第 15 回日本エイズ学会 第 15 回日本エイズ学会 interactive session...

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15 15 第第第第第第第第 第第第第第第第第 Interactive Session Interactive Session 第第第第第第 第第第第第第 HIV HIV 第第第第第第第第 第第第第第第第第 第第 第第 第 第第 第第 第 Karen Beckerman Karen Beckerman 第第 第 第第 第 第第 第第 第第 第第

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Page 1: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

第第 1515 回日本エイズ学会回日本エイズ学会

Interactive SessionInteractive Session症例から学ぶ症例から学ぶ HIVHIV 感染症診療のコツ感染症診療のコツ

   座長 : 青木 眞   座長 : 青木 眞

                 Karen BeckermanKaren Beckerman

   味澤 篤   味澤 篤

        岩本 愛吉        岩本 愛吉

Page 2: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

3333yo, married womanyo, married woman

She was diagnosed HIV positive at week of She was diagnosed HIV positive at week of

11 11 No symptoms No symptoms Concerning about risk of transmission to her Concerning about risk of transmission to her

baby baby CD4+ 616CD4+ 616 、、 HIV-RNA <4.0HIV-RNA <4.0 xx 101022 You fully counseled about the risk of You fully counseled about the risk of

continuing pregnancy continuing pregnancy

Case1 Case1 #1#1

Page 3: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

If she wants to continue If she wants to continue pregnancy, which regimen will you pregnancy, which regimen will you recommend?recommend?

1.1.    ZDVZDV

2.2.    NVP+ZDV+3TCNVP+ZDV+3TC

3.3.    NFV+NFV+ d4d4 T+ddIT+ddI

4.4.    NFV+ZDV+3TCNFV+ZDV+3TC

5.5. No antiretrovirals No antiretrovirals

Case1 #2Case1 #2

Page 4: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

When will you start her When will you start her treatment?treatment?

1.1.    IImmediately mmediately

2.2.    AAt week of 14th t week of 14th

3.3.    AAt week of 24th t week of 24th

4.4.    AAt week of 34th t week of 34th

5.5.    OOne day prior to delivery ne day prior to delivery

Case1 #3Case1 #3

Page 5: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Case 1Case 1 (( Cont.Cont. ))

She started ZDV at week of 14 She started ZDV at week of 14

Elective C/S at week of 35 Elective C/S at week of 35

ZDV prophylaxsis to the infant ZDV prophylaxsis to the infant

One year later: CD4 658One year later: CD4 658 、、 HIV-RNA <4.0HIV-RNA <4.0 xx101022

Baby is HIV-RNA negative, and growing Baby is HIV-RNA negative, and growing normaly normaly

Case1 Case1 #4#4

Page 6: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

  27 27 yo married womenyo married women

In 1997, she was diagnosed HIVIn 1997, she was diagnosed HIV (+)(+) in perinatal care in perinatal care

She delivered her baby without HIV management,She delivered her baby without HIV management,

But her baby was not infected with HIV.But her baby was not infected with HIV.

In 1999 ,She came to your clinic and showingIn 1999 ,She came to your clinic and showing thrombocytopenia thrombocytopenia

(( OctoberOctober )) CD4: 300CD4: 300 HIV-RNA : HIV-RNA : 2.52.5 xx 101055 Plt:60,000 Plt:60,000

No subjective symptom No subjective symptom

Case2 #1Case2 #1

Page 7: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

She is concerning her next baby.She is concerning her next baby.Which regimen will you Which regimen will you recommend?recommend?

