HIV (Human Immunodefincy Virus ) Infection in Pregnancy Eliminate Mother to Child Transmission

HIV (Human Immunodefincy Virus )

Infection in Pregnancy

Eliminate Mother to Child Transmission

Dr. Hythum Salah H. Mohamed King Adualziz Medical City –Riyadh - 19 November 2014 .

Introduction

• HIV transmission from mother to child during pregnancy, delivery, or breastfeeding is known as perinatal transmission and is the most common route of HIV infection in children. When HIV is diagnosed before or during pregnancy, perinatal transmission can be reduced to less than 1% if appropriate medical treatment is given, the virus becomes undetectable, and breastfeeding is avoided. Since the mid-1990s, HIV testing and preventive interventions have resulted in more than a 90% decline in the number of children perinatally infected with HIV in the United States.

cdc.gov


Global View

• Globally, it is estimated that more than 1,000 babies are born with HIV every day. Many will die by age of two if they do not receive medication. (In 2009, an estimated 370,000 children contracted HIV during the perinatal and breastfeeding period; p.9, UNAIDS Global Report).

• In 2005, only 15 per cent of HIV-positive pregnant women in low- and middle-income countries received antiretroviral drugs for the prevention of mother-to-child HIV transmission . In 2009, 53 per cent of women who needed antiretroviralsreceived them.

• In low- and middle-income countries, on average, 35 per cent of babies born to HIV-positive mothers received ARV’s at birth in 2009, up slightly compared to 32 per cent in 2008, but a significant increase over 18 per cent in 2006.

unicef.org - Fifth Stocktaking Report, 2010


• The number of women with HIV giving birth in the United States increased approximately 30%, from 6,000–7,000 in 2000 to 8,700 in 2006.

• From the beginning of the epidemic through 2009, an estimated 5,626 people who were diagnosed with AIDS when they were younger than 13 years died in the 50 states and the District of Columbia. Of the total, 4,986 (89%) of them were infected perinatally.

cdc.gov/hiv/risk


Risk of mother-to-child transmission (MTCT)

• Higher levels of maternal viraemia.• Lower maternal CD4 count.• Primary HIV Infection occurring during pregnancy.• Chorioamnionitis.• Co-existing other sexually transmitted disease and malaria .• Invasive intrapartum procedures, eg fetal scalp electrodes, forceps, ventouse.• Rupture of membranes (especially if delivery is more than 4 hours after the

membranes ruptured).• Vaginal delivery.• Preterm birth• Female babies more likely to be infected early .• Advanced maternal age.• The firstborn of twins (born to an HIV-infected mother).

patient.co.uk Dr. Hythum Salah H. Mohamed King Adualziz Medical City –Riyadh - 19 November 2014 .

http://www.patient.co.uk/search.asp?searchterm=ACUTE+HUMAN+IMMUNODEFICIENCY+VIRUS+SEROCONVERSION+ILLNESS&collections=PPsearch

http://www.patient.co.uk/search.asp?searchterm=SEXUALLY+TRANSMITTED+DISEASES&collections=PPsearch

http://www.patient.co.uk/search.asp?searchterm=MALARIA&collections=PPsearch

http://www.patient.co.uk/search.asp?searchterm=FORCEPS+DELIVERIES&collections=PPsearch

Factors that decrease risk of transmission are

• Higher levels of neutralising HIV antibody.

• Elective Caesarean section.

• Zidovudine (ZDV)

• Less invasive monitoring and intrapartum procedures.

patient.co.uk


Antenatal Care

• All pregnant HIV-infected women should receive cART to prevent perinatal transmission regardless of plasma HIV RNA copy number or CD4 T lymphocyte count (AI).

• The known benefits and potential risks of ARV use during pregnancy should be discussed with all HIV-infected women (AIII) .

• Combined antepartum, intrapartum, and infant antiretroviral (ARV) prophylaxis is recommended because ARV drugs reduce perinatal transmission by several mechanisms, including lowering maternal antepartum viral load and providing infant pre- and post-exposure prophylaxis (AI).

aidsinfo.nih.gov/guidelines Last updated March 28, 2014 .


