Characteristics and outcomes of people living with HIV hospitalised at tertiary healthcare institutions during the COVID-19 pandemic in Mexico City.

BACKGROUND: While existing research on people living with HIV (PWH) during the COVID-19 pandemic primarily focused on their clinical outcomes, a critical gap remains in understanding the implications of COVID-19 delivery of in-hospital care services to PWH. Our study aimed to describe the characteristics and outcomes of PWH hospitalised during 2020 in Mexico City, comparing patients admitted due to COVID-19 vs. patients admitted due to other causes. METHODS: All PWH hospitalised for ≥ 24 h at four institutions in Mexico City from January 1st to December 31st, 2020 were included. Patients were classified into two groups according to the leading cause of their first hospitalisation: COVID-19 or non-COVID-19. Characteristics among groups were compared using chi-square and Kruskal tests. A Cox model was used to describe the risk of death after hospitalisation and the characteristics associated with this outcome. Mortality and hospitalisation events were compared to data from 2019. RESULTS: Overall, we included 238 PWH hospitalised in 2020. Among them, 42 (18%) were hospitalised due to COVID-19 and 196 (82%) due to non-COVID-19 causes, mainly AIDS-defining events (ADE). PWH hospitalised due to COVID-19 had higher CD4 + cell counts (380 cells/mm3 [IQR: 184-580] vs. 97 cells/mm3 [IQR: 34-272], p < 0.01) and a higher proportion of virologic suppression (VS) compared to those hospitalised due to non-COVID-19 causes (92% vs. 55%, p < 0.01). The adjusted hazard ratio (aHR) for AIDS was 3.1 (95%CI: 1.3-7.2). COVID-19 was not associated with death (aHR 0.9 [95%CI: 0.3-2.9]). Compared to 2019, mortality was significantly higher in 2020 (19% vs. 9%, p < 0.01), while hospitalisations decreased by 57%. CONCLUSIONS: PWH with COVID-19 had higher VS and CD4 + cell counts and lower mortality compared to those hospitalised due to non-COVID-19-related causes, who more often were recently diagnosed with HIV and had ADEs. Most hospitalisations and deaths in 2020 in PWH were related to advanced HIV disease. The increased mortality and decreased hospitalisations of PWH during 2020 evidence the impact of the interruption of health services delivery for PWH with advanced disease due to the pandemic. Our findings highlight the challenges faced by PWH during 2020 in a country where advanced HIV remains a concern.

Retiring the term AIDS for more descriptive language.

The term acquired immunodeficiency syndrome (AIDS) was coined to describe a condition marked by weakened cell-mediated immunity in the absence of a clear cause. Due to unfortunate messaging during the early days of the HIV epidemic, this term became loaded with stigma. After the discovery of HIV, the term AIDS became redundant, but its use has persisted and has come to embody negative connotations in the current landscape of the HIV epidemic. People commonly associate AIDS with a terminal illness. This misconception promotes stigma by others, including health-care workers, but also self-stigma, which can prevent individuals from accessing health care. Also, the link between AIDS and gay men generated during the early epidemic with use of the term gay-related immune disorder is misleading regarding which populations are at risk, which can delay diagnosis. The use of the term AIDS is now discouraged by several professional associations, some of which ironically have the word as part of their name. Ending use of the term AIDS would not eradicate stigma. However, this term has outlasted its usefulness, and we should transition towards more descriptive language that aligns with contemporary challenges in HIV.

How the COVID-19 pandemic and the health system's response reduced HIV testing and increased late diagnoses in Mexico.

OBJECTIVES: This study aims to evaluate the disruption in HIV screening and diagnoses due to the coronavirus disease 2019 (COVID-19) pandemic and to investigate the pandemic's subsequent influence on the HIV epidemic. DESIGN: A retrospective examination of testing and confirmed diagnoses time series was undertaken from 2011 to 2022. The analysis encompassed testing, positive tests, positivity rates, and diagnosis outcomes, including new HIV diagnoses, asymptomatic HIV diagnoses, and symptomatic HIV diagnoses. METHODS: We used Autoregressive Integrated Moving Average (ARIMA) models to estimate the COVID-19 epidemic's impact on screening and diagnosis outcomes. We gauged the pandemic's effect between January 2020 and December 2022 by comparing modeled predicted results with actual outcomes. RESULTS: The advent of COVID-19 prompted a reduction of 50.7% in HIV testing, followed by a monthly escalation in testing afterward, estimated at 30.2 and 65.1% for 2021 and 2022, respectively. Although new diagnoses reported between 2020 and 2022 gradually increased to prepandemic levels, we estimate a gap of 13 207 new diagnoses, with symptomatic detections increasing more than proportionally in 2021 and 2022. CONCLUSION: Our results suggest that the COVID-19 pandemic resulted in missed HIV diagnoses and a rise in late HIV diagnoses. Implementing tailored post-COVID-19 strategies to accelerate timely HIV testing and prevention is needed to avert additional burdens and remain on track toward achieving the 2030 HIV management goals.

