western cape art guidelines presentation...

WESTERN CAPE ART GUIDELINES PRESENTATION

2013

• The WC guidelines are based on SA National ART guidelines dated 24th March 2013

• Acknowledgement goes to members of the Adult and Paediatric HAST policy advisory groups for their valuable input and comment

GOALS OF THE PROGRAMME

• Save lives and improve the quality of life of people living with HIV• Achieve best health outcomes in the most cost‐efficient manner• Implement nurse‐initiated treatment• Decentralise service delivery to PHC facilities• Integrate services for HIV, TB, MCH, SRH and wellness• Diagnose HIV earlier• Prevent HIV disease progression• Avert AIDS‐related deaths• Retain patients on lifelong therapy• Prevent new infections among children, adolescents, and adults• Mitigate the impact of HIV and AIDS

SPECIFIC OBJECTIVES

• To prioritise initiation of combination antiretroviral treatment – see detail under FDC Implementation

• To test all HIV exposed children under‐five years and treat all those found to be infected with HIV.

• To standardise first and second line therapy for children, adolescents, and adults in the public and private sector.

• To move patients currently on Stavudine‐containing regimens to Tenofovir‐based FDCs, once creatinine clearance has been checked. Stavudine (d4T) to be used only under specific circumstances.

• To strengthen capacity of nurses to initiate ARVs for treatment of pregnant women who are HIV positive for their own health and to prevent mother to child transmission.

• To strengthen PHC facilities to initiate, manage, monitor and refer patients.

Adults &Adolescents

ELIGIBILITY FOR STARTING HAART

CD4 count <350 cells/mm3 irrespective of WHO clinical stage

ORIrrespective of CD4 count

• All types of TB • HIV positive women who are pregnant or

breast feeding • WHO stage 3 or 4

Patients requiring fast tracking(i.e. ART initiation within 7 days of being eligible)

HIV positive women who are pregnant or breast feeding [where capacity exits: initiate SAME day as eligibility

established]OR

•Patients with a CD4 ≤ 200OR

Patients with WHO stage 4 disease OR

Patients with TB/HIV co morbidity with CD4 count < 50

Patients with CD4 above 350: Not yet eligible for ART

Transfer to a wellness programme for regular follow-up and repeat CD4 testing 6 monthly.Advise on how to avoid HIV transmission to sexual partners and childrenInitiate INH prophylaxis if asymptomatic for TB AND a positive mantoux testProvide counselling on nutrition and contraceptionPap smear should be doe on diagnosis and if normal every 3 years

[

Standardised Western Cape ART regimensfor adults and adolescents

1st Line

All new patients needing treatment, including pregnant women

Tenofovir [TDF] +Emtricitabine [FTC] (or Lamivudine [3TC) + Efavirenz [EFV]

fixed dose combination

preferred

Adolescents - new: TDF 300mg daily if ≥15 years of age AND ≥40kg AND eGFR is ≥ 80*Adolescents – on treatment:switch to TDF 300mg daily if ≥15 years of age AND ≥40kg AND VL < 400 copies/ml IF eGFR is ≥ 80

Contra = indications to Efavirenz [EFV]

Tenofovir [TDF] +Emtricitabine[FTC] (or Lamivudine [3TC) + Nevirapinie[NVP]

Use NVP based regimen in patients with significant psychiatric co-morbidity or intolerance to EFV where the neuro-psychiatric toxicity may impair daily functioning, e.g. shift workers.Patients should not be initiated on NVP if:- Female with an initial CD4 >

250 cells/mm3

- Males with an initial CD4 > 400 cells/mm3

Contra = indication to Tenofovir [TDF]

Zidovudine [AZT] +Lamivudine [3TC] + Efavirenz [EFV] OR Nevirapine [NVP]

Renal disease [Cr Cl ≤ 50 ml/min] or the concurrent use of other nephrotoxic drugs e.g. aminoglycosides [kanamycin]Pregnant women: Cr < 85µmol/l