1.1.    EFV+ZDV+3TCEFV+ZDV+3TC

2.2.    NFV+ZDV+3TCNFV+ZDV+3TC

3.3.    EFV+EFV+ d4d4 T+ddIT+ddI

4.4.    NVP+ZDV+3TCNVP+ZDV+3TC

5.5.    ZDVZDV

Case2 #2Case2 #2

Page 8: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Case2Case2 (( Cont.Cont. ))

She started HAART with NFV+ZDV+3TC She started HAART with NFV+ZDV+3TC

3 3 month later CD4:412 HIV-RNA: <50 copies month later CD4:412 HIV-RNA: <50 copies

6 6 month later switched ZDV to d4T because month later switched ZDV to d4T because she developed anemia she developed anemia

12 12 month later CD4:648 HIV-RNA: <50 copies month later CD4:648 HIV-RNA: <50 copies

18 18 month later She found herself pregnant. month later She found herself pregnant. Plt:180,000Plt:180,000

Case2 #3Case2 #3

Page 9: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Which treatment plan will you Which treatment plan will you recommend?recommend?

1.1. Stop HAART till week of 14 Stop HAART till week of 14thth , then come back on , then come back on samesame

regimen after 14regimen after 14thth week week

2.2. Stop HAART till week of 14Stop HAART till week of 14thth , start her , start her treatment again with ZDV treatment again with ZDV

3.3. Stop HAART, and start her treatment again after Stop HAART, and start her treatment again after delivery delivery

4.4.    CContinue HAARTontinue HAART

5.5.    CContinue HAART , and change d4T to ZDVontinue HAART , and change d4T to ZDV

Case2 #4Case2 #4

Page 10: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Case2Case2 (Cont.) (Cont.)

She continued HAART with same She continued HAART with same regimen(d4T+3TC+NFV) regimen(d4T+3TC+NFV)

At the week of 32, CD4: 600 HIV-RNA: <50 At the week of 32, CD4: 600 HIV-RNA: <50 copies copies

She delivered her baby without complication. She delivered her baby without complication. 3 3 month later CD4: 758month later CD4: 758 、、 HIV-RNA: <50 copies HIV-RNA: <50 copies Her baby’s HIV-RNA is negative, and growing Her baby’s HIV-RNA is negative, and growing

normally normally

Case2 Case2 #5#5

Page 11: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

19931993 ZDV for 2 months and ZDV for 2 months and d4T, ZDV, ddI for 1 d4T, ZDV, ddI for 1

monthmonth

19981998 NVP, 3TC, IDV for two NVP, 3TC, IDV for two monthsmonths

19991999 ZDV, 3TC, EFV ZDV, 3TC, EFV (12 June - 14 July)(12 June - 14 July)

S.O.S.O. is a 30 year-old G is a 30 year-old G66 P P33 A A22. . She was She was diagnosed HIV+ in 1991. One of diagnosed HIV+ in 1991. One of her three her three children died at one year of age. children died at one year of age. The other two are healthy. She is The other two are healthy. She is highly highly antiretrovirally exposed, with a antiretrovirally exposed, with a history of:history of:

Beckerman, Case 3 #1

Case3 Case3 #1#1

Page 12: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Recent laboratory values for S.O. are:Recent laboratory values for S.O. are:

DateDate CD4 CD4 (cells/(cells/l)l) pl HIV RNA pl HIV RNA (copies/ml)(copies/ml) (1999) (1999)16 July16 July Positive Urine Pregnancy TestPositive Urine Pregnancy Test

211211 100,000100,000

12 August12 August 7373 111,834111,834

19 August 19 August Resistance testing shows resistance to Resistance testing shows resistance to all nnRTIs.all nnRTIs.

8 September8 September 116116 206,519206,519Beckerman, Case 3 #2

Case3 Case3 #2#2

Page 13: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

You first meet S.O. in your office on You first meet S.O. in your office on 12 August. She 12 August. She hashas taken no taken no antiretrovirals since discovering she antiretrovirals since discovering she was pregnant in July. She is feeling was pregnant in July. She is feeling well. She thinks she is about “three well. She thinks she is about “three months” pregnant. On this first visit, months” pregnant. On this first visit, you would:you would:

Beckerman, Case 3 #3

1.1. Advise immediate termination of Advise immediate termination of pregnancy because of efavirenz pregnancy because of efavirenz exposure.exposure.