SARS-CoV-2 infection in health care workers during the first 2-years of the pandemic at a cancer hospital in Mexico.

BACKGROUND: Health care workers (HCWs) are occupationally exposed to severe acute respiratory syndrome coronavirus (SARS-CoV-2). This study aimed to characterize COVID-19 in HCWs at an oncology hospital in Mexico City over 2-years, identify factors associated with severity, and establish transmission dynamics. METHODS: This retrospective study included HCWs with confirmed COVID-19. Socio-demographic, clinical, and outcome data were retrieved from March 2020 to March 2022. We compared the proportion of HCWs affected in each wave. A survey on COVID-19 transmission dynamics was conducted in a subgroup. RESULTS: We included 1,058 workers. The risk of COVID-19 was higher during the Omicron odds ratio (OR 2.10, 95% confidence interval [CI] 1.77-2.50, P < .001). Age ≥41 years old (OR 6.32, 95% CI 2.4-16.62) and being administrative staff (OR 5.51, 95% CI 1.72-17.6) or medical staff (OR 6.82, CI 95% 1.77-26.23), compared to nursing staff, were associated with severity. Vaccination with ≥1 vaccine against SARS-CoV-2 was a protective factor for severe disease (OR 0.04, 95% CI 0.005-0.331). CONCLUSIONS: This study highlights the impact of COVID-19 on HCWs in a cancer hospital in Mexico City and the impact of vaccination as a protective factor against severity.

Importance of Confirmatory Tests for Sars-Cov-2 Infection in Hemodialysis Patients: A Multicenter Mexican Registry

Abstract Background: Since the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, patients with chronic kidney disease vulnerable to suffering more severe COVID-19 disease and worse outcomes have been identified Objectives: Our study's aim was to determine the incidence, characteristics, and outcomes of SARS-CoV-2 infection in patients of hemodialysis (HD) units in Mexico and to describe the availability of confirmatory testing Methods: This study was multicentric study of 19 HD units, conducted between March 2020 and March 2021 Results: From a total of 5779 patients, 955 (16.5%) cases of suspicious COVID-19 were detected; a SARS-CoV-2 reverse transcription polymerase chain reaction test was done in only 50.6% of patients. Forty-five percentages were hospitalized and 6% required invasive mechanical ventilation (IMV). There was no significant difference in mortality between confirmed (131/483) and suspicious (124/472) cases (p = 0.74). The percentage of patients in need of hospitalization, IMV, and deceased was greater than in the rest of the study population Conclusions: The study revealed that 49.4% of the cases were not confirmed, a worrisome observation given that this is a highly vulnerable population (higher probability of contagion and worse outcomes), in which 100% of patients should have a confirmatory test

Risk factors associated with HCV co-infection amongst MSM and transgender women living with HIV in Mexico City: A case-control study.

INTRODUCTION AND OBJECTIVES: Hepatitis C virus infection (HCV) is a major cause of co-morbidity in people living with HIV (PLWHIV). The modes of HCV transmission in the local population of PLWHIV are still unclear. We conducted this study to identify risk factors for HCV transmission amongst PLWHIV in central Mexico. MATERIAL AND METHODS: We enrolled HIV/HCV co-infected cases and HIV controls receiving care in two outpatient clinics in Mexico City. Structured questionnaires were applied, covering demographics, history of percutaneous exposures, sexual behaviors, self-reported STD and recreational drug use. The statistical analysis for between-group comparisons were multivariate logistic regression models to assess the risk factors associated with HCV co-infection. We limited the final analysis to men who have sex with men (MSM) to avoid confounders potentially related to HCV acquisition in other populations. RESULTS: Three hundred and thirty-four MSM with HIV (175 with HCV co-infection and 159 without) were analysed. We did not identify percutaneous exposures as risk factors for HCV. Intravenous drug use (IVDU) occurred in two cases and one control case. Risk factors independently associated with acquiring HCV co-infection were: history of an ulcerative STD (aOR=2.65, 95%CI=1.44-4.88), a HCV positive partner (aOR=5.25, 95%CI=2.78-9.91), having practiced insertive fisting (aOR=2.62, 95%CI=1.01-6.90), and rectal administration of drugs during sex (aOR=2.46, 95%CI=1.25-4.84). CONCLUSIONS: Risky sexual behaviors and chemsex seem to be the main drivers of HIV/HCV co-infection amongst PLWHIV in Central Mexico. IVDU and percutaneous exposures have a minor role in the local HCV epidemic. These findings highlight the importance of testing for HCV in sexually active MSMs.

