WHO Guidelines for treatment monitoring

Nathan FordDept of HIV/AIDS

World Health Organization

WHO ART guidelines evolution

Topic 2002 2003 2006 2010 2013

When to start

CD4 ≤200 CD4 ≤ 200 CD4 ≤ 200- Consider 350 - CD4 ≤ 350 for TB

CD4 ≤ 350-Irrespective CD4 for TB and HBV

CD4 ≤ 500-Irrespective CD4 for TB, HBV, PW and SDC- CD4 ≤ 350 as priority

1st Line 8 options- AZT preferred

4 options- AZT preferred

8 options- AZT or TDFpreferred- d4T dose reduction

6 options &FDCs- AZT or TDF preferred- d4T phase out

2 options & FDCs- TDF and EFV preferred

across all populations

2nd Line Boosted and non-boosted PIs

Boosted PIs-IDV/r LPV/r, SQV/r

Boosted PI- ATV/r, DRV/r, FPV/r LPV/r, SQV/r

Boosted PI - Heat stable FDC: ATV/r, LPV/r

Boosted PIs - Heat stable FDC: ATV/r, LPV/r

3rd Line None None None DRV/r, RAL, ETV DRV/r, RAL, ETV

Viral LoadTesting

No No (Desirable)

Yes(Tertiary centers)

Yes(Phase in)

Yes(preferred)

Vitoria M, et al, Current Opinions HIV/AIDS, 2013

WHO ART guidelines evolution

Topic 2002 2003 2006 2010 2013

When to start

CD4 ≤200 CD4 ≤ 200 CD4 ≤ 200- Consider 350 - CD4 ≤ 350 for TB

CD4 ≤ 350-Irrespective CD4 for TB and HBV

CD4 ≤ 500-Irrespective CD4 for TB, HBV, PW and SDC- CD4 ≤ 350 as priority

1st Line 8 options- AZT preferred

4 options- AZT preferred

8 options- AZT or TDFpreferred- d4T dose reduction

6 options &FDCs- AZT or TDF preferred- d4T phase out

2 options & FDCs- TDF and EFV preferred

across all populations

2nd Line Boosted and non-boosted PIs

Boosted PIs-IDV/r LPV/r, SQV/r

Boosted PI- ATV/r, DRV/r, FPV/r LPV/r, SQV/r

Boosted PI - Heat stable FDC: ATV/r, LPV/r

Boosted PIs - Heat stable FDC: ATV/r, LPV/r

3rd Line None None None DRV/r, RAL, ETV DRV/r, RAL, ETV

Viral LoadTesting

No No (Desirable)

Yes(Tertiary centers)

Yes(Phase in approach)

Yes(preferred for monitoring, use of PoC, DBS)

Earlier initiation

Simpler treatment

Less toxic, more robust regimens

Better monitoringVitoria M, et al, Current Opinions HIV/AIDS, 2013

Recommendations on ART Monitoring

Viral load is recommended as the preferred monitoring approach to diagnose and confirm ARV treatment failure

(strong recommendation, low-quality evidence)

If viral load is not routinely available, CD4 count and clinical monitoring should be used to diagnose treatment failure

(strong recommendation, moderate-quality evidence)

Definition of virological failure: plasma viral load above 1000 copies/ml based on two consecutive viral load measurements after 3 months, with adherence support (6 months post ART)

Higher threshold for DBS and point-of-care technologies

Implementation considerations• ART access should be the first priority: Lack of

laboratory tests for monitoring treatment response should not be a barrier to initiating ART

• Prioritization: If viral load availability is limited, it should be phased in using a targeted approach to confirm treatment failure.

• This may be particularly relevant in populations receiving ARVs to reduce HIV transmission, such as pregnant and breastfeeding women and in sero-discordant couples.

Implementation considerations• Feasibility of phasing in VL capacity (DBS)• PoC viral load on horizon• Enables monitoring of treatment for

prevention • Equity• Cost-effectiveness influenced by monitoring

approach (frequency, additive or as replacement to CD4)