Antenatal Care

• Antenatal screening for HIV should be offered at the booking visit .

• It should be reoffered to women who decline initial testing at about 28 weeks’ gestation and to any woman thought to have an ongoing risk for HIV .

• Screening for STIs and syphilis is important to minimise MTCT and should be done as early as possible in pregnancy and should be repeated at 28 weeks’ gestation .

bhiva.org April 2013 .


Antenatal Care

• HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women.

• HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines .

• A serologic test for syphilis should be performed on all pregnant women at the first prenatal visit .

• All pregnant women should be routinely tested for hepatitis B surface antigen (HBsAg) during an early prenatal visit .

• All pregnant women should be routinely screened for Chlamydia trachomatis .

• All pregnant women at risk for gonorrhea or living in an area in which the prevalence of Neisseria gonorrhoeae is high should be screened at the first prenatal visit for N. gonorrhoeae.

cdc.gov/std


Recommendations for Use of Antiretroviral Drugs during Pregnancy• In general, the same regimens as recommended for treatment of non-pregnant

adults should be used in pregnant women unless there are known adverse effects for women, foetuses or infants that outweigh benefits (AII).

• Multiple factors must be considered when choosing a regimen for a pregnant woman including comorbidities, convenience, adverse effects, drug interactions, resistance testing results, pharmacokinetics (PK), and experience with use in pregnancy (AIII).

• PK changes in pregnancy may lead to lower plasma levels of drugs and necessitate increased dosages, more frequent dosing, or boosting, especially of protease inhibitors (AII).



HIV-Infected Pregnant Women Who Have Never Received Antiretroviral Drugs(Antiretroviral Naive)

• All HIV-infected pregnant women should receive a potent combination antiretroviral (ARV) regimen to reduce the risk of perinatal transmission of HIV (AI).

• The decision as to whether to start the regimen in the first trimester or delay until 12 weeks’ gestation will depend on CD4 T lymphocyte count, HIV RNA levels, and maternal conditions (e.g., nausea and vomiting) (AIII). Earlier initiation of a combination ARV regimen may be more effective in reducing transmission, but benefits must be weighed against potential fetal effects of first-trimester drug exposure.

• ARV drug-resistance studies should be performed before starting the ARV regimen if HIV RNA is above the threshold for resistance testing (i.e., >500 to 1,000 copies/mL) unless drug-resistance studies have already been performed (AI) .



• If HIV is diagnosed later in pregnancy, the ARV regimen should be initiated promptly without waiting for the results of resistance testing (BIII) .

• If there is no evidence of resistance, combination ARV regimens that are preferred for the treatment of antiretroviral-naive HIV-infected pregnant women include: a dual nucleoside reverse transcriptase inhibitor combination (abacavir/lamivudine, tenofovir/emtricitabine or lamivudine, or zidovudine/lamivudine) and either a ritonavir-boosted protease inhibitor (ritonavir—boosted atazanavir or ritonavir-boosted lopinavir) or a non-nucleoside reverse transcriptase inhibitor (efavirenz initiated after 8 weeks of pregnancy) (AIII).



HIV-Infected Pregnant Women Who Are Currently Receiving Antiretroviral Therapy• In general, HIV-infected pregnant women receiving combination antiretroviral

therapy (cART) who present for care during the first trimester should continue treatment during pregnancy, assuming the regimen is tolerated and effective in suppressing viral replication (HIV-1 viral load less than lower limits of detection of the assay) (AII).

• The Panel recommends that efavirenz be continued in pregnant women receiving efavirenz-based cART who present for antenatal care in the first trimester provided the regimen is achieving virologic suppression (CIII).

• HIV antiretroviral drug-resistance testing is recommended for pregnant women who have detectable viremia (AI) .



HIV-Infected Pregnant Women Who Have Previously Received Antiretroviral Treatment or Prophylaxis but Are Not Currently Receiving Any Antiretroviral Medications• Obtain an accurate history of all prior antiretroviral (ARV) regimens used for

treatment of HIV disease or prevention of transmission , including virologicefficacy, tolerance to the medications, results of prior resistance testing, and any adherence issues (AIII).

