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Background: No published studies have evaluated in pregnant women with HIV weight gain with different antiretroviral drug classes., Methods: Data from a national cohort study were used. We compared absolute weight gain and occurrence of excessive weight gain in women with HIV who received during pregnancy integrase inhibitors (INSTI), protease inhibitors (PI), or non-nucleoside reverse transcriptase inhibitors (NNRTI). Excessive weight gain was defined according to the Institute of Medicine recommendations. Possible predictors of weight gain were assessed using univariate and multivariate analyses., Results: Among 273 cases (PI: 191, NNRTI: 43, INSTI: 39), the mean weight increase was 11.3 kg, and 25.4% of the mothers had an excessive weight increase. No significant differences were found among the three treatment groups for absolute weight increase, occurrence of excessive weight gain, infant birthweight, and other pregnancy and laboratory outcomes. The comparisons of individual drugs, although based on a limited number of cases, suggested no major differences. A significant positive correlation was found between weight gain and CD4 + T-cell increase during pregnancy. In multivariate analyses, drug class and nucleoside backbone were not associated with absolute or excessive weight increase. Excessive weight increase was significantly associated with week of delivery (adjusted odds ratio: 1.74, 95% CI 1.15, 2.63), obesity (5.21, 95% CI 1.85, 14.64), overweight (7.95, 95% CI 3.26, 19.39), recent substance use (5.96, 95% CI 1.13, 31.40) and fasting 2nd trimester hyperglycaemia (3.94, 95% CI 1.14, 13.65)., Conclusions: No significant differences in absolute weight change or occurrence of excessive weight gain were found among women with HIV who received during pregnancy different classes of antiretroviral drugs.

Background: The long-term trajectory of and factors affecting lean mass in people living with HIV (PLWH) are incompletely described., Methods: PLWH in the Modena HIV Metabolic Cohort underwent dual-energy X-ray absorptiometry (DXA) scans every 6-12 months for up to 10 years (median 4.6 scans). Mixed effect regression modelling in combined and sex-stratified models determined annual rates of and clinical factors significantly associated with appendicular lean mass (ALM)., Results: A total of 839 women and 1,759 men contributing ≥2 DXA scans had baseline median age 44 years and 14 years since HIV diagnosis; 76% were virologically suppressed on antiretroviral therapy (ART). Baseline median ALM was 16.9 kg for women and 24.8 kg for men. ALM decreased during the study period, with mean yearly ALM loss of -231 g in women and -322 g in men. Less ALM was associated with female sex, age >50 years, detectable HIV-1 RNA, and tenofovir and integrase inhibitor use. Greater ALM was associated with longer ART duration. In sex-stratified models, relationships between ALM and total ART duration and integrase inhibitor use were not significant for women, but the relationship with tenofovir use persisted. For men, AIDS wasting and CD4 + T-lymphocyte nadir <200 cells/μl were independently associated with lower ALM., Conclusions: ALM steadily declined over time in this cohort of PLWH on ART that included a large number of women. HIV- and ART-specific risk factors emerged that varied by sex. The observed associations between tenofovir or integrase inhibitor use and lower ALM particularly warrant further study.

Background: There is an increasing need for new diagnostic tools to monitor antiretroviral drug-related toxicities. Magnetic resonance (MR) imaging and MR spectroscopy are non-invasive diagnostic methods used in the detection and quantification of liver fat. The aim of this study was to compare sensitivity and specificity of different MR techniques in the quantitative assessment of liver steatosis, using liver biopsy as the reference standard, in patients with and without HIV infection., Methods: Sequentially evaluated patients with suspected steatosis who were referred for liver biopsy at our tertiary care site were eligible. MR liver fat content (LFC) was estimated by T2-weighted and fat-suppressed T2-weighted spin-echo, dual-phase T1-weighted gradient-echo, multiecho gradient-echo and (1)H spectroscopy. Association between LFC and histological steatosis percentage was calculated by using univariate linear regressions and Pearson's coefficient. Respective receiver operating characteristic (ROC) curves were used to compare specificity and sensitivity of MR methods in diagnosis (cutoff 5%) and in quantitative evaluation (cutoff 33%) of steatosis., Results: A total of 28 patients were identified: 12 refused or had contraindications for liver biopsy and 16 had biopsies plus MR. LFC and histological steatosis percentage were strongly associated (fat-suppressed r=0.86 [P<0.001], dual-phase r=0.88 [P<0.001], multiecho r=0.95 [P<0,001] and spectroscopy r=0.84 [P=0.01]). MR techniques had high sensitivity and specificity in diagnosis and quantitative assessment of steatosis (areas under ROC curves ranging from 0.88 to 0.98)., Conclusions: This pilot study confirms that MR may be a sensitive non-invasive alternative to biopsy for the quantitative assessment of liver fat and a potential end point to monitor antiretroviral-drug-related toxicities.

