Clinical Manual for Management of the HIV-Infected ... - myCME.com

Nelfinavir (Viracept) Adequate drug levels are achieved
in pregnant women with nelfinavir
1,250 mg, given twice daily.
Alternative Agents
Indinavir (Crixivan) Two studies including 18 women
receiving indinavir 800 mg 3 times
daily showed markedly lower drug
levels during pregnancy compared
with postpartum, although
suppression of HIV RNA was seen.
Ritonavir (Norvir) Phase I/II study during pregnancy
showed lower drug levels during
pregnancy compared with
postpartum.
Saquinavir hardgel
capsule [HGC]
(Invirase)/ ritonavir
PK studies of saquinavir soft-gel
capsules (SGC) indicated that
inadequate drug levels were
observed in pregnant women given
1,200 mg of saquinavir SGC as a
sole PI 3 times daily, but adequate
levels were achieved when 800
mg saquinavir SGC boosted with
ritonavir 100 mg was given twice
daily. However, saquinavir SGC are
no longer produced. Limited PK
data on saquinavir HGC suggest
that 1,000 mg saquinavir HGC/100
mg ritonavir given twice daily will
achieve adequate saquinavir drug
levels in pregnant women.
Insufficient Data to Recommend Use
Amprenavir
(Agenerase)
No evidence of human teratogenicity.
Well-tolerated, short-term safety was
demonstrated for mother and infant.
Nelfinavir dosing at 750 mg 3 times daily
produced variable and generally low levels in
pregnant women.
Theoretical concern exists about increased
indirect bilirubin levels, which may
exacerbate physiologic hyperbilirubinemia in
the neonate, but minimal placental passage.
Use of unboosted indinavir during pregnancy
is not recommended.
Limited experience at full dose in human
pregnancy, has been used as low-dose
ritonavir boosting with other PIs.
Well-tolerated, short-term safety
demonstrated for mother and infant for both
saquinavir SGC and HGC in combination with
low-dose ritonavir.
No studies in human pregnancy. Oral solution is contraindicated in pregnant
women because of high levels of propylene
glycol, which may not be adequately
metabolized during pregnancy.
Atazanavir (Reyataz) No studies in human pregnancy. Theoretical concern exists about increased
indirect bilirubin levels, which may
exacerbate physiologic hyperbilirubinemia
in the neonate, although transplacental
passage of other PIs has been low.
Section 3—Antiretroviral Therapy | 3–29
Given PK data and extensive experience with use during
pregnancy compared with other PIs, preferred PI for
combination regimens in pregnant women, particularly
if ART is being given solely for perinatal prophylaxis. In
clinical trials of initial therapy in nonpregnant adults,
nelfinavir-based regimens had a lower rate of viral
response compared with lopinavir/ritonavir or efavirenzbased
regimens, but a similar viral response compared
with atazanavir or nevirapine-based regimens.
Alternate PI to consider if unable to use recommended
agents, but would need to give indinavir as ritonavirboosted
regimen. Optimal dosing for the combination of
indinavir/ritonavir during pregnancy is unknown.
Given low levels in pregnant women when used alone,
ritonavir is recommended for use in combination with
a second PI as low-dose “boost” to increase levels of
second PI.
Saquinavir SGC are no longer available. There are only
limited PK data on saquinavir HGC during pregnancy.
Ritonavir-boosted saquinavir HGC is an alternative PI for
combination regimens in pregnancy, and is an alternative
initial antiretroviral recommendation for nonpregnant
adults. No data on saquinavir tablet formulation +
ritonavir in pregnancy.
Capsule formulation no longer available.
Safety and pharmacokinetics in pregnancy data are
insufficient to recommend use during pregnancy.
Darunavir (Prezista) No studies in human pregnancy. No experience in human pregnancy. Safety and PK data in pregnancy data are insufficient to
recommend use during pregnancy.
Fosamprenavir
(Lexiva)
No studies in human pregnancy. No experience in human pregnancy. Safety and PK data in pregnancy are insufficient to
recommend use during pregnancy.
Tipranavir (Aptivus) No studies in human pregnancy. No experience in human pregnancy. Safety and PK data in pregnancy are insufficient to
recommend use during pregnancy.