Contra = indication to Tenofovir [TDF] and Zidovudine [AZT]

Stavudine [d4T] + Lamivudine [3TC] + Efavirenz [EFV] OR Nevirapine [NVP]

Renal disease [Cr Cl ≤ 50 ml/min] or the concurrent use of other nephrotoxic drugs e.g. aminoglycosides [kanamycin] and anaemia [Hb ≤ 8g/dl: use Zidovudine 200mg bd; Hb ≤ 6.5 g/dl: change medicine]

Contra = indication to Tenofovir [TDF]; Zidovudine [AZT] and Stavudine [d4T]

Abacavir [ABC] +Lamivudine [3TC] +Efavirenz [EFV] OR Nevirapine [NVP]

Renal disease [Cr Cl ≤ 50 ml/min] or the concurrent use of other nephrotoxic drugs e.g. aminoglycosides [kanamycin]; anaemia [Hb ≤ 8g/dl: use Zidovudine 200mg bd; Hb ≤ 6.5 g/dl: change medicine]; peripheral neuropathy; hyperlactataemia; lypoatrophy [circular H34 2012: submit motivation]

Currently on d4T-based regimen

Tenofovir [TDF] + Emtricitabine[FTC] (or Lamivudine [3TC) + Efavirenz [EFV]

If patients experience, or are at high risk of toxicity (high BMI or pregnant). Switch to TDF if virologicallysuppressed and the patient’s creatinineclearance is normal

2ND LINE

Management of virological failure

If plasma HIV RNA > 1 000 copies/ml:

- Check adherence, compliance, tolerability, drug-drug interactions and assess any psychological issues.

- Repeat VL test within 3 months.

If plasma VL confirmed > 1 000 copies/ml change to second line therapy

Patients on Tenofovir and Emtricitabine [or Lamivudine]:- Check Hepatitis B status prior to changing

regimen- If HepB sAg positive: maintain patients on

Tenofovir and Emtricitabine [or Lamivudine]Suggested regimen would be: TDF + AZT + FTC [or 3TC] + LPV/r

Failing on a Tenofovir [TDF] -based 1st line regimen

Zidovudine [AZT] + Lamivudine [3TC] + Lopinavir / ritonavir [LPV/r]

Failing on a Stavudine [d4T] or Zidovudine [AZT] based 1st line regimen

Tenofovir [TDF] + Lamivudine [3TC] + Lopinavir / ritonavir [LPV/r]

LPV/r may increase the levels of TDF: monitor for TDF side effects

Contraindication to Tenofovir [TDF]; Zidovudine [AZT] and Stavudine [d4T]

Abacavir [ABC] + Lamivudine [3TC] + Lopinavir / ritonavir [LPV/r]

Renal disease [Cr Cl ≤ 50 ml/min] or the concurrent use of other nephrotoxic drugs e.g. aminoglycosides [kanamycin]; anaemia [Hb ≤ 8g/dl: use Zidovudine 200mg bd; Hb ≤ 6.5 g/dl: change medicine]; peripheral neuropathy; hyperlactataemia; lypoatrophy [circular H34 2012: submit motivation]v

Lopinavir / ritonavir [LPV/r] related adverse effects:Hypertriglyceridaemia: fasting triglycerides > 5mmol/lCardiovascular event risk > 20%Severe hypercholesterolaemia: Total Cholesterol > 7.5mmol/lEstablished clinical cardiovascular diseaseSevere GIT side effects: > 6 weeks

Switch Lopinavir / ritonavir [LPV/r] to Atazanavir / ritonavir [ATV/r]

No motivation requiredRefer to Circular H148 2011

Third line

Failing any 2nd

line regimen: A provincial policy will be forthcoming

Specialist referral: Should be managed by an infectious disease specialist on the basis of genotype resistance testing. Most likely regimen may include one or more of the following: Raltegravir, Darunavir or Etravirine.

