ART duration was 25 years, with 13 years of sustained viral suppression. Prior NNRTI failure was documented in 41% of participants, and 46% had resistance mutations to at least one NNRTI. ART consisted of 2-drug (53%) and 3-drug (42%) combinations. Median follow-up was 30 months. One VF occurred by W48 (0.9%, 95%CI: 0.0-5.0); viral suppression was regained without ART change. Four patients discontinued doravirine-based ART due to adverse events; strategy success rate was 91.7% (95% CI: 84.9-96.2) at W48. No significant changes in CD4 counts and weight were observed. CONCLUSION: Doravirine-based ART maintained virological suppression in PWH switching from etravirine-based ART, even in presence of prior NNRTI resistance. Its once-daily dosing, favourable safety profile, and minimal drug interactions support its use in long-term ART strategies.
Introduction: Using three categories of stages of HIV disease at access to care (advanced, intermediate, early HIV disease), we explored the impact of delayed access on the risk of death at up to 5 years and whether progress in antiretroviral regimens has mitigated this impact. Methods: Adults from the French Hospital Database on HIV (ANRS CO4-FHDH) cohort with HIV-1 infection and first access to care during 2002-2021 were included. To study the impact of the stage of HIV disease at first access to care on the risk of death, only participants included from 2002 to 2016 were analysed to allow for at least 5 years of follow-up until 31 December 2021. Fine and Gray competing risk models considering lost to follow-up as a competing event were used adjusting for age, gender, mode of acquisition, region of origin, time between diagnosis and access to care, period of access to care (2002-2013 vs 2014-2016). Results: Among the 64 400 people living with HIV included, 18 305 (28.4%) had advanced and 13 042 (20.3%) intermediate HIV disease. The 5-year cumulative incidence of death was estimated as 1.8% (95% CI 1.7% to 1.9%) overall, from 0.9% (0.8% to 1.0%) for those with early HIV disease to 6.0% (5.4% to 6.7%) for those with AIDS. People with AIDS had a much higher risk of death than those with early HIV disease, with a sub-distribution HR (sHR) of 18.4 (95% CI 12.0 to 28.4) in the first 6 months of follow-up, which remained significant at 48-60 months: sHR=2.1 (1.3 to 3.3). The risk of death was higher for the other categories of advanced HIV disease but to a smaller extent. The risk of death was not statistically different depending on the calendar period. Conclusions: Delayed access to care remains associated with an elevated risk of death, even after 48 months. There was no significant improvement in the risk of death after 2014 when immediate initiation of combined antiretroviral therapy was recommended and integrase strand transfer inhibitor-based regimens became the preferred first-line.
Objectives: BICSTaR is a multinational, prospective, observational study that aimed to evaluate bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV treatment-naïve (TN) and treatment-experienced (TE) participants in routine clinical practice. Methods: Month 12 analysis of the French cohort with respect to virologic effectiveness, drug-related adverse events (DRAEs), emergence of resistance, body weight, and patient-reported outcomes using the HIV Symptom Index and the HIV Treatment Satisfaction Questionnaire. Results: A total of 240 participants initiated B/F/TAF in January-July 2019 (56 TN, 184 TE), 79% of whom were male, with a median age of 50 years. At baseline, 63% (TN: 46%, TE: 68%) presented with comorbidities. At month 12, HIV-1 RNA was <50 cp/mL in 92% (43/47) of TN and 96% (134 of 139) of TE in missing = excluded analysis (discontinuation = failure analysis: TN: 92% [43 of 47], TE: 92% [134 of 146]). No major mutations associated with B/F/TAF resistance emerged. A total of 7% (16 of 240) discontinued B/F/TAF, including 4% (10 of 240) due to DRAEs and none for virologic reasons. DRAEs were reported in 13% (30 of 240) (no renal DRAE). The median changes in body weight were +6.5 kg in TN and +1.0 kg in TE. The number of bothersome symptoms decreased in the TN group, and treatment satisfaction significantly increased in the TE group. Conclusions: These French real-world data confirm the effectiveness, safety, and tolerability of B/F/TAF in TN and TE participants with a high prevalence of comorbidities.
