CATEGORY A CONTROLLED STUDIES SHOW NO RISK. Adequate, well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester of pregnancy

CATEGORY B NO EVIDENCE OF RISK IN HUMANS. Adequate, well-controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote, but remains a possibility.

CATEGORY C RISK CANNOT BE RULED OUT. Adequate,well-controlled human studies are lacking, and animal studies have shown a risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is administered during pregnancy; but the potential benefits may outweigh the potential risks.

CATEGORY D POSITIVE EVIDENCE OF RISK. Studies in humans, or investigational or post- marketing data, have demonstrated fetal risk. Nevertheless, potential benefits from the use of the drug may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

CATEGORY X CONTRAINDICATED IN PREGNANCY. Studies in animals or humans, or investigational or post-marketing reports, have demonstrated positive evidence of fetal abnormalities or risks which clearly outweighs any possible benefit to the patient.

Acyclovir (Zovirax ® ) Antiviral CATEGORY: B Crosses placenta CATEGORY: B Inhibitor of viral DNA polymerase& Block viral syntesis (maternal:cord ratio of ~ 1.3 after IV/PO exposure). In a prospective epidemiological registry 1st trimester exposure to acyclovir in 749 pregnancies resulted in no increase in major or minor fetal anomalies. However, the manufacturer cautions, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. BREAST FEEDING:Compatible. Concentrated in human milk. Compatible NEONATAL SIDE EFFECTS: None reported. Sid effects: Local burning,Nephrotoxicity,Neurotoxicity,Mutagenic Decrease spermatogenesis and cause testicular atrophy in animals

Amantadine (Symmetrel) Antiviral CATEGORY: C In a surveillance study of Michigan Medicaid patients 1st trimester exposure in 64 infants resulted in 5 birth defects The sample size is too small to draw firm conclusions. BREAST FEEDING: The manufacturer reports amantadine is excreted in human milk, and recommends the drug not be used in nursing mothers CATEGORY: C sample NEONATAL SIDE EFFECTS:Potential release of levodopa, urinary retention, vomiting, and rash after breast feeding. Side effects: Dose dependent GI and CNS complications (nervousness,ligtheadedness,difficulty in concentration,insomnia,losspf apetitenausea.)

Gancyclovire Category: C Inhibits viral replication Side effects: Myelosuppression,Neutropenia(2 nd week) CNS side effects,Anemia,Rash,Fever Mutagenic,Carcinogenic,immunosuppressive &irreversible repoductive toxicity Tratogrnicity,emberitoxicity,testicular atrophy

Safety of HAART in pregnancy Similar adverse events occur as with HAART in non- pregnant patients little hard data suggesting major problems with pregnancy outcomes - difficult to separate out effects of HIV and drug therapy only drug which is absolutely contraindicated is efavirenz - teratogenic in cyanomolgus monkeys Didanosine and stavudine together seem to pose and especial risk of lactic acidosis in pregnancy very very rare reports of AZT and lamivudine associated with mitochondrial toxicity in non-infected exposed infants

Lamivudine Category:C Placental passage:yes Carcingenicity:No Animal teratogrnicity:No Nucleoside and nucleotide analoge reverse transcriptase inhibitor

Zidovoidine Category: C Placental passage:Yes Long term anima carcinogenicity:Positive Animal Teratogenicity:Yes Nucleoside and nucleotide analoge reverse transcriptase inhibitor