RESUMEN
BACKGROUND: Chemsex, a type of sexualised drug use, is expanding among gay, bisexual, and other men who have sex with men (GBMSM), with physical and mental health risks. Health-seeking behaviours of GBMSM practising chemsex is not clear. METHODS: Harm reduction (HR) consultations for GBMSM engaging in chemsex and seeking comprehensive services including HR were offered in a Parisian infectious disease unit. From December 2021 to January 2022, HR consultation patients completed an online survey on their consumption, health, used services, and perspective on consultations. We generated descriptive statistics, and tested (χ 2 ) the relationship between reporting a specialised follow-up and perceived usefulness of intervention. RESULTS: Of 172 patients, a total of 96 GBMSM (55.2%) completed the survey. Most ever consumed substance was 3-methylmethcathinone (3MMC; 92/96; 95.8%). Before consultations, about half consumed at least once a week (50/96; 52%), most reported negative impacts of chemsex on their social (60/96, 62.5%), professional (56/96, 58.3%), intimate (53/96; 55.21%), or sexual life (52/96; 54.17%). Also, more than two-thirds (n =57; 69.38%) had received a follow-up in specialised services: one-third had been followed in addictology (28/96, 29.2%) and/or psychotherapy (32/96, 33.3%), and one-fourth (24/96, 25.0%) had used emergency services. After consultations, three-quarters perceived the intervention as useful (n =74; 77.08%); we found no significant relationship with receiving a specialised follow-up; and most were satisfied with professionals' listening (90/96; 93.8%), and reported reduced risks (80/96; 83.3%). DISCUSSION: Multidisciplinary HR, preventive, diagnostical, and therapeutic sexological and psychiatric interventions are greatly needed among GBMSM practising chemsex. HR interventions accessible in services already attended by GBMSM are a valuable option.
Asunto(s)
Enfermedades Transmisibles , Infecciones por VIH , Minorías Sexuales y de Género , Trastornos Relacionados con Sustancias , Masculino , Humanos , Homosexualidad Masculina/psicología , Reducción del Daño , Conducta Sexual , Trastornos Relacionados con Sustancias/epidemiología , Trastornos Relacionados con Sustancias/psicología , Infecciones por VIH/prevención & controlRESUMEN
BACKGROUND: Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen. METHODS: We conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections. RESULTS: Of the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P=0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P=0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P=0.002) and renal adverse events (18% vs. 10%, P=0.03). CONCLUSIONS: The use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT01473472.).
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Emtricitabina/uso terapéutico , Infecciones por VIH/prevención & control , VIH-1 , Homosexualidad Masculina , Profilaxis Pre-Exposición , Tenofovir/uso terapéutico , Adulto , Condones/estadística & datos numéricos , Método Doble Ciego , Quimioterapia Combinada , Emtricitabina/efectos adversos , Humanos , Estimación de Kaplan-Meier , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Factores de Riesgo , Conducta Sexual , Enfermedades de Transmisión Sexual/epidemiología , Tenofovir/efectos adversosRESUMEN
OBJECTIVES: In the ANRS IPERGAY pre-exposure prophylaxis (PrEP) trial, a single dose of tenofovir disoproxil fumarate and emtricitabine was taken orally 2-24 h before sexual intercourse. A sub-study was conducted to assess the pharmacokinetics of tenofovir and emtricitabine in blood, saliva and rectal tissue following this initial oral intake. METHODS: Plasma, PBMC, saliva and rectal tissue sampling was performed over 24 h in 12 seronegative men before enrolment in the ANRS IPERGAY trial, following a single dose of 600 mg tenofovir disoproxil fumarate/400 mg emtricitabine. Ex vivo HIV infectibility of rectal biopsies was also assessed. RESULTS: The median plasma Tmax of tenofovir (median Cmax: 401 µg/L) and emtricitabine (median Cmax: 2868 µg/L) was obtained 1 h (range: 0.5-4) and 2 h (range: 1-4) after dosing, respectively. The median C24 of tenofovir and emtricitabine was 40 and 63 µg/L, respectively. The median PBMC tenofovir diphosphate and emtricitabine triphosphate levels were 12.2 and 16.7 fmol/106 cells and 2800 and 2000 fmol/106 cells at 2 and 24 h after dosing, respectively. Saliva/plasma AUC0-24 ratios were 2% and 17% for tenofovir and emtricitabine, respectively. Emtricitabine was detected in rectal tissue 30 min after dosing, whereas tenofovir was only detectable at 24 h. Ex vivo HIV infectibility assays of rectal biopsies showed partial protection after dosing (Pâ<â0.07). DISCUSSION: A single high dose of oral tenofovir disoproxil fumarate/emtricitabine provides rapid and high blood levels of tenofovir and emtricitabine, with rapid diffusion of emtricitabine in saliva and rectal tissue.
