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Article ; Online: Bictegravir/emtricitabine/tenofovir alafenamide as first-line treatment in naïve HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial.

International journal of antimicrobial agents

2024 Volume 63, Issue 6, Page(s) 107164

Abstract: Objective: Multiple strategies have been utilised to reduce the incidence of HIV, including PrEP and rapid antiretroviral therapy initiation. The study objectives were to evaluate the efficacy, safety, satisfaction, treatment adherence, and system ... ...

Abstract	Objective: Multiple strategies have been utilised to reduce the incidence of HIV, including PrEP and rapid antiretroviral therapy initiation. The study objectives were to evaluate the efficacy, safety, satisfaction, treatment adherence, and system retention obtained with rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in naïve patients. Methods: This phase IV, multicenter, open-label, single-arm, 48-week clinical trial enrolled patients between January 2020 and June 2022. Adherence to treatment was evaluated with the SMAQ questionnaire and patient satisfaction with the EQ-5D. Results: Two hundred eight participants were enrolled with mean age of 35.6 years; 87.6% were males; mean CD4 count was 393.5 cells/uL (<200 cells/uL in 22.1%); viral load log was 5.6 (VL>100 000 cop/mL in 43.3%); 22.6% had AIDS, and 4.3% were coinfected with HBV. BIC/FTC/TAF was initiated on the day of their first visit to the HIV specialist in 98.6% of participants, and 9.6% were lost to follow-up. The efficacy at week 48 was 84.1 % by intention-to- treat (ITT), 94.6% by modified ITT, and 98.3% by per protocol analysis. The regimen was discontinued in two subjects (0.9%) during week 1 for grade 3 adverse events. Treatment adherence (weeks 4 [90%, IQR: 80-99%] vs. 48 [90%, IQR: 80-95%; P = 0.49]) and patient satisfaction (weeks 4 [90%, IQR: 80-99%] vs. 48 [90%, IQR: 80-95 P = 0.49]) rates were very high over the 48- week study period. Conclusions: BIC/FTC/TAF is an appropriate option for rapid ART initiation in naïve HIV patients, offering high efficacy, safety, durability, treatment adherence, retention in the healthcare system, and patient satisfaction. Number Clinical Trial registration: NCT06177574.
Language	English
Publishing date	2024-04-02
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1093977-5
ISSN	1872-7913 ; 0924-8579
ISSN (online)	1872-7913
ISSN	0924-8579
DOI	10.1016/j.ijantimicag.2024.107164
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Article ; Online: DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks).

Hidalgo-Tenorio, Carmen / Pasquau, Juan / Vinuesa, David / Ferra, Sergio / Terrón, Alberto / SanJoaquín, Isabel / Payeras, Antoni / Martínez, Onofre Juan / López-Ruz, Miguel Ángel / Omar, Mohamed / de la Torre-Lima, Javier / López-Lirola, Ana / Palomares, Jesús / Blanco, José Ramón / Montero, Marta / García-Vallecillos, Coral

Viruses

2022 Volume 14, Issue 3

Abstract: Brief: Real-world data in naïve HIV-1 patients demonstrate that dolutegravir plus lamivudine in a multiple tablet regimen is effective, safe, and satisfactory; it causes moderately increasing weight and abdominal circumference and is administrable on a ... ...