Clinical Follow-Up in People Living with HIV During the COVID-19 Pandemic in Mexico.

Clinical follow-up in people living with HIV (PLWH) has individual and public health implications. The objectives of this study were to measure variables related to follow-up failures, identify self-reported reasons to maintain adequate follow-up or for having follow-up failures, and know how the pandemic influenced patients' clinical follow-up. Participants were PLWH receiving HIV-health care at a hospital-based clinic in Mexico City which became an exclusive COVID-19 health service. Participants completed a telephone semi-structured interview and online psychological questionnaires. Lower educational and socioeconomic level, longer times of transportation to the clinic, being attended by different doctors, detectable viral load, having previous dropouts, inadequate antiretroviral adherence, and less HIV knowledge were related to follow-up failures. COVID-19 had a significant negative impact, but it also had positive repercussions for patients with adequate follow-up. These results could help develop effective psychosocial programs and improve healthcare in institutions to facilitate patient retention.

RESUMEN: El seguimiento clínico en las personas que viven con VIH (PVV) tiene implicaciones individuales y de salud pública. Los objetivos de este estudio fueron medir las variables relacionadas con las fallas en el seguimiento, identificar las razones reportadas para mantener un seguimiento adecuado o para tener fallas en el seguimiento, y conocer cómo la pandemia influyó en el seguimiento clínico de los individuos. Los participantes eran PVV que recibían atención médica para el VIH en una clínica hospitalaria de Ciudad de México que se convirtió en un servicio exclusivo para COVID-19. Los participantes completaron una entrevista semiestructurada por teléfono y cuestionarios psicológicos en línea. El nivel educativo y socioeconómico más bajo, mayor tiempo de transporte a la clínica, falta de continuidad del médico, carga viral detectable, tener abandonos previos, inadecuada adherencia al tratamiento antirretroviral y menor conocimiento del VIH se relacionaron con las fallas en el seguimiento. La pandemia demostró tener un importante impacto negativo, pero también tuvo repercusiones positivas para los pacientes con un seguimiento adecuado. Estos resultados son importantes para desarrollar programas psicosociales eficaces y mejorar la atención sanitaria en las instituciones para facilitar la retención de los pacientes.

Importance of Confirmatory Tests for Sars-Cov-2 Infection in Hemodialysis Patients: A Multicenter Mexican Registry.

Background: Since the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, patients with chronic kidney disease vulnerable to suffering more severe COVID-19 disease and worse outcomes have been identified. Objectives: Our study's aim was to determine the incidence, characteristics, and outcomes of SARS-CoV-2 infection in patients of hemodialysis (HD) units in Mexico and to describe the availability of confirmatory testing. Methods: This study was multicentric study of 19 HD units, conducted between March 2020 and March 2021. Results: From a total of 5779 patients, 955 (16.5%) cases of suspicious COVID-19 were detected; a SARS-CoV-2 reverse transcription polymerase chain reaction test was done in only 50.6% of patients. Forty-five percentages were hospitalized and 6% required invasive mechanical ventilation (IMV). There was no significant difference in mortality between confirmed (131/483) and suspicious (124/472) cases (p = 0.74). The percentage of patients in need of hospitalization, IMV, and deceased was greater than in the rest of the study population. Conclusions: The study revealed that 49.4% of the cases were not confirmed, a worrisome observation given that this is a highly vulnerable population (higher probability of contagion and worse outcomes), in which 100% of patients should have a confirmatory test.

Retention in Care, Mortality, Loss-to-Follow-Up, and Viral Suppression among Antiretroviral Treatment-Naïve and Experienced Persons Participating in a Nationally Representative HIV Pre-Treatment Drug Resistance Survey in Mexico.

