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Women: HIV, ART and PMTCT HIV Care and ART: A Course for Pharmacists Introductory Case: Alem A 32 year-old woman returns to the pharmacy one month after starting ART. As she reaches for her prescriptions, you notice that she is scratching her arms. You know that many ART medications can cause a rash, so you look to see what she is taking Her regimen is as follows: Nevirapine 200 mg bid, lamivudine 150 mg bid and stavudine 40 mg bid You see a rash on her arms that is blistering. She does not look well 2 Introductory Case: Alem (cont.) Which of the following statements is true about nevirapine and the potential for side effects in women? 1. There are no differences between men and women in regard to nevirapine side effects 2. Women are equally at risk as men for developing hepatitis from nevirapine 3. Women have a higher risk for developing severe (grade 3 or 4) skin rashes than men 4. Women are at greater risk of developing lactic acidosis from nevirapine than men 3 Learning Objectives Part 1: Women and HIV Explain the epidemiology of HIV disease in women Recognize the gender differences regarding ART between men and women Identify significant toxicities of antiretroviral therapy that are more common in women than men 4 Learning Objectives Part 2: Pregnancy, ART and PMTCT Identify risk factors for maternal to child transmission and ways to reduce risk Identify ARV drugs that can be used during pregnancy to prevent MTCT Recognize indications for ART and first line regimens in pregnancy Understand the safety and efficacy of ARVs during pregnancy 5 Part 1: Women and HIV Global Facts Of 40 million people living with HIV/AIDS worldwide, 17.5 are women (2005) 77% of all women living with HIV are in subSaharan Africa (2005) Among HIV positive adults, women account for 57% in sub-Saharan Africa, 26% in southeast Asia, 27% in Europe, and 25% in the US (2005) 7 UNAIDS Estimates for Ethiopia There were 1.9 million HIV-positive adults, over half of whom (1.1 million, 57.9%) were women, (1.5, 770K women, 2003) The group with the highest prevalence in the country is women ages 15-24 Decline in HIV prevalence has been detected among young inner-city women in Addis Ababa; infection levels among women 15–24 attending antenatal clinics dropped from 24.2% in 1995 to 15.1% in 2001 8 Prevalence of HIV in Young Women (Sub-Saharan Africa) 9 Source: UNAIDS Report on the Global AIDS Epidemic 2004 Vulnerability Factors Biological Economic Social Cultural “Women are most vulnerable to HIV infection, given the social and economic disadvantages they face in their day to day lives.” • Dr. Nafis Sadik, Executive Director of the United Nations Population Fund 10 Gender Differences Viral load Disease progression Drug pharmacokinetics Lipodystrophy Lactic acidosis Contraceptives Adherence Gynecological Issues 11 Viral Load and Disease Progression Women may have lower viral loads than men in early disease Low viral load may NOT truly reflect low risk for progression Women and men progress at similar rates Gender not significantly associated with time to AIDS or survival time 12 Drug Pharmacokinetics Body size—differences in weight Fat to muscle distribution Concentration of enzymes needed for drug metabolism is different Hormonal effects Pregnancy Hormonal replacement therapy Oral contraceptives 13 Lipodystrophy Fat accumulation more common in women; fat depletion more common in men Accumulation and depletion in different body areas of same person occurs equally in men and women Lipid abnormalities: triglyceride and cholesterol level elevations more common in men 14 Lactic Acidosis The FDA has received 60 reports of lactic acidosis associated with dual nucleosides, with 55% mortality 83% in women; 50% >175lbs Presented with nonspecific symptoms Link between mitochondrial dysfunction and lactic acidosis? Occurs in women with high CD4 15 Contraception and ART Efavirenz is contraindicated in pregnancy Additional barrier methods are recommended to prevent pregnancy and transmission of HIV and STIs Dual methods of contraception highly recommended for sexually active EFV users: barriers plus: Progestins (Depo-Provera) IUCD 16 Antiretrovirals and Oral Contraceptives NNRTIs and PIs interfere with blood levels of combination oral contraceptives Nelfinavir, Nevirapine and Ritonavir