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Fármacos Anti-VIH/farmacocinética , Profilaxis Antibiótica/métodos , Emtricitabina/farmacocinética , Infecciones por VIH/prevención & control , Profilaxis Pre-Exposición/métodos , Saliva/química , Tenofovir/farmacocinética , Adulto , Fármacos Anti-VIH/uso terapéutico , Emtricitabina/sangre , Emtricitabina/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Humanos , Masculino , Placebos/farmacología , Tenofovir/sangre , Tenofovir/uso terapéutico , Sexo InseguroRESUMEN
BACKGROUND: We evaluated complex pre-exposure prophylaxis (PrEP) situations linked to kidney issues in a cohort of on-demand and daily PrEP users. SETTING: We conducted a single-center retrospective cohort study in France including all PrEP users who received a tenofovir disoproxil (TD)-emtricitabine (FTC) prescription between January 1, 2012 and December 31, 2019 with at least 1 creatinine measurement available before and after PrEP initiation. METHODS: A complex kidney situation (CKS) was defined as an estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73m 2 on 2 consecutive measurements. We estimated the incidence of this event, described case management, and identified associated factors using a Cox model. RESULTS: Three thousand one hundred and fourteen individuals were included in this study. Almost all were men (99%) with a median age of 35 years, 25% had an eGFR <90 mL/minute/1.73m 2 at baseline, and 65% used on-demand PrEP. Nine users (0.29%) had a CKS at baseline; 8/9 initiated on-demand PrEP without renal function worsening after a median (interquartile range [IQR]) follow-up time of 14 months (7-31). Thirteen cases of CKS occurred during the follow-up for a 0.25 per 100 person-years incidence (95% confidence interval [CI]: [0.14; 0.45]). On-demand PrEP was used in 7/13 participants with no further episode of confirmed eGFR <60 mL/minute/1.73m 2 after a 17-month median follow-up (IQR 4-18). CKS was associated with an age ≥50 years (hazard ratio [HR] 13, 95% CI: [4-39]) or with a baseline eGFR <90 mL/minute/1.73m 2 (HR 34, 95% CI: [4-261]). 9/22 CKS were linked to high-protein intake for weight training. CONCLUSIONS: CKS were rare in our cohort. On-demand PrEP did not result in subsequent renal function worsening in these few situations.
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Fármacos Anti-VIH , Infecciones por VIH , Profilaxis Pre-Exposición , Masculino , Humanos , Adulto , Persona de Mediana Edad , Femenino , Fármacos Anti-VIH/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiología , Infecciones por VIH/prevención & control , Estudios Retrospectivos , Incidencia , Emtricitabina/uso terapéutico , Riñón , Homosexualidad MasculinaRESUMEN
OBJECTIVES: We wished to assess time to protection from HIV-1 infection following oral tenofovir disoproxil and emtricitabine (TDF/FTC) as preexposure prophylaxis (PrEP), using ex-vivo rectal tissue infections and drug concentration measures in blood and rectal tissue. DESIGN/METHODS: Participants from the ANRS PREVENIR study (NCT03113123) were offered this sub-study after a 14-day wash-out. We used an ex-vivo model to evaluate rectal tissue HIV-1 susceptibility before and after PrEP, 2âh after two pills or 7 days of a daily pill of TDF/FTC. PrEP efficacy was expressed by the difference (after-before) of 14-day cumulative p24 antigen levels. TFV-DP and FTC-TP levels were measured in rectal tissue and PBMCs and correlated with HIV-1 infection. RESULTS: Twelve and 11 men were analyzed in the 2 h-double dose and 7 days-single dose groups, respectively. Cumulative p24 differences after-before PrEP were -144âpg/ml/mg (IQR[-259;-108]) for the 2 h-double dose group ( P â=â0.0005) and -179âpg/ml/mg (IQR [-253;-86]) for the 7 days-single dose group ( P â=â0.001), with no differences between groups ( P â=â0.93). Rectal TFV-DP was below quantification after a double dose, but FTC-TP levels were similar to levels at 7 days. There was a significant correlation between rectal FTC-TP levels and p24 changes after a double dose ( R â=â-0.84; P â=â0.0001). CONCLUSION: Oral TDF/FTC provided similar protection against HIV-1 infection of rectal tissue 2âh after a double dose or 7âdays of a daily dose. At 2âh, this protection seems driven by high FTC-TP concentrations in rectal tissue. This confirms the importance of combining TDF and FTC to achieve early protection.
