Decision No. 4139/QD-BYT dated November 2nd, 2011, on the modification and supplement of contents in “Guideline on HIV/AIDS diagnosis and treatment” promulgated at the Decision No. 3003/QD-BYT

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:

- Change the criterion “HIV-infected persons with clinical stage 1, 2 and CD4 count < 200 cells/mm3” to:

- “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

Indication: Use only either one of these two regimens for all patients starting ART.

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:

- 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:

Criteria for initiating ART in HIV-infected pregnant women are similar to that for non-pregnant HIV positive adults regulated at item 2 Article 1 of this Decision.

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:

- 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.

Dose: AZT 300mg twice a day

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

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.

+ Or children in clinical stage 3, 4 regardless of TCD4 count.

- 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:

AZT/d4T + 3TC + NVP

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

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:

AZT + 3TC + NVP or AZT + 3TC + ABC

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.

Article 3: This Decision will be applied in all HIV/AIDS care and treatment clinics.

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.