RESUMEN
The two-drug regimen dolutegravir plus lamivudine demonstrated durable efficacy for up to 3 years in phase III studies and a high barrier to resistance in treatment-naive and virologically suppressed people with HIV (PWH). This systematic literature review summarizes real-world evidence evaluating effectiveness and safety of dolutegravir plus lamivudine. We searched Ovid MEDLINE®, Embase®, PubMed, Cochrane library, and relevant international conference proceedings from 2013 to 2020. Qualitative synthesis of virologic suppression at Week 48, treatment-emergent resistance, discontinuation rates, and comorbidities was undertaken, with no statistical analyses conducted. Linked publications and potential for duplication in reporting of outcomes for cohorts and populations were identified, and the publication reporting the highest number of PWH receiving dolutegravir plus lamivudine was included in the analysis. Thirty-four studies reporting on cohorts of PWH not suspected to be linked or to include duplicate data receiving dolutegravir plus lamivudine were identified (N = 5017). Of 3744 virologically suppressed PWH who switched to dolutegravir plus lamivudine, 603 (16%) reported history of virologic failure. Nineteen studies included effectiveness data (n = 3558), four of which included data from treatment-naive PWH (n = 69). In studies with > 100 PWH, high rates of virologic suppression (Week 48, 97-100%) were maintained with dolutegravir plus lamivudine, with low rates of virologic failure (0-3.3 per 100 person-years of follow-up); one instance of emergent integrase strand transfer inhibitor resistance was reported in a complex treatment-experienced individual. Rates of discontinuation due to adverse events were low and consistent with previously observed trial data. Dolutegravir plus lamivudine minimally impacted renal function and had minimal impact on or improved lipid profiles and bone mineral density. This systematic review demonstrates that effectiveness and safety of dolutegravir plus lamivudine in clinical practice support data from randomized controlled trials with regard to high rates of virologic response, low rates of discontinuation, and a high barrier to resistance.
RESUMEN
OBJECTIVES: Significant liver disease may develop in HIV mono-infected patients, usually associated with fatty liver and/or cART exposure. We estimated the prevalence and predictors of hepatic steatosis and fibrosis as assessed by ultrasound and transient elastography (TE). METHODS: We enrolled 125 consecutive HIV mono-infected patients who underwent ultrasound and TE. Clinical, biochemical, immunological, virological features and medication history were analysed. RESULTS: Mean age was 39.5±10.3years and 91% were male. Metabolic syndrome (MS) was present in 9.8%, diabetes in 5.6%, hypertension in 9.7%, dyslipidemia in 32.8%. Increased AST and ALT were found in 5.6% and 16.8% respectively. Eighty-five (68%) patients were on cART (median length of treatment of 3 years, IQR 0-17). Hepatic steatosis was detected in 61 (55%) patients and was independently associated with male sex (OR 14.6, 95% CI 1.44-148.17), age (OR 1.082, 95% CI 1.01-1.16), HOMA (OR 2.56, 95% CI 1.101-5.96) and GGT (OR 1.037, 95% CI 1.007-1.075). Significant fibrosis (stiffness>7.4kPa) was present in 22 patients (17.6%) and was significantly associated with MS (OR 3.99, 95% CI 1.001-16.09). CONCLUSIONS: Liver fibrosis can develop in asymptomatic HIV mono-infected patients. This is likely associated with NAFLD and usually manifests with normal transaminases. Non-invasive screening for the presence of NAFLD and fibrosis should be considered in the routine care of such patients.