To the Editor—We read with great interest the recent article from Martín-Carmona et al, who found that human immunodeficiency virus (HIV) does not increase mortality risk after hepatitis C virus (HCV) cure from direct-acting antivirals (DAAs) in people with advanced liver fibrosis [1]. By publishing long-term follow-up data, the authors provide valuable insights into the unresolved question of whether or not HIV increases the risk of mortality after HCV cure. We would like to bring further elements to address this issue by studying the impact of HIV clinical markers (plasma HIV RNA and CD4 cell count) on mortality risk in adults coinfected with HIV and HCV who participated in the French national prospective cohort ANRS CO13 HEPAVIH [2]. From this prospective cohort, we selected HCV-cured participants with available sociobehavioral data before or after DAA treatment, who had a fibrose-4 index (FIB-4) assessment at the time of HCV cure (defined as a sustained virologic response 24 weeks after completing DAA treatment), and who had completed at least 1 clinical follow-up visit after HCV cure. We computed a Cox proportional hazards model with the time of HCV cure as the entry date and all-cause mortality as the outcome, adjusted for age, sex, history of drug injection, and advanced liver fibrosis (FIB-4 score >3.25 [3]), all assessed at the time of HCV cure, as well as HIV RNA load (detectable or not, according to the laboratory test threshold) and CD4 count (<500 or ≥500 cells/mL), both used as time-dependent variables.
Background: The COVID-19 pandemic has severely affected vulnerable populations, especially individuals living with HIV/AIDS (PLWHA). The convergence of HIV/AIDS and COVID-19 presents unique challenges, exacerbating existing health concerns and magnifying the strain on individuals already grappling with compromised immune systems. This study aimed to investigate the mental well-being repercussions faced by PLWHA co-infected with SARS-CoV-2 in France. Methods: COVIDHIV is a French multicenter cohort of PLWHA co-infected with SARS-CoV-2, which collected sociodemographic, clinical, and mental health data. Anxiety and depression symptoms and post-traumatic stress disorder (PTSD) were assessed by the Hospital Anxiety and Depression Scale (HADS) and the PTSD Checklist (PCL-S), respectively. Multivariable logistic regression was performed to identify factors associated with mental health outcomes at inclusion in the cohort. Results: Of the 397 participants included, 64.7% were male. The mean age was 51.6 (± 11.8) years. The prevalence of mental health outcomes was 33.5% ([95%CI: 28.5-39.0%]) for anxiety, 21.0% ([16.8-25.9%]) for depression, and 12.2% ([8.9-16.5%]) for PTSD. In multivariable regression adjusted for sex, COVID-19 wave and duration between COVID-19 confirmation and enrolment, age (adjusted odds-ratio (aOR): 0.97 [0.95-0.99]), being professionally active (0.43 [0.25-0.75]), and the number of self-reported symptoms (1.17 [1.11-1.24]) were associated with anxiety. Being professionally active (0.34 [0.18-0.65]), living in a couple (0.52 [0.20-0.98]), number of self-reported symptoms (1.15 [1.08-1.22]), and hospitalization for COVID-19 (3.35 [1.34-8.33]) were associated with depression. The number of self-reported symptoms (1.27 [1.16-1.41]), psychiatric disorders (4.04 [1.48-11.11]), and perceived vulnerability to COVID-19 (4.53 [1.69-14.60]) were associated with PTSD. Conclusion: The mental health is a challenging issue among the participants and needs to be closely monitored among people already affected by a chronic disease such as HIV. The findings underscore the urgent need for targeted support and interventions tailored to address the mental health needs of PLWHA facing the dual burden of HIV/AIDS and COVID-19.