2. Ascertain whether this is a desired 2. Ascertain whether this is a desired pregnancy.pregnancy.

3. Restart combination antiretroviral 3. Restart combination antiretroviral therapy immediately.therapy immediately.

4. Start zidovudine alone to prevent vertical 4. Start zidovudine alone to prevent vertical transmission.transmission.

5. Resolve never to prescribe efavirenz to 5. Resolve never to prescribe efavirenz to any woman of reproductive age.any woman of reproductive age.

Case3 Case3 #3#3

Page 14: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

S.O. relates that this was not a S.O. relates that this was not a planned pregnancy, but is very planned pregnancy, but is very much desired, and that she does much desired, and that she does not want an abortion “no matter not want an abortion “no matter what.” Your next step in providing what.” Your next step in providing care for her is to:care for her is to:

Beckerman, Case 3 #4

1.1. Advise her of the risks of neural tube Advise her of the risks of neural tube defects in defects in

monkey studies following in utero monkey studies following in utero efavirenz exposure.efavirenz exposure.

2. Obtain an obstetrical ultrasound to 2. Obtain an obstetrical ultrasound to determine fetal gestational age.determine fetal gestational age.

3. Tell patient you cannot care for her 3. Tell patient you cannot care for her because of the risk that you might be because of the risk that you might be held responsible for the birth of a held responsible for the birth of a deformed baby.deformed baby.

4. Start zidovudine monotherapy 4. Start zidovudine monotherapy immediately.immediately.

5. Obtain resistance testing.5. Obtain resistance testing.

Case3 Case3 #4#4

Page 15: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Notes for case 3 #4Notes for case 3 #4

Neural tube defects (and most congenital Neural tube defects (and most congenital anomalies) occur well before 11 weeks anomalies) occur well before 11 weeks gestation.gestation.

S.O. cannot be advised of the risk to her S.O. cannot be advised of the risk to her baby if you do not know her gestational baby if you do not know her gestational age.age.

Similarly, recommendations regarding Similarly, recommendations regarding antiretrovirals cannot be made until the antiretrovirals cannot be made until the gestational age is known.gestational age is known.

Beckerman, Case 3 #5

CaseCase3 3 #5#5

Page 16: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

If you document first trimester fetal If you document first trimester fetal efavirenz exposure, reassuring efavirenz exposure, reassuring data can be obtained from which of data can be obtained from which of the following:the following:

Beckerman, Case 3 #6

1. 1. Ultrasound as early as 10 weeks Ultrasound as early as 10 weeks gestational age.gestational age.

2.2.Maternal blood tests at 16-20 weeks Maternal blood tests at 16-20 weeks gestational gestational

age.age.

3. Ultrasound at 18-22 weeks 3. Ultrasound at 18-22 weeks gestational age.gestational age.

4. All of the above.4. All of the above.

Case3 Case3 #6#6

Page 17: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Notes for case 3 #6:Notes for case 3 #6: Obstetrical ultrasound can often rule out Obstetrical ultrasound can often rule out

anencepahly as early as 10 weeks gestation.anencepahly as early as 10 weeks gestation. Maternal serum alpha fetal protein (MSAFP) Maternal serum alpha fetal protein (MSAFP)

is a marker for open fetal neural tube and is a marker for open fetal neural tube and abdominal wall defects. A value >2MOM is abdominal wall defects. A value >2MOM is not diagnostic, but a normal value would be not diagnostic, but a normal value would be very reassuring.very reassuring.

Ultrasound at18-22 weeks is highly sensitive Ultrasound at18-22 weeks is highly sensitive at detecting neural tube defects and many at detecting neural tube defects and many other congenital anomalies.other congenital anomalies.

