Prevalence and risk factors for efavirenz-based antiretroviral treatment-associated severe vitamin D deficiency: A prospective cohort study

Medicine (Baltimore). 2016 Aug;95(34):e4631. doi: 10.1097/MD.0000000000004631.

Abstract

Initiation of efavirenz-based combination antiretroviral therapy (cART) is associated with Vitamin D deficiency, but the risk factors including efavirenz pharmacokinetics for cART-induced severe vitamin D deficiency (SVDD) and the impact of anti-tuberculosis (TB) cotreatment are not explored. We investigated the prevalence of SVDD in HIV and TB-HIV coinfected patients and associated risk factors for treatment-induced SVDD.Treatment-naïve Ethiopian HIV patients with (n = 102) or without (n = 89) TB co-infection were enrolled prospectively and received efavirenz-based cART. In TB-HIV coinfected patients, rifampicin-based anti-TB treatment was initiated 4 or 8 weeks before starting cART. Plasma 25-hydroxyvitamin D (25 [OH]D), cholesterol and 4-beta hydroxycholesterol concentrations were measured at baseline, 4, 16, and 48 week of cART. Plasma efavirenz concentrations were determined at 4 and 16 weeks of cART.TB-HIV patients had significantly lower plasma 25 (OH)D3 levels than HIV-only patients at baseline. TB co-infection, low Karnofsky score, high viral load, and high CYP3A activity as measured by plasma 4β-hydroxycholesterol/cholesterol ratios were significant predictors of low 25 (OH)D3 levels at baseline. In HIV-only patients, initiation of efavirenz-based cART increased the prevalence of SVVD from 27% at baseline to 76%, 79%, and 43% at 4, 16, and 48 weeks of cART, respectively. The median 25 (OH)D3 levels declined from baseline by -40%, -50%, and -14% at 4, 16, and 48 weeks of cART, respectively.In TB-HIV patients, previous anti-TB therapy had no influence on 25 (OH)D3 levels, but the initiation of efavirenz-based cART increased the prevalence of SVDD from 57% at baseline to 70% and 72% at the 4 and 16 weeks of cART, respectively. Median plasma 25 (OH)D3 declined from baseline by -17% and -21% at week 4 and 16 of cART, respectively.Our results indicate low plasma cholesterol, high CYP3A activity, and high plasma efavirenz concentrations as significant predictors of early efavirenz-based cART-induced vitamin D deficiency. Low plasma 25 (OH)D3 level at baseline is associated with TB co-infection and HIV diseases progression. Initiation of efavirenz-based cART is associated with high incidence of SVDD, whereas rifampicin based anti-TB therapy co-treatment has no significant effect. Supplementary vitamin D during cART initiation may be beneficial for HIV patients regardless of TB coinfection.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Alkynes
  • Antiretroviral Therapy, Highly Active / adverse effects*
  • Antitubercular Agents / administration & dosage
  • Benzoxazines / administration & dosage
  • Benzoxazines / adverse effects*
  • Cholesterol / blood
  • Cohort Studies
  • Cyclopropanes
  • Ethiopia / epidemiology
  • Female
  • HIV Infections / blood
  • HIV Infections / complications
  • HIV Infections / drug therapy*
  • Humans
  • Male
  • Prevalence
  • Prospective Studies
  • Rifampin / administration & dosage
  • Risk Factors
  • Treatment Outcome
  • Tuberculosis, Pulmonary / complications
  • Tuberculosis, Pulmonary / drug therapy
  • Vitamin D / analogs & derivatives
  • Vitamin D / blood
  • Vitamin D Deficiency / blood
  • Vitamin D Deficiency / chemically induced
  • Vitamin D Deficiency / epidemiology*

Substances

  • Alkynes
  • Antitubercular Agents
  • Benzoxazines
  • Cyclopropanes
  • Vitamin D
  • Cholesterol
  • 25-hydroxyvitamin D
  • efavirenz
  • Rifampin