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Fármacos Anti-VIH , Infecciones por VIH , Seropositividad para VIH , VIH-1 , Profilaxis Pre-Exposición , Masculino , Humanos , Tenofovir , Emtricitabina , Infecciones por VIH/prevención & control , Infecciones por VIH/tratamiento farmacológico , Fármacos Anti-VIH/uso terapéutico , Seropositividad para VIH/tratamiento farmacológicoRESUMEN
BACKGROUND: Increased rates of sexually transmitted infections (STIs) are reported among men who have sex with men (MSM) and new interventions are needed. We aimed to assess whether post-exposure prophylaxis (PEP) with doxycycline could reduce the incidence of chlamydia or syphilis (or both) and whether the meningococcal group B vaccine (4CMenB) could reduce the incidence of gonorrhoea in this population. METHODS: ANRS 174 DOXYVAC is a multicentre, open-label, randomised trial with a 2â×â2 factorial design conducted at ten hospital sites in Paris, France. Eligible participants were MSM aged 18 years or older, HIV negative, had a history of bacterial STIs within the 12 months before enrolment, and who were already included in the ANRS PREVENIR study (a cohort of MSM using pre-exposure prophylaxis with tenofovir and emtricitabine for HIV prevention). Participants were randomly assigned (2:1) to doxycycline PEP (two pills of 100 mg each orally within 72 h after condomless sex, with no more than three doses of 200 mg per week) or no PEP groups and were also randomly assigned (1:1) to the 4CMenB vaccine (GlaxoSmithKline, Paris, France; two intramuscular injections at enrolment and at 2 months) or no vaccine groups, using a computer-generated randomisation list with a permuted fixed block size of four. Follow-up occurred for at least 12 months (with visits every 3 months) up to 24 months. The coprimary outcomes were the risk of a first episode of chlamydia or syphilis (or both) after the enrolment visit at baseline for the doxycycline intervention and the risk of a first episode of gonorrhoea starting at month 3 (ie, 1 month after the second vaccine dose) for the vaccine intervention, analysed in the modified intention-to-treat population (defined as all randomly assigned participants who had at least one follow-up visit). This trial is registered with ClinicalTrials.gov, NCT04597424 (ongoing). FINDINGS: Between Jan 19, 2021, and Sept 19, 2022, 556 participants were randomly assigned. 545 (98%) participants were included in the modified intention-to-treat analysis for the doxycycline PEP and no PEP groups and 544 (98%) were included for the 4CMenB vaccine and no vaccine groups. The median follow-up was 14 months (IQR 9-18). The median age was 40 years (34-48) and all 545 participants were male. There was no interaction between the two interventions (p≥0·1) for the primary outcome. The incidence of a first episode of chlamydia or syphilis (or both) was 8·8 per 100 person-years (35 events in 362 participants) in the doxycycline PEP group and 53·2 per 100 person-years (80 events in 183 participants) in the no PEP group (adjusted hazard ratio [aHR] 0·17 [95% CI 0·12-0·26]; p<0·0001). The incidence of a first episode of gonorrhoea, starting from month 3 was 58·3 per 100 person-years (103 events in 274 participants) in the 4CmenB vaccine group and 77·1 per 100 person-years (122 events in 270 participants) in the no vaccine group (aHR 0·78 [95% CI 0·60-1·01]; p=0·061). There were no deaths during the study. One drug-related serious adverse event (fixed-drug eruption) occurred in the doxycycline PEP group. Six (2%) participants in the doxycycline group discontinued doxycycline PEP because of gastrointestinal adverse events. INTERPRETATION: Doxycycline PEP strongly reduced the incidence of chlamydia and syphilis in MSM, but we did not show efficacy of the 4CmenB vaccine for gonorrhoea. Doxycycline PEP should be assessed in other populations, such as heterosexual men and women, and its effect on antimicrobial resistance carefully monitored. FUNDING: ANRS Maladies Infectieuses Emergentes. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.