Background: Prevalence and factors associated with sexual dysfunction in HIV-positive women are poorly known., Methods: This was a cross-sectional study in a cohort of HIV-infected women. Clinically stable women were invited to participate in a female sexual dysfunction (FSD) evaluation with Female Sexual Function Index (FSFI) exploring desire, arousal, lubrication, orgasm, pain and satisfaction. An FSFI score <23 was used for defining FSD. Variables evaluated included body appearance satisfaction, interference of body changes with habits, social life and attitudinal aspects of body image, health-related quality of life, hormonal assessment, menopause, cumulative exposure to antiretroviral drug classes and immune-virological parameters. Lipodystrophy was defined according to the HIV Outpatient Study definition., Results: A total of 185 women completed the FSFI. The mean (+/-SD) age was 42 years (+/-5), 27% had CDC stage C, the mean (+/-SD) CD4+ T-cell count was 508 cells/microl (+/-251) and median HIV RNA was 1.7 log10 copies/ml (interquartile range 1.7-2.6). Among 161 evaluable patients, 59 (32%) reported FSD. In a multiple linear regression analysis, desire, arousal and satisfaction domains were associated with interference of body changes with habits, social life and attitudinal aspects of body image (beta = 0.22, 95% confidence interval [CI] 0.06-0.37; beta = 0.29, 95% CI 0.10-0.48; and beta = 0.20, 95% CI 0.02-0.38, respectively). Lubrication and orgasm domains were associated with body image satisfaction (beta = -0.49, 95% CI -0.88 - -0.10 and beta = -0.58, 95% CI -1.00 - -0.16, respectively). No significant associations with sex hormones, CDC stage, CD4+ T-cell count, HIV RNA viral load and cumulative exposure to antiretroviral drug classes were found. In women with FSD, severity of self-perceived abdominal fat accumulation showed a trend towards lower FSFI scores (ANOVA P = 0.02)., Conclusions: FSD was highly prevalent in this cohort. Self-perceived body changes was identified as its major determinant.

Background: Both psychological and organic factors have been recognized to be associated with sexual dysfunction in HIV-infected individuals., Methods: In this cross-sectional study we evaluated the prevalence and factors associated with sexual dysfunction in a cohort of HIV-infected adult men. Evaluation tools included: the International Index of Erectile Function (erectile dysfunction [ED], desire, orgasm, intercourse satisfaction, overall satisfaction), the Assessment of Body Change and Distress (body image satisfaction), the Medical Outcomes Study HIV Health Survey (mental and physical health-related quality of life), and plasma free and total testosterone level (hypogonadism)., Results: Three-hundred and fifty-seven men were enrolled. Among 336 patients reporting sexual activities in the 4 weeks before, 94 (29.6%) had mild, 30 (9.4%) moderate and 34 (10.1%) severe dysfunction. The Mental Health Summary score was 2.28 units (95% confidence interval [CI] 1.51, 3.06) lower for each unit higher of body image dissatisfaction and 0.31 units (95% CI 0.27, 0.36) higher for each unit higher of the score for body change interference with habits. At regression analysis, ED was independently related to the body mass index (B = 0.31, 95% CI 0.08, 0.62). Desire, orgasm and overall satisfaction domains were associated with mental health score (B = 0.87, 95% CI 0.47, 1.27; B = 0.75, 95% CI 0.23, 1.26; B = 0.86, 95% CI 0.45, 1.28, respectively). An improved intercourse satisfaction domain was associated with a lower interference of body changes with habits and social life (B = 0.39, 95% CI 0.05, 0.73). Testosterone, metabolic alterations and HAART were not associated with sexual function domains., Conclusions: Body image and mental health but not HAART or hypogonadism were associated with sexual function domains.

