Impact of lipodystrophy syndrome on the quality of life of patients receiving antiretroviral treatment: a cross-sectional, observational study

doi:10.21203/rs.3.rs-4617804/v1

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Impact of lipodystrophy syndrome on the quality of life of patients receiving antiretroviral treatment: a cross-sectional, observational study

https://doi.org/10.21203/rs.3.rs-4617804/v1

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To evaluate the impact of lipodystrophy syndrome on the quality of life (QoL) of people living with HIV/AIDS (PLWHA). The Sociodemographic and Clinical Health Characterization Form for PLWHA, Quality of Life Assessment Scale, and Self-Perceived Body Changes Questionnaire were administered to subjects with a confirmed diagnosis of HIV infection, receiving antiretroviral therapy for ≥ 6 months. Facial examination was performed to obtain Facial Lipoatrophy Index (FLI). The Student's t-test and chi-squared test were applied using a significance level of 5%. Of the 95 subjects, 77.89% were male, 62.11% identified as homosexual, and 52.63% were < 40 years. Seventy-three (76.84%) subjects reported having noticed body changes, mainly in the abdominal region (71.23%), and waist (54.79%). FLI revealed a mild degree of facial lipoatrophy in 91.58% of subjects, moderate in 7.37%, and severe in 1.05%. The mean QoL was 72.01. The domains of life satisfaction, medication concerns, and acceptance of HIV revealed lower scores in subjects who self-perceived body changes (p < 0.05) than in those who did not. The objectively assessed degree of loss in facial volume did not significantly affect QoL. PLWHA exhibited low QoL, which was even more significant among those who presented with lipodystrophy associated with the use of antiretrovirals.

Health sciences/Diseases

Health sciences/Health care

HIV. HIV-Associated Lipodystrophy Syndrome. Quality of life. Self-concept

Free access to diagnosis and combined antiretroviral therapy (ART) have had a significant impact on public policies for treating HIV infection, resulting in a reduction in morbidity and mortality associated with the disease¹. This resulted in AIDS becoming chronic disease, which, despite remaining incurable, has been characterized by a significant increase in life expectancy², from 31.0 to 69.5 years in Latin American countries³. Furthermore, ART can affect quality of life (QoL)², given that these medications are not free from side effects, including changes in body composition such as those caused by lipodystrophy syndrome (LS)⁴.

LS is characterized by changes in the distribution of body fat and manifests as a loss of adipose tissue (lipoatrophy) in regions of the face, buttocks and upper and lower limbs, with an increase in adipose tissue (lipohypertrophy) in the central abdominal region, breasts, and dorsocervical region, resulting in a “buffalo hump” appearance, or in a mixed form, with the simultaneous combination of both events⁵. Research investigating LS makes the diagnosis through patient self-report^6–10, physical examination^6,11–13, combination of patient reports and medical assessment^14–21 or through imaging examinations, such as dual X-ray absorptiometry^22,23, magnetic resonance imaging^24,25, and ultrasound²⁶.

Although the psychological impact(s) of lipodystrophy has been investigated^10,27–34, there has been a lack of studies comparing the impact of bodily changes related to LS, analyzed objectively, obtained through physical examination, and subjectively, through patient self-report, on the QoL of individuals receiving ART. Thus, the objective of the present study was to evaluate the impact of LS on the QoL of people living with HIV/AIDS (PLWHA) treated with ART.

Characterization of people living with HIV/AIDS

The sample consisted of 95 PLWHA, the majority of whom were male (77.89%), identified as homosexual (62.11%), < 40 years of age (52.63%), Caucasian (68.42%), single (56.84%), and were employed (74.74%).

When queried about health habits, 43 (45.26%) participants reported that they did not engage in physical activity; among those who did, 49 (94.23%) performed daily activity. Fifty-six participants (58.95%) consumed alcoholic beverages, and 29 (30.53%) and 17 (17.89%) used tobacco and illicit drugs, respectively.

Participant characteristics and clinical variables are summarized in Table 1. The mean age was 40.85 years and the mean time since HIV diagnosis was 116.48 months.

