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2008 Women and HIV International Clinical Conference Reproductive Dilemmas for Women Living with HIV

2008 Women and HIV International Clinical Conference Reproductive Dilemmas for Women Living with HIV . Carmen D. Zorrilla, MD Professor Ob-Gyn UPR School of Medicine PI: UPR-CTU, PR-CCHD,CEMI. We are both burdened and blessed by the great responsibility of free will- the power of choice.

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2008 Women and HIV International Clinical Conference Reproductive Dilemmas for Women Living with HIV

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  1. 2008 Women and HIV International Clinical ConferenceReproductive Dilemmas for Women Living with HIV Carmen D. Zorrilla, MD Professor Ob-Gyn UPR School of Medicine PI: UPR-CTU, PR-CCHD,CEMI

  2. We are both burdened and blessed by the great responsibility of free will- the power of choice. Our future is determined, in large part, by the choices we make now. We cannot always control our circumstances, but we can and do choose our response to whatever arises. Reclaiming the power of choice, we find the courage to live fully in the world. Dan Millman The Laws of Spirit The Law of Choices: Reclaiming our power

  3. Objectives • To describe the issues and interventions to deal with reproductive health particularly the following: • Infertility • Preconceptional care • Pregnancy considerations

  4. Introduction • HIV infection has changed from a life-threatening to a chronic illness because of the availability of HAART • Some of the behaviors that place women at risk for HIV (IDU, Sex work) also place them at risk for infertility • Even though some women will postpone pregnancy because of an HIV diagnosis, it will not change the desire for reproduction

  5. Pregnancy and HIV • Transmission rates have decreased substantially with current management (ART, C/S, infant formula) • Current MTCT rates are around or less than 1% • Pregnancy does not affect the progression of HIV disease • Women living with HIV do not have to postpone pregnancies indefinitely

  6. Infertility • Seen in 10-15% of couples (general population) • The factors may relate to the female (65%) or the male (20%) and 15% unknown. • Women living with HIV might have additional problems due to the risks of STI’s and tubal occlusion. • STI’s also increase the risk for pregnancy losses. HIV+ women might have more abnormal cycles (longer or shorter) than controls* • HIV + women might have anovulation and infertility especially IDUs** *Harlow S, Schuman P, Cohen M, et al Effect of HOV infection on menstrual cycle length. J. Acquir Immune Defic Syndr 2000;24;68-75 ** Chirgwin KD, Feldman J, Muneyyirci-Delale O et al. menstrual function in HIV infected women without AIDS J. Acquir Immune Defic Syndr Hum retrovirol 1996;12;489-494 **Clark RA, Mulligan K, Stamenovic E, et al. Frequency of anovulation and early menopause among women enrolled in select ACTG studies J infect Dis 2001; 184; 1325-1327

  7. Fertility evaluation: History • Menstrual cycle frequency (25-35 days), and quality (dysmenorrhea is associated to endometriosis, abnormal or profuse bleeding can be a symptom of fibroids) • Changes in weight (>10 lbs) • Signs of insulin resistance • Concurrent medications (HAART) • Exercise (vigorous exercise impairs fertility) • Dieting • Cigarette smoking (impairs fertility) • History of STIs or PID • Substance use (IDU, Heroin blocks ovulation, methadone restores ovulation) • Testosterone use (males)

  8. Fertility Evaluation: Physical exam • Body habitus (metabolic syndrome: GDM, PCO) • BMI (<18 and >27 related to decreased fertility) • Hirsutism (Poly Cystic Ovaries-PCO) • Pelvic exam with signs of PID • Males: testicular size

  9. Fertility evaluation: Labs • Preconception counseling labs • Serum Prolactin and TSH • Tubal patency by HSG or laparoscopy • Ovarian reserve: day 3 FSH (>10-15 IU/L) abnormal and estradiol (>75-80 pg/ml) abnormal • Day #3 FSH > 25 or age> 44 equals close to 0% success rate • Ovulation tests: • Progesterone >3ng/ml on day 21 (1 week before menses) • Positive LH (commercial ovulation kits) or • BBT chart