Methods: Data from a large national surveillance study was used to describe antiretroviral regimens in pregnant women with HIV, with particular reference to the presence at conception of antiretroviral treatments contraindicated in pregnancy. Therapeutic changes during pregnancy were also analysed., Results: Among 334 women on antiretroviral treatment at conception, less than half (42.4%) reported current pregnancy as planned. A large number of different regimens (80) was observed. All the regimens included at least one nucleoside or nucleotide reverse transcriptase inhibitor. Non-nucleoside reverse transcriptase inhibitors and protease inhibitors were present in similar proportions (39.2% and 40.7%, respectively). The most commonly used drugs were lamivudine (83.2% of regimens), zidovudine (50.0%), stavudine (d4T; 38.0%), nevirapine (25.7%), didanosine (ddl; 17.7%) and nelfinavir (17.7%). Treament with efavirenz (13.5% of regimens) and ddl+d4T (9.6%) was markedly frequent. Use of efavirenz at conception was associated with a subsequent treatment change during pregnancy (odds ratio [OR]: 13.2.; 95% confidence interval [CI]: 3.2-53.8, P < 0.001). A similar but less strong association was found for ddl (OR: 1.8; 95% CI: 1.03-3.25, P = 0.033), whereas being on nevirapine was associated with a lower risk (OR: 0.58; 95% CI: 0.38-0.81, P = 0.013)., Conclusions: Our data show that treatment at conception frequently represents the regimen previously selected for the treatment of the non-pregnant woman. The observed rates of exposure to contraindicated treatment should lead prescribing physicians to consider in HIV-positive women therapeutic choices that take into account the likelihood of an unplanned pregnancy. Such an approach is likely to reduce not only unintended exposures to contraindicated drugs, but also therapeutic changes during pregnancy.

Background: Damage to mitochondria (mt) is a major side effect of highly active antiretroviral therapy (HAART) that includes a nucleoside reverse transcriptase inhibitor (NRTI). Such damage is associated with the onset of lipodystrophy in HAART-treated HIV+ patients. To further investigate mt changes during this syndrome, we analysed the expression of mtRNA in adipocytes from lipodystrophic HIV+ patients taking NRTI-containing HAART and compared it with similar cells from healthy individuals., Materials and Methods: Total RNA was extracted from adipocytes collected from different anatomical locations of 11 HIV+ lipodystrophic patients and seven healthy control individuals. RNA was reverse transcribed and Taqman-based real-time PCR was used to quantify three different mt transcripts (ND1, CYTB and ND6 gene products). mtRNA content was normalized versus the housekeeping transcript L13., Results: ND1, CYTB and ND6 expression was significantly reduced in HIV+ lipodystrophic patients. HIV+ men and women did not differ in a statistically significant way regarding the levels of ND1 and ND6, whereas the opposite occurred for CYTB., Conclusions: Lipodystrophy following treatment with NRTI-containing HAART is associated with a decrease in adipose tissue mtRNAs.

Objective: To compare autologous fat transfer (AFT), injections of reabsorbable [polylactic acid (PLA)] and non-reabsorbable [polyacrylamide hydrogel (PAAG)] filler materials for the treatment of HIV-related facial lipoatrophy., Design and Methods: Eligible individuals with enough residual subcutaneous fat in the abdomen or in the dorso-cervical region were offered AFT surgery. Other individuals were blindly assigned to two different surgical teams, who administered a set of PLA or PAAG injections every 4 weeks. The primary endpoint was the measurement of Bichat's fat pad region, determined by the result of dermal plus subcutaneous thickness. Secondary endpoints included body image evaluation (determined by ABCD questionnaire), facial aesthetic satisfaction (determined by Visual Analogue Scale), and aesthetic pre- and post-picture comparisons by independent reviewers. All variables were measured at baseline and at 24 weeks after the last treatment session., Results: Twenty-four individuals received AFT and 35 were selectively randomized to PLA (20) or PAAG (15) infiltrations. PLA and PAAG groups received a mean of 5 and 6 injections respectively (P = NS). The mean change in dermal and subcutaneous thickness was 3.3 +/- 4.1 mm, 3.5 +/- 4.0 mm; 2.1 +/- 3.0 mm (P = 0.687), respectively. The mean change in ABCD score result was poorer in the AFT arm, but there were no other differences in other measured factors. Four serious adverse events were documented in the AFT arm only., Conclusions: All three interventional techniques were highly effective in improving the aesthetic satisfaction of the patients. Longer follow-up is necessary to determine the most durable and suitable treatment.