Assessment of regional body composition, physical function and sarcopenia among peruvian women aging with HIV: A cross-sectional study.

Management of chronic conditions and optimization of overall health has become a primary global health concern in the care of people living with HIV in the era of highly active antiretroviral therapy (ART), particularly in lower-and-middle income countries where infrastructure for chronic disease management may be fragmented. Alterations in body composition can reflect important changes in musculoskeletal health, particularly among populations at risk for developing fat and muscle redistribution syndromes, such as women with HIV on ART. Given the lack of data on this topic in Latin America and the Caribbean, we designed an exploratory study to measure these outcomes in a population of women aging with HIV in Peru. We conducted a cross-sectional study among Peruvian women with and without HIV aged ≥40 years. Dual X-ray absorptiometry was used to measure trunk and limb lean mass (LM) and fat mass (FM). Physical performance was assessed with the Short Physical Performance Battery (SPPB) and physical strength with a dynamometer. Sarcopenia was assessed based upon EWGSOP criteria. We used linear regression to model associations between body composition, sarcopenia and physical performance scores. 104 women with HIV and 212 women without HIV were enrolled (mean age 52.4±8.2 vs. 56.4±8.8 years, p≤0.001). Among women with HIV, mean years since diagnosis was 11.8±6 and all were on ART. Mean SPPB score was 9.9 vs 10.8 (p<0.001) between both groups. Sarcopenia spectrum was found in 25.9% and 23.1%, respectively. In the multivariable regression analysis, trunk FM and older age were negatively correlated with physical performance among women with HIV. Severe sarcopenia was found among a greater proportion of those with HIV (3.8% vs. 0.9%, p = 0.84), however this finding was not statistically significant. Women with HIV had significantly lower SPPB scores compared to women without HIV, and trunk FM and upper limb LM were independent predictors for the SPPB and Grip Strength tests, respectively. Larger, prospective studies are needed in Latin America & the Caribbean to identify individuals at high risk for sarcopenia and declines in physical function, and to inform prevention guidelines.

Prevalence of and risk factors for vertebral fracture and low bone mineral density among Peruvian women aging with HIV.

Osteoporosis and fracture risk among women with HIV in Latin America is understudied. In a sample of Peruvian women with and without HIV, women with HIV had lower femoral neck and total hip BMD and a higher proportion of vertebral fractures. Important treatment gaps were identified across both groups. PURPOSE: Studies have shown that patients with HIV are at increased risk for bone loss and fracture due to a combination of host, viral, and antiretroviral therapy (ART)-related factors. We aimed to explore the prevalence of vertebral fracture (VF) and low bone mineral density (BMD) among women aging with HIV in Peru and identify risk factors for osteoporosis and fracture in this population. METHODS: We enrolled women living with and without HIV aged ≥40 years between 2019 and 2020. Participants completed a survey and obtained dual X-ray absorptiometry (DXA) test to assess BMD at the lumbar spine (LS), femoral neck (FN), and total hip (TH). A subset of patients also obtained lateral thoracolumbar X-rays. Presence of VF was determined using the Genant semiquantitative method. Regression analyses were used to model associations between key risk factors and BMD. RESULTS: 104 women living with HIV and 212 women living without HIV were enrolled with a mean age of 52.4±8.2 and 56.4±8.8 years (p < 0.001). Among postmenopausal women (257/316, 81.3%), 26.3% of women living with HIV and 25.9% of those without HIV had osteoporosis. Among the 88 women living with HIV and 178 women living without HIV who obtained thoracolumbar X-rays, 12.5% and 6.2%, respectively, had at least one VF. Based on DXA and the FRAX score, 22/104 women living with HIV met criteria for osteoporosis treatment according to national guidelines; however, none were on treatment. Propensity score matching revealed that women living with HIV had 0.032 g/cm2 lower FN BMD (p = 0.012) and 0.034 g/cm2 lower TH BMD (p = 0.041) compared to women without HIV. CONCLUSION: In this study, women living with HIV on long-standing ART had increased VF prevalence compared to the slightly older group of women without HIV. Age and BMI were independent predictors for BMD at the lumbar spine, hip, and femoral neck among women living with HIV, and there was a treatment gap among women who met criteria for osteoporosis treatment. Larger studies are needed in this region to identify individuals at risk for fracture and to inform prevention guidelines.

Health-related quality of life among women aging with and without HIV in Peru.

