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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No: 4139/QD-BYT
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Hanoi, November 2nd, 2011
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DECISION
ON
THE MODIFICATION AND SUPPLEMENT OF CONTENTS IN “GUIDELINE ON HIV/AIDS DIAGNOSIS
AND TREATMENT” PROMULGATED AT THE DECISION No. 3003/QĐ-BYT DATED ON AUGUST 19,
2009 BY MINISTER OF HEALTH
MINISTER OF HEALTH
Pursuant to the Government
Decree No. 188/2007/ND-CP dated December 27, 2007 assigning roles,
responsibilities, authorities and organizational structures for the Ministry of
Health;
At the proposal of the
Director General of Vietnam Administration for HIV/AIDS Control (VAAC),
Director of Department of Management of Examination and Treatment,
DECIDES:
Article 1: Modify and supplement (add) some contents in “Guideline on
HIV/AIDS diagnosis and treatment” promulgated at the decision No. 3003/QĐ-BYT
dated on August 19, 2009 by Minister of Health (hereafter referred as Decision
3003) as follows:
1. Modify Part A, section III, item 1,
point 1.1 on “Indication of Co-trimoxazole prophylaxis” as follows:
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- “HIV infected persons with CD4 count ≤ 350 cells/mm3
regardless to clinical stages”
- Other contents of this point are remained the same as in Decision
3003.
2. Modify Part A, section VI, item 2 on
“Criteria for initiation of ARV” as follows:
Criteria for initiation of ARV:
- HIV infected persons with CD4 count ≤ 350 cells/mm3
regardless to clinical stages or
- HIV infected persons with clinical stage 3, 4 regardless to CD4
count.
3. Modify Part A, section VI, item 4 on
“ First-line ARV regimens” as follows:
4.1. Prioritized regimens:
TDF + 3TC + EFV or TDF + 3TC +
NVP
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For the regimen TDF + 3TC +
EFV: 3TC is used with dose of 300mg once daily.
4.2. Alternative regimens:
AZT + 3TC + EFV or AZT + 3TC +
NVP
Indication: Use either one of these two regimens if there is contraindication
of TDF.
4. Modify Part A, section VI, item 8,
point 8.3.1 on “ Selection of 2nd line regimen” as follows:
1st line regimen
2nd line regimen
TDF + 3TC + NVP/EFV
AZT + 3TC
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LPV/r or ATV
AZT + 3TC + NVP/EFV
TDF + 3TC
- Other contents of this point are remained the same as in Decision
3003.
5. Modify, supplement Part A, section
VI, point 9.2.1 on “Choice of ARV regimen for HIV/HBV co-infected patients” as
follows:
- Regimen for HIV/HBV co-infected patients
TDF + 3TC + EFV
- Other contents of this point are remained the same as in Decision
3003.
6. Modify Part A, section VII, item 1,
point 1.1.1 on “Criteria for ART initiation in pregnant women” as follows:
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7. Modify Part A, section VII, item 2,
point 2.1 on “ Who needs ARV prophylaxis for PMTCT” as follows:
Change the content
“HIV-infected women not eligible for ART (women in clinical stage 1-2 with CD4
count > 250cells/mm3, women in clinical stage 3-4 with CD4 count
>350cells/mm3)” to “HIV-infected women not eligible for ART
(women in clinical stage 1-2 with CD4 count > 350cells/mm3)”
Other contents of this point
are remained the same as in Decision 3003.
8. Modify Part A, section VII, item 2, point 2.2 on “ARV
regimens for the mother and the infant in PMTCT”
as follows:
- Modify
point 2.2.1 on “Prioritized regimen AZT + single dose NVP” as follows:
Mother
Antepartum
AZT 300mg twice a day, daily
from week 14 of pregnancy or right after HIV infection is detected after week
14 until beginning labor.
Intrapartum
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Postpartum
AZT 300mg + 3TC 150mg twice a
day in 7 days
Infant
Immediately after birth
Single dose NVP 6 mg, once
right after birth + AZT 4mg/kg twice a day.
Postnatal
Continue with AZT 4mg/kg
twice a day in 4 weeks
- Modify
the regimen: AZT + 3TC + LPV/r:
+ Mother:
daily from week 14 of pregnancy or right after HIV infection is detected after
week 14 until beginning labor. If the mother does not breastfeed then stop
taking pills; if the mother breastfeeds then continue taking pills until after
1 week of weaning.
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3TC 150mg twice a day
LPV/r 400/100 mg twice a day
+ Infant: AZT 4mg/kg twice a
day in 4 weeks.
- Other
contents of this point are remained the same as in Decision 3003.