  10. Clomiphene Challenge Test • An Assay of FSH response • Patient takes 100mg on cycle day 5-9, FSH is checked on day 3 & 10 • FSH >26 poor prospect for pregnancy • Abnormal tests increase with age • 3% in pts less than 30 y/o • 26% in pts greater than 39 y/o • 38% unexplained fertility…

  11. Assisted reproductive technology • HIV+ female/HIV- male • HIV+ male/HIV- female • Both HIV+ • Donor gametes

  12. HIV+ woman/HIV- male • If the male is HIV-, sperm is handled with the usual precautions • Check female health status: Low viral load, high CD4, clinically stable, avoid efavirenz, ddI, d4T

  13. HIV+ woman/HIV- maleTechniques • Self insemination (12-36 hrs after the LH peak) using a syringe and an angio-cath • Intrauterine insemination (IUI) when there is oligospermia, semen is washed and resuspended and it can be inserted into the uterine cavity (risks: infection, anaphylaxis) • Ovulation induction with Clomiphene • Ovulation induction with Gonadotropins (FSH) • In vitro Fertilization with embryo transfer (IVF-ET)

  14. HIV- woman/HIV+ male • HIV infection has been reported in 6 cases of donor insemination* • Some states regulate (control) the use of “contaminated semen” and consider it as a felony *Wortley PM, Hammett TA, Flemming PL. Donor insemination and HIV transmission Obstet Gynecol 1998;91:515-518

  15. HIV- woman/HIV+ maleTechniques • Sperm-washing and artificial insemination (intrauterine) with nested PCR to detect HIV in post wash sample has been used in Europe (3,600 attempts with no seroconversions)* *Semprini AE, Levi-Setti P, Bozzo M et al insemination of HIV- women with processed semen of HIV+ partners *Sauer MV. Sperm washing techniques address the fertility needs of HIV+ men: a clinical review Reprod Biomed Online 2005;10:135-140

  16. Safety and Efficacy of Sperm Washing in HIV-1-serodiscordant Couples Where the male is Infected: Results From the European CREAThE Network Bujan; Hollander; Coudert;Gilling-Smith; Vucetich;Guibert; Vernazza; Ohl; Weigel; Englert; Semprini AIDS. 2007;21(14):1909-1914 • Sperm washing used to obtain motile spermatozoa for 3,390 assisted intrauterine inseminations, 107 IVF, 394 ICSI (intra-cytoplasmic sperm injections) and 49 frozen embryo transfers. • A total of 580 pregnancies were obtained from 3,315 cycles. Pregnancy outcome was unknown in 47 cases.

  17. Safety and Efficacy of Sperm Washing in HIV-1-serodiscordant Couples Where the male is Infected: Results From the European CREAThE Network Bujan; Hollander; Coudert;Gilling-Smith; Vucetich;Guibert; Vernazza; Ohl; Weigel; Englert; Semprini AIDS.  2007;21(14):1909-1914 • The 533 pregnancies resulted in 410 deliveries and 463 live births. • The result of female HIV testing after assisted reproduction was known in 967 out of 1036 woman (7.1% lost to follow-up). • All tests recorded were negative. • The calculated probability of contamination was equal to zero (95% confidence interval, 0-0.09%).

  18. Safety and Efficacy of Sperm Washing in HIV-1-serodiscordant Couples Where the male is Infected: Results From the European CREAThE Network Bujan; Hollander; Coudert;Gilling-Smith; Vucetich;Guibert; Vernazza; Ohl; Weigel; Englert; Semprini AIDS.  2007;21(14):1909-1914 Conclusions: This first multicentre retrospective study of assisted reproduction following sperm washing demonstrates the method to be effective and to significantly reduce HIV-1 transmission risk to the uninfected female partner. These results support the view that assisted reproduction with sperm washing could not be denied to serodiscordant couples in developed countries and, where possible, could perhaps be integrated into a global public health initiative against HIV in developing countries

  19. Tenofovir-Based HIV Postexposure Prophylaxis K Mayer et alJ Acquir Immune Defic Syndr 2008;47:494-499 • 68 patients who presented after high-risk sexual exposure were prescribed a course of tenofovir DF 300 mg and lamivudine 300 mg, each given as one pill once a day, and a further 44 patients who received a course of tenofovir DF 300 mg and emtricitabine 200 mg (Truvada) given as a single fixed-dose tablet once daily, for NPEP. • The treatment courses were completed by 87.5% of patients in the tenofovir/lamivudine group and 72.7% of those in the tenofovir/emtricitabine group. Adherence was significantly higher than the 42.1% reported in 122 historical controls who were prescribed 126 courses of zidovudine and lamivudine for NPEP • No one in the tenofovir DF-containing NPEP groups became HIV-infected during the study period, whereas three individuals who used zidovudine-containing regimens became infected during or shortly after their course of NPEP (not statistically significant).