BACKGROUND: Studies have shown that women aging with HIV have significantly lower health-related quality of life (HRQoL) compared to women without HIV. However, no studies have examined this issue in Latin America and the Caribbean. We aimed to explore HRQoL measured by the 36-Item Short Form Health Survey (SF-36) among women aging with and without HIV in Peru. MATERIALS AND METHODS: We conducted a cross-sectional study at a large HIV-clinic in Peru. Outcomes of the SF-36 were evaluated, exploring the relationship between physical activity (International Physical Activity Questionnaire), sociodemographic factors (ethnicity, alcohol/tobacco use, age, BMI) and clinical data (AIDS progression, treatment duration, CD4+ cell count and viral load, years since HIV diagnosis) with HRQoL using regression analysis. Statistical significance was set with a two-tailed p-value <0.05. RESULTS: We enrolled 427 women (175 HIV-infected) with mean age of 54±8 years. From the SF-36 individual domains: physical functioning, role limitations due to physical and emotional health, and emotional wellbeing were significantly lower for HIV-infected women. Summary component scores were lower for the HIV-subset for both physical (45.8 vs 47.3) and mental (45.1 vs 45.8) components, although they did not achieve statistical significance. Regression analysis of the HIV-infected women revealed that the physical component score was significantly associated with physical activity, ethnicity, and chronic comorbidities while the mental component was significantly associated with physical activity, employment, and CD4+ cell count. CONCLUSION: In our study, HIV-infected women scored lower in both physical and mental component scores. Important determinants for each component included CD4+ cell count as an assessment of HIV severity for the mental component, and ethnicity, reflecting socio-cultural factors, for the physical component. These results reveal the importance of a holistic approach to addressing HRQoL in this population. Better understanding of these factors will help shape future policies and interventions to improve HRQoL of women aging with HIV.

Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV.

OBJECTIVES: To evaluate safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in adults living with HIV. DESIGN: In this phase 3 study (V114-018; NCT03480802), pneumococcal vaccine-naive adults with HIV (CD4+ cell count ≥50 cells/µl, plasma HIV RNA <50 000 copies/ml, receiving antiretroviral therapy) were randomized 1 : 1 to receive one dose of V114 or licensed 13-valent PCV (PCV13) on day 1; participants received PPSV23 at week 8. METHODS: Adverse events and serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) antibodies were evaluated after each vaccination. RESULTS: Of 302 participants enrolled, 292 (96.7%) completed the study. Proportions of participants experiencing at least one adverse event were 73.0 and 62.7% in the V114 and PCV13 groups following PCV and 60.7 and 71.6% following PPSV23. Most solicited adverse events were of mild or moderate severity and short duration. OPA geometric mean titers (GMTs) and IgG geometric mean concentrations (GMCs) were generally comparable between groups for shared serotypes at day 30 and maintained at week 12. OPA and IgG responses for additional serotypes in V114 (22F, 33F) were higher following V114 than PCV13 at day 30 but comparable at week 12, 30 days post-PPSV23. CONCLUSION: In pneumococcal vaccine-naive adults living with HIV, V114 was well tolerated and induced immune responses for all 15 pneumococcal serotypes. V114 can be followed by PPSV23 8 weeks later to broaden serotype coverage.

Microscopic observation drug susceptibility assay for tuberculosis screening before isoniazid preventive therapy in HIV-infected persons.

BACKGROUND: Active tuberculosis (TB) must be excluded before initiating isoniazid preventive therapy (IPT) in persons infected with human immunodeficiency virus (HIV), but currently used screening strategies have poor sensitivity and specificity and high patient attrition rates. Liquid TB culture is now recommended for the detection of Mycobacterium tuberculosis in individuals suspected of having TB. This study compared the efficacy, effectiveness, and speed of the microscopic observation drug susceptibility (MODS) assay with currently used strategies for TB screening before IPT in HIV-infected persons. METHODS: A total of 471 HIV-infected IPT candidates at 3 hospitals in Lima, Peru, were enrolled in a prospective comparison of TB screening strategies, including laboratory, clinical, and radiographic assessments. RESULTS: Of 435 patients who provided 2 sputum samples, M. tuberculosis was detected in 27 (6.2%) by MODS culture, 22 (5.1%) by Lowenstein-Jensen culture, and 7 (1.6%) by smear. Of patients with any positive microbiological test result, a MODS culture was positive in 96% by 14 days and 100% by 21 days. The MODS culture simultaneously detected multidrug-resistant TB in 2 patients. Screening strategies involving combinations of clinical assessment, chest radiograph, and sputum smear were less effective than 2 liquid TB cultures in accurately diagnosing and excluding TB (P<.01). Screening strategies that included nonculture tests had poor sensitivity and specificity. CONCLUSIONS: MODS culture identified and reliably excluded cases of pulmonary TB more accurately than other screening strategies, while providing results significantly faster than Lowenstein-Jensen culture. Streamlining of the ruling out of TB through the use of liquid culture-based strategies could help facilitate the massive up-scaling of IPT required to reduce HIV and TB morbidity and mortality.