Abstract	Brief: Real-world data in naïve HIV-1 patients demonstrate that dolutegravir plus lamivudine in a multiple tablet regimen is effective, safe, and satisfactory; it causes moderately increasing weight and abdominal circumference and is administrable on a test-and-treat strategy. Background: Our objectives were to determine the real-life effectiveness and safety of DT with dolutegravir (50 mg/QD) plus lamivudine (300 mg/QD) in a multiple-tablet regimen (MTR) in naïve PLHIV followed up for 48 weeks and to evaluate the compliance and satisfaction of patients. Material and methods: An open, single-arm, multicenter, non-randomized clinical trial from May 2019 through September 2020 with a 48-week follow-up. Results: The study included 88 PLHIV patients (87.5% male) with a mean age of 35.9 years; 76.1% were MSM patients. The mean baseline CD4 was 516.4 cells/uL, with a viral load (VL) of 4.49 log10, and 11.4% were in the AIDS stage. DT started within 7 days of first specialist consultation in all patients and the same day in 84.1%; 3.4% had baseline resistance mutations (K103N, V106I + E138A, and V108I); 12.5% were lost to follow-up. At week 48, 86.3% had VL < 50 cop/uL by intention-to-treat analysis and 98.7% by per-protocol (PP) analysis. Virological failure (VF) was recorded in 1.1%, with no resistance mutation. One blip was detected in 5.2% without VF. Three reported anxiety, dizziness, and cephalgia, respectively, at week 4 and one reported insomnia at week 24; none reported adverse events at week 48. The mean weight was 4 kg higher at 48 weeks (p = 0.0001) and abdominal circumference 3 cm larger at 24 weeks (p = 0.022). No forgetfulness occurred in 98.7% of patients. Patient satisfaction was 90/100 at 4, 24, and 48 weeks. Conclusion: Real-world data demonstrate that dolutegravir plus lamivudine in MTR is effective, safe, and satisfactory, moderately increasing weight and abdominal circumference and administrable on a test-and-treat strategy.
MeSH term(s)	Adult ; Anti-HIV Agents/therapeutic use ; Drug Therapy, Combination ; Female ; HIV Infections/drug therapy ; HIV Seropositivity ; HIV-1/genetics ; Heterocyclic Compounds, 3-Ring/therapeutic use ; Homosexuality, Male ; Humans ; Lamivudine/therapeutic use ; Male ; Oxazines ; Piperazines ; Pyridones ; Sexual and Gender Minorities ; Viral Load
Chemical Substances	Anti-HIV Agents ; Heterocyclic Compounds, 3-Ring ; Oxazines ; Piperazines ; Pyridones ; Lamivudine (2T8Q726O95) ; dolutegravir (DKO1W9H7M1)
Language	English
Publishing date	2022-03-04
Publishing country	Switzerland
Document type	Clinical Trial ; Journal Article ; Multicenter Study
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v14030524
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Article: DOLAVI Real-Life Study of Dolutegravir Plus Lamivudine in Naive HIV-1 Patients (48 Weeks)

Viruses. 2022 Mar. 04, v. 14, no. 3

2022

Abstract	Brief: Real-world data in naïve HIV-1 patients demonstrate that dolutegravir plus lamivudine in a multiple tablet regimen is effective, safe, and satisfactory; it causes moderately increasing weight and abdominal circumference and is administrable on a test-and-treat strategy. Background: Our objectives were to determine the real-life effectiveness and safety of DT with dolutegravir (50 mg/QD) plus lamivudine (300 mg/QD) in a multiple-tablet regimen (MTR) in naïve PLHIV followed up for 48 weeks and to evaluate the compliance and satisfaction of patients. Material and methods: An open, single-arm, multicenter, non-randomized clinical trial from May 2019 through September 2020 with a 48-week follow-up. Results: The study included 88 PLHIV patients (87.5% male) with a mean age of 35.9 years; 76.1% were MSM patients. The mean baseline CD4 was 516.4 cells/uL, with a viral load (VL) of 4.49 log₁₀, and 11.4% were in the AIDS stage. DT started within 7 days of first specialist consultation in all patients and the same day in 84.1%; 3.4% had baseline resistance mutations (K103N, V106I + E138A, and V108I); 12.5% were lost to follow-up. At week 48, 86.3% had VL < 50 cop/uL by intention-to-treat analysis and 98.7% by per-protocol (PP) analysis. Virological failure (VF) was recorded in 1.1%, with no resistance mutation. One blip was detected in 5.2% without VF. Three reported anxiety, dizziness, and cephalgia, respectively, at week 4 and one reported insomnia at week 24; none reported adverse events at week 48. The mean weight was 4 kg higher at 48 weeks (p = 0.0001) and abdominal circumference 3 cm larger at 24 weeks (p = 0.022). No forgetfulness occurred in 98.7% of patients. Patient satisfaction was 90/100 at 4, 24, and 48 weeks. Conclusion: Real-world data demonstrate that dolutegravir plus lamivudine in MTR is effective, safe, and satisfactory, moderately increasing weight and abdominal circumference and administrable on a test-and-treat strategy.
Keywords	anxiety ; clinical trials ; compliance ; lamivudine ; males ; mutation ; patients ; sleep disorders ; viral load
Language	English
Dates of publication	2022-0304
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2516098-9
ISSN	1999-4915
ISSN	1999-4915
DOI	10.3390/v14030524
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Article: Oxidative stabilization of ultra-high omega-3 concentrates as ethyl esters or triacylglycerols