Background We evaluated 1-year engagement in pre-exposure prophylaxis (PrEP) care and associated factors among gay, bisexual, and other men who have sex with men (GBMSM) in a large cohort of oral PrEP users in the Paris region, France. Methods We included in this analysis cisgender GBMSM enrolled in the ANRS PREVENIR cohort study from 3 May 2017 to 28 February 2019. We categorized 1-year PrEP engagement into 4 categories: high (consistent visits, attendance, and prescription refills at months 3, 6, 9, and 12), low (missed visits or no prescription refills), disengagement (PrEP discontinuation), and lost to follow-up. We used a logistic regression model to identify sociodemographic and behavioral factors associated with high engagement in PrEP care. Results Of 3211 participants, 2685 GBMSM were included in the analysis. At enrollment, participants had a median age of 36 years, with 88% born in Europe and 52.4% already undergoing PrEP. At month 12, 1612 (60.0%) participants met the high engagement definition, 438 (16.3%) exhibited low engagement, 459 (17.1%) disengaged from PrEP care, and 176 (6.6%) were lost to follow-up. In multivariable analysis, high engagement in PrEP care at 1 year was associated with older age (P < .001), being born in Europe (P = .01), having a higher education level (P = .05), already undergoing PrEP at enrollment (P < .001), having a bacterial sexually transmitted infection in the prior year (P = .01), earlier enrollment in the study (P = .04), and using PrEP daily or switching between PrEP regimens within the first year (P < .001). Conclusions Younger GBMSM, those born outside Europe, and those who were PrEP naive had lower engagement rates in the cohort, requiring tailored support.
An oral two-drug regimen (O2DR) in the form of a once-a-day single tablet is now recommended for treatment switching and treatment initiation for HIV. In clinical care, the process of treatment change refers to adaptation issues, both individual and within the care relationship. The study aim is to present the determinants involved in the acceptability of switching to O2DR in the PROBI (Patient-Reported Outcomes BItherapy) qualitative study. The study includes 30 interviews: 15 were conducted with doctors caring for people living with HIV, 15 were conducted with patients who had been offered a change of treatment. A double analysis was carried out: lexicometric analysis to highlight the structuring of the discourse around the change in treatment and a thematic analysis to understand the associated issues more precisely. The results highlighted common concerns with respect to switching to O2DR. Also, the caregiver-patient relationship was a central determinant in treatment switching. Information, knowledge and representations of O2DR are also factors facilitating treatment change and should be taken into account for doctors’ and patients’ adherence.
Prevention of cardiovascular disease is a major issue in the current management of people living with HIV. Concern is growing about the metabolic impact of integrase strand transfer inhibitors (INSTIs), which could lead to an increased risk of diabetes, but the data are conflicting. This is an updated version of our previous analysis, with longer follow-up and new molecules.
Background Some migrant men who have sex with men (MSM) acquire HIV in France. Aims We investigated, in migrant MSM receiving HIV care in France, the (i) rate of post-migration-HIV acquisition in France, (ii) delay between arrival and HIV acquisition and (iii) factors affecting HIV acquisition within 1 year after migration. Methods This cross-sectional study focused on ≥ 18-year-old MSM born outside France, receiving HIV care in the Paris region. Information on migration history, socioeconomic condition, sexual activity, and health was collected in May 2021–June 2022 through self-administered questionnaires and medical records. Post-migration-HIV-acquisition rate and delay between arrival in France and HIV acquisition were estimated from biographical data and CD4 + T-cell counts. Predictors of HIV acquisition within 1 year after migration were determined using logistic regression. Results Overall post-migration HIV-acquisition rate was 61.7% (715/1,159; 95%CI: 61.2–62.2), ranging from 40.5% (95%CI: 39.6–41.6) to 85.4% (95%CI: 83.9–86.0) in participants from Latin America and North Africa. Among post-migration-HIV acquisitions, those within 1 year after migration represented 13.1% overall (95%CI: 11.6–14.6), being highest in participants from sub-Saharan Africa (25%; 95%CI: 21.5–28.3). Participants ≥ 15-years old at migration, with post-migration-acquired HIV, had a 7.5-year median interval from arrival in France to HIV acquisition (interquartile range (IQR): 3.50–14.75). Older age at arrival, region of origin (sub-Saharan Africa and Asia), degree of social disadvantage and numbers of sexual partners were independently associated with acquiring HIV within 1 year in France. Conclusion Our findings may guide HIV prevention policies for most vulnerable migrants to Europe.