Metabolic and Cardiovascular Comorbidities Among Clinically Stable HIV Patients on Long-Term ARV Therapy in Five Ambulatory Clinics in Lima-Callao, Peru.

BACKGROUND: There is scarcity of data about the prevalence of non-AIDS defining comorbidities among stable HIV-infected patients in Peru. OBJECTIVE: We aimed to describe the most frequent cardiometabolic comorbidities found among ambulatory adults on ARV in Peru. METHODS: A review of records for patients attending regular visits at 5 clinics in Lima-Callao in January-February 2016 is presented. Patients were adults on ARV for >6 months, with no recent AIDS-defining condition. RESULTS: Three hundred and five medical charts were reviewed. Most patients were male (73.1%, n=223) with a mean age of 46.0 years. Mean time from HIV diagnosis was 9.41 yrs. and mean duration of ARV was 7.78 yrs. Most patients were on an NNRTI-based first line regimen (76.4%, n=233), and 12.1% (n=37) were on rescue regimens. Median CD4 count was 614.2 cells/µL and the proportion of patients with viral load <40 c/mL was 90.8% (n=277). Most frequent metabolic diagnoses were dyslipidemia (51.5%, n=157), obesity (11.1%, n=34), and diabetes mellitus (7.2%, n=22). Hypertension was diagnosed in 8.9% (n=27). Other diagnoses of cardiovascular disease were documented in 3.3% (n=10). Pharmacologic treatment was prescribed in 91.3% of patients with diabetes or hypertension, but in only 29.3% of patients with dyslipidemia. CONCLUSION: A high proportion of metabolic comorbidities was found, with dyslipidemia being the most frequent, followed by obesity and diabetes. In contrast, cardiovascular disease was documented less frequently. Medical treatment was started for only a third of dyslipidemia patients. HIV care policies need to consider proper management of chronic comorbidities to optimize long-term outcomes.

Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial.

BACKGROUND: Fostemsavir is a prodrug of temsavir, an attachment inhibitor that binds directly to HIV-1 gp120, blocking initial viral attachment and entry into host CD4+ T-cells. Efficacy, safety and dose-response data of fostemsavir in treatment-experienced, HIV-1-infected subjects, through week 48, are reported. METHODS: AI438011 is an ongoing Phase IIb, randomized, active-controlled trial (NCT01384734). Subjects were randomized 1:1:1:1:1 into five arms: fostemsavir (400 mg twice daily, 800 mg twice daily, 600 mg once daily or 1,200 mg once daily) and a reference arm (ritonavir-boosted atazanavir [ATV/r] 300/100 mg once daily), each with a backbone of raltegravir 400 mg twice daily plus tenofovir disoproxil fumarate 300 mg once daily. RESULTS: In total, 251 subjects were treated. Through week 48, the proportion of fostemsavir subjects with HIV-1 RNA <50 copies/ml was 61-82% and 77-95% (modified intent-to-treat [mITT] and observed analysis, respectively); 71% and 88% for ATV/r subjects (mITT and observed). Observed virological response rates were 74-100% versus 96% (fostemsavir versus ATV/r) in subjects with baseline viral load <100,000 copies/ml and 60-91% versus 71% when baseline viral load was ≥100,000 copies/ml. Across fostemsavir arms, median CD4+ T-cell count increases from baseline were 145-186 cells/µl and 142 cells/µl for the ATV/r arm. Fostemsavir doses were generally well tolerated and no fostemsavir-related adverse events led to discontinuation. CONCLUSIONS: Through week 48, fostemsavir continued to be well tolerated and showed similar efficacy to ATV/r. These results support the ongoing Phase III trial in heavily treatment-experienced adults with limited therapeutic options (≤2 classes of active antiretrovirals remaining). ClinicalTrials.gov identifier: NCT01384734.