• If HIV RNA is above the threshold for resistance testing (i.e., >500 to 1,000 copies/mL), ARV drug-resistance studies should be performed before starting an ARV drug regimen (AIII).

• In women who present late in pregnancy, therapy should be initiated promptly without waiting for the results of resistance testing (BIII).

• Choose and initiate a combination ARV regimen based on results of resistance testing and prior history of antiretroviral therapy while avoiding drugs with teratogenic potential or with known adverse potential for the mother (AII).



Antiretroviral treatment

• Tenofovir plus emtricitabine, abacavir plus lamivudine or zidovudine plus lamivudine are acceptable nucleoside backbones .

• The third agent in HAART should be efavirenz or nevirapine (if the CD4 count is <250 cells/μL) or a boosted PI .

• Darunavir (which should be dosed twice daily) is the only adult-dose ARV that should have a dose alteration during pregnancy .

• Consider third trimester TDM, particularly if combining tenofovir and atazanavir or if using a non-standard dose of ARV or darunavir .

• All women not on treatment should have commenced ART by week 24 of pregnancy .



• The combination of zidovudine, lamivudine and abacavir can be used if the baseline VL is <100 000 HIV RNA copies/mL plasma.

• Zidovudine monotherapy can be used in women planning a caesarean section (CS) who have a baseline VL <10 000 HIV RNA copies/mL and CD4 count of >350 cells/μL.



Late-presenting woman not on treatment

• A woman who presents after 28 weeks should commence HAART immediately based on the epidemiological incidence of resistance .

• If her viral load is >100 000 copies/mL or unknown ,s he should commence a 3- or 4-drug regimen to include raltegravir .

• If a woman presents at 24–28 weeks, initiation of HAART may be deferred until results are available if the benefits of individualised treatment outweigh risks (such as high VL) .



ART Precautions

• Non pregnant women of childbearing potential should undergo pregnancy testing before initiation of efavirenz and receive counselling about the potential risk to the fetus and desirability of avoiding pregnancy while on efavirenz-containing regimens (AIII).

• Alternate ARV regimens that do not include efavirenz should be strongly considered in women who are planning to become pregnant or are sexually active and not using effective contraception, assuming these alternative regimens are acceptable to the provider and are not thought to compromise the woman’s health (BIII).

aidsinfo.nih.gov/guidelines Last updated March 28, 2014.


• Because the risk of neural tube defects is restricted to the first 5 to 6 weeks of

pregnancy and pregnancy is rarely recognized before 4 to 6 weeks of pregnancy, and unnecessary changes in ARV drugs during pregnancy may be associated with loss of viral control and increased risk of perinatal transmission, efavirenz can be continued in pregnant women receiving an efavirenz-based regimen who present for antenatal care in the first trimester, provided the regimen produces virologicsuppression (CIII).



• Nevirapine-based regimens should be initiated in women with CD4 T lymphocyte (CD4) cell counts >250 cells/mm3 only if the benefits clearly outweigh the risks because of the drug’s potential for causing hepatic toxicity/hypersensitivity reaction (AII).

• Women who become pregnant while receiving nevirapine-containing regimens and who are tolerating the regimen well can continue on the therapy regardless of CD4 cell count (AII).

• The combination of stavudine and didanosine should not be prescribed during pregnancy because of reports of lactic acidosis and maternal/neonatal mortality with prolonged use in pregnancy (AII).



• Clinicians should be aware of a possible small increased risk of preterm birth in pregnant women receiving protease-inhibitor (PI)-based combination antiretroviral therapy; however, given the clear benefits of such regimens for both a woman’s health and prevention of perinatal transmission, PIs should not be withheld for fear of altering pregnancy outcome (AII).