Table 1

Characterization of clinical variables of people living with HIV/AIDS.
Clinical variables	Mean	SD	Minimum	Maximum
Age (years)	40.85	12.88	20.00	75.00
Time since HIV diagnosis (months)	116.48	93.13	6.00	360.00
Antiretroviral treatment time (months)	107.03	89,87	6,00	360.00
Viral load (copies/mL)	5149.25	9669.02	21.00	31728.00
CD4 cell count (cells/mm³)	680.15	334.14	103.00	1906.00

Among the antiretroviral medications taken by the participants, lamivudine was used by 83 (87.37%), followed by tenofovir (n = 75 [78.95%]), and dolutegravir (n = 66 [69.47%]). In addition, 19 (20.0%) participants were taking psychiatric medications.

Self-perceived body changes and objective assessment of loss in facial volume

Seventy-three (76.84%) participants reported noticing body changes, of whom 60 (63.16%) reported an increase in volume and 41 (43.16%) reported a reduction. Data regarding self-perceived body changes, with body areas analyzed in a segmented manner, are summarized in Table 2.

Table 2

Self-perception of body changes by people living with HIV/AIDS.
Body changes self-perceived by patients	n	%
Reduction in the face	27	36.99
Enlargement in the neck	13	17.81
Enlargement in the abdominal region	52	71.23
Enlargement in the chest	27	36.99
Enlargement in the waist	40	54.79
Reduction in the arms	28	38.36
Reduction in the legs	27	36.99
Reduction in the gluteal region	22	30.14

Of the 73 subjects who noticed body changes, 23 (31.51%) believed that they were caused by antiretroviral medications. Other cited factors included HIV infection (12.33%), changes in eating habits (43.84%), lack of physical exercise (49.32%), and aging (21.92%).

Thirty (41.10%) subjects reported that their body changes were addressed by a physician, whereas 27 (36.99%) reported receiving medical recommendations regarding these changes. Medical recommendations included following a diet (21.92%), engaging in regular physical exercise (28.77%), changing antiretroviral drugs (5.48%), and undergoing aesthetic procedures (2.74%).

The average FLI value of the sample was 2.14±2.33. The facial lipoatrophy classifications of the participants consisted of 87 (91.58%) patients with grade I or mild facial lipoatrophy, 7 (7.37%) patients with grade II or moderate facial lipoatrophy and 1 (1.05%) patient with grade III or severe facial lipoatrophy. III. Mean values for the facial areas where there was fat loss, as assessed by the FLI, were malar 1.58±1.78, temporal 0.45±0.55, and pre-auricular 0.12±0.21.

Quality of life and related factors

The mean score for overall QoL was 72.01 (Table 3). Participants who reported self-perceived body changes exhibited significantly lower averages in general QoL (p = 0.010) and in some other domains than those who reported not having noticed body changes (Table 4).

Table 3

Assessment of the quality of life of people living with HIV/AIDS.
Quality of life - HAT-QoL	Average	SD	Minimum	Maximum
Overall function	77.76	17.82	25.00	100.00
Life satisfaction	70.59	25.69	12.50	100.00
Health concerns	81.78	24.34	0.00	100.00
Financial concerns	63.95	33.01	0.00	100.00
Medication concerns	88.84	17.17	25.00	100.00
Acceptance of HIV	75.00	35.21	0.00	100.00
Confidenciality concerns	52.26	32.85	0.00	100.00
Provider trust	60.26	35.55	0.00	100.00
Sexual function	77.63	30.56	0.00	100.00
General quality of life	72.01	15.11	17.08	100.00

Table 4

Assessment of the quality of life according to the self-perception of body changes by people living with HIV/AIDS.
Quality of life - HAT-QoL					p-value

			Self-perception of body changes (n = 73)			Absence of self-perceived body changes (n = 22)
		Average	SD	Average	SD
Overall function	75.91	17.64	83.90	17.41	0.065
Life satisfaction	66.70	25.20	83.52	23.43	0.006
Health concerns	79.11	24.35	90.63	22.64	0.051
Financial concerns	60.50	33.07	75.38	30.80	0.064
Medication concerns	87.05	17.97	94.77	12.86	0.030
Acceptance of HIV	71.23	37.02	87.50	25.30	0.023
Confidenciality concerns	49.73	32.45	60.68	33.53	0.172
Provider trust	63.36	35.57	50.00	34.31	0.123
Sexual function	75.00	31.66	86.36	25.27	0.127
General quality of life	69.84	14.99	79.19	13.47	0.010

When comparing the QoL domains of participants who attributed the use of antiretrovirals to the cause of self-perceived body changes (n = 23) with those who reported other causes for such changes (n = 50), a significant difference was found in the domains overall function, medication concerns and sexual function, with lower scores for the former (p < 0.05) (Table 5).

