Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Non-Nucleoside Reverse Transcriptase Inhibitors

Nevirapine (Viramune, NVP)

Last Updated: December 24, 2019; Last Reviewed: December 24, 2019

Excerpt from Table 8

Excerpt from Table 8
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendationsa Use in Pregnancy
Nevirapine
(NVP)
Viramune
Viramune XR


Note: Generic products are available for some formulations.
NVP (Viramune)
Tablet:
  • 200 mgd
Oral Suspension:
  • 50 mg/5 mLd
Viramune XR
Tablets:
  • 100 mg
  • 400 mgd
Standard Adult Doses:
  • NVP 200 mg once daily (using Viramune immediate release) for a 14-day lead-in period; thereafter, NVP 200 mg twice daily or 400 mg (using Viramune XR tablet) once daily, without regard to food.
  • Repeat lead-in period if therapy is discontinued for >7 days.
  • In patients who develop mild-to-moderate rash without constitutional symptoms during the lead-in period, continue lead-in dosing until rash resolves, but administer for ≤28 days total.
Pregnancy
PKs in Pregnancy:
  • PKs of immediate-release tablets not significantly altered in pregnancy.
  • No data available on extended-release formulations in pregnancy.
Dosing in Pregnancy:
  • No change in dose indicated.
High placental transfer to fetus.b

No evidence of human teratogenicity (can rule out 1.5-fold increase in overall birth defects and two-fold increase in cardiovascular and genitourinary defects).

There is an increased risk of symptomatic liver toxicity when first initiating therapy in women with CD4 counts ≥250/mm3. Liver toxicity is often associated with a rash and can be fatal. Pregnancy does not appear to increase this risk.

NVP should be initiated in pregnant women with CD4 counts ≥250 cells/mm3 only if benefit clearly outweighs risk. There is a potential increased risk of life-threatening hepatotoxicity in women with high CD4 counts. Elevated transaminase levels at baseline may increase the risk of NVP toxicity.

Women who become pregnant while taking NVP-containing regimens and who are tolerating their regimens well can continue taking those regimens, regardless of their CD4 counts.
a Individual ARV drug doses may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Antiretroviral Guidelines, Appendix B, Table 10).

b
Placental transfer categories are determined by mean or median cord blood/maternal delivery plasma drug ratio:
          High: >0.6
          Moderate: 0.3–0.6
          Low: <0.3

d
Generic formulation available

Key: ARV = antiretroviral; CD4 = CD4 T lymphocyte; NVP = nevirapine; PK = pharmacokinetic XR = extended release

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