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The primary study objective was to investigate three decades from 1985 to 2014 of changes in pregnancies among HIV-infected women. The secondary objective was to assess risk factors associated with preterm delivery and severe small-for-gestational-age (SGA) infants in HIV-infected women. A retrospective review of deliveries among pregnant HIV-infected women at the University of Genoa and IRCCS San Martino-IST in Genoa between 1985 and 2014 was performed. Univariate and multivariable analyses were used to study the variables associated with neonatal outcomes. Overall, 262 deliveries were included in the study. An increase in median age (26 years in 1985–1994 vs. 34 years in 2005–2014), in the proportion of foreigners (none in 1985–1994 vs. 27/70 (38·6%) in 2005–2014), and a decrease in intravenous drug use (75·2% (91/121) in 1985–1994 vs. 12·9% (9/70) in 2005–2014) among pregnant HIV-infected women was observed. Progressively, HIV infections were diagnosed sooner (prior to pregnancy in 80% (56/70) of women in the last decade). An increase in combined antiretroviral therapy (cART) prescription during pregnancy (50% (27/54) in 1995–2004 vs. 92·2% (59/64) in 2005–2014) and in HIV-RNA <50 copies/ml at delivery (19·2% (5/26) in 1995–2004 vs. 82·3% (53/64) in 2005–2014) was observed. The rate of elective caesarean section from 1985 to 1994 was 9·1%, which increased to 92·3% from 2004 to 2015. Twelve (10·1%) mother-to-child transmissions (MTCT) occurred in the first decade, and six (8·3%) cases occurred in the second decade, the last of which was in 2000. Preterm delivery (<37 weeks gestation) was 5% (6/121) from 1985 to 1994 and increased to 17·1% (12/70) from 2005 to 2014. In univariate and multivariable logistic regression analyses, advancing maternal age and previous pregnancies were associated with preterm delivery (odds ratio (OR) 2·7; 95% confidence intervals (CI) 1–7·8 and OR 2·6; 95% CI 1·1–6·7, respectively). In the logistic regression analysis, use of heroin or methadone was found to be the only risk factor for severe SGA (OR 3·1; 95% CI 1·4–6·8). In conclusion, significant changes in demographic, clinical and therapeutic characteristics of HIV-infected pregnant women have occurred over the last 30 years. Since 2000, MTCT has decreased to zero. An increased risk of preterm delivery was found to be associated with advancing maternal age and previous pregnancies but not with cART. The use of heroin or methadone has been confirmed as a risk factor associated with severe SGA.

Retrospective multicentre study aiming at analysing the etiology, characteristics and outcome of bloodstream infections (BSI) in people living with HIV (PLWHIV) in an era of modern antiretroviral therapy. Between 2008 and 2015, 79 PLWHIV had at least 1 BSI, for a total of 119 pathogens isolated. Patients were mainly male (72.1%), previous intravenous drug users (55.7%), co-infected with HCV or HBV (58.2%) and in CDC stage C (60.8%). Gram-positive (G+) pathogens caused 44.5% of BSI, followed by Gram-negative (G−), 40.3%, fungi, 10.9%, and mycobacteria, 4.2%. Candida spp. and coagulase-negative staphylococci were the most frequent pathogens found in nosocomial BSI (17% each), while E.coli was prevalent in community-acquired BSI (25%). At the last available follow-up, (mean 3.2 ± 2.7 years) the overall crude mortality was 40.5%. Factors associated with mortality in the final multivariate analysis were older age, (p = 0.02; HR 3.8, 95%CI 1.2–11.7) CDC stage C (p = 0.02; HR 3.3, 95%CI 1.2–9.1), malignancies, (p = 0.004; HR 3.2, 95%CI 1.4–7.0) and end stage liver disease (p = 0.006; HR 3.4, 95%CI 1.4–8.0). In conclusion, the study found high mortality following BSI in PLWHIV. Older age, neoplastic comorbidities, end stage liver disease and advanced HIV stage were the main factors correlated to mortality.

