DRUG REGIMEN	DOSE
ZDV	2mg/kg orally every six hours for six weeks*
ZDV- Nevirapine	ZDV 2 mg/kg orally every six hours for six weeks AND Nevirapine single 2 mg/kg oral dose at age 48-72 hours.
ZDV/ Lamivudine	ZDV 4 mg/kg orally every 12 hours AND Lamivudine 2 mg/kg orally every 12 hours for seven days.
Nevirapine	Single 2 mg/kg oral dose at age 48-72 hours**

* ZDV dosing for infants < 35 weeks gestation at birth is 1.5 mg/kg / dose i.v. or 2 mg/kg/dose orally, every 12 hours. Advancing to every 8 hours at 2 weeks of age if > 30 weeks gestation at birth or at 4 weeks of age if < 30 weeks gestation at birth .

** If the mother received Nevirapine less then one hour prior to delivery, the infant should be given 2 mg/kg oral Nevirapine as soon as possible after birth and again at 48-72 hours.

FORMULATIONS AVAILABLE IN JAIPUR FOR PPTCT

ZIVODIR oral solution (ZIDOVUDINE 50 mg per 5 ml.)

ZIDINE solution
Approx cost for 100 ml. bottle Rs. 75/-

LAMIVIR oral solution (LAMIVUDINE 50 mg per 5 ml.)

LAVIR Solution
Approx cost for 100 ml. bottle Rs. 95/-

NEVINUME oral Suspension (NEVI IMMUNE 50 mg per 5 ml.)

NEVIR Suspension
Approx cost for 100 ml. bottle Rs. 115/-

Keep ZIDOVDINE and NEVIMMUNE in your updated Neonatal Emergency Kit.

CDC GUIDELINE FOR POST EXPOSURE PROPHYLAXIS. (PEP)
UPDATED SEPTEMBER 30,2005

STEP 1 Immediately use soap and water to wash any skin site. Flush exposed mucous membranes with water. Irrigate an open wound with sterile saline or disinfectant solution.

STEP 2 Evaluate the potential to transmit HIV, as described below :

Is the source material blood,bloody fluid, or other potentially infectious material*,
or an instrument contaminated with one of these substances?

* Other potentially infectious materials include semen; cerebrospinal, synovial, pleural,peritoneal, pericardial, amniotic fluids or tissues. Faeces, nasal secretion, saliva, sputum, sweat, tears, urine, and vomitus are not considered potentially infections unless they are visibly bloody. The risk of HIV transmission from these fluid and materials is low.
Note: The transmission of HIV infections through occupational exposure is rare.
The risk of infection via percutaneous exposure is estimated to be approximately 0.3%.
Risk after a mucous membrane exposure is 0.09%.

TABLE 1

Recommended HIV postexposure prophylaxis ( PEP ) for mucous membrane exposures and nonintact skin* exposures

Infection status of source

Exposure type

HIV-positive class1ж

HIV-positive class2 ж

Source of unknown HIV
status#

Unknown source~

HIV-negative

Small volume**

Consider basic 2-drug PEP жж

Recommended basic-drug PEP

Generally, no PEP warranted##

Generally, no PEP warranted

No PEP Warranted

Large volume~~

Recommended basic-drug PEP

Recommended expanded>=3-drug PEP

Generally, no PEP warranted; however,consider basic 2-drug
PEP жж for source with HIV risk factors ##

Generally, no PEP warranted; however,consider basic 2-drug
PEP жж in setting in which exposure to HIV-infected person is likely

No PEP Warranted

* * For skin exposures, follow-up is indicated only if evidence exists of compromised skin integrity (e.g. dermatitis, abrasion, or open wound).

ж     HIV-positive, class 1- asymptomatic HIV infection or known low viral load (e.g.,<1500 ribonucleic acid copies/ml).              HIV-positive, class 2-symptomatic HIV infection ,AIDS, acute seroconversion, or known high viral load. If drug resistance is concern, obtain expert consultation. Initiation of PEP should not be delayed pending expert consultation, and because expert consultation alone cannot substitute for face counseling, resource should be available to provide immediate evaluation and follow up care for all exposures.
#     For example, deceased source person with no sample available for HIV testing.
~     For example, splash from inappropriately disposed blood.
**    For example, a few drops.
жж   The recommendation “consider PEP” indicates that PEP is optional; a decision to initiate PEP should be based on a discussion between the exposed person and the treating clinician regarding the risk versus benefits of PEP.
##   The PEP if offered and administrated and the source is later determined to be HIV-negative, PEP should be discontinued.
~~   For example, a major blood splash.