9. Modify Part B, section III, item 1, point b on “Indication
of prophylaxis for OIs” as follows:
Table
4: Indications of prophylaxis with co-trimoxazole for HIV exposed and infected
children
HIV exposed children
HIV confirmatively infected children
< 24 months of age
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> 60 months of age
- CTX prophylaxis is
indicated for baby, starting at 4-6 weeks of age and continues until
exclusion of HIV infection.
- If HIV infection is
confirmed, see the next columns
Prophylaxis is indicated for
all infected children
- Clinical stage 2, 3, and 4
regardless of TCD4 count.
Or
- % TCD4 < 25% or TCD4
count ≤ cells/mm3 regardless of clinical stage.
- Test for TCD4 count:
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+ TCD4 ≤ 350 cells/mm3
regardless of clinical stage.
- No test for TCD4:
Clinical stage 2, 3, 4
10. Modify Part B, section VI, item 2 on “Criteria for
initiating ART” for children as follows:
Criteria for initiating ART for
children base on diagnostic status of HIV infection, age, clinical and
immunological stage of children.
2.1. Children with confirmed
HIV infection:
- Children
< 24 months: ARV should be provided immediately regardless of clinical stage
and TCD4 count.
- Children
at 24 – 60 months of age: ARV is provided if:
+ Percentage of TCD4 ≤ 25% or
TCD4 count ≤ 750 cells/mm3 regardless of clinical stage.
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- Children
> 60 months: indicated with ARV therapy as for HIV infected adults regulated
at item 2 Article 1 of this Decision.
2.2.
Children under 18 months of age with first-time positive PCR result: provide
ARV therapy and then perform PCR test for the second time. Stop ART if the
diagnostic result is HIV negative.
2.3.
Children under 18 months of age who have not got HIV test result: provide ARV
when the child is diagnosed with severe HIV/AIDS clinical stage.
11. Modify Part B, section VI, item 4 on “First-line ARV
regimens” as follows:
4.1. For children < 24
months of age who have exposed to NVP or EFV due to the mother has been
provided ARV or the children were provided ARV prophylaxis for PMTCT.
AZT + 3TC + LPV/r
4.2. For children < 24
months of age who have not exposed or uncertain to confirm history of exposure
to NVP or EFV due to the mother has been provided ARV or they were provided ARV
prophylaxis for PMTCT.
AZT + 3TC + NVP
4.3. For the children at 24 –
36 months of age:
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4.4. For children > 36
months of age
AZT + 3TC + NVP/EFV
In case of intolerance to AZT
change to ABC. If there is contraindication of ABC, use d4T.
4.5. For children > 12 years
of age and HBV infected:
TDF + 3TC + EFV/NVP
12. Modify Part B, section VI, item 8, point 8.3 on “Choice of
second line regimen” as follows:
Table
10: Switching from 1st line regimens to 2nd line regimen
Choice of switching regimens
1st line regimens
currently provided
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AZT/d4T + 3TC + NVP/EFV
ABC + 3TC/ddI + LPV/r
ABC + 3TC + NVP/EFV
AZT + 3TC/ddI + LPV/r
AZT/d4T + 3TC + ABC
ddI + EFV/NVP + LPV/r
13. Modify Part B, section VI, item 9 on “ART for children with
TB” as follows:
9.3. Use these regimens:
9.3.1. For children ≤ 36 months
of age with TB:
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9.3.2. For children > 36
months of age with TB:
AZT + 3TC + EFV or AZT + 3TC +
ABC
Indication of TB prophylaxis
with INH for HIV-infected children when:
- Children ≥ 12 months of age: no evidence of progressive TB based on clinical
screening and no exposure to TB patients.
- Children
< 12 months of age: exposed to TB patients and excluded from progressive TB.
If children < 12 months of age are not diagnosed progressive TB and have never
exposed to TB patients, TB prophylaxis should not be provided.
- Dose:
10mg/kg/day (maximum 300mg/day).
- Prophylaxis
duration: 6 months.
- Supplement
with Vitamin B6 25mg/day when providing TB prophylaxis with INH.
Article 2: Other contents on HIV diagnoses and treatments not mentioned in
this Decision will be remained unchanged as in Decision No. 3003.
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Article 4: This Decision became effective as from the signed and promulgated
date.
Article 5: Mr. (Mrs.): Chief of Secretariat, Chief Inspector, Heads of
Departments of Ministry of Health, and Directors of Provincial Departments of
Health are responsible for implementing this Decision.
P.O MINISTER OF HEALTH
DEPUTY MINISTER OF HEALTH
Nguyen Thi Xuyen