Martín, Diana / Terrón, Alberto / Fornari, Tiziana / Reglero, Guillermo / Torres, Carlos F

Food research international. 2012 Jan., v. 45, no. 1

2012

Abstract: A comparative study of the oxidative stability of “ultra-high” ω3 concentrates (80%) from fish oils as triacylglycerols (TAG) or ethyl esters (EE), as well as their stabilization by supercritical extracts of rosemary (SER), α-tocopherol or their mixture, ...

Abstract	A comparative study of the oxidative stability of “ultra-high” ω3 concentrates (80%) from fish oils as triacylglycerols (TAG) or ethyl esters (EE), as well as their stabilization by supercritical extracts of rosemary (SER), α-tocopherol or their mixture, by Rancimat method and throughout storage time, was carried out. No significant differences were found between EE and TAG on oxidative stability when measured by Rancimat conditions in the range of 50−90°C. However, storage experiments revealed a poor stability of the EE concentrate form, measured by the monitorization of peroxide and p-anisidine values. Concerning the stabilization by antioxidants, there was a lack of antioxidant effect of evaluated compounds when Rancimat assays were performed at 70°C, whereas an antioxidant effect began to evidence at 60°C, and a clearest antioxidant protection was measured at 50°C for the mixture of the SER plus α-tocopherol in both EE and TAG forms. This selected binary mixture efficiently stabilized the ω3-TAG concentrate throughout 50days of storage conditions, whereas the stabilization of ω3-EE concentrate was worse. Therefore, the combination of SER and α-tocopherol seemed to be a good antioxidant mixture for the efficient stabilization of extremely labile ultra-high ω3 concentrates, especially in the form of ω3 TAG oils.
Keywords	antioxidant activity ; antioxidants ; fish oils ; oxidative stability ; peroxide value ; storage ; storage time ; triacylglycerols
Language	English
Dates of publication	2012-01
Size	p. 336-341.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	1111695-x
ISSN	0963-9969
ISSN	0963-9969
DOI	10.1016/j.foodres.2011.09.022
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Article ; Online: Neurocognitive safety after 96 weeks on dual therapy with atazanavir/ritonavir plus lamivudine: results of the neurocognitive substudy of the SALT randomized clinical trial.

Pérez-Valero, Ignacio / Pasquau, Juan / Rubio, Rafael / Rivero, Antonio / Santos, José / Sanz, Jesus / Mariño, Ana / Crespo, Manel / Hernández-Quero, Jose / Iribarren, José Antonio / Gutiérrez, Félix / Terrón, Alberto / Esteban, Herminia / Pérez-Molina, José Antonio

The Journal of antimicrobial chemotherapy

2018 Volume 73, Issue 9, Page(s) 2444–2451

Abstract: Background: Concerns have been voiced over the capacity of deintensification strategies to preserve neurocognitive function and prevent neurocognitive impairment.: Methods: We present the 96 week results of a neurocognitive substudy nested within the ...