Table 5

Assessment of quality of life according to the association between the use of antiretrovirals as a cause for self-perceived body changes by people living with HIV/AIDS.
Quality of life - HAT-QoL	Self-perception of body changes related to the use of antiretrovirals (n = 23)		Self-perception of body changes attributed to other causes (n = 50)		p-value
Quality of life - HAT-QoL	Average	SD	Average	SD	p-value
Overall function	68.84	20.75	79.17	15.15	0.040
Life satisfaction	63.04	28.26	68.38	23.77	0.405
Health concerns	70.92	28.05	82.88	21.72	0.079
Financial concerns	56.52	40.51	62.33	29.32	0.541
Medication concerns	80.65	22.38	90.00	14.88	0.038
Acceptance of HIV	76.09	36.13	69.00	37.56	0.451
Confidenciality concerns	45.00	31.66	51.90	32.89	0.402
Provider trust	66.67	35.44	61.83	35.88	0.593
Sexual function	60.33	37.05	81.75	26.63	0.018
General quality of life	65.34	18.80	71.91	12.55	0.082

Subjects with more severe facial lipoatrophy exhibited lower QoL scores in the Sexual function domain and higher scores in the Acceptance of HIV domain (p < 0.05) (Table 6).

Table 6

Assessment of quality of life according to the classification of facial lipoatrophy of people living with HIV/AIDS.
Quality of life - HAT-QoL	Mild facial lipoatrophy (n = 87)		Moderate or severe facial lipoatrophy (n = 8)		p-value
Quality of life - HAT-QoL	Average	SD	Average	SD	p-value
Overall function	78.02	17.77	75.00	19.42	0.649
Life satisfaction	70.69	25.65	69.53	27.84	0.904
Health concerns	81.03	25.15	89.84	9.99	0.330
Financial concerns	63.79	32.32	65.62	42.36	0.882
Medication concerns	88.33	17.52	94.38	12.37	0.344
Acceptance of HIV	72.84	36.03	98.44	4.42	0.000
Confidenciality concerns	52.93	33.12	45.00	30.82	0.516
Provider trust	59.39	35.58	69.79	36.17	0.431
Sexual function	79.60	30.03	56.25	29.88	0.038
General quality of life	71.85	15.56	73.76	9.35	0.734

There was no significant difference in any QoL domain between subjects who self-perceived facial reduction (n = 27) and those who presented with moderate and severe degrees of facial lipoatrophy (n = 8) (p > 0.05) (Table 7).

Table 7

Assessment of average quality of life values (HAT-QoL) based on subjective (self-perception) and objective (FLI) assessment of facial lipoatrophy in people living with HIV/AIDS.
Quality of life - HAT-QoL	Self-perception of face reduction (n = 27)		Moderate or severe facial lipoatrophy (n = 8)		p-value
Quality of life - HAT-QoL	Average	SD	Average	SD	p-value
Overall function	77.47	16.02	75.00	19.42	0.722
Life satisfaction	65.05	30.29	69.53	27.84	0.750
Health concerns	78.24	23.73	89.84	9.99	0.319
Financial concerns	63.58	37.49	65.62	42.36	0.688
Medication concerns	86.85	15.70	94.37	12.37	0.143
Acceptance of HIV	76.39	35.75	98.44	4.42	0.104
Confidenciality concerns	48.33	30.63	45.00	30.82	0.768
Provider trust	67.59	34.15	69.79	36.17	0.825
Sexual function	65.28	34.38	56.25	29.88	0.434
General quality of life	69.86	13.24	73.76	9.35	0.623

The impact of sociodemographic variables and health habits on the QoL of PLWHA through the results of the unadjusted and adjusted analyses are summarized in Table 8. In the unadjusted model, satisfactory QoL outcomes were negatively associated with education corresponding to high school completion and positively associated with sporadic physical activity. In the adjusted model, both associations remained statistically significant (p < 0.05).

