Clinical diagnosis of sensory neuropathy in HIV patients treated with tenofovir: A 6-month follow-up study

J Peripher Nerv Syst. 2019 Dec;24(4):304-313. doi: 10.1111/jns.12349. Epub 2019 Oct 28.

Abstract

Background: Sensory neuropathy (SN) is a common and often painful neurological condition associated with HIV-infection and its treatment. However, data on the incidence of SN in neuropathy-free individuals initiating combination antiretroviral therapies (cART) that do not contain the neurotoxic agent stavudine are lacking.

Aims: We investigated the 6-month incidence of SN in ART naïve individuals initiating tenofovir (TDF)-based cART, and the clinical factors associated with the development of SN.

Methods: 120 neuropathy-free and ART naïve individuals initiating cART at a single center in Johannesburg, South Africa were enrolled. Participants were screened for SN using clinical signs and symptoms at study enrolment and approximately every 2-months for a period of ~6-months. Diagnostic criteria for symptomatic SN was defined by the presence of at least one symptom (pain/burning, numbness, paraesthesias) and at least two clinical signs (reduced vibration sense, absent ankle reflexes or pin-prick hypoaesthesia). Diagnostic criteria for asymptomatic SN required at least two clinical signs only (as above).

Results: A total of 88% of the cohort completed three visits within the 6-month period. The 6-month cumulative incidence of neuropathy was 140 cases per 1000 patients (95% CI: 80-210) at an incidence rate of 0.37 (95% CI: 0.2-0.5) per person year. Height and active tuberculosis (TB) disease were independently associated with the risk of developing SN (P < .05).

Interpretation: We found that within the first 6 months of starting cART, incident SN persists in the post-stavudine era, with 11 (9%) of individuals developing asymptomatic SN, and 9 (8%) developing symptomatic SN.

Keywords: HIV; active TB; antiretroviral therapy; sensory neuropathy; tenofovir.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / toxicity*
  • Antiretroviral Therapy, Highly Active / adverse effects*
  • Antiretroviral Therapy, Highly Active / statistics & numerical data
  • Drug Combinations
  • Female
  • Follow-Up Studies
  • HIV Infections / drug therapy*
  • HIV Infections / epidemiology
  • Humans
  • Male
  • Middle Aged
  • Peripheral Nervous System Diseases / chemically induced*
  • Peripheral Nervous System Diseases / diagnosis
  • Peripheral Nervous System Diseases / epidemiology
  • Somatosensory Disorders / chemically induced*
  • Somatosensory Disorders / diagnosis
  • Somatosensory Disorders / epidemiology
  • South Africa / epidemiology
  • Tenofovir / toxicity*

Substances

  • Anti-HIV Agents
  • Drug Combinations
  • Tenofovir