Abstract	Background: Concerns have been voiced over the capacity of deintensification strategies to preserve neurocognitive function and prevent neurocognitive impairment. Methods: We present the 96 week results of a neurocognitive substudy nested within the SALT clinical trial: a randomized, open-label, non-inferiority trial that compares whether atazanavir/ritonavir + lamivudine is non-inferior to atazanavir/ritonavir + two NRTIs in HIV-suppressed patients on stable triple therapy. A global deficit score (GDS) for five neurocognitive tasks was used to assess neurocognitive function. Changes in neurocognitive function (GDS value) were determined at weeks 48 and 96. The effect of atazanavir/ritonavir + lamivudine, adjusted for significant confounders, on the change in neurocognitive function was determined using analysis of covariance (ANCOVA) at week 96. Results: The per-protocol analysis included 92 participants (47 atazanavir/ritonavir + lamivudine and 45 atazanavir/ritonavir + two NRTIs). All baseline characteristics were comparable in both groups. At weeks 48 and 96, changes in GDS [week 48, atazanavir/ritonavir + lamivudine -0.3 (95% CI -0.5 to -0.1) versus atazanavir/ritonavir + two NRTIs -0.2 (95% CI -0.4 to 0.0), P = 0.39; week 96, atazanavir/ritonavir + lamivudine -0.3 (95% CI -0.5 to -0.1) versus atazanavir/ritonavir + two NRTIs -0.2 (95% CI -0.4 to -0.1); P = 0.471] were similar. This absence of differences was also observed in all cognitive tasks. Atazanavir/ritonavir + lamivudine did not impact the change in neurocognitive function at week 96; the adjusted effect of atazanavir/ritonavir + lamivudine on GDS change, considering atazanavir/ritonavir + two NRTIs as a reference, was 0.01 (95% CI -0.18 to 0.21) (P = 0.90). Conclusions: Neurocognitive function remained stable after 96 weeks, both in the atazanavir/ritonavir + lamivudine and in the atazanavir/ritonavir + two NRTIs arms, provided HIV remained suppressed.
MeSH term(s)	Adult ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/adverse effects ; Atazanavir Sulfate/administration & dosage ; Atazanavir Sulfate/adverse effects ; Female ; HIV Infections/complications ; HIV Infections/drug therapy ; Humans ; Lamivudine/administration & dosage ; Lamivudine/adverse effects ; Longitudinal Studies ; Male ; Middle Aged ; Neurocognitive Disorders/chemically induced ; Neurocognitive Disorders/epidemiology ; Ritonavir/administration & dosage ; Ritonavir/adverse effects
Chemical Substances	Anti-HIV Agents ; Lamivudine (2T8Q726O95) ; Atazanavir Sulfate (4MT4VIE29P) ; Ritonavir (O3J8G9O825)
Language	English
Publishing date	2018-06-27
Publishing country	England
Document type	Clinical Trial ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	191709-2
ISSN	1460-2091 ; 0305-7453
ISSN (online)	1460-2091
ISSN	0305-7453
DOI	10.1093/jac/dky212
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Article ; Online: Minor emtricitabine intolerance in treatment-stable patients switched from tenofovir/lamivudine to a fixed-dose combination of tenofovir/emtricitabine (Truvada).

Palacios, Rosario / Terrón, Alberto / Hidalgo, Ana / Rivero, Antonio / Santos, Jesús

The Journal of antimicrobial chemotherapy

2008 Volume 61, Issue 2, Page(s) 462–463

MeSH term(s)	Adenine/administration & dosage ; Adenine/adverse effects ; Adenine/analogs & derivatives ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives ; Drug Combinations ; Drug Therapy, Combination ; Emtricitabine ; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination ; Humans ; Lamivudine/administration & dosage ; Lamivudine/adverse effects ; Organophosphonates/administration & dosage ; Organophosphonates/adverse effects ; Organophosphorus Compounds/administration & dosage ; Sleep Initiation and Maintenance Disorders/chemically induced ; Sleep Initiation and Maintenance Disorders/diagnosis ; Tenofovir
Chemical Substances	Drug Combinations ; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination ; Organophosphonates ; Organophosphorus Compounds ; Deoxycytidine (0W860991D6) ; Lamivudine (2T8Q726O95) ; Tenofovir (99YXE507IL) ; Emtricitabine (G70B4ETF4S) ; Adenine (JAC85A2161)
Language	English
Publishing date	2008-02
Publishing country	England
Document type	Letter
ZDB-ID	191709-2
ISSN	1460-2091 ; 0305-7453
ISSN (online)	1460-2091
ISSN	0305-7453
DOI	10.1093/jac/dkm489
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Article ; Online: Short Communication: Maraviroc Once-Daily: Experience in Routine Clinical Practice.