Associated with decreased levels of ethinyl estradiol, resulting in decreased contraceptive effectiveness Do not combine 17 Drug Interactions Hormonal contraception Nevirapine, lopinavir, ritonavir, and nelfinavir may lead to sub therapeutic levels of ethinyl estradiol (EE) resulting in unwanted pregnancy Atazanavir, efavirenz, & indinavir increase EE/norethindrone Must use additional/alternate method of contraception 18 Women and Adherence Adherence issues are more complicated for women who need special attention and support: Often don’t disclose HIV status due to stigma May feel isolated Caregivers Challenges in accessing and maintaining care include child care, transportation, inexperienced providers, etc. 19 Optimal Adherence for Women Evaluate for mental health, substance abuse and other “adherence interruptus” problems Assess HAART readiness Develop a mutually agreeable HAART regimen specific to her lifestyle Prepare for side effects Encourage atmosphere of communication and trust Be accessible and available 20 Gynecological Issues Conditions causing inflammation or infection increase the likelihood a woman will acquire or transmit HIV Bacterial vaginosis Cervicitis Herpes ulcers Genital warts Condyloma Recurrent candidiasis Prevalent in 25-30% of women with HIV Risk increases 20-fold with CD4<100 HPV genital warts associated with increased incidence of cervical cancer 21 ARV Drugs Toxicity in Women: How Do They Differ From Men? Rash Hepatotoxicity Lactic acidosis/Hepatic steatosis Mitochondrial toxicity Dysmenorrhea Lipodystrophy/Hyperlipidemia Osteoporosis Renal compromise 22 ARV Drugs Toxicity in Women: NNRTIs Nevirapine (NVP) Rash • Females 5.5 to 7.3 x more likely to develop NVP associated severe skin rash than men Hepatotoxicity • Females up to 3 x more likely than men • When CD4 count is >250 there is a much higher risk Time to onset: • Risk of rash or heatotoxicity greatest in the first 4-6 weeks of therapy • NVP first 18 weeks: requires close monitoring 23 Introductory Case: Alem (cont.) 1. There are no differences between men and women in regard to nevirapine side effects FALSE Women are at greater risk of developing both rash and hepatotoxicity from nevirapine than men Women who begin nevirapine should be monitored closely for the first 6 weeks (up to 18 weeks) on therapy 24 Introductory Case: Alem (cont.) 2. Women are equally at risk as men for developing hepatitis from nevirapine FALSE Overall (men and women combined) incidence of symptomatic hepatotoxicity is 4%, asymptomatic hepatitis: 8.8% Hepatotoxicity generally occurs within first 4-6 weeks of therapy 25 ARV Drugs Toxicity in Women: NNRTIs (2) Efavirenz Rash: • 26% of patients experience, <2% requiring discontinuation • Female sex an independent risk factor Teratogenic: causes birth defects • should be avoided in pregnancy • should be avoided in women of childbearing age • should only be used in women of childbearing age if effective contraception is absolutely in place 26 Introductory Case: Alem (cont.) 3. Women have a higher risk for developing severe (grade 3 or 4) skin rashes than men TRUE Overall (men and women combined) the incidence of rash is 15% • Women are as much as 8x more likely than men to develop rash • Rash generally occurs in the first 6 weeks of therapy • Female sex is an independent risk factor 27 ARV Drugs Toxicity in Women: NRTI’s Mitochondrial toxicity: class effect greater in women Attributed to higher intracellular drug levels Lactic acidosis and hepatic steatosis Symptoms are vague May be associated with pancreatitis Other risk factors: obesity and prolonged use of NRTIs DDI + D4T combination is added risk • Must avoid use in pregnancy 28 Introductory Case: Alem (cont.) 4. Women are at greater risk of developing lactic acidosis from nevirapine than men FALSE Women are at greater risk of developing lactic acidosis. It is most likely caused by nucleoside analogues Nevirapine has not been shown to cause lactic acidosis 29 ARV Drugs Toxicity in Women: PI’s Hyperglycemia** PI use, age and Body Mass Index (BMI) are independent predictors of developing diabetes Routine screening for diabetes is essential among patients on PI therapy Drug interactions Oral contraceptives Hormonal replacement therapy Effect of menstrual cycle Drug serum levels 30 ARV Drugs Toxicity in Women: PI’s (2) Lipodystrophy