Objectives We aimed to assess the extent of integration of non‐communicable disease (NCD) assessment and management in HIV clinics across Europe. Methods A structured electronic questionnaire with 41 multiple‐choice and rating‐scale questions assessing NCD assessment and management was sent to 88 HIV clinics across the WHO European Region during March–May 2023. One response per clinic was collected. Results In all, 51 clinics from 34 countries with >100 000 people with HIV under regular follow‐up responded. Thirty‐seven clinics (72.6%) reported shared NCD care responsibility with the general practitioner. Systematic assessment for NCDs and integration of NCD management were common overall [median agreement 80%, interquartile range (IQR): 55–95%; and 70%, IQR: 50–88%, respectively] but were lowest in central eastern and eastern Europe. Chronic kidney disease (median agreement 96%, IQR: 85–100%) and metabolic disorders (90%, IQR: 75–100%) were regularly assessed, while mental health (72%, IQR: 63–85%) and pulmonary diseases (52%, IQR: 40–75%) were less systematically assessed. Some essential diagnostic tests such as glycated haemoglobin (HbA1c) for diabetes ( n = 38/51, 74.5%), proteinuria for kidney disease ( n = 30/51, 58.8%) and spirometry for lung disease ( n = 11/51, 21.6%) were only employed by a proportion of clinics. The most frequent barriers for integrating NCD care were the lack of healthcare workers ( n = 17/51, 33.3%) and lack of time during outpatient visits ( n = 12/51, 23.5%). Conclusion Most HIV clinics in Europe systematically assess and manage NCDs. People with HIV appear to be screened more frequently than the general population at the same age. There are, however, larger gaps among eastern European clinics in general and for clinics in all regions related to mental health, pulmonary diseases and the employment of some essential diagnostic tests.
We evaluated Ibalizumab (IBA)-containing standardized optimized salvage regimen (with or without a 4-week foscarnet induction) in individuals harboring multidrug-resistant human immunodeficiency virus type 2 (HIV-2). Nine were included; 2 achieved virological suppression after foscarnet induction with a sustained suppression at Week 24 after IBA initiation, and an additional individual at Week 24 after Ibalizumab initiation.
BACKGROUND: Hypermutated viruses induced by APOBEC3 (apolipoprotein B mRNA-editing, enzyme-catalytic, polypeptide-like 3) proteins comprise some of the defective viruses in the HIV reservoir. Here, we assessed the proportion of APOBEC3-induced defective proviruses in HIV-positive patients before and after receiving dolutegravir + lamivudine dual therapy. METHODS: PBMCs of virologically suppressed patients enrolled in the ANRS 167 LAMIDOL trial, evaluating a switch from triple therapy to dolutegravir + lamivudine, were collected 8 weeks before (W-8) and 48 weeks after (W48) dual-therapy initiation. The Vif and RT regions were subject to next-generation sequencing. Bioinformatic algorithms were developed to identify APOBEC3-defective sequences and APOBEC3-related drug resistance mutations (APOMuts). All hypermutated sequences and those containing at least one stop codon were considered as defective. RESULTS: One hundred and four patients were enrolled (median virological suppression duration: 4.2 years; IQR: 2.0-9.1). Proviral defective reads at W-8 and W48 were detected in Vif in 22% and 29% of patients, respectively, and in RT in 38% and 42% of patients, respectively. At least one APOMut was present in proviruses of 27% and 38% of patients at W-8 and W48, respectively. The ratio of APOMuts/number of potential APOMut sites was significantly higher at W48 (16.5%) than at W-8 (9.8%, P = 0.007). The presence of APOBEC3-defective viruses at W-8 was not associated with HIV total DNA level, nor with the third drug class received prior to switching to dolutegravir + lamivudine, nor with the duration of virological suppression. CONCLUSIONS: Whereas no significant change in the proportion of patients with APOBEC3-defective proviruses was evidenced after 1 year of dolutegravir + lamivudine maintenance, enrichment in APOMuts was observed. Further longer-term studies are needed to assess the other forms of defective viruses with dual-therapy.