We describe associations of pretreatment drug resistance (PDR) with clinical outcomes such as remaining in care, loss to follow-up (LTFU), viral suppression, and death in Mexico, in real-life clinical settings. We analyzed clinical outcomes after a two-year follow up period in participants of a large 2017-2018 nationally representative PDR survey cross-referenced with information of the national ministry of health HIV database. Participants were stratified according to prior ART exposure and presence of efavirenz/nevirapine PDR. Using a Fine-Gray model, we evaluated virological suppression among resistant patients, in a context of competing risk with lost to follow-up and death. A total of 1823 participants were followed-up by a median of 1.88 years (Interquartile Range (IQR): 1.59-2.02): 20 (1%) were classified as experienced + resistant; 165 (9%) naïve + resistant; 211 (11%) experienced + non-resistant; and 1427 (78%) as naïve + non-resistant. Being ART-experienced was associated with a lower probability of remaining in care (adjusted Hazard Ratio(aHR) = 0.68, 0.53-0.86, for the non-resistant group and aHR = 0.37, 0.17-0.84, for the resistant group, compared to the naïve + non-resistant group). Heterosexual cisgender women compared to men who have sex with men [MSM], had a lower viral suppression (aHR = 0.84, 0.70-1.01, p = 0.06) ART-experienced persons with NNRTI-PDR showed the worst clinical outcomes. This group was enriched with women and persons with lower education and unemployed, which suggests higher levels of social vulnerability.

Pretreatment HIV drug resistance spread within transmission clusters in Mexico City.

BACKGROUND: Pretreatment HIV drug resistance (HIVDR) to NNRTIs has consistently increased in Mexico City during the last decade. OBJECTIVES: To infer the HIV genetic transmission network in Mexico City to describe the dynamics of the local HIV epidemic and spread of HIVDR. PATIENTS AND METHODS: HIV pol sequences were obtained by next-generation sequencing from 2447 individuals before initiation of ART at the largest HIV clinic in Mexico City (April 2016 to June 2018). Pretreatment HIVDR was estimated using the Stanford algorithm at a Sanger-like threshold (≥20%). Genetic networks were inferred with HIV-TRACE, establishing putative transmission links with genetic distances <1.5%. We examined demographic associations among linked individuals with shared drug resistance mutations (DRMs) using a ≥ 2% threshold to include low-frequency variants. RESULTS: Pretreatment HIVDR reached 14.8% (95% CI 13.4%-16.2%) in the cohort overall and 9.6% (8.5%-10.8%) to NNRTIs. Putative links with at least one other sequence were found for 963/2447 (39%) sequences, forming 326 clusters (2-20 individuals). The inferred network was assortative by age and municipality (P < 0.001). Clustering individuals were younger [adjusted OR (aOR) per year = 0.96, 95% CI 0.95-0.97, P < 0.001] and less likely to include women (aOR = 0.46, 95% CI 0.28-0.75, P = 0.002). Among clustering individuals, 175/963 (18%) shared DRMs (involving 66 clusters), of which 66/175 (38%) shared K103N/S (24 clusters). Eight municipalities (out of 75) harboured 65% of persons sharing DRMs. Among all persons sharing DRMs, those sharing K103N were younger (aOR = 0.93, 95% CI 0.88-0.98, P = 0.003). CONCLUSIONS: Our analyses suggest age- and geographically associated transmission of DRMs within the HIV genetic network in Mexico City, warranting continuous monitoring and focused interventions.

Sociodemographic differences among HIV-positive and HIV-negative recently pregnant women in Mexico City: A case-control study.

National HIV preventive programs in Mexico focus on high-risk groups that do not consider women, apart from prenatal screening. Nonetheless, the epidemic in women is growing, and there is a need to better understand sociodemographic factors in women living with HIV (WLH). We performed a case-control study in Mexico City, including HIV+ and HIV- women with a recent pregnancy to compare their sociodemographic characteristics and describe the circumstances of diagnosis in HIV+ women, as well as prenatal screening frequency in both groups. Fifty cases and 102 controls were interviewed. HIV+ women were more frequently the only economic support of the family (20% vs 0%, P < .0001). Thirty-eight percent of cases had their first pregnancy at ≤18 years, versus 16% of controls (odds ratio 2.47, 95% confidence interval 1.07-5.72, P = .03); 16% of cases had lived in the street; 6% reported transactional sex, versus none of the controls (P < .0001). In the multivariate analysis, there was strong evidence of an association between HIV infection and age at the time of the interview, history of sexually transmitted diseases, substance abuse, history of violence, and civil status. Only 6% of controls were tested for HIV during prenatal follow-up. WLH in this study faced important social vulnerability. Targeting women living in these social contexts might increase early diagnosis and could tailor HIV prevention strategies. Prenatal coverage needs to be improved and should represent a national priority.