Interferon-γ receptor 1 (IFN-γR1) deficiency is one of the primary immunodeficiencies conferring Mendelian Susceptibility to Mycobacterial Disease (MSMD). Some cases of neoplasms have been recently reported in patients with MSMD, underlying the already known link between immunodeficiency and carcinogenesis. We report the first case of intracranial tumour, i.e. pineal germinoma, in a 11-year-old patient with complete IFN-γR1 deficiency. The first clinical presentation of the genetic immunodeficiency dates back to when the child was aged 2 y and 10 mo, when he presented a multi-focal osteomyelitis caused by Mycobacterium scrofulaceum . The diagnosis of IFN-γR1 deficiency (523delT/523delT in IFNGR1 gene) was subsequently made. The child responded to antibiotic therapy and remained in stable clinical condition until the age of 11 years, when he started complaining of frontal, chronic headache. MRI revealed a solid pineal region mass lesion measuring 20 × 29 × 36 mm. Histological findings revealed a diagnosis of pineal germinoma. The patient received chemotherapy followed by local whole ventricular irradiation with boost on pineal site, experiencing complete remission, and to date he is tumor-free at four years follow-up. Four other cases of tumors have been reported in patients affected by MSMD in our knowledge: a case of Kaposi sarcoma, a case of B-cell lymphoma, a case of cutaneous squamous cell carcinoma and a case of oesophageal squamous cell carcinoma. In conclusion, in patients with MSMD, not only the surveillance of infectious diseases, but also that of tumors is important.

BackgroundWhole-genome sequencing (WGS) is a key tool for studying HIV-1 diversity, evolution, and epidemiology, especially as new drug classes emerge. The two main technologies, Illumina short-read and Oxford Nanopore (ONT) long-read sequencing, offer complementary advantages: Illumina’s high accuracy (<1% error) enables reliable variant detection, while ONT’s long reads improve haplotype resolution, essential for quasispecies analysis. However, despite improvements, ONT still has ~5% error rate, particularly in homopolymeric regions, which affects variant calling accuracy. This study evaluates WGS libraries obtained with AD4SEQ HIV-1 Whole Genome kit (Arrow Diagnostics) and sequenced on both technologies.Material and MethodsViral RNA was extracted using the ELITech InGenius® system. Illumina libraries were sequenced on iSeq100, while RT-PCR amplicons (~2600 bp) were processed with the Native Barcoding Kit 24 V14 (SQK-NBD114.24) and sequenced on MinION Mk1b for 19 h. Illumina FASTQ reads were analyzed using Smartvir (Smartseq) and an in-house pipeline, while ONT reads were processed with MinKnow and the EPI2ME pipeline. A 10% threshold consensus was obtained, focusing RAMs comparison initially on gag and pol, as they are easily analyzed on HIV Drug Resistance Database (Stanford University).ResultsOut of 24 samples, 2 were excluded due to library failure. The overall WGS coverage was similar for both methods as well as stratification for HIV-RNA levels (figure 1), except that ONT showed higher sample variability on low viral loads (table 1). Subtype-based analysis showed that subtype B had a mean WGS coverage of 83% for Illumina and ONT. Recombinant subtypes (CRF) exhibited the lowest coverage, with 57% (IQR: 45.0–69.0%) in Illumina and 66% (IQR: 48.8–82.1%) in ONT (figure 2). Gene-level analysis showed that at low viral loads (log 2–3), Illumina performed better in vif, tat, vpr and vpu, while ONT had superior coverage in nef; gag and pol were comparable. At higher viral loads, ONT showed better coverage for all accessory genes (figure 3). As per RAMs detection in pol, both technologies showed 100% concordance. In gag, 76% of mutations were detected by both platforms, 16% were found exclusively with ONT and 7% only with Illumina. Further investigations are ongoing.Abstract P178 Figure 1Overall WGS coverage in percentage compared between both sequencing technologies[Figure omitted. See PDF]Abstract P178 Figure 2Subtype-based stratification analysis of coverage between methods[Figure omitted. See PDF]Abstract P178 Figure 3Comparison of mean coverage (%). For simplicity only grouped log 2–3 and 6–7 are shown[Figure omitted. See PDF]Abstract P178 Table 1Stratified analysis of mean coverage in percentage per HIV-RNA levelConclusionsThese findings indicate that for pol RAM’s evaluation both technologies provide good results. As per coverage performance, Illumina ensures more stable sequencing for low viral loads, important for clinical samples, while Nanopore benefits from higher template availability, achieving superior coverage in high-viral-load samples. However, bioinformatics analysis parameters must also be carefully considered. While 99.9% accuracy is typical for Illumina (Q30), ONT operates around 90–95% accuracy (Q10), requiring additional filtering and error correction. Bioinformatics settings significantly impact sequencing outcomes and need to be further analyzed to refine analytical strategies.