Recent evidence suggests that levels of body fat change are comparable among men and women • Lipoatrophy (fat loss) is the predominant body shape change in women Lipid abnormalities • Elevation of triglycerides and cholesterol (much more common in men) 31 ARV Drugs Toxicity in Women: All ARVs Renal toxicity Limited information Decreased bone mineral density 3 studies found that traditional risk factors and not ARVs were associated with decreased bone mineral density (BMD) • CROI 2003 (Abstract 102,103,766) 32 Treatment Guidelines for Women Guidelines are not gender specific Issues to consider when starting treatment Preconception counseling • Teratogenicity of ARVs Drug interactions Efficacy Tolerability, side effects Co-morbidities (TB, pregnancy, depression) 33 Women of Reproductive Age Regimen selection should account for the possibility of planned or unplanned pregnancy Sexual activity, reproductive plans and use of effective contraception, should be discussed with the patients When evaluating for initiation of therapy, counsel on the potential risk of efavirenz containing regimen Avoid efavirenz • in pregnancy • If woman is not using consistent contraception 34 Part 2: HIV, Pregnancy and Preventing Maternal to Child Transmission Introduction HIV is a family infection Mothers and fathers have an impact on transmission of HIV to the baby There is increased chance of transmission to the baby when a woman becomes infected with HIV when she is pregnant or breastfeeding Partners should have safer sex throughout pregnancy and while breastfeeding 36 Pregnant Women Testing HIV Positive 2001, Ethiopia, Urban Shashemene 13.1 Gambella 14.6 Gonder 15.1 Dire dawa 15.2 Addisava 15.6 Adigrat 16.2 Maichew 16.8 MKELIE 17.2 Nazareth 18.7 Jijiga 19 Bahrdar 23.3 0 5 10 15 20 25 Prevalence (%) Source: AIDS in Ethiopia, 4th Edition, October 2002. CDC/MOH 37 Pregnant Women Testing HIV Positive 2001, Ethiopia, Rural Attat 1.5 Gambo 1.1 Aira 2.6 Borena Dadim 1.7 BOREA Gosa 1.7 Ambo Toke 4.6 0 1 2 3 4 5 Prevalence (%) Source: AIDS in Ethiopia, 4th Edition, October 2002. CDC/MOH 38 Pregnancy Outcome: Goals Uncomplicated pregnancy Healthy, uninfected infant Healthy mother who has not compromised her future options for HIV therapy 39 HIV and Pregnancy Pregnancy does not accelerate the progression of HIV disease to AIDS Patients with AIDS are more likely to suffer from pregnancy-related complications 40 Effect of Advanced HIV on Pregnancy Decreased fertility Spontaneous abortion Infections (opportunistic, GU, postpartum, postsurgical) Preterm labor Premature rupture of membranes Low birth weight babies Stillbirths 41 Current Status of Mother-to-Child Transmission Estimates of HIV transmission rates from women to children are about 20-40% MTCT is by far the largest source of HIV infection in children under 15 42 Estimated risk and timing of MTCT in the absence of interventions Timing Transmission Rate During pregnancy 5-10% During labour and delivery 10-15% During breastfeeding 5-20% Overall without breastfeeding 15-25% Overall with breastfeeding to six months 20-35% Overall with breastfeeding to 18-24 months 30-45% Note: Rates vary because of differences in population characteristics such as maternal CD4+ cell counts, RNA viral load and duration of breastfeeding Source: World Health Organization. HIV transmission through breastfeeding. A review of available evidence. 43 Factors Influencing MTCT Viral Load The higher the viral load, the higher the risk of MTCT Lowering risk through: Use of ART during pregnancy and postpartum to mother and newborn Adequate nutrition, particularly vitamin A 44 Factors Influencing MTCT (2) Maternal Factors Increasing Risk Viral or parasitic placental infection (especially malaria) Becoming infected with HIV during pregnancy Severe immune deficiency Advanced clinical and immunological state Maternal malnutrition 45 Factors Influencing MTCT (3) Labor and Delivery—Factors Increasing Risk Prolonged rupture of membranes (>4 hours) Injury to birth canal during child birth Antepartum procedures Acute chorioamnionitis Invasive fetal monitoring Instrumental delivery Mixing of maternal and fetal body fluids Delayed infant cleaning and eye care Routine infant airway suctioning 46 Factors Influencing MTCT (4) Fetal Conditions Premature delivery Low birth weight Immature immune status