RESUMEN
Following US Food and Drugs Administration approval in July 2012 of daily oral tenofovir and emtricitabine for pre-exposure prophylaxis (PrEP) to prevent HIV infection in high-risk individuals in the USA, there has been much controversy about the implementation of this PrEP regimen in other countries throughout the world, and in Europe in particular. In this review, we focus on the challenges and opportunities of a daily oral PrEP regimen to curb the rising incidence of HIV infection in high-risk groups, and particularly in men who have sex with men. A number of issues would need to be addressed before PrEP could be implemented, including assessing the real effectiveness and cost-effectiveness of daily PrEP, the sustainability of daily adherence, the risk of selecting resistance, the long-term safety, and the risk of change in sexual behavior that might offset the benefit of PrEP. Alternatives to a daily oral PrEP regimen are being explored.
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Fármacos Anti-VIH/administración & dosificación , Infecciones por VIH/epidemiología , Infecciones por VIH/prevención & control , Administración Oral , Animales , Antirretrovirales/administración & dosificación , Ensayos Clínicos como Asunto/tendencias , Europa (Continente)/epidemiología , HumanosRESUMEN
OBJECTIVES: Atazanavir has been associated with kidney stones and renal failure. We measured urine and plasma concentrations of recent protease inhibitors (PIs) and searched for PI crystals in the urine of asymptomatic patients. METHODS: A cross-sectional analysis of HIV-infected patients taking ritonavir-boosted atazanavir 300 mg/day (ATV300/r), unboosted atazanavir 400 mg/day (ATV400), ritonavir-boosted darunavir at either 800 mg/day (DRV800/r) or 1200 mg/day (DRV1200/r) or ritonavir-boosted lopinavir 800 mg/day was performed. Plasma and urine were collected and PI levels measured using HPLC. Crystals were detected and identified in urine using polarized microscopy. RESULTS: PI levels were measured in 266 patients, 142 of whom were assessed for urinary crystals. Their mean age was 46 years. The mean duration of HIV infection was 10.5 years and the mean duration of the current PI-containing regimen was 22.5 months. The mean CD4 cell count was 494 cells/mm(3); 74% showed controlled HIV replication. Median urinary PI levels were 22.3, 14.3, 26.9 and 29.7 mg/L for ATV300/r, ATV400, DRV800/r and DRV1200/r, respectively, significantly higher than plasma levels, which were all <5 mg/L (Pâ<â0.001). In contrast, median urinary lopinavir concentrrations did not significantly differ from plasma concentrations (4.2 and 6.4 mg/L, respectively; Pâ=â0.7) and were significantly lower than those of other PIs (Pâ<â0.001). Atazanavir crystals were found in 7/78 patients receiving ATV300/r (8.9%; 95% CIâ=â2.6%-15.2%) and darunavir crystals were found in 4/51 patients receiving darunavir (7.8%; 95% CIâ=â0.4%-15.2%). Longer exposure to atazanavir was the only risk factor associated with the presence of atazanavir crystalluria (Pâ=â0.04). CONCLUSIONS: Unlike lopinavir, atazanavir and darunavir reached high concentrations in urine. Urinary crystals were found in a few patients receiving ritonavir-boosted atazanavir or darunavir and may favour nephrolithiasis.