BackgroundGlobally, 8% to 10% of people living with HIV (PLWH) are also infected with chronic HBV. An isolated hepatitis B core antibody (IAHBc) profile, characterized by a positive anti-HBc with negative HBsAg and anti-HBs, is found in 14% to 44% of PLWH and in up to 31% of those coinfected with HIV and hepatitis C virus (HCV). This study aims to assess the antibody response (AR) after vaccination, defined by an HBsAb result of ≥10 mIU/mL, and the associated factors, in a selected group of PLWH with an IAHBc serological profile.Material and MethodsThis retrospective study analysed data from PLWH who attended the outpatient clinic at Policlinico San Martino Hospital, between 2016 and 2025. The focus was on individuals with an IAHBc profile who received at least one dose of HBV vaccine. Clinical data included CD4 counts before HBV vaccination and HCV coinfection status. CD4 counts were analysed both as continuous and dichotomized variables at 350 cells/μL according to literature (CD4 350: 0=≤350, 1=>350). Age was similarly analysed both continuously and dichotomized at the mean value.ResultsOf the 926 PLWH subjects attending the outpatient clinic, 24 were included in the analysis. HBV DNA testing was available and negative in 20 subjects (83.3%). The study population had a mean age of 62.25 (SD 4.9) and a predominance of males (83.3%). HCVAb were detected in 19 subjects, representing the 79.2%. HBVAb serology was assessed in two groups (figures 1 and 2): in the first group (8 subjects), it was assessed at least one month after the single recall dose; in the second group (14 subjects), after a full vaccination cycle (3 doses).In the first group, 50% achieved an AR, 25% did not achieved an AR and thus completed the full vaccination cycle, 25% were lost to follow-up. Among those who completed the cycle, none achieved an immunological response (IR). In the second group, 42.9% achieved an IR, 42.9% did not respond, and 12.5% were lost to follow-up. Of the 6 non-responders, 4 received a second complete vaccination cycle and 2 of them achieved an IR. Fisher’s exact test showed no significant association between age and protective antibody levels (p=0.266) after one cycle. However, a non-significant trend was observed, with 75% of participants above the mean age having protective titres, compared to 33.3% in participants below the mean age. Spearman’s correlation revealed no significant association between pre-vaccination CD4 counts and post-single recall dose antibody titres (rho=-0.1670, p=0.6823). The same analysis showed a strong association when considering the antibody titre after one complete cycle (rho = 0.55, p = 0.053).Abstract P173 Figure 1Correlation matrix between age, CD4 count pre vaccination and titre post single recall dose[Figure omitted. See PDF]Abstract P173 Figure 2Correlation matrix between age, CD4 count pre vaccination and titre post first vaccination cycle[Figure omitted. See PDF]ConclusionsThis study found variable antibody responses to HBV vaccination in PLWH with an IAHBc profile. Age and CD4 counts showed no significant impact, although a trend toward better responses in older individuals was noted. However larger samples are needed to better understand factors influencing vaccine efficacy.