OBJECTIVES: We aimed to examine the association of the country of birth and the other patients' characteristics with the prescription of two-drug regimens (2DRs) in virally suppressed people with HIV (PWH) in France. DESIGN: Observational study conducted from the national Dat'AIDS prospectively collected database. METHODS: We included all adults who were actively in care on 31 December 2020 in 26 French centers, with an HIV plasma viral load (pVL) <50 copies/ml for at least 6 months while on antiretroviral therapy (ART). Patients with chronic hepatitis B were excluded because they are not eligible to 2DRs. Univariate and multivariate logistic regressions were built to analyze relationships between patients' characteristics and receiving a 2DR. RESULTS: We analyzed data from 28 395 PWH: 41.7% men who have sex with men, 31.7% women and 26.5% heterosexual men; 35% born abroad. Median age was 53 years [interquartile range (IQR) 44-60]; ART duration 14 years (8-23); duration of virological suppression 87 months (42-142). 2DRs (mainly dolutegravir/rilpivirine, 53.8%, or dolutegravir/lamivudine, 41.7%) were prescribed in 16.3% of the patients and were less common in the 'born abroad' group (18.9% versus 11.5%). The multivariate model showed that individuals born in France were more likely to receive a 2DR [adjusted odds ratio (aOR): 1.62 [1.50-1.74]], independently of other characteristics. Older PLWH and those with higher CD4 + T-cell counts were also more likely to receive a 2DR. CONCLUSION: Despite unrestricted access to ART in France, independently from HIV disease parameters, PWH born abroad were less likely to receive 2DRs as a maintenance regimen than those born in France. Qualitative data are needed to better understand physicians' prescribing practices.
OBJECTIVES: Because NRTIs can have fetal toxicities, we evaluated a perinatal NRTI-sparing strategy to prevent perinatal HIV transmission. Our primary objective was to determine the proportion maintaining a viral load (VL) of <50 copies/mL up to delivery on darunavir/ritonavir monotherapy, without requiring treatment intensification. METHODS: In a one-arm, multicentre Phase 2 clinical trial, eligible patients in the first trimester of pregnancy on ART with plasma VL < 50 copies/mL received maintenance monotherapy with darunavir/ritonavir, 600/100 mg twice daily. VL was monitored monthly. ART was intensified in the case of VL > 50 copies/mL. Neonates received nevirapine prophylaxis for 14 days. RESULTS: Of 89 patients switching to darunavir/ritonavir monotherapy, 4 miscarried before 22 weeks' gestation, 2 changed treatment for elevated liver enzymes without virological failure, and 83 were evaluable for the main outcome. Six had virological failure confirmed on a repeat sample (median VL = 193 copies/mL; range 78-644), including two before switching to monotherapy. In these six cases, ART was intensified with tenofovir disoproxil fumarate/emtricitabine. The success rate was 75/83, 90.4% (95% CI, 81.9%-95.7%) considering two patients with VL missing at delivery as failures, and 77/83, 92.8% (95% CI, 84.9%-97.3%) when considering them as successes since both had undetectable VL on darunavir/ritonavir throughout pregnancy. In ITT, the last available VL before delivery was <50 copies/mL in all of the patients. There was no case of perinatal HIV transmission. CONCLUSIONS: Darunavir/ritonavir maintenance monotherapy required intensification in nearly 10% of cases. This limits its widespread use, thus other regimens should be evaluated in order to limit exposure to antiretrovirals, particularly NRTIs, during pregnancy.
BACKGROUND: In a 4 days/week (4/7 days) maintenance strategy (ANRS-170 QUATUOR trial), the virological impact of an intermittent strategy was assessed by ultrasensitive virological analyses of reservoirs and resistance. METHODS: HIV-1 total DNA, ultra-sensitive plasma viral load (USpVL) and semen VL were measured in the first 121 participants. Sanger and ultra-deep sequencing (UDS) were performed on the HIV-1 genome (Illumina technology) according to the ANRS consensus. A generalized estimation equation with a Poisson distribution was used to compare changes in the proportion of residual viraemia, detectable semen HIV RNA and HIV DNA within and between the two groups over time. RESULTS: The proportion of participants with residual viraemia at Day 0 (D0) and Week 48 (W48) was 16.7% and 25.0% in the 4/7 days group and 22.4% and 29.7% in the 7/7 days group, respectively (+8.3% versus +7.3%, P = 0.971). The proportion of detectable DNA (>40 copies/106 cells) at D0 and W48 was 53.7% and 57.4% in the 4/7 days group and 56.1% and 51.8% in the 7/7 days group, respectively (+3.7% versus -4.3%, P = 0.358). Semen HIV RNA was detectable (≥100 copies/mL) in 2.2% of participants at D0 and 4.5% at W48 in the 4/7 days group versus 6.1% and 9.1% in the 7/7 days group, respectively (+2.3% versus +3.0%, P = 0.743). Emerging resistance at failure was more frequent in the 4/7 days group detected by Sanger sequencing: 3/6 participants versus 1/4 in the 7/7 days group, and similar with the UDS assay: 5/6 versus 4/4, respectively. CONCLUSIONS: These findings support the potency of a 4/7 days maintenance strategy on virological suppression at the reservoirs and emergent resistance level, including minority variants.