Saumoy, Maria / Llibre, Josep M / Terrón, Alberto / Knobel, Hernando / Arribas, José Ramón / Domingo, Pere / Arroyo-Manzano, David / Rivero, Antonio / Moreno, Santiago / Podzamczer, Daniel

AIDS research and human retroviruses

2017 Volume 33, Issue 1, Page(s) 29–32

Abstract: To assess the efficacy and safety of maraviroc (MVC) administered once-daily in routine clinical practice. A retrospective multicenter study (27 centers in Spain) was conducted. Data were collected from the records of patients starting a regimen with MVC. ...

Abstract	To assess the efficacy and safety of maraviroc (MVC) administered once-daily in routine clinical practice. A retrospective multicenter study (27 centers in Spain) was conducted. Data were collected from the records of patients starting a regimen with MVC. Laboratory and clinical data were recorded every 3 months the first year and every 6 months thereafter. Data are presented as median and interquartile range. Among 667 patients treated with MVC, 142 (21.3%) received MVC once-daily: 108 (76.1%), 150 mg and 34 (23.9%), and 300 mg. Age was 47 (42-45) years, there were 76.1% men, and 81 (57%) patients had baseline HIV-RNA <50 copies/mL. Viral tropism was R5 in 118 (83.1%) patients. Reasons for prescribing MVC: salvage therapy (36.6%), drug toxicity (31.2%), simplification (16.9%), and immunodiscordant response (7.1%). Median follow-up was 13 (9-16) months. In 95.8%, a PI/r was part of the regimen (67% on dual therapy). At months 12 and 24, 73.3% and 68.2% of patients had HIV-RNA <50 copies/mL, respectively (p = .041 and p < .001 vs. baseline). CD4
Language	English
Publishing date	2017-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	639130-8
ISSN	1931-8405 ; 0889-2229
ISSN (online)	1931-8405
ISSN	0889-2229
DOI	10.1089/AID.2015.0386
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Article: Natural history of compensated and decompensated HCV-related cirrhosis in HIV-infected patients: a prospective multicentre study.

Girón-González, José A / Brun, Francisco / Terrón, Alberto / Vergara, Antonio / Arizcorreta, Ana

Antiviral therapy

2007 Volume 12, Issue 6, Page(s) 899–907

Abstract: Objective: To define the course of HIV-HCV-coinfected patients with compensated and decompensated liver cirrhosis and to investigate the survival and the risk factors for death.: Patients and methods: Ninety-two HIV-infected patients with HCV-related ...

Abstract	Objective: To define the course of HIV-HCV-coinfected patients with compensated and decompensated liver cirrhosis and to investigate the survival and the risk factors for death. Patients and methods: Ninety-two HIV-infected patients with HCV-related cirrhosis (50 of them without and 42 with previous decompensations) were prospectively followed up during a median period of 20 months. Clinical, biochemical, virological and immunological factors were analysed. Multivariate analyses were performed of those factors associated with decompensations and mortality. Results: There were 168 readmissions due to liver-disease-related causes. A Child-Pugh index > or =6 in those without previous decompensations (hazard ratio [HR] 7.94, 95% confidence interval [CI] 1.59-39.58; P = 0.014), and Child-Pugh index > or =9 (HR 2.68, 95% CI 1.13-6.33; P = 0.003) and absence of HAART (HR 0.44, 95% CI 0.19-0.98; P = 0.048) in those with previous decompensations were independently associated with decompensation during the follow up. There were 27 deaths, 22 of them attributable to liver disease. Independent factors associated with liver-related mortality were a Child-Pugh index > or =9 (HR 6.24, 95% CI 2.31-16.85; P < 0.001), progression of Child-Pugh index during the follow up (HR 4.27, 95% CI 1.54-11.80; P = 0.008), more than one decompensation (HR 24.25, 95% CI 7.27-40.45; P < 0.001) and absence of HAART (HR 0.35, 95% CI 0.12-0.98; P = 0.002). Conclusions: Evolution from compensated to decompensated cirrhosis and death is influenced by markers of liver function and the absence of HAART. The importance of this last element must be adequately stressed.
MeSH term(s)	Adult ; Anti-HIV Agents/therapeutic use ; Antiretroviral Therapy, Highly Active ; Antiviral Agents/therapeutic use ; CD4 Lymphocyte Count ; Cohort Studies ; Disease Progression ; Female ; HIV/physiology ; HIV Infections/complications ; HIV Infections/drug therapy ; HIV Infections/virology ; Hepatitis C/complications ; Hepatitis C/drug therapy ; Hepatitis C/virology ; Humans ; Liver Cirrhosis/complications ; Liver Cirrhosis/mortality ; Liver Cirrhosis/physiopathology ; Male ; Prospective Studies ; Risk Factors ; Viral Load
Chemical Substances	Anti-HIV Agents ; Antiviral Agents
Language	English
Publishing date	2007
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	1339842-8
ISSN	1359-6535
ISSN	1359-6535
DOI	10.1177/135965350701200605
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Article ; Online: CNS safety at 48-week of switching to ATV/r plus 3TC or two nucleos(t)ides in HIV-suppressed patients on stable ART: the SALT neurocognitive sub-study.