BackgroundModern antiretrovirals such as integrase inhibitors (INSTIs) and tenofovir alafenamide (TAF) have been associated with excess weight gain (WG) in people living with HIV (PWH). The single tablet regimen bictegravir/emtricitabine/TAF (B/F/TAF) contains the INSTI+TAF combination, and its role in further weight gain is object of investigation. The aim of the present study is to assess metabolic and weight changes in ART-naïve (nPWH ) and experienced (ePWH) people initiating B/F/TAF, focusing on non-infectious comorbidities and, in ePWH, according to previous ART regimen.Material and MethodsObservational retrospective single centre study including all PWH starting B/F/TAF between January 2020 and August 2022. Demographics, laboratory data and comorbidities were extracted from electronic charts. Data are showed as means (standard error). Changes of continue variables over time were studied by paired t-test. A GLM procedure was used to perform the multivariable analysis.ResultsWe enrolled 475 PWH, of which 47 nPWH. Females were 156 (32.8%) and people in CDC stage C were 50 (10.5%). Mean age at enrolment was 49 (0.6) years, and 81% were Caucasian.Blood lipids showed a different trend in nPWH or ePWH, as total cholesterol, TC [-6 (2) mg/dL, p=0.005], LDL [-9 (3) mg/dL, p=0.0008] and triglycerides [-21 (5) mg/dL, p<0.0001] all significantly decreased in ePWH, while TC [+17 (6) mg/dL, p=0.009] and HDL [+8 (2) mg/dL, p=0.002] increased in nPWH (figure 1). Weight significantly increased in either nPWH [+3.6 (1.0) kg, p=0.0008] and ePWH [+1.1 (0.4) kg, p=0.002], with a sharper increase in nPWH (p=0.0387).Among study participants, five (1.0%) had a history of myocardial infarction (MI), 21 (4.4%) of dyslipidemia, 44 (9.3%) of hypertension, 24 (5.1%) of diabetes, 10 (2%) of chronic kidney disease (CKD), and 29 (6.1%) of depression. PWH with at least one comorbidity experienced on average a reduction in blood lipids, while weight did not change significantly, except in people with CKD, in which a slight increase was reported (figure 2).At multivariable analysis, in a model including the above reported comorbidities, age (>50 or < 50 years), sex, being ART naïve/experienced and baseline weight, this last variable was the only one significantly linked to WG (p=0.0064).Finally, we explored if weight change, in ART experienced PWH, was different in people who were on INSTI (N = 351), PI (N=59) or NNRTI (N=18) before switching to B/F/TAF (figure 3). After correcting for age, sex and baseline weight, the anchor drug resulted not correlated to different WG after the switch.ConclusionsIn this large cohort of people taking B/F/TAF, PWH with comorbidities associated with increased cardiovascular risk, such as previous MI, diabetes, dyslipidemia and hypertension, experienced favorable changes in lipids and indifferent changes in weight. Switching to B/F/TAF from PI or NNRTI did not result in a greater WG than switching from INSTI-based regimens.Abstract P-75 Figure 1–3

BackgroundGenotyping Resistance Test (GRT) of HIV DNA in NGS is a useful tool for clinical treatment optimization, especially when GRT on RNA is unavailable and/or unfeasible and treatment history unreliable, and is particularly relevant when considering the prescription of long-acting (LA) therapies based on cabotegravir (CAB) and rilpivirine (RPV). However, NGS data interpretation, along with APOBEC-related mutations discrimination, remains complex and its clinical implications are still under investigation. This study evaluates NGS-GRT on DNA in individuals not eligible to standard enrolment criteria for CAB-RPV LA treatment, highlighting its potential in the challenges in HIV care.Materials and MethodsA retrospective observational study was conducted at a single tertiary hospital, in individuals who underwent NGS-GRT on DNA and later started LA therapy. Library for NGS was prepared using the commercial kit AD4SEQ HIV-1 Solution v2 (Arrow Diagnostics). Consensus sequences were analyzed on HIV Drug Resisting Database (Stanford University). Mutations were considered APOBEC-induced if they appeared at low frequency