• Mitochondrial dysfunction should be considered in uninfected children with perinatal exposure to antiretroviral (ARV) drugs who present with severe clinical findings of unknown etiology , particularly neurologic findings (AII).

aidsinfo.nih.gov/guidelines Last updated March 28, 2014 . Dr. Hythum Salah H. Mohamed King Adualziz Medical City –Riyadh - 19 November 2014 .

Monitoring of the Woman and Fetus During Pregnancy .

• Plasma HIV RNA levels should be monitored at the initial visit (AI); 2 to 4 weeks after

initiating (or changing) antiretroviral (ARV) drug regimens (BI) , monthly until RNA levels are undetectable (BIII) ,and then at least every 3 months during pregnancy (BIII).

• HIV RNA levels also should be assessed at approximately 34 to 36 weeks’ gestation to inform decisions about mode of delivery (AIII).

• CD4 T lymphocyte (CD4) cell count should be monitored at the initial antenatal visit (AI) and at least every 3 months during pregnancy (BIII).

• Monitoring of CD4 cell count can be performed every 6 months in patients on combination ARV therapy (cART) with consistently suppressed viral load who have immune reconstitution (CD4 count increase well above threshold for opportunistic infection risk) related to use of the regimen (CIII).



• Monitoring for complications of ARV drugs during pregnancy should be based on what is known about the adverse effects of the drugs a woman is receiving (AIII).

• HIV-infected women taking cART during pregnancy should undergo standard glucose screening at 24 to 28 weeks’ gestation (AIII).

• Some experts would perform earlier glucose screening in women receiving ongoing protease inhibitor-based regimens initiated before pregnancy, similar to recommendations for women with high risk factors for glucose intolerance (BIII).

• Early ultrasound is recommended to confirm gestational age and, if scheduled caesarean delivery is necessary, to guide timing of the procedure (AII).



Stopping Antiretroviral Drugs during Pregnancy

• If an antiretroviral (ARV) drug regimen is stopped acutely for severe or life-threatening toxicity, severe pregnancy-induced hyperemesis unresponsive to antiemetic's, or other acute illnesses that preclude oral intake, all ARV drugs should be stopped and reinitiated at the same time (AIII).

• If an ARV drug regimen is being stopped for non-life-threatening reasons and the patient is receiving a non-nucleoside reverse transcriptase inhibitor (NNRTI), consideration should be given to either:

1- Stopping the NNRTI first and continuing the other ARV drugs for a period of time; or

2- Switching from an NNRTI to a protease inhibitor (PI) before interruption and continuing the PI with the other ARV drugs for a period of time before electively stopping.



• The optimal interval between stopping an NNRTI and the other ARV drugs is

unknown; at least 7 days is recommended. Given the potential for prolonged detectable efavirenz concentrations for >3 weeks in patients receiving efavirenz-based therapy, some experts recommend continuing the other ARV agents or substituting a PI plus 2 other agents for up to 30 days after stopping the NNRTI drug(CIII).



Intrapartum Care

• Women should continue their antepartum combination antiretroviral (ARV) drug regimen on schedule as much as possible during labor and before scheduled caesarean delivery (AIII).

• Intravenous (IV) zidovudine should be administered to HIV-infected women with HIV RNA >1,000 copies/mL (or unknown HIV RNA) near delivery (AI), but is not required for HIV-infected women receiving combination ARV regimens who have HIV RNA ≤1,000 copies/ mL consistently during late pregnancy and near delivery and no concerns regarding adherence to the regimen (BII).

• For women who have suboptimal viral suppression near delivery (i.e., HIV RNA >1,000 copies/mL), scheduled caesarean delivery is recommended (AI).



• Women whose HIV status is unknown who present in labor should undergo rapid HIV antibody testing (AII). If the results are positive, a confirmatory HIV test should be done as soon as possible and maternal (IV zidovudine)/infant (combination ARV prophylaxis) ARV drugs should be initiated pending results of the confirmatory test (AII). If the confirmatory HIV test is positive, infant ARV drugs should be continued for 6 weeks (AI); if the confirmatory HIV test is negative, the infant ARV drugs should be stopped.