Table 8

– Hierarchical poisson regression for impact of sociodemographic variables and health habits on the quality of life of patients with HIV/AIDS.
Sociodemographic variables and health habits		Quality of life assessment (HAT-QoL)				Chi-Square test p-value	Bivariate Unadjusted PR*		p-value (95% CI)	Multivariate Unadjusted PR**		p-value (95% CI)
		Satisfactory(> 75)		Unsatisfactory(< 75)
		n	%	n	%
Gender	Male	35	47.30	39	52.70	0.979
Gender	Female	10	47.62	11	52.38	0.979
Age group	20 \|--- 30 years	10	43.48	13	56.52	0.935
	30 \|--- 40 years	13	48.15	14	51.85
	40 \|--- 50 years	8	44.44	10	55.56
	50 years or more	14	51.85	13	48.15
Sexual orientation	Heterosexual	14	50.00	14	50.00	0.923
	Homosexual	27	45.76	32	54.24
	Bisexual	4	50.00	4	50.00
Self-declared race/ethnicity	Caucasian	32	49.23	33	50.77	0.804
	Black	10	45.45	12	54.55
	Brown	3	37.50	5	62.50
Marital status	Single	26	48.15	28	51.85	0.435
	Married	11	55.00	9	45.00
	Divorced/separated	4	28.57	10	71.43
	Widow	4	57.14	3	42.86
Level of education	Elementary school	9	57.14	7	42.86	0.016	0.878	1.041 (0.621–1.746)		0.878	1.041 (0.621–1.746)
	High School	13	30.95	29	69.05		0.018	0.539 (0.323–0.899)		0.018	0.539 (0.323–0.899)
	Higher Education	23	62.16	14	37.84			1.00			1.00
Occupation	Employed	33	46.48	38	53.52	0.956
	Unemployed	6	50.00	6	50.00
	Retired/pensioner	6	50.00	6	50.00
Religion	Yes	28	48.28	30	51.72	0,824
Religion	Not	17	45.95	20	54.05	0,824
Regular practice of physical activity	Yes	29	55.77	23	44.23	0.071	-	1		-	-
Regular practice of physical activity	Not	16	37.21	27	62.79	0.071		1.00		-	-
Frequency of physical activity	Never	16	37.20	27	62.80	0.056	0,185	0.730 (0.459–1.162)		0.185	0.730 (0.459–1.162)
	Occasionally	3	100.00	0	0.00		0,003	1.819 (1.225–2.701)		0.003	1.819 (1.225–2.701)
	Daily	26	53.06	23	46.94			1.00			.,00
Alcohol consumption	Yes	27	48.21	29	51.79	0.843
Alcohol consumption	Not	18	46.15	21	53.85	0.843
Frequency of alcohol consumption	Occasionally	16	59.26	11	40.76	0.407
	Monthly	1	25.00	3	75.00
	Weekly	10	40.00	15	60.00
Tobacco consumption	Yes	15	51.72	14	48.28	0.573
Tobacco consumption	Not	30	45.45	36	54.55	0.573
Frequency of tobacco consumption	Occasionally	3	100.00	0	0.00	0.266
	Weekly	2	33.33	4	66.67
	Daily	10	50.00	10	50.00
Use of illicit drugs	Yes	8	47.06	9	52.94	0.977
Use of illicit drugs	Not	37	47.44	41	52.56	0.977
*Unadjusted Poisson regression for independent variables and impact on child’s quality of life (p < 0.20).
**Variables incorporated in adjusted multivariate model (p < 0.05).

Due to limitations of research that evaluates the impact of body changes related to LS on the QoL of PLWHA, and knowing that these changes have a significant psychological impact on patients^32,34 and affect QoL^10,30,35, we aimed to evaluate the influence of LS on the QoL of PLWHA receiving ART. To determine lipodystrophy in different body segments, subjective assessment based on self-perception in relation to changes in the redistribution of body fat, and objective assessment through tactile and visual analysis of the face, were used.