OBJECTIVES: We aimed to describe factors associated with the choice of first antiretroviral therapy (ART) in persons with HIV (PWH) in France, included the country of birth, as well as the time to undetectable viral load and treatment discontinuation. DESIGN: Observational study conducted from the national Dat'AIDS prospectively collected database. METHODS: We included all adults who started their first ART between 01 January 2014 and 31 December 2020, with a pretherapeutic plasma viral load (pVL) at least 400 copies/ml. Univariable and multivariable logistic regressions were used to analyze PWH characteristics driving to an integrase strand transfer inhibitors (INSTI)-based first prescribed regimen. We also analyzed time to first line discontinuation, and to a first undetectable pVL, using Kaplan-Meier model. RESULTS: We analyzed data from 9094 PWH: 45% MSM, 27% women and 27% heterosexual men; 48% born abroad; 4.7 and 2.8% with concomitant hepatitis B and tuberculosis, respectively. INSTIs were prescribed as first-line therapy in 50% of PWH, which increased over time. Native French PWH were more likely to receive an INSTI-based regimen than PWH born abroad [adjusted prevalence ratio 1.47, 95% confidence interval (CI) 1.33-1.60], as were high pVL at diagnosis, hepatitis B or concomitant tuberculosis. Time before discontinuation of the first ART and reaching a first undetectable pVL was not different according to the place of birth. CONCLUSION: Despite unrestricted access to INSTIs in France, independently from HIV disease parameters, PWH born abroad received INSTIs less frequently as a first regimen than those born in France. Qualitative data are needed to better understand physicians' prescribing practices.
OBJECTIVE: It is unknown whether hepatitis C virus (HCV)-cured people with HIV (PWH) without cirrhosis reached the same mortality risk as HCV-uninfected PWH. We aimed to compare mortality in PWH cured of HCV by direct-acting antivirals (DAAs) to mortality in individuals with HIV monoinfection. DESIGN: Nationwide hospital cohort. METHODS: HIV-controlled participants without cirrhosis and HCV-cured by DAAs started between September 2013 and September 2020, were matched on age (±5 years), sex, HIV transmission group, AIDS status, and body mass index (BMI) (±1 kg/m 2 ) to up to 10 participants with a virally suppressed HIV monoinfection followed at the time of HCV cure ±6 months. Poisson regression models with robust variance estimates were used to compare mortality in both groups after adjusting for confounders. RESULTS: The analysis included 3961 HCV-cured PWH (G1) and 33 872 HCV-uninfected PWH (G2). Median follow-up was 3.7 years in G1 [interquartile range (IQR): 2.0-4.6], and 3.3 years (IQR: 1.7-4.4) in G2. Median age was 52.0 years (IQR: 47.0-56.0), and 29 116 (77.0%) were men. There were 150 deaths in G1 [adjusted incidence rate (aIR): 12.2/1000 person-years] and 509 (aIR: 6.3/1000 person-years) in G2, with an incidence rate ratio (IRR): 1.9 [95% confidence interval (CI), 1.4-2.7]. The risk remained elevated 12 months post HCV cure (IRR: 2.4 [95% CI, 1.6-3.5]). Non-AIDS/non-liver-related malignancy was the most common cause of death in G1 (28 deaths). CONCLUSIONS: Despite HCV cure and HIV viral suppression, after controlling on factors related to mortality, DAA-cured PWH without cirrhosis remain at higher risk of all-cause mortality than people with HIV monoinfection. A better understanding of the determinants of mortality is needed in this population.