• Scheduled caesarean delivery at 38 weeks’ gestation to minimize perinatal transmission of HIV is recommended for women with HIV RNA levels >1000 copies/mL or unknown HIV levels near the time of delivery, irrespective of administration of antepartum antiretroviral drugs (AII).



• In women with HIV RNA levels ≤1000 copies/mL, caesarean delivery performed for standard obstetrical indications should be scheduled at 39 weeks’ gestation.

• It is not clear whether caesarean delivery after rupture of membranes or onset of labor provides benefit in preventing perinatal transmission. Management of women originally scheduled for caesarean delivery who present with ruptured membranes or in labor must be individualized at the time of presentation based on duration of rupture and/or labor, plasma HIV RNA level, and current antiretroviral regimen (BII).



Mode of delivery and ARVs in labour

• For women with a plasma viral load of <50 copies/mL at 36 weeks, and in the absence of obstetric contraindications, a planned vaginal delivery is recommended.

• For women with a plasma viral load of 50–399 copies/mL at 36 weeks, a pre-labour caesarean section (PLCS) should be considered.

• PLCS is recommended where the viral load is >400 copies/mL at 36 weeks and for women taking zidovudine monotherapy irrespective of VL with the exception of elite controllers .



• Intrapartum IV zidovudine infusion is recommended for untreated women and women with unknown and/or a VL >100 000 copies/mL in labour or with ROMs, and women having PLCS .

• Labour should be managed as for HIV-negative women, apart from the following consideration , Forceps should be used in preference to vacuum as less fetaltrauma.

• In spontaneous pre-labour ROMs delivery should be augmented with induction if VL< 50 copies/mL or immediate CS if VL >1000 copies/mL and consideration of CS if VL 50–999 copies/mL .



Postpartum Care

• Decisions regarding continuing combination antiretroviral therapy (cART) after delivery should be made in consultation with the woman and her HIV provider, ideally before delivery (AIII).

• ART is currently recommended for all HIV-infected individuals to reduce the risk of disease progression and to prevent HIV sexual transmission, although the strength and evidence for this recommendation varies by pre-treatment CD4 T lymphocyte (CD4) count. Decisions should take into account current recommendations for initiation of cART in adults.

• Contraceptive counselling should be a critical aspect of postpartum care (AIII) .

• Breastfeeding is not recommended for HIV-infected women in the United States, including those receiving cART (AII) .



Postpartum Care

• ART should be continued in all women who commenced HAART for MTCT with a CD4 count of between 350 and 500 cells/μL during pregnancy who are coinfectedwith hepatitis B virus (HBV) or hepatitis C virus (HCV) in accordance with adult treatment guidelines.

• ART should be discontinued in all women who commenced HAART for MTCT with a CD4 count of >500 cells/μL unless there is discordance with her partner or co-morbidity.

• Exclusive formula feeding should still be recommended to all HIV-positive mothers in the UK .



• Women with fully suppressed HIV on ART, who choose to breastfeed against medical advice, should be supported to maximise adherence to maintain an undetectable HIV viral load throughout breastfeeding .

• Monthly testing should be undertaken on mother (HIV RNA) and infant (HIV RNA or DNA) during breastfeeding, and mothers should be encouraged to breastfeed for the shortest time possible.



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• Globally, it is estimated that more than 1,000 babies are born with HIV every day.

• Antenatal screening for HIV should be offered at the booking visit .

• When HIV is diagnosed before or during pregnancy, perinatal transmission can be reduced to less than 1% if appropriate medical care is provided .

• All pregnant HIV-infected women should receive cART to prevent perinatal transmission regardless of plasma HIV RNA copy number or CD4 T lymphocyte count (AI).

• Avoidance of efavirenz if possible is recommended for teratogenicity effect .

• For women who have suboptimal viral suppression near delivery (i.e., HIV RNA >1,000 copies/mL), scheduled caesarean delivery is recommended .

• Breastfeeding is not recommended for HIV-infected women .


HIV (Human Immunodefincy Virus ) Infection in Pregnancy Eliminate Mother to Child Transmission

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