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Fármacos Anti-VIH/orina , Infecciones por VIH/tratamiento farmacológico , Oligopéptidos/orina , Piridinas/orina , Sulfonamidas/orina , Adulto , Anciano , Fármacos Anti-VIH/administración & dosificación , Fármacos Anti-VIH/sangre , Terapia Antirretroviral Altamente Activa/métodos , Sulfato de Atazanavir , Cromatografía Líquida de Alta Presión , Estudios Transversales , Cristalización , Darunavir , Femenino , Humanos , Masculino , Microscopía de Polarización , Persona de Mediana Edad , Oligopéptidos/administración & dosificación , Oligopéptidos/sangre , Plasma/química , Piridinas/administración & dosificación , Piridinas/sangre , Sulfonamidas/administración & dosificación , Sulfonamidas/sangre , Orina/química , Adulto JovenRESUMEN
BACKGROUND: There are few data available regarding the use of on-demand pre-exposure prophylaxis (PrEP) for HIV prevention. We aimed to assess PrEP effectiveness, adherence, and safety in adults using daily or on-demand PrEP. METHODS: We conducted a prospective observational cohort study (ANRS PREVENIR) at 26 sites in the Paris region, France. We enrolled HIV-negative adults (aged ≥18 years) at high risk of HIV infection who were starting or continuing PrEP. PrEP was prescribed as a fixed-dose combination of tenofovir disoproxil and emtricitabine (245 mg and 200 mg, respectively, per pill). PrEP could be prescribed as a daily regimen with one pill per day or, in men who have sex with men (MSM) or in transgender women who have sex with men, as an on-demand regimen following the IPERGAY dosing recommendation. At enrolment and every 3 months thereafter, participants were tested for HIV and provided information regarding the PrEP dosing regimen used. Adherence to PrEP was assessed by self-report and by tenofovir diphosphate concentrations in dried blood spots. The primary outcome of HIV-1 incidence was assessed using Poisson regression among participants who started PrEP. This study is registered with ClinicalTrials.gov, NCT03113123, and EudraCT, 2016A0157744. FINDINGS: Between May 3, 2017, and May 2, 2019, 3082 people were assessed for eligibility and 3065 participants were enrolled. 3056 (99·7%) of 3065 participants reported using PrEP and were included in the analyses. The median age was 36 years (IQR 29-43), 1344 (44·0%) of 3056 participants were PrEP-naive, and 3016 (98·7%) were MSM. At enrolment, 1540 (50·5%) of 3049 participants opted for daily PrEP dosing and 1509 (49·5%) opted for on-demand PrEP dosing; these proportions remained stable during follow-up. Median follow-up was 22·1 months (IQR 15·9-29·7) and incidence of study discontinuation was 17·6 participants (95% CI 16·5-18·7) per 100 person-years. At the data cutoff on Sept 30, 2020, there had been six HIV-1 seroconversions (three participants using daily PrEP and three using on-demand PrEP; all were MSM) over 5623 person-years. Overall HIV-1 incidence was 1·1 cases (95% CI 0·4-2·3) per 1000 person-years, and did not differ between participants using daily PrEP and those using on-demand PrEP (incidence rate ratio 1·00, 95% CI 0·13-7·49; p=0·99). Four participants (two using daily PrEP and two using on-demand PrEP) discontinued PrEP due to treatment-related adverse events (nausea [n=2], vomiting and diarrhoea [n=1], and lumbar pain [n=1]). INTERPRETATION: In this study, which enrolled mainly MSM, HIV-1 incidence on PrEP was low and did not differ between participants using daily PrEP and those using on-demand PrEP. On-demand PrEP therefore represents a valid alternative to daily PrEP for MSM, providing greater choice in HIV prevention. FUNDING: ANRS/Maladies Infectieuses Emergentes, Gilead Sciences, SIDACTION, and Région Ile de France. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.