and especially if associated with unusual mutations and/or stop codons. Data were described using the mean and standard deviation (SD) for normally distributed continuous variables and the median and interquartile range (IQR) for non-normally distributed continuous variables. Virological failure (VF) was defined as the occurrence of two consecutive viral load measurements >50 copies/mL.ResultsOur study included a cohort of 82 people living with HIV (PLWH) receiving LA therapy. Of these, 51 had NGS-GRT on DNA, 22 had mutations or stop codons, 10 had APOBEC-related mutations at sites that could potentially confer drug resistance (4 NRTI, 2 PI, 4 NNRTI, 6 INSTI).Among the nine individuals with APOBEC-associated INSTI or NNRTI mutations, none experienced VF. Only one study participant was switched to an oral INSTI-containing regimen due to the historical detection of E138Q in GRT on RNA, a low-level resistance mutation for RPV. Comparing individuals with (n=22) and without (n=29) APOBEC-associated mutations, the mean time from diagnosis to virological suppression was 10.2 (±7.9) vs. 3.2 (±5.3) years (p=0.002) and the mean duration of infection was 25.4 (±10.1) vs. 2.1 (±5.6) years (p=0.001). This suggests that a longer duration of unsuppressed viral replication may be associated with a higher likelihood of APOBEC- related mutation emergence.ConclusionAs the presence of mutations attributed to APOBEC activity is associated to defective virus, it does not preclude the efficacy of LA therapy with CAB/RPV; in fact, their correct identification in the INSTI and NNRTI drug classes should rather encourage clinicians in the use of LA therapy, in a setting of reduced viral fitness and growing capability. An accurate interpretation of NGS-GRT on DNA is therefore crucial to avoid unnecessary exclusion of individuals from LA therapy with CAB/RPV.

BackgroundThe COVID-19 pandemic profoundly reshaped healthcare services, affecting the management of chronic pathologies, including HIV. This study aimed to evaluate the interplay between COVID-19 pandemic and late HIV diagnosis (LD) in Italy.Material and MethodsAll people with HIV (PWH) enrolled in the Icona cohort between January2016 and December2023, diagnosed with HIV within 3 months before enrolment, were included. The incidence of LD (defined as CD4 count<350 cell/mm3 at diagnosis or AIDS-defining event [ADE] regardless of CD4 within 3 months from diagnosis) and AIDS presentation (AIDS-P, ADE within 3 months from diagnosis) were compared between pre-COVID (2016–2019) and post-COVID (2021–2023) period. The difference in prevalence of LD by period and by participants’ socio-demographics was compared using Poisson regression models with an interaction term. Survival analysis was used to assess the effect of LD and AIDS-P on all-cause mortality risk and its interaction with the calendar period.ResultsOverall, 5,081 newly diagnosed PWH were enrolled in the Icona cohort over the study period, of whom 2,928 (58%) were LD and 612 (12%) were AIDS-P. The proportions of LD and AIDS-P remained stable across the pre- and post-COVID period: 1,817/3,172 (57.3%; 95%CI:55.5–59%) and 1,111/1,909 (58.2%, 95CI% :5.9–60.4%) for LD and 372/3,172 (11.7%; 95%CI:10.6–12.9%) and 240/1,909 (12.6% 95%CI:11.1–14.1%) for AIDS-P, respectively [figure 1]. LD were more likely to be women, elderly, migrants, and heterosexuals (compared to MSM), and to have lower educational level. Risk patterns for LD remained consistent pre- and post-COVID, although there was weak evidence that the risk of LD in heterosexuals vs. MSM weakened in post-COVID (interaction p-value=0.38, table 1). Over the follow-up, a total of 138 deaths occurred: 114 in pre-COVID and 24 in post-COVID period (41 and 73 for ADEs; 16 and 8 for not-AIDS related events). At survival analysis, LD/AIDS-P had a significantly higher probability of all-cause mortality both in the pre-COVID (3-year risk [95%CI]: non-LD (nLD) 0.94% [0.38–1.49%], LD 4.3%[3.3–5.3%], AIDS-P 9.6% [6.8–13%],p<0.001) and post-COVID (3-year risk [95%CI]: nLD 0.18%[0.02–0.52%], LD 2.7%[1.6–3.9%], AIDS-P 7.5%[3.4–11.5%], p<0.001). After