Beckerman, Case 3 #7

Case3 Case3 #7#7

Page 18: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

After her third visit (8 September) After her third visit (8 September) to your office, at 16 weeks to your office, at 16 weeks gestational age, you become gestational age, you become concerned about S.O.’s high viral concerned about S.O.’s high viral load and low CD4 count. You offer:load and low CD4 count. You offer:1.1. ZDV monotherapy because it is the only ZDV monotherapy because it is the only

thing proven safething proven safe in pregnancy.in pregnancy.2. A one-pill ZDV/3TC combination because it 2. A one-pill ZDV/3TC combination because it

is easy for this non-compliant individual to is easy for this non-compliant individual to take.take.

3. A four-drug combination aimed at maximal 3. A four-drug combination aimed at maximal potency for control of maternal plasma potency for control of maternal plasma viremia.viremia.

4. ZDV/3TC combination plus NVP for ease of 4. ZDV/3TC combination plus NVP for ease of administration and benefits of triple administration and benefits of triple combination therapy.combination therapy.

5. No therapy or prophylaxis now, because 5. No therapy or prophylaxis now, because mother is not sick, and baby will probably mother is not sick, and baby will probably not survive anyway, due to the efavirenz not survive anyway, due to the efavirenz exposure.exposure.

Beckerman, Case 3 #8

Case3 Case3 #8#8

Page 19: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Recent laboratory values for S.O. are:Recent laboratory values for S.O. are:

DateDate CD4 CD4 (cells/(cells/l)l) pl HIV RNA pl HIV RNA (copies/ml)(copies/ml) (1999) (1999)16 July16 July Positive Urine Pregnancy TestPositive Urine Pregnancy Test

211211 100,000100,000

12 August12 August 7373 111,834111,834

19 August 19 August Resistance testing shows resistance Resistance testing shows resistance to all nnRTIs.to all nnRTIs.

8 September8 September 116116 206,519206,519Beckerman, Case 3 #9

Case3 Case3 #9#9

Page 20: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Notes for case 3 #8Notes for case 3 #8 Pregnant women should receive access to HIV Pregnant women should receive access to HIV

therapy regardless of their reproductive status.therapy regardless of their reproductive status. By any standard, SO has AIDS and a high chance of By any standard, SO has AIDS and a high chance of

dying in the next five years. She should be offered dying in the next five years. She should be offered potent therapy aimed and durable suppression of potent therapy aimed and durable suppression of viral replication.viral replication.

Neither ZDV monotherapy nor Combivir alone are Neither ZDV monotherapy nor Combivir alone are potent enough to control SO’s high viral load.potent enough to control SO’s high viral load.

Given her history, there is a high likelihood that she Given her history, there is a high likelihood that she may be resistant to ZDV, 3TC and NVP.may be resistant to ZDV, 3TC and NVP.

NVP is not the best choice for someone who has had NVP is not the best choice for someone who has had major adherence problems in the past.major adherence problems in the past.

Beckerman, Case 3 #10

Case3 Case3 #10#10

Page 21: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Which of the following options Which of the following options would you offer this mother?would you offer this mother?1. 1. Switch to a “megaHAART” regimen that Switch to a “megaHAART” regimen that

includes efavirenz and hydroxyurea.includes efavirenz and hydroxyurea.2. Discontinue all medications and begin ZDV 2. Discontinue all medications and begin ZDV

monotherpay per ACTG 076 guidelines.monotherpay per ACTG 076 guidelines.3. Complete switch to d4T/ABC/RTV/IDV.3. Complete switch to d4T/ABC/RTV/IDV.4. Nothing. Counsel patient and her husband 4. Nothing. Counsel patient and her husband

that there is now little to do to prevent that there is now little to do to prevent transmission of a highly resistant virus to transmission of a highly resistant virus to their baby.their baby.

5. Return to most recent combination. 5. Return to most recent combination. Counsel patient and her husband that the Counsel patient and her husband that the baby is likely to be born with birth defects baby is likely to be born with birth defects if she decides to take efavirenzif she decides to take efavirenz

Beckerman, Case 3 #11

Case3 #11Case3 #11

Page 22: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Notes for case 3 #11Notes for case 3 #11 While hydroxyurea has been used safely in While hydroxyurea has been used safely in

pregnancy for treatment of sickle cell anemia, pregnancy for treatment of sickle cell anemia, there are many other options to this.there are many other options to this.