Asunto(s)
Fármacos Anti-VIH , Infecciones por VIH , VIH-1 , Profilaxis Pre-Exposición , Minorías Sexuales y de Género , Adolescente , Adulto , Fármacos Anti-VIH/uso terapéutico , Emtricitabina , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiología , Infecciones por VIH/prevención & control , Homosexualidad Masculina , Humanos , Masculino , Cumplimiento de la Medicación , Estudios Prospectivos , TenofovirRESUMEN
BACKGROUND: On-demand oral tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) has been approved for pre-exposure prophylaxis (PrEP) in MSM in France following the results of clinical studies, but data are limited on real-world experience. DESIGN: A single-center, open-label, prospective cohort study that recruited people at high risk of HIV infection in Paris. METHODS: Participants were enrolled in a single hospital-based outpatient clinic and were proposed to start PrEP with daily or on demand TDF/FTC. At baseline and every 3 months thereafter, patients were tested for HIV and creatinine plasma levels, and data on sexual behavior, other sexually transmitted infections (STIs), and tolerability were collected. RESULTS: From 10 November 2015 to 30 April 2017, 1069 patients were screened and 1049 (98.1%) started PrEP. Median age was 36 years, 99.4% were MSM with a median number of partners of 10, and 793 (75.6%) opted for on demand PrEP. Over 486 person-years of follow-up, four HIV-infections were diagnosed in poorly or nonadherent patients (incidence 0.82/100 person-years). Rate of condomless sex at last intercourse increased from 53.3% at baseline to 79% at month 12 (Pâ<â10), but increase in bacterial STI rates was modest (14.6% at baseline vs. 19.2% at month 12; Pâ<â10). Most adverse events were gastrointestinal and did not lead to PrEP discontinuation. CONCLUSIONS: Most PrEP users were high-risk MSM and opted for on-demand PrEP. PrEP use was associated with a low HIV incidence and a high rate of condomless sex with a modest increase in bacterial STIs.
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Fármacos Anti-VIH/administración & dosificación , Quimioprevención/métodos , Emtricitabina/administración & dosificación , Infecciones por VIH/prevención & control , Profilaxis Pre-Exposición/métodos , Tenofovir/administración & dosificación , Administración Oral , Adulto , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Femenino , Hospitales , Humanos , Incidencia , Masculino , Pacientes Ambulatorios , Paris , Estudios Prospectivos , Conducta SexualRESUMEN
BACKGROUND: Health authorities in several countries recently recommended the expansion of human immunodeficiency virus (HIV) antibody testing, including the use of rapid tests. Several HIV rapid tests are now licensed in Europe but their sensitivity on total blood and/or oral fluid in routine healthcare settings is not known. METHODS AND FINDINGS: 200 adults with documented HIV-1 (n=194) or HIV-2 infection (n=6) were prospectively screened with five HIV rapid tests using either oral fluid (OF) or finger-stick whole blood (FSB). The OraQuick Advance rapid HIV1/2 was first applied to OF and then to FSB, while the other tests were applied to FSB, in the following order: Vikia HIV 1/2, Determine HIV 1-2, Determine HIV-1/2 Ag/Ab Combo and INSTI HIV-1/HIV-2. Tests negative on FSB were repeated on paired serum samples. Twenty randomly selected HIV-seronegative subjects served as controls, and the results were read blindly. Most patients had HIV-1 subtype B infection (63.3%) and most were on antiretroviral therapy (68.5%). Sensitivity was 86.5%, 94.5%, 98.5%, 94.9%, 95.8% and 99% respectively, with OraQuick OF, OraQuick FSB, Vikia, Determine, Determine Ag/Ab Combo and INSTI (p<0.0001). OraQuick was less sensitive on OF than on FSB (p=0.008). Among the six patients with three or more negative tests, two had recent HIV infection and four patients on antiretroviral therapy had undetectable plasma viral load. When patients positive in all the tests were compared with patients who had at least one negative test, only a plasma HIV RNA level<200 cp/ml was significantly associated with a false-negative result (p=0.009). When the 33 rapid tests negative on FSB were repeated on serum, all but six (5 negative with OraQuick, 1 with INSTI) were positive. The sensitivity of OraQuick, Determine and Determine Ag/Ab Combo was significantly better on serum than on FSB (97.5%, p=0.04; 100%, p=0.004; and 100%, p=0.02, respectively). CONCLUSION: When evaluated in a healthcare setting, rapid HIV tests were less sensitive on oral fluid than on finger-stick whole blood and less sensitive on finger-stick whole blood than on serum.