ABSTRACT
INTRODUCTION: Dolutegravir + rilpivirine (DTG + RPV) is an effective antiretroviral therapy regimen approved in clinical guidelines as a switch therapy for virologically suppressed people with HIV. Our study aimed to compare the effectiveness and tolerability of DTG + RPV in women and men in real-world clinical practice. METHODS: This was a retrospective analysis of treatment-experienced people with HIV from a large HIV unit who switched to DTG + RPV. We analysed treatment effectiveness, rates of adverse events and discontinuation, and metabolic changes after 48 weeks of treatment. HIV-RNA levels <50 copies/mL were analysed at 48 weeks using both intention-to treat analysis (where missing data were interpreted as failures) and per-protocol analysis (excluding those with missing data or changes due to reasons other than virological failure). Outcomes were compared between women and men based on sex at birth. RESULTS: A total of 307 patients were selected (71 women and 236 men). No transgender people were included. At baseline, women had lived with HIV infection and received antiretroviral therapy for longer than men (23.2 vs 17.4 years and 18.9 vs 14.2 years, respectively). In the intention-to-treat analysis, 74.6% (95% confidence interval [CI] 63.4-83.3%) of women and 83.5% (95% CI 78.2-87.7) of men had HIV-RNA <50 copies/mL. In the per-protocol analysis, 96.4% (95% CI 87.7-99) of women and 99% (95% CI 98.9-99.7) of men had HIV-RNA levels <50 copies/mL. Two women and two men had HIV-RNA >50 copies/mL at 48 weeks. Discontinuation due to adverse events was more frequent in women than in men: 12.7% vs 7.2% (p < 0.02). Neuropsychiatric and gastrointestinal events were the most frequently reported. A median (interquartile range) weight gain of 1.9 kg (0-4.2) in women and 1.2 kg (-1-3.1) in men was reported (median of differences between baseline visit and week 48); the remaining changes in metabolic parameters were neutral. CONCLUSIONS: DTG + RPV exhibited good and similar virological effectiveness in women and men in real-world settings. However, poorer tolerability and more treatment interruptions were observed in women.
Subject(s)
Anti-HIV Agents , HIV Infections , Heterocyclic Compounds, 3-Ring , Oxazines , Piperazines , Pyridones , Rilpivirine , Humans , Rilpivirine/therapeutic use , Rilpivirine/adverse effects , Rilpivirine/administration & dosage , Female , Pyridones/adverse effects , Pyridones/therapeutic use , Male , Heterocyclic Compounds, 3-Ring/adverse effects , Heterocyclic Compounds, 3-Ring/therapeutic use , Heterocyclic Compounds, 3-Ring/administration & dosage , Oxazines/therapeutic use , Oxazines/administration & dosage , Oxazines/adverse effects , HIV Infections/drug therapy , Retrospective Studies , Piperazines/adverse effects , Adult , Anti-HIV Agents/therapeutic use , Anti-HIV Agents/adverse effects , Anti-HIV Agents/administration & dosage , Middle Aged , Treatment Outcome , Sex Factors , Drug Substitution , Viral Load , RNA, ViralABSTRACT
INTRODUCCIÓN: se conoce la existencia de pacientes con hepatitis C perdidos en el sistema, pero se desconocen su prevalencia y características. Además, su identificación colisiona con la barrera de la protección de datos. MÉTODOS: se presentó un protocolo de identificación y contacto al Comité de Ética Asistencial. Se obtendrían las serologías anti-VHC+ de Microbiología entre 2010-18. Se analizaría su situación en la base de datos hospitalaria y regional. Se clasificarían: a) hepatitis C crónica, si última determinación de ARN-VHC+; b) hepatitis C curada, si última determinación de ARN-VHC- tras 12 semanas de tratamiento; c) hepatitis C posible, si anti-VHC+ sin determinación de ARN-VHC. Se considerarían perdidos aquellos con hepatitis C crónica o posible sin seguimiento en Digestivo o Medicina Interna. Se contactaría con ellos mediante correo postal y, posteriormente, por teléfono para ofrecerles tratamiento. RESULTADOS: el Comité de Ética consideró que el protocolo cumplía los principios bioéticos de autonomía, beneficencia, no maleficencia y justicia, y que el contacto era éticamente deseable. Sobre 4.816 serologías anti-VHC+ identificamos 677 pacientes perdidos (14,06 %; IC 95 %: 13,2-15,2): edad 54 años, 61 % hombres, 12 % extranjeros y 95 % monoinfectados. Se consumieron 1,3 minutos en el estudio de cada serología. Un 25 % de las perdidas habían sido solicitadas por Digestivo o Medicina Interna. De los 677 perdidos, 228 (33,7 %) tenían también ARN-VHC+ y 449 (66,3 %) solo tenían solicitada la serología. CONCLUSIÓN: un número importante de pacientes con hepatitis C se encuentran perdidos en el sistema. Su búsqueda y contacto es posible desde el punto de vista ético-legal
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Subject(s)
Humans , Male , Female , Middle Aged , Aged , Hepatitis C/diagnosis , Hepatitis C/epidemiology , RNA, Viral/blood , Computer Security/ethics , Clinical Record , Medical Records , Confidentiality/ethics , Spain/epidemiology , IncidenceABSTRACT
INTRODUCTION: data on the prevalence and characteristics of hepatitis C patients lost to follow-up are lacking. In addition, the identification of this population clashes with data protection regulations. METHODS: the identification and contact protocol was submitted to the Health Care Ethics Committee. The protocol was based on anti-HCV serology test results for 2010-2018, which were obtained from the Microbiology Department. In addition, the situation of the patients in the hospital and regional database was analyzed, based on the following classification: a) chronic hepatitis C, if the last HCV RNA determination was positive; b) cured hepatitis C, if the last HCV RNA determination was negative after 12 weeks of treatment; and c) possible hepatitis C, if anti-HCV antibodies were positive with no result for HCV RNA. Lost patients were defined as those with chronic or possible hepatitis C and no follow-up in the Digestive Diseases or Internal Medicine Departments. The patients were contacted by postal mail and then by telephone, so that they could be offered treatment. RESULTS: the Ethics Committee considered that the protocol fulfilled the bioethical principles of autonomy, beneficence, non-maleficence and justice and that contact was ethically desirable. From 4,816 positive anti-HCV serology results, 677 patients were identified who were lost to follow-up (14.06 %; 95 % CI, 13.2-15.2). The mean age was 54 years, 61 % were male, 12 % were foreign born and 95 % were mono-infected. The study of each serology result took 1.3 minutes. One-quarter (25 %) of the losses corresponded to the Digestive Diseases and Internal Medicine Departments. Of the 677 losses, serology testing had only been ordered for 449 patients (66.3 %) and the remaining 228 (33.7 %) also had a positive HCV RNA result. CONCLUSION: a large number of patients with hepatitis C are lost to follow-up. Searching for and contacting these patients is legally and ethically viable.
Subject(s)
Hepatitis C, Chronic , Hepatitis C , Hepacivirus/genetics , Hepatitis C/diagnosis , Hepatitis C/epidemiology , Hepatitis C Antibodies , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/epidemiology , Humans , Male , Middle Aged , PrevalenceABSTRACT
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Subject(s)
Humans , Male , Aged, 80 and over , Bronchopneumonia/diagnostic imaging , Heart Failure/diagnostic imaging , Diagnosis, Differential , Ultrasonography/methodsABSTRACT
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