Valero, Ignacio Pérez / Pasquau, Juan / Rubio, Rafael / Ribero, Antonio / Santos, Jose / Sanz, Jesus / Mariño, Ana / Crespo, Manel / Hernandez, Jose / Iribarren, Jose Antonio / Gutierrez, Felix / Terron, Alberto / Esteban, Herminia / Pérez-Molina, Jose Antonio

Journal of the International AIDS Society

2014 Volume 17, Issue 4 Suppl 3, Page(s) 19656

Abstract: Introduction: Due to their low CNS penetrance, there are concerns about the capacity of non-conventional PI-based ART (monotherapy and dual therapies) to preserve neurocognitive performance (NP).: Methods: We evaluated the NP change of aviremic ... ...

Abstract	Introduction: Due to their low CNS penetrance, there are concerns about the capacity of non-conventional PI-based ART (monotherapy and dual therapies) to preserve neurocognitive performance (NP). Methods: We evaluated the NP change of aviremic participants of the SALT clinical trial (1) switching therapy to dual therapy (DT: ATV/r+3TC) or triple therapy (TT: ATV/r+2NRTI) who agreed to perform an NP assessment (NPZ-5) at baseline and W48. Neurocognitive impairment and NP were assessed using AAN-2007 criteria (2) and global deficit scores (GDS) (3). Neurocognitive change (GDS change: W48 - baseline) and the effect of DT on NP evolution crude and adjusted by significant confounders were determined using ANCOVA. Results: A total of 158 patients were included (Table 1). They had shorter times because HIV diagnosis, ART initiation and HIV-suppression and their virologic outcome at W48 by snapshot was higher (79.1% vs 72.7%; p=0.04) compared to the 128 patients not included in the sub-study. By AAN-2007 criteria, 51 patients in each ART group (68% vs 63%) were neurocognitively impaired at baseline (p=0.61). Forty-seven patients were not reassessed at W48: 30 lost of follow-up (16 DT-14 TT) and 17 had non-evaluable data (6 DT-11 TT). Patients retested were more likely to be men (78.9% vs 61.4%) and had neurological cofounders (9.6% vs 0%) than patients non-retested. At W48, 3 out of 16 (5.7%) patients on DT and 6 out of 21 (10.5%) on TT who were non-impaired at baseline became impaired (p=0.49) while 10 out of 37 (18.9%) on DT and 7 out of 36 (12.3%) on TT who were neurocognitively impaired at baseline became non-impaired (p=0.44). Mean GDS changes (95% CI) were: Overall -0.2 (-0.3 to -0.04): DT -0.26 (-0.4 to -0.07) and TT -0.08 (-0.2 to 0.07). NP was similar between DT and TT (0.15). This absence of differences was also observed in all cognitive tests. Effect of DT: -0.16 [-0.38 to 0.06]) (r(2)=0.16) on NP evolution was similar to TT (reference), even after adjusting (DT: -0.11 [-0.33 to 0.1], TT: reference) by significant confounders (geographical origin, previous ATV use and CD4 cell count) (r(2)=0.25). Conclusions: NP stability was observed after 48 weeks of follow up in the majority of patients whether DT or TT was used to maintain HIV-suppression. Incidence rates of NP impairment or NP impairment recovery were also similar between DT and TT.
Language	English
Publishing date	2014
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2467110-1
ISSN	1758-2652 ; 1758-2652
ISSN (online)	1758-2652
ISSN	1758-2652
DOI	10.7448/IAS.17.4.19656
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Article ; Online: Stepped-dose versus full-dose efavirenz for HIV infection and neuropsychiatric adverse events: a randomized trial.