Monitoring of Adult and Adolescents with HIV

At initial Diagnosis of HIV PurposeConfirm HIV status Ensure that Western Cape testing

algorithm has been followedDo CD4 count and WHO clinical staging if HIV positive

To assess eligibility for ART To assess eligibility for fast-tracking

Screen for pregnancy or ask if planning to conceive

To identify women who need ART

Screen for TB symptoms To identify TB/HIV co-infection [refer to WC TB screening tool]

Mantoux test [TST] Identify need for IPTCLAT: All HIV + patients with an initial CD4 < 100 cells/mm3

Identify patients who required cryptococcal meningitis prophylaxis with fluconazole

At Routine Follow-Up Visits for those not yet eligible for

ART

Purpose

Repeat CD4 count 6 monthly

To determine if patient has become eligible for ART

WHO clinical staging at every visit


Screen for TB symptoms to identify TB suspectsOffer IPT if no TB symptoms AND mantoux positivei

To identify TB/HIV co-infection

To prevent TB activation

Prior to initiation of ART (Baseline)

Purpose

Hb and differential WCC: for patients initiating on Zidovudine [AZT]

To detect anaemia; neutropenia

ALT: for patients initiating on Nevirapine [NVP]

To assess for liver dysfunction

Serum creatinine and creatinine clearance: for patients initiating on Tenofovir [TDF]

If pregnant: serum creatinine level

To detect renal insufficiency: if CrCl ≤ 50: DO NOT use Tenofovir. Zidovudine and Lamivudine may be used: doses should be adjusted for renal impairment. [Appendix 1: Adult dosages in renal impairment]Should be ≤ 85 µmol/l

On ART PurposeCD4 at 1 year on ART. If CD4 < 200 cells/mm3 repeat 6 monthly until two consecutive CD4’s > 200 cells/mm3

To monitor immune response to ARTStop prophylactic cotrimoxazole and fluconazole after two consecutive CD4’s > 200 cells/mm3

VL at month 4, month 12 and then annually If on DR TB treatment: VL 6 monthly until DR TB treatment completedIf pregnant or breastfeeding: VL 6 monthlyvii. Do a VL at 36 weeks if no VL has been done in the last 4 months

To monitor response to treatment and identify treatment failures

To ensure optimal viral suppression prior to delivery

ALT: if on Nevirapine [NVP] or Efavirenz [EFV] and develops rash or symptoms of hepatitis

To identify Nevirapine [NVP] or Efavirenz [EFV] toxicity

HB and diff WCC at month 1, 2, 3 and 6 if on Zidovudine [AZT]

To identify Zidovudine [AZT] toxicity

Creatinine clearance at month 1; 4; 12 and then every 12 months if on Tenfovoir [TDF]

To identify Tenofovir [TDF] toxicity. *If < 16 years: the following formula should be used:

GFR = height [cm] x 40creatinine [µmol/l]

If > 16 years: use adult weight-based formula for GFRFasting cholesterol and triglycerides: baseline on initiating Lopinavir / ritonavir [LPV/r].Then at month 4, month 12 and then annually

To identify Lopinavir / ritonavir [LPV/r] toxicity

Hep B sAg Patients on Tenofovir [TDF] and Emtricitabine [FTC] or Lamivudine [3TC] changing to second line treatment

INFANTS & CHILDREN

Eligibility criteria for initiating ARTin infants and children

Eligibility for starting ART

All children less than 5 years of age: irrespective of CD4Children 5 years to 15 years:

WHO clinical stage 3 or 4 ORCD4 <350 cells/ mm3

Patients requiring fast tracking (i.e. start ART within 7 days of being eligible)

Children less than 1 year of ageWHO clinical Stage 4MDR or XDR-TBCD4 count < 200 cells/mm3 or < 15%

ART regimens for infants and children

First Line RegimenAll infants and children under 3 years (or < 10kg)

Abacavir [ABC] + Lamivudine [3TC] + Lopinavir / Ritonavir [LPV/r]