SO is efavirenz-experienced and non-adherent, SO is efavirenz-experienced and non-adherent, therefore very likely nnRTI resistant.therefore very likely nnRTI resistant.

While there are other reasonable While there are other reasonable combinations, this one offered highly potent combinations, this one offered highly potent agents with a complete switch.agents with a complete switch.

Even though unlikely to be effective, efavirenz Even though unlikely to be effective, efavirenz would not induce birth defects at this would not induce birth defects at this gestational age.gestational age.

SO’s infant was uninfected.SO’s infant was uninfected.Beckerman, Case 3 #12

Case3 #12Case3 #12

Page 23: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

C.M.C.M. is a 34 year-old, Gravida 3, is a 34 year-old, Gravida 3, Para 1 at 30 weeks of pregnancy. Para 1 at 30 weeks of pregnancy. She has taken She has taken combination antiretroviral therapy combination antiretroviral therapy since since 1996. One year ago her viral load 1996. One year ago her viral load was 1,665, was 1,665, CD4 529. She is very adherent to CD4 529. She is very adherent to therapy.therapy.Current data:Current data:

Viral loadViral load 33,525 copies/ml33,525 copies/ml     CD4CD4 229 cells/229 cells/ll

     Genotypic resistance to:Genotypic resistance to:     all NRTI all NRTI      NVP NVP      all available PIsall available PIs

Beckerman, Case 4 #1

Case4 Case4 #1#1

Page 24: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

CM’s current regimen is ABC, NVP, CM’s current regimen is ABC, NVP, RTV (200 mg) and IDV (800 mg) all RTV (200 mg) and IDV (800 mg) all twice daily. Which of the following twice daily. Which of the following options would you offer this mother?options would you offer this mother?

Beckerman, Case 4 #2

1.1. Switch to a “megaHAART” regimen that Switch to a “megaHAART” regimen that includes includes

efavirenz and hydroxyurea.efavirenz and hydroxyurea.2. Discontinue all medications and begin 2. Discontinue all medications and begin

ZDValone per ACTG 076 guidelines.ZDValone per ACTG 076 guidelines.3. Empiric switch to d4T/ddI/RTV/IDV.3. Empiric switch to d4T/ddI/RTV/IDV.4. Counsel patient and her husband that there 4. Counsel patient and her husband that there

is now little to do to prevent transmission of is now little to do to prevent transmission of a highly resistant virus to their baby.a highly resistant virus to their baby.

5. Counsel patient and her husband that the 5. Counsel patient and her husband that the baby is likely to be born with birth defects if baby is likely to be born with birth defects if she decides to take efavirenzshe decides to take efavirenz

Case4 Case4 #2#2

Page 25: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Notes for case 4 #2Notes for case 4 #2 At this point, there are many more highly potent At this point, there are many more highly potent

options available. While hydroxyurea has been options available. While hydroxyurea has been safely used in pregnancy for sickle cell anemia, we safely used in pregnancy for sickle cell anemia, we have no experience in the setting of HIV. NVP have no experience in the setting of HIV. NVP resistance suggests EFV resistance.resistance suggests EFV resistance.

ZDV alone offers doubtful benefit to mother and ZDV alone offers doubtful benefit to mother and baby in this setting of documented clinical and baby in this setting of documented clinical and genotypic resistance.genotypic resistance.

The d4T/ddI combination has resulted in a handful of The d4T/ddI combination has resulted in a handful of case reports of lactic acidosis in pregnant women. case reports of lactic acidosis in pregnant women.

To date there is only one case report of vertical To date there is only one case report of vertical transmission of resistant virus.transmission of resistant virus.