[In-hospital mortality in HIV-infected patients: 10 years after the implementation of universal access to HAART in Mexico]. / Mortalidad hospitalaria en pacientes con infección por VIH: a diez años del acceso universal a TARAA en México.

OBJECTIVE: To establish the characteristics and causes of death of HIV patients who die while hospitalized. MATERIALS AND METHODS: We included HIV+ patients who died during hospitalization, in three hospitals in Mexico City between 2010 and 2013. Sociodemographic and clinical data were collected as well as causes of death. We identified preventable deaths (defined as deaths that occurred in patients with less than six months of HAART, or without HAART, with less than 350 CD4 at diagnosis and/or opportunistic events as the cause of hospitalization). RESULTS: 128 deaths were analyzed. The median of CD4 count was 47 cells/mm³; 18% of the patients ignored their HIV status at the time of hospitalization, 51% had less than six months of HAART, 40.5% had never received HAART before. The main causes of death were AIDS defining events, with 65.6%. We identified 70 preventable deaths (57%). CONCLUSIONS: Despite universal access to HAART, HIV patients in Mexico are still dying of AIDS defining illnesses, an indicator of late diagnosis. It is urgent to implement HIV testing programs to allow earlier diagnosis and make HAART benefit accessible to all.

Mortalidad hospitalaria en pacientes con infección por VIH: a diez años del acceso universal a TARAA en México / In-hospital mortality in HIV-infected patients: 10 years after the implementation of universal access to HAART in Mexico

Objetivo. Establecer las características y causas de muerte de pacientes VIH positivos que fallecen al estar hospitalizados. Material y métodos. Se incluyeron pacientes VIH positivos que fallecieron durante la hospitalización entre 2010 y 2013. Se recabaron datos sociodemográficos y clínicos, causas de muerte y muertes prevenibles. Se consideraron prevenibles aquellas muertes en pacientes con menos de seis meses de terapia antirretroviral altamente activa (TARAA) o sin tratamiento y con menos de 350 CD4+ al momento del diagnóstico o del internamiento, con o sin enfermedades oportunistas. Resultados. Se identificaron 128 muertes. La mediana de CD4+ fue 47 cels/mm³; 18% llegó al internamiento sin diagnóstico de VIH, 51% tenía menos de seis meses de haber sido diagnosticado y 40.5% no había recibido TARAA. Las principales causas de muerte fueron eventos definitorios de sida (65.6%). Se identificaron 70 muertes prevenibles (57%). Conclusión. A pesar del acceso universal a TARAA, en México los pacientes VIH positivos siguen falleciendo por eventos relacionados con sida, que es un indicador de diagnóstico tardío del VIH. Es urgente implementar programas de detección temprana para hacer accesible el beneficio de la TARAA.

Objective. To establish the characteristics and causes of death of HIV patients who die while hospitalized. Materials and methods. We included HIV+ patients who died during hospitalization, in three hospitals in Mexico City between 2010 and 2013. Sociodemographic and clinical data were collected as well as causes of death. We identified preventable deaths (defined as deaths that occurred in patients with less than six months of HAART, or without HAART, with less than 350 CD4 at diagnosis and/or opportunistic events as the cause of hospitalization). Results. 128 deaths were analyzed. The median of CD4 count was 47 cells/mm³; 18% of the patients ignored their HIV status at the time of hospitalization, 51% had less than six months of HAART, 40.5% had never received HAART before. The main causes of death were AIDS defining events, with 65.6%. We identified 70 preventable deaths (57%). Conclusions. Despite universal access to HAART, HIV patients in Mexico are still dying of AIDS defining illnesses, an indicator of late diagnosis. It is urgent to implement HIV testing programs to allow earlier diagnosis and make HAART benefit accessible to all.

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of a Chemokine Receptor 5 (CCR5) Antagonist to Decrease the Occurrence of Immune Reconstitution Inflammatory Syndrome in HIV-Infection: The CADIRIS Study.