In the present sample, low QoL was identified, which was more significant among subjects with body changes attributed to the use of ART. Furthermore, the degree of objectively assessed facial volume loss did not significantly affect QoL. Because the face was the segment evaluated using both methods, it enabled a comparison of the impact of objective and subjective changes on participant QoL, demonstrating that there was no difference between those who presented with higher degrees of objective facial volume loss and those who reported only self-perceived reduction in the facial region.

The low values regarding the concern about revealing the disease domain are consistent with previous results^{2,18,29,31,36–43} and demonstrate that, despite advances in reducing morbidity and mortality, stigmatization and prejudice remain major challenges. In this sense, the fear of experiencing rejection as others ascertain their serology remains among PLWHA³⁶.

Regarding feelings toward physicians, low scores were also reported in previous research^2,43; however, they conflict with other studies^{18,37–40,42}, which found scores for this domain to be the most satisfactory. This result indicates that the levels of trust and satisfaction in relation to reception during medical care were lower than expected, which may indicate a need for more “humanized” care. Trust in the physician appears as a demonstration of the faith that the patient places in the professional, favoring the individual’s adherence and acceptance of the serological condition and treatment⁴⁴.

The low scores in the financial concern domain coincided with those observed in previous investigations^{2,18,29,36–43,45}. They may be associated with concerns about confidentiality regarding the status of the disease and stigma, which can negatively impact the patient’s ability to work and, consequently, harm their financial situation¹⁸. In the present study, financial concerns also warrant assessment considering the country’s economic situation in the immediate post-pandemic context when the research was performed.

The low score in the life satisfaction domain is consistent with other studies^36,39,43,46. This can be justified by the impact of HIV diagnosis, which raises concerns about the disease and the need for adaptation to recent reality², imposing new behaviors and feelings in relation to life.

Self-perception of body changes was reported by 76.84% of subjects, with a greater perception of lipohypertrophy than lipoatrophy. In previous studies from Brazil, the prevalence of LS ranged from 27.9–69.84%^{26,47,48,49,50}. The diversity of results can be explained by differences in the definition of LS, the methodology used for the diagnosis, and in the medications used in the antiretroviral regimens⁴⁷. The lack of a consensual and standardized method for defining and evaluating lipoatrophy and lipohypertrophy led us to choose two research instruments to collect signs of LS: a questionnaire addressing self-perception of body changes⁴⁸; and clinical assessment of the face using the FLI⁵¹. The definition of lipodystrophy based on patient assessment appears to better describe the impact of the severity of the syndrome on health status compared with the assessment(s) performed by a physician³³.

Subjects who reported having noticed body changes exhibited lower scores in some QoL domains than those who reported not having noticed physical changes. Body modifications have the potential to cause a negative perception of self-image, reduced self-confidence, avoidance of social contacts, changes in mood states, and feelings of frustration in the absence of satisfactory results⁴. Self-evaluation in relation to body changes interferes more with the perception of dissatisfaction with the body image of PLWHA than anthropometric measurements⁵².

Among the subjects who reported body changes, 23 (31.51%) associated these changes with ART and exhibited compromised QoL compared with those who reported other causes of these changes. The impact on medication concerns in patients who relate body changes to ART has been established^9,53. Lipodystrophy is often considered to be an important obstacle to adherence to ART, which highlights the threats to the health of these patients, as many consider abandoning treatment for fear of developing lipodystrophy and those who have not yet started ART hesitate to do so for fear related to changes in body image⁹. The influence on sexual function of patients who observe body changes related to LS has also been described^14,54. The psychological effects of lipodystrophy can also have a negative impact on intimate and emotional relationships, including problems with libido¹³.

A minority of subjects reported that their body changes were addressed by a physician or they received medical advice regarding them. Guidance regarding engaging in regular physical exercise was among the most cited recommendations. In fact, the adoption of a physically active lifestyle has been shown to be a protective factor against body changes resulting from LS^55,56. Despite having been the most recommended medical recommendation, it still appears with low frequency, which can justify the low score in the feeling toward the physician domain. This indicates that the relationship between health professionals and PLWHA needs to include an approach to body changes and guidance regarding preventive and mitigating measures aimed at alleviating body changes resulting from LS and, consequently, its negative impact on QoL.