Efavirenz started at 30 weeks of pregnancy will not Efavirenz started at 30 weeks of pregnancy will not cause neural tube defects.cause neural tube defects. Beckerman, Case 4

#3

Case4 Case4 #3#3

Page 26: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

You discover that C.M. had self-You discover that C.M. had self-adjusted her ritonavir dosage to adjusted her ritonavir dosage to 100 mg twice daily. Still, she has 100 mg twice daily. Still, she has decided to try a “switch” to twice-decided to try a “switch” to twice-daily d4T/ddI/RTV200/IDV800. Over daily d4T/ddI/RTV200/IDV800. Over the next month her viral burden the next month her viral burden falls to 3,452 copies/ml. C.M. has falls to 3,452 copies/ml. C.M. has requested an elective cesarean requested an elective cesarean section at 37 4/7 weeks. section at 37 4/7 weeks.

Six days before delivery, Six days before delivery, phenotypic testing results return, phenotypic testing results return, showing high resistance to ZDV and showing high resistance to ZDV and NVP and high sensitivity to NVP and high sensitivity to efavirenz.efavirenz. Beckerman, Case 4 #4

Case4 Case4 #4#4

Page 27: 第 15 回日本エイズ学会 第 15 回日本エイズ学会 Interactive Session 症例から学ぶ HIV 感染症診療のコツ 座長 : 青木 眞 座長 : 青木 眞 Karen

Which of the following delivery plans Which of the following delivery plans offered to C.M. do you think is the offered to C.M. do you think is the worstworst??

Beckerman, Case 4 #5

1. 1. Continue all medications. Add IV ZDV one Continue all medications. Add IV ZDV one day prior to day prior to delivery. Administer ZDV prophylaxis to delivery. Administer ZDV prophylaxis to the infant the infant until six weeks of age. until six weeks of age. 2. Continue all medications. Add EFV, 3TC, 2. Continue all medications. Add EFV, 3TC, IV ZDV one IV ZDV one day prior to delivery. Administer ZDV day prior to delivery. Administer ZDV prophylaxsis to prophylaxsis to the infant until six weeks of age. the infant until six weeks of age. 3. Continue all medications. Add IV ZDV one 3. Continue all medications. Add IV ZDV one day prior day prior to delivery. Administer ZDV and NVP to delivery. Administer ZDV and NVP prophylaxis to prophylaxis to the infant until six weeks of age.the infant until six weeks of age.4. Stop all medications one day prior to 4. Stop all medications one day prior to delivery and start delivery and start IV ZDV. Administer ZDV prophylaxis to the IV ZDV. Administer ZDV prophylaxis to the infant infant until six weeks of age. until six weeks of age. 5. Continue all medications. Add EFV, 3TC, IV 5. Continue all medications. Add EFV, 3TC, IV ZDV one ZDV one day prior to delivery. Administer d4T, ddI, day prior to delivery. Administer d4T, ddI, NVP NVP prophylaxis to the infant.prophylaxis to the infant.

Case4 #5Case4 #5

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Based on this information the Based on this information the following delivery plans were offered following delivery plans were offered to C.M. Which do you believe is the to C.M. Which do you believe is the bestbest??

Beckerman, Case 4 #6

1.1. Continue all medications. Add IV ZDV one Continue all medications. Add IV ZDV one day prior to day prior to

delivery. Administer ZDV prophylaxis to the delivery. Administer ZDV prophylaxis to the infant until six weeks of age. infant until six weeks of age.

2. Continue all medications. Add EFV, 3TC, IV 2. Continue all medications. Add EFV, 3TC, IV ZDV one day prior to delivery. Administer ZDV one day prior to delivery. Administer ZDV prophylaxsis to the infant until six ZDV prophylaxsis to the infant until six weeks of age. weeks of age.

3. Continue all medications. Add IV ZDV one 3. Continue all medications. Add IV ZDV one day prior to delivery. Administer ZDV and day prior to delivery. Administer ZDV and NVP prophylaxis to the infant until six NVP prophylaxis to the infant until six weeks of age.weeks of age.