First infant in a multiple birth Oral diseases 47 ART Clinical Scenarios Four possible clinical scenarios of a pregnant woman: On ART and become pregnant Pregnant and ART indicated and available Pregnant and not requiring ART or ART not available Pregnant and presenting after 34 weeks with no prior ART 48 Scenario 1: On ART and Become Pregnant Woman on efavirenz Counsel about potential teratogenicity Stop EFV and start NVP if in first trimester Woman on D4T/3TC/nevirapine Woman on ZDV/DDI/LPV/r Continue treatment Full blood count monthly Monitor blood glucose levels as appropriate Continue treatment or change D4T to ZDV (full blood count monthly if on ZDV) ALT monthly & when indicated 49 Scenario 2: Pregnant and Eligible for ART Begin first line therapy for woman: ZDV 300 mg bid or D4T 40 mg every 12 hours (or 30 mg q 12 hours if <60 kg) + 3TC 150 mg q12 hrs + NVP 200 mg qd for 2 weeks, then 200 mg q12 hrs If unable to use NVP, PI options include NFV, LPV/r or SQV/r ALT q 2 weeks for 1 month, then q month, then as indicated Begin AZT 4 mg/kg for 7 days for infant 50 Scenario 3: Pregnant and Not Requiring ART Early stage HIV (WHO Stage I or II disease with CD4 >200) Follow the national PMTCT guidelines 51 Scenario 4: Pregnant Presenting After 34 Weeks Defer ART Provide PMTCT Review need for ART after delivery 52 Use of Antiretrovirals in Pregnancy: Potentially Competing Issues Safety & Efficacy for Mother Safety of Infant Prevention of Transmission 53 Antiretroviral Therapy to Reduce Perinatal Transmission: Options Short course ARV prophylaxis for PMTCT HAART not available or indicated HIV+ woman presents in labor with no prior ARV Capacity for ARV prophylaxis limited to Nevirapine to mother and infant 54 Short course ARV Prophylaxis for PMTCT* - Scenario #1 Maternal antepartum Maternal intrapartum Maternal postpartum Infant NVP 2 mg/kg AZT 300 mg single dose bid orally AZT 300 mg HAART not with 72 starting at Single dose and 3TC available or hours of 28 weeks NVP 200 150 mg not birth AND pregnancy mg orally orally BID 7 indicated AZT 4 or as soon days mg/kg orally as possible bid for 7 days 55 Short course ARV Prophylaxis for PMTCT* - Scenario #2 Maternal antepartum HIV + woman presents in labor with no prior ARV Maternal intrapartum Single dose NVP 200 mg orally AND AZT 300 mg orally every 12 hours until delivery Maternal postpartum Infant If mother received NVP less than 2 hours before delivery, infant should be given TWO doses of NVP 2 mg/kg orally -ONCE as soon as possible after delivery -SECOND dose at 48-72 hours of life 56 Short course ARV Prophylaxis for PMTCT* - Scenario #3 Capacity for ARV prophylaxi s limited to Nevirapine for mother and infant Maternal Maternal Maternal antepartum intrapartum postpartum Infant Single dose NVP 200 mg orally NVP 2 mg/kg orally within 72 hours of birth 57 WHO Recommendations For mothers presenting in labor without prior ART, Single dose nevirapine and zidovudine given to the mother during labor And, single dose nevirapine and four weeks of zidovudine from birth given to the infant Or Zidovudine/lamivudine during delivery and for 7 days postpartum given to the mother And, Zidovudine/lamivudine for 7 days given to the infant from birth Where capacity to deliver only minimal range of ARVs exists: Single dose nevirapine for the mother during labor And, single dose nevirapine for the infant within 72 hours of birth Source: WHO, Antiretroviral drugs and prevention of mother-to-child transmission of HIV infection in resource-limited settings: Recommendations for a public health 58 approach (2005 Revision). Single Dose Nevirapine: ART Prophylaxis for PMTCT Advantages: Rapid oral absorption Rapid transplacental passage Highly potent antiviral Long half-life, persists for 7-10 days NVP provides prophylaxis to the baby during birth Toxicities rare: severe rash, hepatitis Disadvantage: Rapidly selects for drug-resistant mutants 59 MTCT: Single-Dose Nevirapine Vs Ultra-Short ZDV % Transmission Breastfed Infants 14-16 weeks 18 months Nevirapine INTRA POST versus 13.1% 15.7% 25.1% 25.8% 200 mg x1 2 mg/kg x1 Ultra-Short INTRA ZDV 300 mg q 3 hr POST 4 mg/kg bid x1 wk NVP resistance 19% at 6-8 weeks (mothers), 46% at 6-8 weeks (infants) Sources: Guay L.A. et al. Lancet 1999;354:795; Jackson J.B. et al. Lancet 2003;362:859 60 MTCT: Single-Dose Nevirapine vs ZDV/3TC % Transmission: Birth Nevirapine (variant of INTRA POST HIVNET 012) versus ZDV/3TC (PETRA) 7.0% 200 mg x1 Mom 200 mg x1 Baby 2 mg/kg x1 INTRA POST Q 3 hr Mom & baby x1 wk NVP resistance 6 weeks 67% moms, 53% infants Btn Birth-8 Wks 5.7% Overall, 8 wks: 12.3% 5.9% 3.6% Overall, 8 wks: 9.3% (Overall: p=0.11) 61 Source: Moodley D et al. JID 2003;187:725-35 Higher Transmission with Breast (N=623) than Formula (N=694) Feeding % Transmission 25 20 15 10 5 0 Birth ZDV/ 3TC Formula 4 Weeks Breast NVP 8 Weeks Formula Regardless of Treatment Breast 62 Based on data from Moodley D. et al. JID 2003;187:725-35 Conclusions: Nevirapine Prophylaxis Regimens When only intrapartum (IP)/postpartum (PP) prophylaxis is given, single dose NVP is: • Superior to IP/PP ZDV alone • Similar to IP/PP ZDV/3TC 63 Pharmacokinetics of ARVs in Pregnancy Few trials evaluated the clinical significance of physiologic changes during pregnancy on the PK of commonly used drugs Half life of NVP is reduced from 66 hr in nonpregnant women to 45 hr in pregnant women Nelfinavir levels a third lower in pregnancy Unboosted IDV levels are sub-therapeutic, but still may be indicated Pregnancy does not change the PK of ZDV, 3TC and DDI 64 Risk of Development of Resistance: Mother Non-HAART regimens associated with the development of resistance ZDV monotherapy: 0.3 - 14% risk of low-level ZDV resistance ZDV + 3TC: 38% high-level 3TC resistance (ANRS 075) Nevirapine monotherapy: 15% - 18% high level NVP resistance ► No longer detectable 12 months postpartum 65 Risk of Development of Resistance: Infant ZDV: longer courses (28 weeks) may result in resistance transmission to the infant ~50% of infants develop NVP resistance The mutations are often different from the mother’s because of de novo selection or emergence of a mutant with greater fitness 66 Safety of NRTIs in Pregnancy Human pregnancy data only for ZDV, 3TC, DDI, D4T No increase in birth defects have been observed Lactic acidosis and hepatic steatosis Rare, but potentially fatal syndrome Linked to prolonged use of NRTIs, esp DDI, D4T, DDC (AVOID the use of DDI/D4T combination in pregnancy) Vague symptoms 67 Safety of NNRTIs in Pregnancy Nevirapine single dose has not been associated with adverse side effects in women and children Nevirapine resistance risk as above Nevirapine elimination may be accelerated in infants whose mother received chronic nevirapine as part of ART Pregnancy should be avoided in women receiving efavirenz No human pregnancy data on long term use of NNRTIs 68 Safety of PIs In Pregnancy Protease inhibitors associated with reduced insulin sensitivity Pregnancy also associated with varying degrees of insulin resistance Risk of diabetes greater with PI-containing regimen Monitor fasting glucose and 2 hr GTT Avoid indinavir and liquid amprenavir Source: Justman, 6th CROI 69 Data on the Use of ART During Pregnancy Category B Animal reproduction studies fail to demonstrate a risk to the fetus and adequate but well controlled studies of pregnant women have not been conducted Examples: DDI, FTC, TDF, Atazanavir, Nelfinavir, Ritonavir Category C Safety in human pregnancy has not been determined; animal studies are either positive for fetal risk or have not been conducted Examples: ABC, 3TC, D4T, ZDV, NVP, DLV, Amprenavir (fosamprenavir), Indinavir, Lopinavir/r Category D Positive evidence of human fetal risk that is based on adverse reaction data from investigational or marketing experiences, but the potential benefits from the use of the drug among pregnant women may be acceptable despite it’s potential risks Example: EFZ 70 Summary: ARVs to Avoid in Pregnancy Efavirenz containing regimens Teratogenic DDI + D4T combination therapy Lactic acidosis Oral liquid formulation of amprenavir Propylene glycol Indinavir • Avoid in late pregnancy (avoid use of unboosted IDV in pregnancy) 71 Summary: Safety & Efficacy Issues in Pregnancy HAART results in the lowest risk of transmission to the infant Use of HAART best preserves mother’s future therapeutic options Monitoring required for: Lactic acidosis/hepatic steatosis Rash, hepatotoxicity in women with CD4 >250 Glucose intolerance 72 Summary: Antiretroviral Toxicities to Fetus/Infant No increased risk of birth defects with exposure to ARVs overall or for first trimester ZDV or 3TC exposures No patterns of toxicity associated