Gutiérrez-Valencia, Alicia / Viciana, Pompeyo / Palacios, Rosario / Ruiz-Valderas, Rosa / Lozano, Fernando / Terrón, Alberto / Rivero, Antonio / López-Cortés, Luis F

Annals of internal medicine

2009 Volume 151, Issue 3, Page(s) 149–156

Abstract: Background: More than 50% of patients who start efavirenz treatment develop limiting neuropsychiatric adverse events (NPAEs).: Objective: To assess whether stepwise dosing of efavirenz decreases the incidence and severity of NPAEs while maintaining ... ...

Abstract	Background: More than 50% of patients who start efavirenz treatment develop limiting neuropsychiatric adverse events (NPAEs). Objective: To assess whether stepwise dosing of efavirenz decreases the incidence and severity of NPAEs while maintaining virologic efficacy. Design: Randomized, double-blind, controlled trial. Setting: 7 HIV clinics in Spain. Patients: 114 HIV-infected patients eligible for efavirenz treatment plus 2 nucleoside or nucleotide reverse transcriptase inhibitors. Intervention: Random assignment (by computer-generated sequence) to receive efavirenz, 200 mg/d on days 1 through 6, 400 mg/d on days 7 through 13, and 600 mg/d on day 14 and after, or efavirenz, 600 mg/d, from day 1. Both groups received 2 nucleoside or nucleotide reverse transcriptase inhibitors chosen by the patient's physician. Measurements: Neuropsychiatric symptoms and sleep quality were assessed by questionnaires at 0, 7, 14, and 30 days. The primary outcome was efavirenz-related NPAEs during the first 2 weeks, and the secondary outcome was plasma HIV RNA level at 24 weeks. Results: Compared with the stepped-dose group, the full-dose group had higher incidence and severity of dizziness (66.0% vs. 32.8%; P = 0.001), hangover (45.8% vs. 20.7%; P = 0.008), impaired concentration (22.9% vs. 8.9%; P = 0.038), and hallucinations (6.1% vs. 0%; P = 0.056) during the first week. From week 2, the incidence of efavirenz-related NPAEs was similar in both groups, although the severity was greater in the full-dose group. Virologic and immunologic efficacy seemed similar in both groups. Limitations: The sample size was calculated on the basis of a high absolute difference in rates of efavirenz-related NPAEs between the groups. A lower absolute difference and a larger sample size could have made the differences between groups reach statistical significance beyond the first week. In addition, the sample size does not allow confirmation of similar efficacy between treatment groups. Conclusion: Stepwise dose escalation of efavirenz over 2 weeks reduces the incidence and intensity of efavirenz-related NPAEs while maintaining efficacy. Primary funding source: Consejería de Salud, Junta de Andalucía, Spain.
MeSH term(s)	Adult ; Aged ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/adverse effects ; Anti-HIV Agents/blood ; Benzoxazines/administration & dosage ; Benzoxazines/adverse effects ; Benzoxazines/blood ; CD4 Lymphocyte Count ; Double-Blind Method ; Drug Administration Schedule ; Female ; HIV Infections/drug therapy ; HIV Infections/immunology ; HIV Infections/virology ; Humans ; Male ; Mental Disorders/chemically induced ; Middle Aged ; Reverse Transcriptase Inhibitors/administration & dosage ; Reverse Transcriptase Inhibitors/adverse effects ; Reverse Transcriptase Inhibitors/blood ; Sample Size ; Sleep Wake Disorders/chemically induced ; Viral Load
Chemical Substances	Anti-HIV Agents ; Benzoxazines ; Reverse Transcriptase Inhibitors ; efavirenz (JE6H2O27P8)
Language	English
Publishing date	2009-07-06
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/0003-4819-151-3-200908040-00127
Database	MEDical Literature Analysis and Retrieval System OnLINE

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