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 7, 2018; Last Reviewed: December 7, 2018

Excerpt from Table 10a

Note: When using FDCs, refer to other sections in Appendix B and Table 10 for information about the dosing and safety of individual drug components of the FDC during pregnancy.

Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendations Use in Pregnancy
Nevirapine
(NVP)
Viramune
Viramune XR (Extended Release)


Note: Generics available for some formulations.
NVP (Viramune)
Tablets:
  • 200 mgd
Oral Suspension:
  • 50 mg/5 mL

Viramune XR 
Tablets:
  • 100 mg
  • 400 mgd
Standard Adult Dose:
  • 200 mg once-daily Viramune (immediate release) for 14 days (lead-in period); thereafter, 200 mg twice daily or 400 mg (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 lead-in period, continue lead-in dosing until rash resolves, but administer for ≤28 days total.
PK in Pregnancy:
  • PK of immediate release tablets is not significantly altered in pregnancy.
  • No data are 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 2-fold increase in cardiovascular and genitourinary defects).

Increased risk of symptomatic, often rash-associated, and potentially fatal liver toxicity among women with CD4 cell counts ≥250/mm3 when first initiating therapy; pregnancy does not appear to increase risk.

NVP should be initiated in pregnant women with CD4 cell counts ≥250 cells/mm3 only if benefit clearly outweighs risk because of potential increased risk of life-threatening hepatotoxicity in women with high CD4 cell 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 therapy, regardless of CD4 cell count.
a Individual ARV drug doses may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Guidelines Appendix B, Table 8).
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 to Acronyms: : ARV = antiretroviral; CD4 = CD4 T lymphocyte; NVP = nevirapine; PK = pharmacokinetic

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