with antiretrovirals within 5-10 years Mitochondrial toxicity may occur rarely Long-term studies underway to ascertain if carcinogenic 73 Case Studies Case 1 Case Study: Beza Beza is a 22 year-old woman newly diagnosed with HIV who comes to the pharmacy to begin antiretroviral therapy with NVP, 3TC and ZDV She is ready to start therapy and wants to be healthy so that she can have a baby. She has a new prescription for prenatal vitamins with her that she would like to fill today 76 Case Study: Beza (2) She asks you if it is okay to continue taking her antiretrovirals (ART) should she become pregnant. She has heard that ART can be harmful to infants. 1. How would you counsel this patient? 2. Which antiretrovirals should be avoided in pregnancy? 77 Case 2 Case Study: Tsegenet Tsegenet is a 34 year-old woman in her third pregnancy who delivered a healthy 3.5 kg baby girl an hour after she arrived at the maternity. After the birth, she told the staff she had a positive HIV test done in clinic but did not take the tablet given to her before rushing to the maternity because she did not want her family to know about her HIV infection 79 Case Study: Tsegenet (2) 1. What treatment does Tsegenet require now? 2. What treatment does her baby require? 80 Case 3 Case Study: Mihret Mihret, a 27 year-old female with a CD4 cell count of 182 cells/mm3 presents to clinic three weeks after starting her new antiretroviral regimen. She states she has been taking most of her medications. She admits to not always practicing safe sex and is concerned about getting pregnant. Her weight is 63 kg Her medical provider decides to start her on norethindrone/ethinyl estradiol 0.5mg / 0.035 mg and reinforces her need to use condoms 82 Case Study: Mihret (2) Current Medications: Stavudine 40 mg PO bid Lamivudine 150 mg PO bid Nevirapine (Viramune): 200 mg PO bid Cotrimoxazole DS (160 mg/800 mg) PO qd 83 Case Study: Mihret (3) Which of the following is TRUE regarding a potential drug-drug interaction? A) Nevirapine reduces the plasma levels of ethinyl estradiol. B) Nevirapine increases the plasma levels of ethinyl estradiol. C) Nevirapine reduces the plasma levels of norethindrone D) Nevirapine increases the plasma levels of norethindrone 84 Case 4 Case Study: Rahel Rahel, a 31 year-old, single HIV positive woman came to the clinic with pain in her mouth and chest upon swallowing. She had night sweats and diarrhea for one month. Her usual weight was 58 kg On exam she weighed 51 kg, had no palpable lymph nodes, and had oral candidiasis. She was diagnosed with presumed esophageal candidiasis and treated with oral fluconazole for 2 weeks. Her pain subsided and she began to eat 86 Case Study: Rahel (2) Based on the esophageal candidiasis, she had WHO Stage IV disease, although no CD4 count was available. She began daily Cotrimoxazole for PCP prophylaxis and was started on HAART at the same time with stavudine 30 mg bid, lamivudine 150 mg bid, and efavirenz 600 mg qhs She has been adherent with her medications. The night sweats and diarrhea have stopped, her appetite has increased, and she has gained 6 kg 87 Case Study: Rahel (3) At her 6-month follow-up visit she reports that her menstrual period is 2 months late. A pregnancy test is positive Should she continue her antiretroviral therapy? If she requires a change in her regimen, what would you suggest as an alternative? 88 Key Points Women are more susceptible than men to contracting HIV through heterosexual intercourse HIV infected women require special care Women are affected differently by HIV and ARVs Increased rates of certain toxicities in women may be due to differences in drug metabolism 89 Key Points (2) Issues to consider when starting treatment include: preconception counseling, teratogenicity of ARVs, drug interactions, efficacy, tolerability, and co-morbidities Patients with AIDS are more likely to suffer from pregnancy-related complications Transmission of HIV infection from mother to child can occur during pregnancy, birth, or breastfeeding 90 Key Points (3) MTCT is the largest source of HIV infection in children under 15 HAART can reduce the risk of MTCT to less than 2% ART to reduce perinatal transmission must be given to the mother and infant Regardless of treatment strategy, a higher rate of transmission occurs with breast feeding rather than formula 91