4. Stop all medications one day prior to 4. Stop all medications one day prior to delivery and start IV ZDV. Administer ZDV delivery and start IV ZDV. Administer ZDV prophylaxis to the infant until six weeks of prophylaxis to the infant until six weeks of age. age.

5. Continue all medications. Add EFV, 3TC, IV 5. Continue all medications. Add EFV, 3TC, IV ZDV one day prior to delivery. Administer ZDV one day prior to delivery. Administer d4T, ddI, NVP prophylaxis to the infant.d4T, ddI, NVP prophylaxis to the infant.

Case4 Case4 #6#6

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Notes for case 4 #5 and Notes for case 4 #5 and #6:#6:

There are no right answers to these questions. There are no right answers to these questions. Guidelines do not yet exist to help us decide Guidelines do not yet exist to help us decide

whether ZDV prophylaxis is effective when whether ZDV prophylaxis is effective when there is clear evidence of high level maternal there is clear evidence of high level maternal clinical, genotypic and phenotypic ADV clinical, genotypic and phenotypic ADV resistance. resistance.

In San Francisco, we have found it helpful to In San Francisco, we have found it helpful to separate issues of maternal health from issues separate issues of maternal health from issues of perinatal transmission prophylaxis when of perinatal transmission prophylaxis when identifying options.identifying options.

CM chose option 5, adding EFV, 3TC and IV ZDV CM chose option 5, adding EFV, 3TC and IV ZDV one day before delivery by elective cesarean one day before delivery by elective cesarean section. She requested that her infant be section. She requested that her infant be placed on d4T, ddI and NVP for prophylaxis.placed on d4T, ddI and NVP for prophylaxis.

Beckerman, Case 4 #7

Case4 #7Case4 #7

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Notes for case 4 #5 and Notes for case 4 #5 and #6:#6: CM is an unusual case of advanced HIV CM is an unusual case of advanced HIV

disease and resistance to all available disease and resistance to all available medications. She requested “everything medications. She requested “everything possible” that could be done to prevent possible” that could be done to prevent transmission to her infant.transmission to her infant.

There is no justification for jeopardizing There is no justification for jeopardizing maternal viral control by stopping maternal viral control by stopping medications here.medications here.

We reasoned that the addition of 3 We reasoned that the addition of 3 medications that CM had not taken for medications that CM had not taken for some time could be of benefit. The fetus some time could be of benefit. The fetus was given triple prophylaxis because of was given triple prophylaxis because of mother’s resistance profile.mother’s resistance profile.

Beckerman, Case 4 #8

Case4 #8Case4 #8

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Notes for case 4 #5 and Notes for case 4 #5 and #6:#6:

C.M. delivered a healthy 2850 g girl by C.M. delivered a healthy 2850 g girl by elective cesarean section as planned.elective cesarean section as planned.

Today, eighteen months later, C.M. is feeling Today, eighteen months later, C.M. is feeling well, and is happy with her two children after well, and is happy with her two children after recovering from a serious post-partum recovering from a serious post-partum depression. She has mild symptoms of depression. She has mild symptoms of lipodystrophy.lipodystrophy.

Most recent laboratory values:Most recent laboratory values:Mother:Mother: VLVL <50 copies/ml<50 copies/ml