Children ≥ 3 years (or ≥ 10kg): •NOT exposed to Nevirapine during PMTCT•EXPOSED to Nevirapine during PMTCT for 6 weeks or longer

Abacavir [ABC] + Lamivudine [3TC] + Efavirenz [EFV]

Abacavir [ABC] + Lamivudine [3TC] + Lopinavir / Ritonavir [LPV/r]

Currently on Stavudine [d4T] -based regimen

Change Stavidine [d4T] to Abacavir [ABC] if viral load is undetectable If viral load >1000 copies/ml manage as treatment failureIf viral load between 50 – 1000 copies/ml –consult with expert for advice

Second Line Regimen

Failed first line Protease Inhibitor (PI) based regimen

ABC + 3TC + LPV/r

Consult with Paediatric Infectious Disease Specialist for advice*

D4T + 3TC + LPV/r

Unboosted PI-based regimenRifampicin while on LPV/r

Failed First line NNRTI based regimen (discuss with expert before changing)

First line NNRTI-based regimen

Recommended second line regimen

ABC +3TC + EFV (or NVP)

AZT + 3TC +LPV/r

d4T +3TC + EFV (or NVP AZT + ABC + LPV/r

Third line regimens

Failing any 2nd line regimen

Should be managed by a Paediatric Infectious Disease Specialist on the basis of genotype resistance testing.

Monitoring for infants and children with HIV

At initial Diagnosis of HIV PurposeConfirm HIV status Ensure that Western Cape testing

algorithm has been followedDocument weight, height, head circumference (<2yrs) and development

To monitor growth and development and identify eligibility for ART

Screen for TB symptoms To identify TB/HIV co-infectionWHO Clinical Staging [≥ 5 years] To determine if patient is eligible

for ARTCD4 count Children < 5 years: DO NOT wait

for CD4 count to start ART Children ≥ 5 years: to determine eligibility for ART and start cotrimoxazole prophylaxis as per Western Cape guideline

FBC + diff To detect anaemia; neutropenia; thrombocytopaenia

Neurocognitive developmental assessments

With appropriate available tool

At Routine Follow-Up Visits for those not yet

eligible for ART

Purpose

Document weight, height, head circumference (<2 years) and development

To monitor growth and development

Repeat CD4 count 6 monthly


WHO clinical staging at every visit


Screen for TB symptoms

To identify TB/HIV co-infection



Prior to initiation of ART (Baseline)

Purpose

FBC If less than 8g/dl start ART and discuss with specialist

CD4 count (if not performed in last 6 months)

Baseline assessment

HIV Viral Load (VL) Baseline assessment. DO NOT wait for viral load result before starting ART in infants

Cholesterol + Triglyceride if on PI-based regimen

Baseline assessment

Creatinine if on TDF regimen

If abnormal refer for specialist opinion

ALT (if jaundiced or on TB treatment)

To assess for liver dysfunction



Urine dipsticks dispsticks

Baseline assessment

Serum phosphate [if on TDF]:

Baseline assessment

On ART PurposeHeight, weight, head circumference (<2yrs) and development

To monitor growth and developmental stages

Clinical assessment To monitor response to ART and exclude adverse effects

CD4: ALL at month 4 and month 12. Then1-5 years: 6 monthly5 years: If CD4 < 200 cells/mm3 repeat 6 monthly until two consecutive CD4’s > 200 cells/mm3

To monitor response to ART.When to stop prophylactic cotrimoxazole: • All children to take prophylaxis until 12 months of

age• 1 – 5 years: CD4 count > 500 cells/mm3 for two

consecutive occasions 3 to 6 months apart• >5 years: CD4 count > 200 cells/mm3 for two

consecutive occasions 3 to 6 months apart• If previous PCP: stop at 5 years of age

When to stop secondary fluconazole prophylaxis:• All children to take prophylaxis until 24 months of

age• 2-5 years: if completed 1 year of prophylaxis AND

CD4 > 750 cells/mm3 on at least two occasions• > 5 years: if completed 1 year of prophylaxis AND