TABLE 2

Recommended HIV postexposure prophylaxis (PEP) for percutaneous

Infection status of source

Exposure type

HIV-positive class1*

HIV-positive class2 *

Source of unknown HIV
status ж

Unknown source~

HIV-negative

Less severe~

Recommend basic 2-drug PEP

Recommended expanded>=3-drug PEP

Generally, no PEP warranted; however, consider basic 2-drug
PEP ** for source with HIV risk factorsжж

Generally, no PEP warranted; however, consider basic 2-drug
PEP ** in setting in which exposure to HIV-infected person is likely

No PEP Warranted

Less severe##

Recommended basic-drug PEP

Recommended expanded>=3-drug PEP

Generally, no PEP warranted; however, consider basic 2-drug
PEP ** for source with HIV risk factorsжж

Generally, no PEP warranted; however, consider basic 2-drug
PEP ** in setting in which exposure to HIV-infected person is likely

No PEP Warranted

* HIV-positive, class 1- asymptomatic HIV infection or known low viral load (e.g.,<1500 ribonucleic acid copies/ml). HIV-positive, class 2-symptomatic HIV infection ,acquired immunodeficiency syndrome, acute seroconversion, or known high viral load. If drug resistance is concern, obtain expert consultation. Initiation of PEP should not be delayed pending expert consultation, and because expert consultation alone cannot substitute for face counseling, resource should be available to provide immediate evaluation and follow up care for all exposures.

ж For example, deceased source person with no sample available for HIV testing.

# For example a needle from a sharp disposal container.

~ For example, solid needle or superficial injury.

** The recommendation “consider PEP” indicates that PEP is optional; a decision to initiate PEP should be based on a discussion between the exposed person and the treating clinician regarding the risk versus benefits of PEP.

жж IF PEP is offered and administered and the source is later determined to be HIV negative, PEP should be discountinued.

## For example, larg-bore hollow needle, deep puncture, visible blood on device, or needle used in patient’s artery or vein.

STEP 3

Starting PEP

1 PEP should be initiated preferably within 1-2 hours of exposure.

2 If a query exists whether to use a 2 or 3 drug regimen , the 2 drug regimen should be started immediately, rather then delay PEP administration.

3 The duration of therapy for both regimens is 28 days.

4 The regimens for PEP :

Basic regimen ( 28 days )

Duovir* 1 tab bid
Zidovudine 300 mg + Lamivudine 150 mg

Tenvir 1 tab od + Lamivir 1 tab bid
Tenofovir 300 mg Lamivudine 150 mg

Lamivir-s 30/40 1tab bid
Stavudine 30/40 mg + Lamivudine 150 mg

* can be used by pregnant HCP

Expanded regimen ( 28 days )

Basic regimen, plus either

Lopimune 3 caps bid with food
Lopinavir 133.3 mg / Ritonavir 33.3 mg

Indivan 2 caps bid + Ritomune 1 cab bid
Indinavir 400 mg Ritonavir 100 mg

Saquinavir 200 mg, 5 hard gelatin capsul bid + Ritomune 1 cap bid
Ritonavir 100 mg

Efavir-600 1 tab od at bedtime
Efavirenz 600 mg

Nelvir 3 tabs tid
Nelfinavir 250 mg

STEP 4

Follow Up

q HIV testing by ELISA at base line, 6 weeks, 12 weeks and 6 months

q Abstain from sex (or use condoms)

q Avoid breast-feeding, donating blood, semen, organs
( May resume after 6 month if tested HIV negative ).

Dr Jagdish Singh MD
Jaipur

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NEONATAL COMPONENT OF PPTCT VARIOUS DRUG REGIMENS WHICH CAN BE PRESCRIBED BY PEDIATRICIANS

FORMULATIONS AVAILABLE IN JAIPUR FOR PPTCT

CDC GUIDELINE FOR POST EXPOSURE PROPHYLAXIS. (PEP) UPDATED SEPTEMBER 30,2005

Nelvir 3 tabs tid Nelfinavir 250 mg

NEONATAL COMPONENT OF PPTCT
VARIOUS DRUG REGIMENS WHICH CAN BE
PRESCRIBED BY PEDIATRICIANS

CDC GUIDELINE FOR POST EXPOSURE PROPHYLAXIS. (PEP)
UPDATED SEPTEMBER 30,2005

Nelvir 3 tabs tid
Nelfinavir 250 mg