Logro de control metabólico temprano en adultos con diabetes mellitus tipo 2 en Perú

Objetivo: Estimar la proporción de sujetos con diabetes mellitus tipo 2 (DMT2) que alcanzan la meta terapéutica para HbA1C un año después del diagnóstico (control metabólico temprano). Métodos: Revisión retrospectiva de historias clínicas de adultos atendidos en 16 centros médicos distribuidos en nueve ciudades peruanas. Se incluyeron pacientes que recibieron un diagnóstico inicial de DMT2 y tuvieron al menos un año de seguimiento. Se consideraron las metas metabólicas definidas en los estándares ADA 2018. Resultados: Se incluyeron 457 sujetos (53,03% mujeres). Cuando fueron diagnosticados, la edad media fue de 55,75 años (DE ± 12,92), la media de HbA1C fue de 9,10% (DE ± 2,28). Hubo diagnóstico concomitante de hipertensión arterial o de dislipidemia en 27,13% y 52,40%, respectivamente. Al año de seguimiento, 57,76% de los sujetos alcanzó la meta de HbA1C ( 40 mg / dL), 24,31% para HDL-c en mujeres (>50 mg/dL), 48,24% para triglicéridos (<150 mg/dL), y 89,23% para presión arterial (<140/90 mmHg). Conclusiones: En este estudio en condiciones de la vida real, en adultos con DMT2 con un año de seguimiento, el logro de la meta de HbA1C (<7%) se alcanzó en el 58% de los pacientes. Si bien estos resultados son compatibles con los reportados en otros estudios de la región, se evidencia la oportunidad de mejorar el logro temprano de metas con el objetivo de optimizar los resultados a largo plazo.

Aim: To estimate the proportion of subjects with type 2 diabetes mellitus (T2DM) who attain therapeutic goal for HbA1C one year after diagnosis (early metabolic control). Methods: Retrospective review of medical records of adults cared for at 16 centers in nine Peruvian cities. Patients who received an initial diagnosis of T2DM and had at least one year of follow up were included. Metabolic goals were as defined by ADA 2018 standards. Results: 457 subjects were included (53,03% female). At diagnosis, mean age was 55,75 years (SD ± 12.92), mean HbA1C was 9,10% (SD ± 2,28). Concomitant hypertension or dyslipidemia were present in 27,13% and 52,40%, respectively. At one year follow up, 57,76% of subjects attained the goal for HbA1C ( 40 mg/dL), 24,31% for HDL-c in women (>50 mg/dL), 48,24% for triglycerides (<150 mg/dL), and 89,23% for blood pressure (<140/90 mmHg). Conclusions: In this real-life study of adults with T2DM with one year of follow up, metabolic control for HbA1C (<7%) was attained in 58% of subjects. While the results are compatible with those reported in other studies in the region, there is opportunity to further improve early treatment goal attainment to optimize long-term outcomes.

Poor quality of life and incomplete self-reported adherence predict second-line ART virological failure in resource-limited settings.

We evaluated health-related quality of life (QoL) and self-reported incomplete adherence as predictors of early second-line antiretroviral (ART) virological failure (VF). ACTG A5273 study participants completed the ACTG SF-21 measure which has 8 QoL domains. We used exact logistic regression to assess the association of QoL at baseline and week 4 with early VF adjusted for self-reported adherence. Of 500 individuals (51% women, median age 39 years) in this analysis, 79% and 75% self-reported complete adherence (no missing doses in the past month) at weeks 4 and 24, respectively. Early VF was experienced by 7% and more common among those who self-reported incomplete adherence. Participants with low week 4 QoL scores had higher rates of early VF than participants with high scores. After adjusting for self-reported adherence at week 4, VL and CD4 at baseline, cognitive functioning, pain and mental health domains were significantly associated with subsequent early VF. In this post-hoc analysis, poorer QoL adds to self-reported incomplete adherence after 4 weeks of second-line ART in predicting VF at week 24. Evaluation is needed to assess whether individuals with poorer QoL might be targeted for greater support to reduce risk of VF.Trial registration: ClinicalTrials.gov identifier: NCT01352715.

Quality of life improvement in resource-limited settings after one year of second-line antiretroviral therapy use among adult men and women.

OBJECTIVE: We evaluated improvement of quality of life (QoL) after 1 year of second-line antiretroviral therapy (ART) use in resource-limited settings (RLS) among adult men and women, comparing two randomized treatment arms. DESIGN: The AIDS Clinical Trial Group A5273 was a randomized clinical trial of second-line ART comparing lopinavir/ritonavir (LPV/r) + raltegravir with LPV/r + nucleos(t)ide reverse transcriptase inhibitors (NRTIs) in participants failing a non-NRTI-containing regimen at 15 sites in nine RLS. Participants completed the AIDS Clinical Trial Group short-form-21 which has eight QoL domains with a standard score ranging from 0 (worst) to 100 (best). METHODS: Differences in QoL by randomized arm, as well as by demographic and clinical variables, were evaluated by regression models for baseline and week 48 QoL scores fitted using the generalized estimating equations method. RESULTS: A total of 512 individuals (49% men, median age 39 years) were included. A total of 512 and 492 participants had QoL assessments at baseline and week 48, respectively. QoL improved significantly from baseline to week 48 (P < 0.001 for all domains). There was no significant difference between treatment arms for any domain. Individuals with higher viral load and lower CD4 cell count at baseline had lower mean QoL at baseline but larger improvements such that mean QoL was similar at week 48. CONCLUSION: Improvements in QoL were similar after starting second-line ART of LPV/r combined with either raltegravir or NRTIs in RLS. QoL scores at baseline were lower among participants with worse disease status prior to starting second-line, but after 1 year similar QoL scores were achieved.