controlling for confounding, LD and particularly AIDS-P were confirmed to be at higher risk of death compared to nLD, with some modest evidence that this excess in risk was exacerbated in the post-COVID period (aHR LD vs. nLD and AIDS-P vs. nLD: 13 and 49.9 in the post-COVID vs 3.56 and 7.07 in the pre-COVID [figure 2, interaction p>10%]).Abstract OC8 Figure 1Proportion of late HIV diagnosis and AIDS presentation by period[Figure omitted. See PDF]Abstract OC8 Table 1Prevalence risk ratio of late HIV diagnosis by socio-demographic characteristics by fitting univariate Poisson regression modelAbstract OC8 Figure 2Hazard ratio of all-cause mortality stratified by late diagnosis and period by univariable and multivariable Cox regression models[Figure omitted. See PDF]ConclusionsOur data shows that the frequency of LD remained stable before and after COVID-19, regardless of participants’ socio-demographics. LD was confirmed to be associated with an increased mortality risk, with evidence suggesting that this risk may have been more pronounced in the post-pandemic period. Longer follow-up is needed to further validate these findings.

BackgroundBictegravir, co-formulated with emtricitabine and tenofovir alafenamide and (B/F/TAF), is approved for the treatment of HIV-1 in antiretroviral (ART)-naïve people with HIV (PWH). While its efficacy has been demonstrated in several trials, there is a paucity of data in PWH with high HIV RNA loads and non-B subtypes. The aim of this study is to describe the efficacy of B/F/TAF in an unselected population of naïve PWH.Material and MethodsThis two-center retrospective study included ART-naïve PWH starting B/F/TAF between 01/02/2020 and 31/12/2024. Time to virologic success (TVS) was defined as days between HIV diagnosis and first HIV RNA load below 50 cp/mL. The outcome assessed at 6, 12 and 24 months was virologic suppression, defined as HIV RNA <50 cp/mL. Baseline characteristics were summarized as count and percentage or as median with interquartile range (IQR).Univariate and multivariate gamma regression analyzed associations between viral subtype and resistance profile with TVS, adjusting for gender, age >50 years, CD4+ <200 cells/mm³ and HIV RNA >105 cp/mL. Logistic regression assessed factors associated with failure to suppress viral load at 6 and 12 months using the same covariates. A p-value ≤ 0.05 was deemed statistically significant. Analyses conducted with SAS software version 9.4 (SAS Institute Inc., Cary, NC, USA).Results128 PWH were enrolled, 88 (68.8%) male, with a median age of 39 years (IQR: 30–52). HIV subtype B was found in 79 (61.7%), wild-type 100 (78.1%). At diagnosis, 52 (40.6%) had CD4+ <200 cells/mm³, and 75 (58.6%) had HIV RNA >105 cp/mL (table 1).The median TVS was 115 days (IQR: 45–605). TVS was not associated with neither HIV subtype (aRR for B-subtipe vs non-B 0.85, 95% CI: 0.63–1.14, p = 0.3) nor with resistance profile (aRR for wild-type virus vs any resistance mutation 1.24, 95% CI: 0.89–1.72, p = 0.2). On multivariate analysis, male sex (aRR 1.37, 95% CI: 1.01–1.85, p = 0.0400) and HIV RNA >105 cp/mL at diagnosis (aRR 2.2, 95%CI 1.6–2.3, p<0.0001) were significantly associated with longer TVS (table 2a and 2b).At 6 months, 18 (14.1%) PWH failed to achieve viral suppression, with HIV RNA >105 cp/mL at diagnosis being a significant predictor (aOR = 17.01, 95% CI: 2.07–100, p = 0.008). At 12 months, 4.8% of 104 PWH with available data did not achieve viral suppression. HIV RNA >105 cp/mL at diagnosis showed a strong trend towards failure (aOR = 9.02, 95% CI: 0.70–100, p = 0.092), but was not statistically significant (table 3).At 24 months, HIV RNA data were available for 60 PWH, three of whom failed to achieve suppression (all with wild-type virus at baseline, all with HIV RNA < 105 cp/mL and two with non-B subtypes).Abstract P91 Table 1–3ConclusionsIn this cohort of ART-naïve PWH treated with B/F/TAF, HIV subtype and resistance mutations did not significantly affect TVS. High HIV RNA viral load at baseline was the strongest predictor of delayed viral suppression, but not of long-term virological failure.