The low prevalence of subjects with severe facial lipoatrophy in the present study can be explained by the antiretroviral regimen used, in which lamivudine, tenofovir, and dolutegravir were predominant. These medications are less likely to cause LS^57,58. Furthermore, it must be considered that, because previous treatment for facial lipoatrophy was an exclusion criterion, it is possible that many patients who experienced a higher degree of facial lipoatrophy did not participate in the research because they had previously sought treatment for the condition.

When comparing subject QoL according to the severity of facial lipoatrophy, a lower mean score was observed for the Sexual function domain and a higher mean for the Acceptance of HIV domain in subjects with moderate or severe lipoatrophy. These results suggest that the impact on subject QoL is not always proportional to the severity of the disease; therefore, there is no direct correlation between the severity of facial lipoatrophy and psychological impact, and even individuals with low FLI may experience negative repercussions on their lives, both professional and social.

The present study revealed no significant differences in any QoL domain between subjects who presented with higher degrees of objective facial lipoatrophy and those who reported only self-perceived facial reduction. Although other investigations^6,52 have reported that subjective body changes have a greater impact on patient QoL than objective changes, analyzing the face in isolation was not observed in our study. The presence of subjective body changes resulted in worse scores for some QoL domains. However, when the face was considered in isolation and compared with objective changes, this was not observed, suggesting that self-perception of fat loss on the face may have had a smaller impact than self-perceived changes in other parts of the body. Other studies indicate that the changes observed on the face as a result of LS are among the most impactful to PLWHA^6,8,59 because they are more easily noticed by others than changes occurring in other parts of the body, thereby increasing stigmatization⁶.

The differences observed between studies reinforce the need for LS to be analyzed considering its complexity, both in terms of the way it manifests in the body and in relation to the way in which changes in each body segment can affect the patient in different, individual ways. Therefore, objective clinical findings must be analyzed in a manner that is associated with the subjectivity inherent to patient self-perception, especially when the purpose is to investigate their impact on PLWHA's QoL. Future research with the aim of comparing objective and subjective findings from other body segments without disregarding the influence of sociodemographic and cultural aspects of the population investigated has the potential to contribute to a better understanding of this issue.

In the present study, subjects with a higher educational level exhibited better overall QoL than those who completed high school. A higher educational level directly facilitates access to information regarding HIV infection and, therefore, promotes better internal and external resources for individuals to live with their serological conditions^2,40.

It was also found that subjects who reported engaging in sporadic regular physical activity exhibited better overall QoL than those who engaged daily. These results need to be interpreted with caution because the proportion of subjects who reported sporadic physical exercise was very low and all had high QoL scores. Although there have been no studies relating the frequency of physical activity to QoL in this population, the regular practice of physical activity, whether through aerobic, weight, or flexibility exercises, promotes significant improvement(s) in the QoL of PLWHA^60,61.

Some limitations of the present study should be acknowledged. LS was defined clinically and through subject and professional self-perceptions. There remains a shortage of studies in the literature that use the FLI as well as no uniformity or standardization for classifying the severity of cases. Despite being an evaluator-dependent method, its execution is low cost, applicable as a comparative method between different studies, and enables the evaluation of patients at different times, making it possible to monitor the evolution of facial involvement and compare the degrees of severity of facial lipoatrophy among different patients. Another limitation is that, due to the cross-sectional design, the study did not evaluate subject condition years before the research was performed, which makes it exceedingly difficult to determine subject biotype and body composition in the absence of HIV infection or which would be present in the absence of LS.

PLWHA receiving ART exhibited a low QoL, which was even more significant among those with body changes characteristic of LS. The degree of objectively assessed facial volume loss did not significantly impact QoL, suggesting that varying degrees of LS may affect individuals differently, which demands a more in-depth analysis of the socioeconomic and cultural contexts in which they occur. Results of the present study add new knowledge that supports the development of strategies focused on improving care practices and health monitoring of individuals receiving ART. The objective was to contribute to improving QoL by directing care to PLWHA experiencing body changes related to LS.