Quality of life among HIV-infected individuals failing first-line antiretroviral therapy in resource-limited settings.

We evaluated health-related quality of life (QoL) in HIV infection participants with virologic failure (VF) on first-line antiretroviral therapy (ART) in 9 resource-limited settings (RLS). ACTG SF-21 was completed by 512 participants at A5273 study entry; 8 domains assessed: general health perceptions (GHP), physical functioning (PF), role functioning (RF), social functioning (SF), cognitive functioning (CF), pain (P), mental health (MH), and energy/fatigue (E/F); each was scored between 0 (worst) to 100 (best). Mean QoL scores ranged from 67 (GHP) to 91 (PF, SF, CF). QoL varied by country; high VL and low CD4 were associated with worse QoL in most domains, except RF (VL only), SF (CD4 only) and CF (neither). Number of comorbidities, BMI and history of AIDS were associated with some domains. Relationships between QoL and VL varied among countries for all domains. The association of worse disease status with worse QoL may reflect low QoL when ART was initiated and/or deterioration associated with VF.

Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study.

BACKGROUND: For second-line antiretroviral therapy, WHO recommends a boosted protease inhibitor plus nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs). However, concerns about toxicity and cross-resistance motivated a search for regimens that do not contain NRTIs. We aimed to assess whether boosted lopinavir plus raltegravir would be non-inferior to boosted lopinavir plus NRTIs for virological suppression in resource-limited settings. METHODS: A5273 was a randomised, open-label, phase 3, non-inferiority study at 15 AIDS Clinical Trials Group (ACTG) research sites in nine resource-limited countries (three sites each in India and South Africa, two each in Malawi and Peru, and one each in Brazil, Kenya, Tanzania, Thailand, and Zimbabwe). Adults with plasma HIV-1 RNA concentrations of at least 1000 copies per mL after at least 24 weeks on a regimen based on a non-NRTI inhibitor were randomly assigned (1:1) to receive oral ritonavir-boosted lopinavir (100 mg ritonavir, 400 mg lopinavir) plus 400 mg raltegravir twice a day (raltegravir group) or to ritonavir-boosted lopinavir plus two or three NRTIs selected from an algorithm (eg, zidovudine after failure with tenofovir and vice versa; NRTI group). Randomised group assignment was done with a computer algorithm concealed to site personnel, and stratified by HIV-1 RNA viral load, CD4 cell count, and intention to use zidovudine, with the groups balanced by each site. The primary endpoint was time to confirmed virological failure (two measurements of HIV-1 RNA viral load >400 copies per mL) at or after week 24 in the intention-to-treat population. Non-inferiority (10% margin) was assessed by comparing the cumulative probability of virological failure by 48 weeks. This trial was registered with ClinicalTrials.gov, NCT01352715. FINDINGS: Between March 13, 2012, and Oct 2, 2013, we randomly assigned 515 participants: 260 to the raltegravir group and 255 to the NRTI group; two participants in the raltegravir group and one in the NRTI group were excluded from analyses because of ineligibility. By the end of follow-up (October, 2014), 96 participants had virological failure (46 in the raltegravir group and 50 in the NRTI group). By 48 weeks, the cumulative probability of virological failure was 10·3% (95% CI 6·5-14·0) in the raltegravir group and 12·4% (8·3-16·5) in the NRTI group, with a weighted difference of -3·4% (-8·4 to 1·5), indicating that raltegravir was non-inferior, but not superior, to NRTIs. 62 (24%) participants in the raltegravir group and 81 (32%) in the NRTI group had grade 3 or higher adverse events; 19 (7%) and 29 (11%), respectively, had serious adverse events. Three participants in each group died, all from HIV-related causes. INTERPRETATION: In settings with extensive NRTI resistance but no available resistance testing, our data support WHO's recommendation for ritonavir-boosted lopinavir plus NRTI for second-line antiretroviral therapy. Ritonavir-boosted lopinavir plus raltegravir is an appropriate alternative, especially if NRTI use is limited by toxicity. FUNDING: National Institutes of Health.

Retroviral infection in Peruvian men who have sex with men.

We tested 2655 Peruvian men who have sex with men for the presence of retroviral infection. Human T cell lymphotropic virus type 1 (HTLV-1) was detected in 48 (1.8%) of the patients, HTLV-2 was detected in 28 (1.1%), and HTLV-1 and HTLV-2 were both detected in 5 (0.2%). Human immunodeficiency virus infection was detected in 329 (12.4%) of the patients; 24 (7.3%) had HTLV coinfection. Risk factors for HTLV-1 and HTLV-2 infection varied with sexual role.

Risk factors for HTLV-II infection in Peruvian men who have sex with men.

Human T-cell lymphotropic virus type-II (HTLV-II) infection is endemic in indigenous groups in the Americas and injection drug users (IDUs) worldwide. In Peru, HTLV-II infection was previously identified in two indigenous Amazonians. We examined risk factors for HTLV-II infection in 2,703 Peruvian men who have sex with men (MSM): 35 (1.3%) were HTLV-II positive. HTLV-II infection was associated with syphilis, HSV-2 infection, unprotected receptive anal intercourse, and older age. This is the first report of HTLV-II in a non-indigenous non-IDU population in Peru. Additional studies are needed to determine if HTLV-II is a sexually transmitted infection in this and other sexually active populations.