WESTERN CAPE ART GUIDELINES PRESENTATION 2013

Transcription

1 WESTERN CAPE ART GUIDELINES PRESENTATION 2013

2 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

3 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

4 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 Tenofovirbased 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.

5 Adults & Adolescents

6 ELIGIBILITY FOR STARTING HAART CD4 count <350 cells/mm3 irrespective of WHO clinical stage OR Irrespective of CD4 count All types of TB HIV positive women who are pregnant or breast feeding WHO stage 3 or 4

7 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 200 OR Patients with WHO stage 4 disease OR Patients with TB/HIV co morbidity with CD4 count < 50

8 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 children [ Initiate INH prophylaxis if asymptomatic for TB AND a positive mantoux test Provide counselling on nutrition and contraception Pap smear should be doe on diagnosis and if normal every 3 years

9 Standardised Western Cape ART regimens for adults and adolescents 1 st 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

10 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/mm 3 - Males with an initial CD4 > 400 cells/mm 3

11 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

12 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]

13 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 H : submit motivation]

14 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 virologically suppressed and the patient s creatinine clearance is normal

15 2 ND LINE Management of virological failure If plasma HIV RNA > copies/ml: - Check adherence, compliance, tolerability, drug-drug interactions and assess any psychological issues. - Repeat VL test within 3 months. If plasma VL confirmed > 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

16 Failing on a Tenofovir [TDF] - based 1 st line regimen Failing on a Stavudine [d4t] or Zidovudine [AZT] based 1 st line regimen Contraindication to Tenofovir [TDF]; Zidovudine [AZT] and Stavudine [d4t] Zidovudine [AZT] + Lamivudine [3TC] + Lopinavir / ritonavir [LPV/r] Tenofovir [TDF] + Lamivudine [3TC] + Lopinavir / ritonavir [LPV/r] Abacavir [ABC] + Lamivudine [3TC] + Lopinavir / ritonavir [LPV/r] LPV/r may increase the levels of TDF: monitor for TDF side effects 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 H : submit motivation] v

17 Lopinavir / ritonavir [LPV/r] related adverse effects: Hypertriglyceridaemi a: fasting triglycerides > 5mmol/l Cardiovascular event risk > 20% Severe hypercholesterolaem ia: Total Cholesterol > 7.5mmol/l Established clinical cardiovascular disease Severe GIT side effects: > 6 weeks Switch Lopinavir / ritonavir [LPV/r] to Atazanavir / ritonavir [ATV/r] No motivation required Refer to Circular H

18 Third line Failing any 2 nd 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.

19 Monitoring of Adult and Adolescents with HIV At initial Diagnosis of HIV Confirm HIV status Do CD4 count and WHO clinical staging if HIV positive Screen for pregnancy or ask if planning to conceive Screen for TB symptoms Mantoux test [TST] CLAT: All HIV + patients with an initial CD4 < 100 cells/mm 3 Purpose Ensure that Western Cape testing algorithm has been followed To assess eligibility for ART To assess eligibility for fast-tracking To identify women who need ART To identify TB/HIV co-infection [refer to WC TB screening tool] Identify need for IPT Identify patients who required cryptococcal meningitis prophylaxis with fluconazole

20 At Routine Follow-Up Visits for those not yet eligible for ART Repeat CD4 count 6 monthly WHO clinical staging at every visit Screen for TB symptoms to identify TB suspects Offer IPT if no TB symptoms AND mantoux positive i Purpose To determine if patient has become eligible for ART To determine if patient has become eligible for ART To identify TB/HIV co-infection To prevent TB activation

21 Prior to initiation of ART (Baseline) Hb and differential WCC: for patients initiating on Zidovudine [AZT] ALT: for patients initiating on Nevirapine [NVP] Purpose To detect anaemia; neutropenia 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

