Nondumiso Nondumiso Nondumiso has been taking TDFFTCEFV FDC

Nondumiso

Nondumiso • Nondumiso has been taking TDF/FTC/EFV (FDC) for 1 year. • She had her VL, CD 4 and creatine clearance done at her 1 year followup. • She attends the clinic today for results. Discuss in groups (5 minutes): • What must you ask this patient? • What must you look for on examination? • What tests must you check for this patient?

What must you ask this patient? • TB and STI screen: She is well and has no TB or genital symptoms. • Adherence: She started a new job 4 months ago and admits she has found it difficult to be adherent to her ART. • Side effects: She has had no side effects form her ART. • Drug Interactions: She is not taking any new drugs or over the counter medications • Family Planning and fertility intentions: She uses condoms with her partner and attends reliably for her injectable contraception. She is not planning to get pregnant in the next two years • Mental Health screen: She has no symptoms of depression or substance abuse or dementia. • NCDs: She has no CVD risk factors.

What must you look for on examination? • Her vitals are normal • Her weight and stage are stable • She has no mouth or skin problems • Urine dipstix is clear • All other systems are normal

What tests must you check for this patient? • Her CD 4 is now 245. • Her creatine clearance is 90. • Her pap smear is normal. • Her HBs. Ag and RPR was negative at diagnosis. • Her viral load is 1500 (it was suppressed at 6 months on ART). What is your approach to assessing and managing Nondumiso’s VL?

What is your approach to assessing and managing Nondumiso’s VL Do a thorough assessment of possible causes • A – Adherence • B – Bugs (intercurrent Infections) • C – Correct dose • D – Drug Interactions • E – Resistance • Implement interventions, provide enhanced adherence support • Repeat VL in 3 months to see if interventions have worked

Scenario 1: Nondumiso had her VL repeated after 3 months and now attends today for the results Her previous viral load was 1500. She is still on TDF/FTC/EFV (FDC). She is well and has no TB or genital symptoms. You saw her weekly for a month, then monthly. She attended reliably with excellent pill counts. • She denies having had any side effects. • No signs of depression/ substance abuse. • Her repeat VL is 20 000 c/ml • • How will you mange managing Nondumiso’s VL today?

Scenario 2: Nondumiso had her VL repeated after 3 months and now attends today for the results • Her previous viral load was 1500. • She is still on TDF/FTC/EFV (FDC). • All else is normal as in Scenario 1 • Her repeat VL is 550 c/ml How will you manage Nondumiso’s VL today?

Feedback from Groups: Scenario 1

Nondumiso’s repeat VL is 20 000 c/ml • Does she meet the definition of confirmed virological failure? • Yes, she meets the definition of confirmed virological failure on an NNRTI regimen, i. e. 2 VL’s > 1000 c/ml • Should she switch to second line? • Yes • Which second line regimen would you switch her to? • AZT, 3 TC, and DTG • What if she was HBV co-infected: • TDF, AZT, 3 TC, DTG • Are there any blood tests you would want to do • HBs. Ag (was negative) and HB (AZT)

Part 1

Part 2 VL Monitoring – Interpreting the Results of the VL Repeated after 3 Months Switching for virological failure will now depend on • Current regimen (NNRTI vs In. STI/PI) • Duration on ART

Scenario 1: Nondumiso’s repeat VL is 20 000 c/ml • Is there anything you need to discuss with the client before considering a switch from EFV to DTG? • Fertility intentions, • risks and benefits of DTG, • contraceptive choices (see next slide)

Enabling a Client to Make an Informed Choice • The clinician should enable a client to make an informed choice by doing the following: 1 2 Understand her current pregnancy status and fertility intentions: Is she pregnant? Does she desire a pregnancy: now? or in the future? or not at all? Explain the risks and benefits of DTG vs EFV (see next slide) Remember that EFV remains a safe and effective alternative 3 Discuss and provide a choice of contraceptive options as desired Remember that dual methods are recommended

Risks and Benefits of DTG vs EFV Benefits of using DTG Provides rapid viral suppression High genetic barrier to resistance No interaction with hormonal contraceptives Side effects are mild and uncommon Benefits of using EFV Safe in pregnancy No significant interaction with TB treatment Risks of using DTG may increase the risk of neural tube defects (NTDs) if used before or in the first four weeks after conception Drug interactions with rifampicin, metformin, anticonvulsants, and polyvalent cations (Mg 2+, Fe 2+, Ca 2+, etc. ) Risks of using EFV Low genetic barrier to resistance Drug interactions with contraceptives Neuropsychiatric side effects Should she choose DTG despite recommendations, document her choice in writing in clinical notes

Feedback from Groups: Scenario 2

Scenario 2: Nondumiso had her VL repeated after 3 months and now attends today for the results • Her previous viral load was 1500. • She is still on TDF/FTC/EFV (FDC). • All else is normal as in Scenario 1 • Her repeat VL is 550 c/ml How will you manage Nondumiso’s VL today?

Scenario 2: Nondumiso’s repeat VL is 550 c/ml • Does she meet the definition of confirmed virological failure? • No, she does not have 2 VL’s > 1000 c/ml • Should she switch to second line? • No • Does she qualify for any kind of regimen change? • Yes, as her second VL was < 1000 c/ml, she qualifies for a single drug switch to DTG. • We can do a single drug switch to TLD provided we have excluded outright failure by proving that their VL’s are not persistently over 1000.

Part 2 VL Monitoring – Interpreting the Results of the VL Repeated after 3 Months Switching for virological failure will now depend on • Current regimen (NNRTI vs In. STI/PI) • Duration on ART

Scenario 2: Nondumiso’s repeat VL is 550 c/ml • Are there any blood tests you would want to do • No • Is there anything you need to discuss with the client before considering a switch from EFV to DTG? • Fertility intentions, • risks and benefits of DTG, • contraceptive choices (see previous slides provided in scenario 1)

Enabling a Client to Make an Informed Choice • The clinician should enable a client to make an informed choice by doing the following: 1 2 Understand her current pregnancy status and fertility intentions: Is she pregnant? Does she desire a pregnancy: now? or in the future? or not at all? Explain the risks and benefits of DTG vs EFV (see next slide) Remember that EFV remains a safe and effective alternative 3 Discuss and provide a choice of contraceptive options as desired Remember that dual methods are recommended

Risks and Benefits of DTG vs EFV Benefits of using DTG Provides rapid viral suppression High genetic barrier to resistance No interaction with hormonal contraceptives Side effects are mild and uncommon Benefits of using EFV Safe in pregnancy No significant interaction with TB treatment Risks of using DTG may increase the risk of neural tube defects (NTDs) if used before or in the first four weeks after conception Drug interactions with rifampicin, metformin, anticonvulsants, and polyvalent cations (Mg 2+, Fe 2+, Ca 2+, etc. ) Risks of using EFV Low genetic barrier to resistance Drug interactions with contraceptives Neuropsychiatric side effects Should she choose DTG despite recommendations, document her choice in writing in clinical notes

Questions and Discussion