Patients and procedures

Exploratory descriptive research using a cross-sectional design and quantitative approach was conducted at the Guidance and Counseling Center (COA) of the Municipal Health Department of the city of Curitiba (southern Brazil). The COA is a reference center for HIV/AIDS treatment, where PLWHA attend periodically for outpatient care and the withdrawal of antiretroviral medications. The study was approved by the institutional Ethics and Research Committees and the Municipal Health Department. All research was performed in accordance with relevant regulations, and in accordance with the Declaration of Helsinki. An informed consent was obtained from all participants.

The sample calculation was performed using the proportion sampling method with 95% confidence, assuming p = Q = 0.5 for a finite population (n = 5,000) and a maximum margin of error of 10%. The sample size calculated was 94 PLWHA on ART. The inclusion criteria were age ≥ 18 years, confirmed diagnosis of HIV infection, on ART for ≥ 6 months, and outpatient follow-up at the COA. Subjects who presented changes at the level of consciousness related to HIV/AIDS^47,52, those who were visually impaired⁵², pregnant women^4,47, those who had undergone facial filler procedures to treat facial lipoatrophy⁴⁸, and those who had diseases and/or clinical conditions that contraindicated facial examination were not included.

Data collection

Data were collected by a researcher specialized in orofacial harmonization after the subjects had signed a free and informed consent form. An interview was conducted with the individual application of three data collection instruments, in addition to an extraoral physical examination. The sociodemographic and clinical health characterization form for PLWHA^62,63 was applied to obtain the sociodemographic, epidemiological, and clinical variables. Clinical information was obtained from medical records.

To assess QoL, the HIV/AIDS-Quality of Life (HAT-QoL) questionnaire, which consists of 34 questions divided into 9 domains, was used. All items are rated on a five-point Likert scale. The score obtained for each domain was converted to a scale of 0 to 100, in which values close to zero correspond to the worst and values close to 100 indicate better QoL⁵¹, using 75 as the cut-off point, below which the QoL was considered to be unsatisfactory^2,64.

A questionnaire was administered to obtain information regarding subject self-perceived body change(s)⁴⁸. Subjects were asked to respond whether they observed an increase or reduction of any severity in the face, neck, abdominal region, chest, waist, arms, legs, or gluteal region. If so, they were asked when these changes were first noticed, to which factors they were attributed, whether the changes were addressed by the responsible physician during their clinical follow-up, and whether recommendations regarding these changes were offered. Two distinct patterns of change were recorded: perception of enlargement in the neck, chest, waist, or abdominal region; and perception of reduction in the face, arms, legs, or gluteal region⁴⁸.

Physical examinations included extraoral evaluations to obtain the Facial Lipoatrophy Index (FLI). This index is used to objectively assess the degree of facial atrophy in patients receiving ART. The examination was performed using visual assessment and digital pressure on the face^65,66. The extent and depth of the affected areas were evaluated by multiplying the extent of the affected area in the malar, temporal, and pre-auricular regions by the corresponding correction factor. This correction factor is stipulated for each region of the face and corresponds to the degree of importance of each factor in facial atrophy, such as 0.7 for the malar region, 0.2 for the temporal region, and 0.1 for the pre-auricular region. The extent of involvement was evaluated using scores from 0 to 5, as follows: 0 (no involvement); 1 (< 20% of the region affected); 2 (21–50%); 3 (51–70%); 4 (71–90%); and 5 (91–100%). Depth was evaluated using scores from 0 to 4, as follows: 0 (absence of facial atrophy); 1 (mild atrophy); 2 (moderate atrophy); 3 (severe atrophy); and 4 (very severe atrophy). The side of the face with the greatest involvement was considered. The FLI results can vary from zero to 20, and facial lipoatrophy is classified into grades I to IV, corresponding to mild, moderate, severe, and very severe lipoatrophy, respectively^65,66.

Statistical analysis

The data obtained were exported to SPSS version 25.0 (IBM Corp., Armonk, NY, USA). To compare QoL based on self-perceived body changes and facial lipoatrophy assessed according to FLI, the Student’s parametric t-test was applied for independent samples. The dependent variable was QoL scores divided by domains, whereas the independent variables were self-perceived body changes, attribution of antiretrovirals as the cause of body changes, and facial lipoatrophy. For the latter, a very low frequency of severe lipoatrophy was identified; as such, it was grouped with moderate lipoatrophy for association tests.