  20. International AIDS Society Conference on HIV Pathogenesis, Treatment and PreventionPietro Vernazza et al St. Gallen Hospital (Switzerland) Abstract • 21 Serodiscordant couples where the men were already taking antiretrovirals (HIV below the detectable level). • The female partners received two doses of tenofovir, one to be taken 36 hours before intercourse and another 12 hours before. • After each of the couples had made three attempts, 11 of the 21 couples (52%) had conceived, after 10 attempts, 15 (71%) were pregnant. • All the women in the study tested negative for HIV, 3 months after the last exposure.

  21. Timed Intercourse • Considered unsafe for serodiscordant couples • Transmission risk is small (0.1-0.2%) but cumulative exposure will increase the risk • Unprotected intercourse during the following 2 days after the LH surge (ovulation kits) • Consider timed intercourse with tenofovir PREP* * CZ

  22. Both partners HIV+ • Risks of reinfection/superinfection and other STIs • Ideally: washed inseminations or IVF-ET • Consider timed intercourse with tenofovir PREP if the woman is not on ART*

  23. Pregnancy Considerations Pre-conception Care is important for those women living with HIV who have postponed a pregnancy and want to achieve it now Therapy options might be different if you acknowledge a potential future pregnancy For new patients in care, the suspicion and detection of early pregnancy is crucial

  24. Preconception Care The main goal of preconception care is to provide health promotion, screening, and interventions for women of reproductive age to reduce risk factors that might affect future pregnancies It is part of a larger health-care model that results in healthier women, infants and families

  25. Recommendations to Improve Preconception Health and Health Care –United StatesMMWR April 21, 2006/Vol.55/No. RR-6 • Improve the knowledge and attitudes and behaviors of men and women related to preconception health • Assure that all women of childbearing age in the USA receive preconception care services

  26. Recommendations to Improve Preconception Health and Health Care –United StatesMMWR April 21, 2006/Vol.55/No. RR-6 3. Reduce risks indicated by a previous adverse pregnancy outcome through interventions during the interconception period, which can prevent or minimize health problems for a mother and her future children 4. Reduce the disparities in adverse pregnancy outcomes

  27. The law of expectationExpanding our reality Energy follows thought; we move toward, but not beyond, what we can imagine. What we asume, expect, or believe creates and colors our experience. By expanding our deepest beliefs about what is possible, we change our experience of life. Dan Millman The Laws of Spirit

  28. Preconception counseling and care specifically recommended for HIV-infected womenDHHS Perinatal Guidelines November 2, 2007 • Select effective and appropriate contraceptive methods to reduce the likelihood of unintended pregnancy. Providers should be aware of potential interactions of antiretroviral drugs with hormonal contraceptives that could lower contraceptive efficacy. • Counsel on safe sexual practices that prevent HIV transmission to sexual partners and protect women from acquiring sexually transmitted diseases (STDs) and the potential to acquire more virulent or resistant HIV strains. • Counsel on eliminating alcohol, illicit drug use, and cigarette smoking.

  29. Interactions Between Anti-HIV Drugs and OC’s

  30. Interactions Between Anti-HIV Drugs and OC’s

  31. Preconception counseling and care specifically recommended for HIV-infected womenDHHS Perinatal Guidelines November 2, 2007 d. Educate and counsel women about risk factors for perinatal HIV transmission, strategies to reduce those risks, and potential effects of HIV or treatment on pregnancy course and outcomes. e. When prescribing antiretroviral treatment to women of childbearing potential, considerations should include the regimen’s effectiveness for treatment of HIV disease and the drugs’ potential for teratogenicity should pregnancy occur. Women who are planning to get pregnant should strongly consider use of antiretroviral regimens that do not contain efavirenz (EFV) or other drugs with teratogenic potential. In addition, the effectiveness of a regimen in preventing mother-to-child HIV transmission should be considered.