CD4CD4 517 cells/517 cells/ll

Baby:Baby: HIV-1 DNA PCRHIV-1 DNA PCR negative negative x 4x 4

HIV-1 antibodyHIV-1 antibody negative at 16 negative at 16 monthsmonths

Beckerman, Case 4 #9

Case4 #9Case4 #9

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M.B.,M.B., a 30 year old Gravida 5 a 30 year old Gravida 5 Para 1 is Para 1 is referred to you after testing HIV+ referred to you after testing HIV+ on on prenatal screening. She denies any prenatal screening. She denies any risk risk factors except for unprotected factors except for unprotected vaginal vaginal intercourse. She is 15 weeks intercourse. She is 15 weeks pregnant and complains of a pregnant and complains of a vaginal discharge. vaginal discharge. Over the next month, you attempt Over the next month, you attempt toto treattreather bacterial vaginosis first with her bacterial vaginosis first with metronidazole, then with metronidazole, then with clindamycin, but she refuses to clindamycin, but she refuses to take the medication and states she take the medication and states she does not like “putting unnatural does not like “putting unnatural chemicals” in her body and chemicals” in her body and that that she hates taking pills.she hates taking pills.

Beckerman, Case 5 #1

Case5 Case5 #1#1

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By 22 weeks gestation you are By 22 weeks gestation you are becoming concerned about her becoming concerned about her ability to take antiretroviral therapy ability to take antiretroviral therapy during pregnancy. Her during pregnancy. Her CD4CD4 =492 =492 and and VLVL=2,490. She refuses to take =2,490. She refuses to take more than one pill to prevent more than one pill to prevent transmission to her baby, and wants transmission to her baby, and wants no therapy for her health. Which no therapy for her health. Which option do you think is safest for her option do you think is safest for her and the fetus?and the fetus?

Beckerman, Case 5 #2

1. 1. Late second trimester abortion .Late second trimester abortion .2. One Combivir (ZDV/3TC) capsule 2. One Combivir (ZDV/3TC) capsule twice daily.twice daily.3. Combivir + nevirapine twice daily.3. Combivir + nevirapine twice daily.4. Nevirapine alone.4. Nevirapine alone.5. ZDV 300mg twice daily. 5. ZDV 300mg twice daily.

Case5 #2Case5 #2

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Notes for case 5 #2:Notes for case 5 #2:

Reproductive choice involves self-Reproductive choice involves self-determination. While M.B. requires determination. While M.B. requires education regarding HIV disease and education regarding HIV disease and pregnancy, it is not appropriate to pregnancy, it is not appropriate to recommendrecommend either continuation or either continuation or termination of the pregnancy at any time.termination of the pregnancy at any time.

Combivir alone is outside of standard of care Combivir alone is outside of standard of care for all individuals and is highly likely to for all individuals and is highly likely to rapidly induce nRTI resistance, which can be rapidly induce nRTI resistance, which can be vertically transmitted.vertically transmitted.

Combivir/nevirapine is a reasonable choice, Combivir/nevirapine is a reasonable choice, however skipped doses will lead rapidly to however skipped doses will lead rapidly to nnRTI resistance. It is pointless to insist on a nnRTI resistance. It is pointless to insist on a regimen that a woman has already told you regimen that a woman has already told you she does not want take.she does not want take.

Beckerman, Case 5 #3

Case5 Case5 #3#3

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CombivirCombivir Alone Alone

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Notes for case 5 #2:Notes for case 5 #2: The risk of transmission at this viral burden is The risk of transmission at this viral burden is

low (<5%) and probably lower still with ZDV low (<5%) and probably lower still with ZDV prophylaxis. ZDV alone is low potency, and may prophylaxis. ZDV alone is low potency, and may not induce resistance in the short time it is given.not induce resistance in the short time it is given.

This mother will require intensive case This mother will require intensive case management after baby is born, with support an management after baby is born, with support an education regarding infant nutrition, testing and education regarding infant nutrition, testing and ZDV prophylaxis.ZDV prophylaxis.

We have found that giving women the power to We have found that giving women the power to make important treatment decisions helps them make important treatment decisions helps them become invested in their own treatment or become invested in their own treatment or prophylaxis strategies. It improves prophylaxis strategies. It improves communication and adherence. If caregivers communication and adherence. If caregivers insist on treatments a patient does not want, she insist on treatments a patient does not want, she will simply agree to one thing and do another.will simply agree to one thing and do another.Beckerman, Case 5 #4

Case5 Case5 #4#4