To compare QoL between subjects who reported self-perception of body changes and facial reduction and those who presented with moderate or severe degrees of facial lipoatrophy, the non-parametric Mann–Whitney U test was applied for independent samples, adopting the QoL divided by domains as dependent variables, and the moderate and severe categories of facial lipoatrophy and the facial reduction category from the variable self-perceived body changes as independent variables. Analysis was performed at an α level of 0.05 (i.e., 5%).

To evaluate the association between QoL and sociodemographic and health condition variables, the Pearson chi-squared test was used, followed by the Z test for differences between two proportions, with Bonferroni correction for nominal dichotomous and polytomous categorical variables, assuming p < 0.20. In the unadjusted and adjusted multivariate regression analyses, Poisson log-linear regression with robust variance was used to obtain prevalence ratios.

Competing interests

The authors declare no competing interests.

Author Contribution

The contributions made by each author to the three following conditions: 1) substantial contributions to conception and design of, or acquisition of data or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, and (3) final approval of the version to be published, are listed below:1) Guarantor of the integrity of the study: Azevedo-Alanis LR1) Study concepts: Oliveira JC, Macedo NF, Mayitondelua N, Kruppa M, Ignácio SA, Camargo ES, Orsi JSR, Souza PHC, Azevedo-Alanis LR1) Study design: Oliveira JC, Macedo NF, Mayitondelua N, Kruppa M, Ignácio SA, Camargo ES, Orsi JSR, Souza PHC, Azevedo-Alanis LR1) Definition of intellectual content: Oliveira JC, Macedo NF, Mayitondelua N, Kruppa M, Ignácio SA, Camargo ES, Orsi JSR, Souza PHC, Azevedo-Alanis LR1) Literature research: Oliveira JC, Macedo NF, Mayitondelua N, Buccio IP, Azevedo-Alanis LR1) Clinical studies: Oliveira JC, Macedo NF, Mayitondelua N, Buccio IP, Kruppa M, Azevedo-Alanis LR1) Data acquisition: Oliveira JC, Macedo NF, Mayitondelua N, Buccio IP, Kruppa M, 1) Data analysis: Oliveira JC, Macedo NF, Mayitondelua N, Buccio IP, Kruppa M, Ignácio SA, Camargo ES, Orsi JSR, Souza PHC, Azevedo-Alanis LR1) Statistical analysis: Oliveira JC, Ignácio SA, Azevedo-Alanis LR2) Manuscript preparation: Oliveira JC, Azevedo-Alanis LR2) Manuscript editing: Oliveira JC, Macedo NF, Mayitondelua N, Buccio IP, Souza PHC, Azevedo-Alanis LR2) Manuscript review: Oliveira JC, Macedo NF, Mayitondelua N, Buccio IP, Kruppa M, Ignácio SA, Camargo ES, Orsi JSR, Souza PHC, Azevedo-Alanis LR3) Final approval of the version to be published: Oliveira JC, Macedo NF, Mayitondelua N, Buccio IP, Kruppa M, Ignácio SA, Camargo ES, Orsi JSR, Souza PHC, Azevedo-Alanis LR

Acknowledgement

The authors thank the individuals who participated in the study, the teams at the Orientation and Counseling Center of the Municipal Health Department of Curitiba. The authors also thank the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) that financed in part this study.

Data Availability

The datasets generated during the current study are available from the corresponding author on reasonable request. All data analysed during this study are included in this published article

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No competing interests reported.

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Impact of lipodystrophy syndrome on the quality of life of patients receiving antiretroviral treatment: a cross-sectional, observational study

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Abstract

Introduction

Results

Characterization of people living with HIV/AIDS

Self-perceived body changes and objective assessment of loss in facial volume

Quality of life and related factors

Discussion

Materials and Methods

Patients and procedures

Data collection

Statistical analysis

Declarations

Competing interests

Author Contribution

Acknowledgement

Data Availability

References

Additional Declarations

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