Background: Protease inhibitors (PI)s have been associated with distal sensory polyneuropathy (DSP) and metabolic complications in high-income countries. No data exist in Africans where second-line antiretroviral therapy (ART) often include PIs.
Method: We performed a cross-sectional study to assess the DSP frequency and metabolic risk factors in community-based South Africans taking ritonavir-boosted lopinavir as PI. Examination findings categorized subjects as having DSP (≥1 neuropathic sign) or symptomatic DSP [DSP with symptom(s)]. Fasting-state glucose and lipid profiles were assessed. We compared the ritonavir/lopinavir-group to a nested group on first-line ART [dideoxy-nucleoside reverse transcriptase inhibitors (d-drugs)] selected from a dataset collected at the same time and matched for d-drug exposure.
Results: The ritonavir/lopinavir-group (n = 86) consisted predominantly of women (84 %) with a median age of 36 years (IQR 32-41). The median current CD4+ count was 489 cells/μL (IQR 291-665). The median exposure time to ritonavir/lopinavir was 18 months (IQR 10-26) and to d-drugs, 24 months (IQR 16-38). DSP was present in 78 % and symptomatic DSP in 48 %; symptoms were most frequently of moderate intensity. Only age independently associated with DSP and symptomatic DSP (p = 0.08 and p = 0.04, respectively). None of the metabolic syndrome components showed associations with DSP or symptomatic DSP despite a trend towards hypertriglyceridemia overall. The ritonavir/lopinavir-group had less DSP compared to the d-drug only group (p = 0.002) but the frequency of symptomatic DSP was similar (p = 0.49).
Conclusion: Ritonavir-boosted lopinavir did not add additional risk to developing DSP in this community-based African cohort after a median of 18 months on second-line ART.
Keywords: African; Anti-retroviral therapy; Distal sensory polyneuropathy; Dysglycemia; Lopinavir; Metabolic; Protease inhibitors; Ritonavir; Symptomatic neuropathy; Triglycerides.