22 On ART CD4 at 1 year on ART. If CD4 < 200 cells/mm 3 repeat 6 monthly until two consecutive CD4 s > 200 cells/mm 3 VL at month 4, month 12 and then annually If on DR TB treatment: VL 6 monthly until DR TB treatment completed If pregnant or breastfeeding: VL 6 monthly vii. Do a VL at 36 weeks if no VL has been done in the last 4 months ALT: if on Nevirapine [NVP] or Efavirenz [EFV] and develops rash or symptoms of hepatitis HB and diff WCC at month 1, 2, 3 and 6 if on Zidovudine [AZT] Creatinine clearance at month 1; 4; 12 and then every 12 months if on Tenfovoir [TDF] Fasting cholesterol and triglycerides: baseline on initiating Lopinavir / ritonavir [LPV/r]. Then at month 4, month 12 and then annually Hep B sag Purpose To monitor immune response to ART Stop prophylactic cotrimoxazole and fluconazole after two consecutive CD4 s > 200 cells/mm 3 To monitor response to treatment and identify treatment failures To ensure optimal viral suppression prior to delivery To identify Nevirapine [NVP] or Efavirenz [EFV] toxicity To identify Zidovudine [AZT] toxicity To identify Tenofovir [TDF] toxicity. *If < 16 years: the following formula should be used: GFR = height [cm] x 40 creatinine [µmol/l] If > 16 years: use adult weight-based formula for GFR To identify Lopinavir / ritonavir [LPV/r] toxicity Patients on Tenofovir [TDF] and Emtricitabine [FTC] or Lamivudine [3TC] changing to second line treatment

23 INFANTS & CHILDREN

24 Eligibility criteria for initiating ART in infants and children Eligibility for starting ART All children less than 5 years of age: irrespective of CD4 Children 5 years to 15 years: WHO clinical stage 3 or 4 OR CD4 <350 cells/ mm 3 Patients requiring fast tracking (i.e. start ART within 7 days of being eligible) Children less than 1 year of age WHO clinical Stage 4 MDR or XDR-TB CD4 count < 200 cells/mm 3 or < 15%

25 ART regimens for infants and children All infants and children under 3 years (or < 10kg) Children 3 years (or 10kg): NOT exposed to Nevirapine during PMTCT EXPOSED to Nevirapine during PMTCT for 6 weeks or longer Currently on Stavudine [d4t] -based regimen First Line Regimen Abacavir [ABC] + Lamivudine [3TC] + Lopinavir / Ritonavir [LPV/r] Abacavir [ABC] + Lamivudine [3TC] + Efavirenz [EFV] Abacavir [ABC] + Lamivudine [3TC] + Lopinavir / Ritonavir [LPV/r] Change Stavidine [d4t] to Abacavir [ABC] if viral load is undetectable If viral load >1000 copies/ml manage as treatment failure If viral load between copies/ml consult with expert for advice

26 Second Line Regimen Failed first line Protease Inhibitor (PI) based regimen ABC + 3TC + LPV/r D4T + 3TC + LPV/r Consult with Paediatric Infectious Disease Unboosted PI-based Specialist for advice* regimen Rifampicin while on LPV/r Failed First line NNRTI based regimen (discuss with expert before changing) First line NNRTI-based Recommended second line regimen regimen ABC +3TC + EFV (or AZT + 3TC +LPV/r NVP) d4t +3TC + EFV (or NVP AZT + ABC + LPV/r

27 Third line regimens Failing any 2 nd line regimen Should be managed by a Paediatric Infectious Disease Specialist on the basis of genotype resistance testing.