CD4 > 200 cells/mm3 on at least two occasions

VL: All: at month 4 and 12, then

- children <5 years: 6 monthly

- children 5 years to 15 years: 12 monthly

To monitor viral suppression response to ARTTo identify treatment failure and to identify

problems with adherence

Hb and diff WCC at month 1, 2, 3 and 6 months if on AZT

To identify AZT-related anaemia

Creatinine clearance at month 1; 4; 12 and then every 12 months if on TDF

To identify TDF toxicity. *If < 16 years: the following formula should be used:

GFR = height [cm] x 40Creatinine [µmol/l]

If > 16 years: use adult weight-based formula for GFR

Cholesterol + Triglyceride at 4 months; 1 year and then every 12 months if on PI-based regimen

To monitor for PI-related metabolic side-effects

Clinical assessment with awareness of drug-related adverse events

To monitor response to ARTTo identify drug-related adverse events. If develops jaundice or rash on EFV or NVP do liver function test and refer to specialist



Urine dipsticks [on TDF]: 6 monthly

Monitor possible adverse effects of tenofovir: particularly if also on Lopinavir / Ritonavir

Serum phosphate [on TDF]: annually

Monitor possible adverse effects of tenofovir

SPECIAL CONSIDERATIONS

TB Patients (adults and adolescents):

HIV positive TB patients qualify for lifelong ART regardless of CD4 cell count.

Suspect TB if 2 or more of the following symptoms are present:

1. Cough any duration 2. Sputum production which may occasionally be blood stained 3. Fever 4. Drenching night sweats 5. Unexplained weight loss 6. Loss of appetite, malaise, tiredness 7. Shortness of breath, chest pains 8. New palpable lymphadenopathy

The patient that presents with TB before commencing ART:

I. All TB patients with CD4< 50, as well as those with WHO stage IV disease[excluding TB meningitis [TBM] or Cryptococcal meningitis [CM)], should bestarted on ARV’s AT 2 weeks post diagnosis.

II. All TB patients with CD4 >50 who are ‘well’, have no stage 4 illness or markersof severity (low BMI or Hb) should start ART between 2 - 10 weeks of initiationof TB treatment .

III. Patients with TBM or CM should be started on ARV’s within 4 to 6 weeks.

Summary: Antiretroviral Treatment for Adults with concomitant TBTB develops while on ART TB diagnosed before starting ART

Continue ARV therapy throughout TB treatment.

First-line regimen.

Patient can remain on their regimen

Second-line regimen:

The lopinavir/ ritonavir dose should be doubled (from 2 tablets 12 hourly to 4 tablets 12 hourly) while the patient is on rifampicin-based TB treatment.

Monitor ALT monthly.

Reduce lopinavir/ ritonavir to standard dose 2 weeks after TB treatment is completed.

CD4 count >350/mm3:

Delay ART for two months (until intensive phase of TB therapy is complete).

CD4< 50 Introduce ART AT two weeksCD4 >50 Introduce ART between 2 and 10 weeks

Cryptococcal and TBM: start between 4 and 6 weeks

INH PROPHYLAXIS

a. All people living with HIV should be screened for active TB and eligibility forART.

b. Those who are eligible should be started on ART. c. TB preventive therapy is an effective intervention for HIV infected individuals. d. All people living with HIV with a positive Mantoux, in whom active TB has been

reasonably excluded, should be started on IPT (as soon as practically possibleafter initiation of ART in those who are eligible for ART).

e. Alcohol abuse, adherence challenges and side-effects should be assessedprior to initiating IPT.

f. Dose: 5mg/kg to a maximum dose of 300mg daily, with pyridoxine 25mg/day.Pregnancy is not a contraindication to INH prophylaxis.

Summary Recommendations

Pre-ART(CD4>350)

On ART

TST negative No IPT NO IPT

TST positive IPT for at least 36 months

IPT for at least 36 months

Thank you

western cape art guidelines presentation...

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