Background: Long-acting injectable antiretroviral therapy (LA-ART) with cabotegravir and rilpivirine (CAB + RPV) has emerged as a promising alternative to daily oral regimens for people living with HIV (PLWH), particularly those facing adherence challenges. While clinical trials have demonstrated its efficacy, real-world evidence remains limited. Methods: This retrospective, multicenter study evaluated the efficacy and safety of CAB + RPV in 160 virologically suppressed PLWH across eight Italian infectious disease units. Participants received intramuscular CAB (600 mg) and RPV (900 mg) every eight weeks without an oral lead-in phase. Clinical, immunological, and biochemical parameters were assessed at baseline and after 24 weeks. Results: At week 24, 96.25% of participants maintained virological suppression, and the proportion of individuals with target-not-detected viral load increased from 71% to 76%. Only one case of virological failure was observed. Significant immunological improvements included an increase in the CD4+/CD8+ ratio (p = 0.0038) and a reduction in CD8+ T-cell count (p = 0.0150). Biochemical analysis showed a decrease in serum creatinine (p < 0.0001) and an increase in HDL cholesterol (p = 0.0223). Treatment discontinuation occurred in 3.75% of participants, primarily due to adverse events or psychological factors. Conclusions: CAB + RPV demonstrated high efficacy and tolerability in a real-world setting, with favorable immunological and metabolic outcomes. These findings support its use as a viable therapeutic option for PLWH, especially those with adherence barriers. Further long-term studies are warranted to confirm these results across broader populations.
In 2022, 20 million women globally were living with HIV, yet they remain underrepresented in clinical trials, including those for antiretroviral treatments (ART). This study assesses the safety and efficacy of the long-acting cabotegravir-rilpivirine (CAB-RPV) regimen in a cohort of 54 women living with HIV (WLWH) over 24 weeks. A retrospective cohort study from the Sardinian HIV Network and Sicilian HIV Cohort (SHiNe-SHiC) included WLWH who switched to CAB-RPV. Primary objectives were achieving and maintaining HIV RNA levels <50 copies/mL at 24 weeks. Secondary objectives included treatment safety, durability, and reasons for discontinuation. Data on demographics, viro-immunological markers, lipid profiles, and treatment interruptions were analyzed. Of 54 WLWH, 46 reached 24 weeks. The median age was 50 years. A total of 71.8% transitioned from dolutegravir (DTG) regimens. Virological suppression was 97.8% at baseline and 95.5% at 24 weeks. Significant increases in the CD4/CD8 ratio (p = 0.0076) and decreases in serum creatinine levels (p = 0.0109) were observed. Cholesterol, triglycerides, ALT, and AST levels remained unchanged. The CAB-RPV regimen demonstrated significant virological and immunological efficacy and safety in women living with HIV over 24 weeks. Notably, the improvement in the CD4/CD8 ratio and the increase in the percentage of women achieving target not detected (TND) status highlight the regimen’s effectiveness. These findings emphasize the importance of gender-focused research in HIV treatment and the need for equitable access to effective treatment options for women, which is crucial for global efforts to eliminate HIV.
SARS-CoV-2 has been identified in multiple organs and fluids, including the liver and peritoneal fluid. Gastrointestinal symptoms, such as abdominal pain, diarrhea, nausea, and vomiting, can exacerbate COVID-19 outcomes by contributing to complications, like acid–base imbalances and cardiovascular dysfunction, particularly in patients with pre-existing conditions. We report three cases of COVID-19 cirrhotic patients with SARS-CoV-2 detected in their ascitic fluid and review the relevant literature on the virus’s presence and clinical significance in peritoneal fluid. These findings underscore diagnostic and prognostic challenges in managing COVID-19 in patients with chronic liver disease and highlight the need for further research to clarify viral dissemination mechanisms and optimize protective measures for healthcare workers during surgical procedures.
BackgroundLenacapavir (LEN) has made the HIV-1 capsid relevant for resistance surveillance, but p24 variation within gag remains less well characterized than the resistance landscape of pol. This limits the clinical interpretation of capsid variation, particularly when detected in biologically distinct compartments such as proviral DNA and circulating RNA. We aimed to characterize p24 amino acid variation in full-length proviral DNA and circulating HIV-1 RNA and to assess the natural occurrence of recognized LEN resistance-associated mutations (LEN RAMs).MethodsComplete HIV-1 sequences and metadata were retrieved from the Los Alamos National Laboratory HIV Sequence Database and classified by nucleic acid source as DNA or RNA. Proviral DNA underwent O’Doherty Lab-derived full-length proviral classification, hypermutation screening, and clone-aware deduplication using a TN93 distance threshold of 0.015. RNA was analyzed in source-specific branches, using all QC-passed sequences for global variability analyses and one representative sequence per donor-year for grouped LEN RAM analyses. The p24 region was extracted after HXB2-guided alignment, and only QC-passed p24 sequences were retained for downstream analyses.ResultsA total of 22,456 complete HIV-1 sequences were retrieved. After source-specific preprocessing and p24 quality control, 9,063 RNA sequences, 12,787 non-deduplicated DNA sequences, and 3,878 deduplicated DNA sequences were available for analysis; the donor-year RNA branch retained 4,367 representative sequences. Across both sources, p24 was highly conserved, but recurrent substitutions clustered at a limited number of positions and were often shared between proviral DNA and circulating RNA. Major Stanford-defined LEN RAMs were rare. In subtype B, detectable major LEN RAM signal was confined to non-intact proviral DNA, where Q67H and M66I were observed at low frequency, whereas no major LEN RAMs were identified in intact DNA. No predefined LEN-associated combination patterns were detected.ConclusionsMajor recognized LEN RAMs were rare in both proviral DNA and circulating RNA and were absent in intact subtype B proviral DNA. Although p24 was highly conserved, recurrent substitutions followed non-random patterns across compartments. These findings support cautious interpretation of gag variation detected in proviral DNA alone and do not support routine baseline capsid resistance testing before LEN use where such testing is not otherwise indicated.