28 Monitoring for infants and children with HIV At initial Diagnosis of HIV Confirm HIV status Document weight, height, head circumference (<2yrs) and development Screen for TB symptoms WHO Clinical Staging [ 5 years] CD4 count FBC + diff Neurocognitive developmental assessments Purpose Ensure that Western Cape testing algorithm has been followed To monitor growth and development and identify eligibility for ART To identify TB/HIV co-infection To determine if patient is eligible for ART 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 To detect anaemia; neutropenia; thrombocytopaenia With appropriate available tool

29 At Routine Follow-Up Visits for those not yet eligible for ART Document weight, height, head circumference (<2 years) and development Repeat CD4 count 6 monthly WHO clinical staging at every visit Screen for TB symptoms Neurocognitive developmental assessments Purpose To monitor growth and development To determine if patient has become eligible for ART To determine if patient has become eligible for ART To identify TB/HIV co-infection With appropriate available tool

30 Prior to initiation of ART (Baseline) FBC CD4 count (if not performed in last 6 months) HIV Viral Load (VL) Cholesterol + Triglyceride if on PIbased regimen Creatinine if on TDF regimen ALT (if jaundiced or on TB treatment) Neurocognitive developmental assessments Urine dipsticks dispsticks Serum phosphate [if on TDF]: Purpose If less than 8g/dl start ART and discuss with specialist Baseline assessment Baseline assessment. DO NOT wait for viral load result before starting ART in infants Baseline assessment If abnormal refer for specialist opinion To assess for liver dysfunction With appropriate available tool Baseline assessment Baseline assessment

31 On ART Height, weight, head circumference (<2yrs) and development Clinical assessment CD4: ALL at month 4 and month 12. Then 1-5 years: 6 monthly 5 years: If CD4 < 200 cells/mm 3 repeat 6 monthly until two consecutive CD4 s > 200 cells/mm 3 Purpose To monitor growth and developmental stages To monitor response to ART and exclude adverse effects 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/mm 3 for two consecutive occasions 3 to 6 months apart >5 years: CD4 count > 200 cells/mm 3 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/mm 3 on at least two occasions > 5 years: if completed 1 year of prophylaxis AND CD4 > 200 cells/mm 3 on at least two occasions

32 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 ART To identify treatment failure and to identify problems with adherence Hb and diff WCC at month 1, 2, 3 and 6 months if on AZT Creatinine clearance at month 1; 4; 12 and then every 12 months if on TDF To identify AZT-related anaemia To identify TDF toxicity. *If < 16 years: the following formula should be used: GFR = height [cm] x 40 Creatinine [µmol/l] If > 16 years: use adult weight-based formula for GFR

33 Cholesterol + Triglyceride at 4 months; 1 year and then every 12 months if on PI-based regimen Clinical assessment with awareness of drugrelated adverse events Neurocognitive developmental assessments Urine dipsticks [on TDF]: 6 monthly Serum phosphate [on TDF]: annually To monitor for PI-related metabolic side-effects To monitor response to ARTTo identify drugrelated adverse events. If develops jaundice or rash on EFV or NVP do liver function test and refer to specialist With appropriate available tool Monitor possible adverse effects of tenofovir: particularly if also on Lopinavir / Ritonavir Monitor possible adverse effects of tenofovir

34 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

35 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 be started on ARV s AT 2 weeks post diagnosis. II. All TB patients with CD4 >50 who are well, have no stage 4 illness or markers of severity (low BMI or Hb) should start ART between 2-10 weeks of initiation of TB treatment. III. Patients with TBM or CM should be started on ARV s within 4 to 6 weeks.

36 Summary: Antiretroviral Treatment for Adults with concomitant TB TB 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. CD4 count >350/mm 3 : Delay ART for two months (until intensive phase of TB therapy is complete). CD4< 50 Introduce ART AT two weeks CD4 >50 Introduce ART between 2 and 10 weeks Cryptococcal and TBM: start between 4 and 6 weeks Monitor ALT monthly. Reduce lopinavir/ ritonavir to standard dose 2 weeks after TB treatment is completed.

37 INH PROPHYLAXIS a. All people living with HIV should be screened for active TB and eligibility for ART. 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 possible after initiation of ART in those who are eligible for ART). e. Alcohol abuse, adherence challenges and side-effects should be assessed prior 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.

38 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

39 Thank you

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