Clinical Outcome of Lopinavir/Ritonavir (Kaletra) as HIV Second-line Treatment: A Retrospective Study at a Single Center Malaysian Tertiary Hospital

Virological failure remains a major challenge in treating HIV. Lopinavir/ritonavir, a protease inhibitor, is a recommended second-line option in Malaysia for patients failing first-line regimens. This study investigated the use of Lopinavir/ritonavir in terms of its efficacy in viral suppression, CD4 response, metabolic side effects, and tolerability following first-line treatment failure.

A retrospective review was conducted on adult HIV patients treated with Lopinavir/ritonavir for at least 6 months after confirmed virological failure (HIV viral load > 1000 copies/mL) on first-line therapy. Data were collected from 265 patients at Hospital Sultanah Aminah between January 2015 and December 2020, and 79 eligible patients were identified from the electronic database. Metabolic data, including lipid profile, were collected from case notes.

Among 79 patients who fulfilled the criteria, most were male (n=52, 65.8%) with a mean age of 41, and the majority were of Malay ethnicity (n=51, 64.5%). Unprotected sexual intercourse was the most common transmission mode (44.3%). After one year, 96% achieved viral suppression (VL <400 copies/mL). Non-suppression was linked to non-adherence due to pill burden. Metabolic complications were common: 77% developed hypertriglyceridemia (mean triglycerides: 3.6 mmol/L), 94% had elevated LDL (mean: 3.1 mmol/L), with smaller numbers developing transaminitis (7.6%), impaired glycaemia (10.1%), hypertension (6.3%), and lipodystrophy (1.3%).

Our study demonstrates that lopinavir/ritonavir (LPV/r) remains clinically effective at achieving viral suppression among HIV patients who have failed first-line therapy, with 76 subjects (96%) achieving viral suppression after 1 treatment. LPV/r continues to play a role in specific clinical contexts, particularly where newer antiretrovirals are not available or are contraindicated. However, LPV/r is associated with notable adverse events including GI intolerance, metabolic complications (most notably dyslipidemia), and high pill burden, all of which can negatively impact adherence and long-term treatment success.

LPV/r remains effective in achieving viral suppression but is associated with significant metabolic side effects. It should be reserved for individuals with limited treatment alternatives, and regimen selection should be guided by individual metabolic risk assessments. Regular metabolic monitoring and adherence support are essential, and multidisciplinary management together with further comparative studies are warranted to optimise treatment strategies that balance virological efficacy with long term metabolic safety.