  32. Preconception counseling and care specifically recommended for HIV-infected womenDHHS Perinatal Guidelines November 2, 2007 f. Attain a stable, maximally suppressed maternal viral load prior to conception in women who are on antiretroviral therapy and want to get pregnant. g. Evaluate and control for therapy-associated side effects that may adversely impact maternal-fetal health outcomes (e.g., hyperglycemia, anemia, hepatic toxicity). h. Evaluate for appropriate prophylaxis for opportunistic infections and administration of medical immunizations (e.g., influenza, pneumococcal, or hepatitis B vaccines) as indicated. i. Encourage sexual partners to receive HIV testing and counseling and appropriate HIV care if infected.

  33. Preconception counseling and care specifically recommended for HIV-infected womenDHHS Perinatal Guidelines November 2, 2007 j. Counsel regarding available reproductive options, such as intrauterine or intravaginal insemination, that prevent HIV exposure to an uninfected partner; expert consultation is recommended. k. Breastfeeding by HIV-infected women is not recommended in the United States due to risk of HIV transmission.

  34. Issues with antiretroviral use in pregnancy • Antiviral Drug resistance testing • Choice of drugs: PI vs non-PI • Missing Pregnancy PK data on new drugs (amprenavir, atazanavir, darunavir) • New classes of drugs: CCR5, entry inhibitors • New formulations: • Lopinavir/ritonavir capsule (lpv 133/rtv33mg) no longer available, no data on tablets (lpv 200/rtv 100mg) • Saquinavir SGC (sqv 800/rtv100 mg had good PK in pregnancy);1,200 mg SQV-hgc/50 mg RTV with AUCs above 10,000 ng • h/mL (n=2) *Lopez-Cortes, L. F., R. Ruiz-Valderas, R. Pascual, M. Rodriguez, and A. Marin Niebla. 2003. HIV Clin Trials. 4:227-9.

  35. Nelfinavir (Viracept) Contamination with ethyl methane sulfonate • Last summer, Viracept was recalled from the European and US market due to high levels of a harmful substance known as ethyl methane mesylate (EMS), a byproduct of the Viracept manufacturing process. EMS is known to be an animal carcinogen (can cause cancer) mutagen (can be harmful to DNA, the genetic material in cells) and a teratogen (can be harmful to the development of an unborn child). The level at which EMS may become carcinogenic in humans is not known.

  36. The DHHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission  Recommendations: • When considering the risk/benefits for use of Viracept (nelfinavir), the needs of the individual patient must always be considered. • Pregnant women who need to begin antiretroviral therapy or prophylaxis should not be offered regimens containing Viracept (nelfinavir) until further notice, but rather begin an alternative antiretroviral regimen. • Pregnant women who are currently receiving Viracept (nelfinavir) should be switched to an alternative antiretroviral regimen.   • For pregnant women with no alternative treatment options, the risk-benefit ratio remains favorable for the continued use of Viracept (nelfinavir) in these women.

  37. Pediatric Patients For pediatric patients who are stable on Viracept-containing regimens, the FDA and Pfizer agree that the benefit-risk ratio remains favorable and those patients may continue to receive Viracept. Pediatric patients who need to begin HIV treatment should not start regimens containing Viracept until further notice. Other Patients There is no change in the recommended use of Viracept for all other patients. Management

  38. Recommendations • Preconceptional care as part of routine care for women living with HIV • Need for provider self-acknowledgement of beliefs and values before reproductive issues are discussed or managed • It is better to refer than to deny options

  39. The universe does not judge us; it only provides consequences and lessons and opportunities to balance and learn through the law of cause and effect. Compassion is the recognition that we are each doing the best we can within the limits of our current beliefs and capacities. Dan Millman The Laws of Spirit The law of compassionAwakening our humanity

  40. Measure time, if you must, in lessons learned, not in minutes or hours or years. Brian Weiss Only Love is Real

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