BackgroundOur aim was to investigate the role of switching from emtricitabine/tenofovir alafenamide (FTC/TAF) based regimen to a dolutegravir (DTG) containing two-drug regimen (2DR) vs continuing FTC/TAF on metabolic parameters.MethodsConsecutive people living with HIV infection (PWH), enrolled in a multicenter observational cohort (SCOLTA) project, on a stable (24 months at least) FTC/TAF based regimen with a HIV-RNA<50 copies/ml were included. Changes from baseline (T0) to follow-up (T1, week 24) were analyzed.ResultsFive hundred and thirty-seven PWH met the inclusion criteria, 415 (77.3%) were males, 290 (54%) were on a previous cobicistat (COBI)-including regimen (IR).At T0 main characteristics were (mean ± standard deviation [SD]): age 49.5 ± 12.0 years, weight 75.6 Kg ±13.8, body mass index (BMI) 25.6 ± 4.2 kg/m2, total cholesterol (TC) 194.7 ± 40.7 mg/dL, LDL-cholesterol (LDL-c) 116.1 ± 35.5 mg/dL, median CD4+ cell count was 680 cell/μL (interquartile range [IQR] 500–901), triglycerides (TGL) 114 mg/dL (IQR 82.5–158.5). 366 (68.2%) PWH started FTC/TAF/bictegravir (BIC), 15 (2.8%) FTC/TAF/DTG, 128 (23.8) DTG/lamivudine (3TC) and 28 (5.2%) DTG/rilpivirine (RPV). Median observation time was 27.2 months (IQR 15.2–77).PWH switching to 2DR differed significantly by FTC/TAF for: INSTI, NNRTI and PI in previous regimen (62.8% vs 79.3%, 30.1% vs 6.3% and 7.7 vs 14.4%, respectively; p<0.0001), HCV coinfection (7.2% vs 25.1%, p<0.0001), baseline CD4 (median 730 and 646, p=0.0002) and CDC stage C (8.4% vs 19.5%, p=0.002), and previous COBI-IR (32.1% in 2DR vs 63.0% in TAF, p<0.0001). PWH with previous COBI-IR entered the study with higher levels of TC (200 vs 188 mg/dL, p=0.0005) and LDL-c (120.4 vs 111 mg/dL, p=0.002).Evaluating 2DR vs continuing FTC/TAF, in strata of switch from a regimen with or without COBI, we observed no difference in lipid profile and weight (table 1).On the other hand, irrespectively of the new treatment, a TC decline was observed in PWH on previous COBI-IR (-9.9 mg/dL, 95% confidence interval -13.6 to -6.2), as well as for LDL-c (-7.4 mg/dL [95% CI -10.8 to -4.1]) and TGL (-15.3 mg/dL [95% CI -23.6 to -7.0).In a MM including sex, age, previous COBI and drug class, and 2DR vs FTC/TAF, no significant difference was found in terms of weight and blood lipid change between continuing FTC/TAF and switching to a 2DR.Abstract P35 Table 1Weight and blood lipids at T0 and T1 (change from baseline)ConclusionsIn PWH already on TAF, stopping TAF does not impact lipid profile and BMI, while only switching by COBI is associated with amelioration of lipid profile. Weight and BMI were not influenced by switching TAF or COBI.