BACKGROUND: Immune Reconstitution Inflammatory Syndrome (IRIS) is a common complication of antiretroviral therapy (ART) in HIV-infected patients. IRIS is associated with an increased risk of hospitalization and death. We ascertained whether CCR5 blockade using maraviroc reduces the risk of IRIS. METHODS: The CADIRIS study was a randomized, double-blind, placebo-controlled, clinical trial that accrued subjects from five clinical sites in Mexico and one in South Africa between November 2009 and January 2012, and followed them for one year. The primary outcome was occurrence of IRIS by 24 weeks. HIV-infected adults, naïve to ART, with CD4 cells <100/µL, and HIVRNA >1,000 copies/mL were eligible. We screened 362 subjects; 279 met inclusion criteria, 3 refused participation, and 276 were randomized. Participants received maraviroc 600 mg twice daily or placebo added to an ART regimen that included tenofovir, emtricitabine, and efavirenz for 48 weeks. FINDINGS: There were 276 patients randomized (140 received maraviroc and 136 placebo). There was no difference in the time to IRIS events between treatment arms (HR 1·08, 95% CI (0·66, 1·77), log-rank test p=0·743). In total, 64 (23%) patients had IRIS events, 33 (24%) in the maraviroc arm and 31 (23%) in the placebo arm (p=0·88). INTERPRETATION: Maraviroc had no significant effect on frequency, time or severity of IRIS events after ART initiation. Including a CCR5 inhibitor in an initial treatment regimen does not confer a meaningful protection from the occurrence of IRIS in persons with advanced HIV infection. FUNDING: The trial was funded as investigator initiated research by Pfizer Inc, New York, NY, USA. TRIAL REGISTRATION: ClinicalTrials.gov. ID: NCT00988780 (http://clinicaltrials.gov/ct2/show/NCT00988780).

Effect of the CCR5 antagonist maraviroc on the occurrence of immune reconstitution inflammatory syndrome in HIV (CADIRIS): a double-blind, randomised, placebo-controlled trial.

BACKGROUND: Immune reconstitution inflammatory syndrome (IRIS) is a common complication of antiretroviral therapy (ART) in patients with HIV. IRIS is associated with an increased risk of admission to hospital and death. We assessed whether CCR5 blockade with maraviroc reduces the risk of IRIS. METHODS: The CADIRIS study was a double-blind, randomised, placebo-controlled trial that recruited participants from five clinical sites in Mexico and one in South Africa and followed them for 1 year. Patients were eligible if they were adults with HIV, who were naive to ART, had CD4 count lower than 100 cells per µL and HIV RNA greater than 1000 copies per mL. Participants were randomly assigned (1:1) by permuted block randomisation to receive either maraviroc (600 mg twice daily) or placebo in addition to an ART regimen that included tenofovir, emtricitabine, and efavirenz for 48 weeks. Patients, care providers, and members of the research team were masked to treatment allocation. Clinical and laboratory evaluations were done at baseline, and weeks 2, 4, 8, 12, 16, 24, 48, and 60. The primary outcome was time to an IRIS event by 24 weeks. All patients who were randomly assigned contributed to the primary time-to-event analysis from the date of ART initiation until week 24, the time of an IRIS event or death. This trial is registered with ClinicalTrials.gov, number NCT00988780. FINDINGS: Between Dec 10, 2009, and Jan 17, 2012, we screened 362 patients; of whom 279 met the inclusion criteria and three refused to participate; thus 276 participants were randomly assigned (140 to receive maraviroc and 136 to receive placebo). 64 (23%) patients had IRIS events, 33 (24%) in the maraviroc group and 31 (23%) in the placebo group (p=0·74). No difference in the time to IRIS events was noted between the treatment groups (HR 1·08, 95% CI 0·66-1·77; log-rank test p=0·74). 37 participants (26%) in the maraviroc group had grade 3 or 4 adverse events compared with 24 (18%) in placebo group; p=0·072); 25 (18%) in the maraviroc group and 21 (15%) in the placebo group had serious treatment emergent adverse events (p=0·63). INTERPRETATION: Maraviroc had no significant effect on development of IRIS after ART initiation. Inclusion of this CCR5 inhibitor in an initial treatment regimen does not confer a meaningful protection from the occurrence of IRIS in people with advanced HIV infection. FUNDING: Pfizer.