Management of HIV Infected Children and Adolescents: Public Sector Approach in Kenya

Transcription

1 Management of HIV Infected Children and Adolescents: Public Sector Approach in Kenya KPA Dr. Margaret Wainaina- Wafula

2 Outline Introduction Evaluation of a child living with HIV. Standard package of Care. ART therapy Monitoring of a child on ART therapy HEP Band Hep C /HIV co-infection

3 Goals of Therapy 1. Restoration of the immune function. 2. Suppression of HIV viral load to undetectable levels 3. Preservation of future therapeutic options 4. Reduction of morbidity and mortality 5. Improvement in quality of life

4 Initial Evaluation of a child or adolescent living with HIV Complete medical history Full medical examination Appropriate Lab Investigations. HIV WHO staging The above done well whether you are starting off with a well patient or a severely immunocompromised patient.

5 Therapeutic Approaches: Well Patient Offer the standard package of care Focus of treatment preparation and counselling Frequency of Follow-up Weekly follow-up until ART initiation, at week 2 and 4 after ART initiation, and monthly until confirmed viral suppression Additional visits as required to address any medical or psychosocial concerns

6 Patients with advanced disease Focus of Treatment Preparation and Counselling: Starting ART early will decrease risk of disease progression, including wasting and OIs Frequency of Follow-up Weekly follow-up until ART initiation, and then at week 2 and 4 after ART initiation, and then monthly until confirmed viral suppression More frequent visits or hospitalization may be required to stabilize acute medical conditions and address psychosocial and other concerns

7 Component of Standard Package of Care Antiretroviral therapy (ART) Positive health, dignity and prevention; GBV and HIV education/counselling Subcomponents Patient preparation ART Monitoring and support Positive health, dignity and prevention Disclosure Partner/family testing Condom use Family planning STI screening, prevention, and treatment Adherence counselling and support Gender-based violence HIV education/counselling Package of Care for the Child/adolescent living with HIV

8 Component of Standard Package of Care Subcomponents Specific opportunistic infection screening and prevention Cotrimoxazole prophylactic therapy TB Intensive case finding Use of genexpert Isoniazid prophylaxis therapy IPC ART for TB/HIV co-infected patients Cryptococcal meningitis

9 Reproductive health services Non-communicable diseases screening and management Sexually transmitted infections Family planning and pre-conception counselling Cervical cancer screening Hypertension Diabetes mellitus Dyslipidemia Chronic kidney disease Mental health screening and management. Depression Alcohol and drug use/addiction Nutritional assessment, counselling and support Assessment Counselling and Education Management and Support Prevention of other infections Immunizations Malaria Safe water, sanitation and hygiene

10 Component of Standard Package of Care Subcomponents Specific opportunistic infection screening and prevention Cotrimoxazole prophylactic therapy TB Intensive case finding Use of genexpert Isoniazid prophylaxis therapy IPC ART for TB/HIV co-infected patients Cryptococcal meningitis

11 Reproductive health services Non-communicable diseases screening and management Mental health screening and management Nutritional assessment, counselling and support Prevention of other infections Sexually transmitted infections Family planning and pre-conception counselling Cervical cancer screening Hypertension Diabetes mellitus Dyslipidemia Chronic kidney disease Depression Alcohol and drug use/addiction Assessment Counselling and Education Management and Support Immunizations Malaria Safe water, sanitation and hygiene

12 HIV specific Test Initial lab Investigations Recommendation HIV-1 RNA (viral load) Baseline viral load (VL) is only recommended (where available) for HEIs after 1st PCR test is positive. Specimen for baseline VL can be drawn before or at time of initiating ART; obtaining a VL should not delay ART initiation

13 HIV specific Test Initial Laboratory Evaluation Recommendation Confirm and document positive HIV test result All positive clients should be retested at enrolment into care CD4 cell count Recommended at baseline but should not delay initiation of ART If CD4 100 cells/ml then perform scrag to rule out Cryptococcal meningitis Serum CrAg: Obtain serum CrAg in all patients with a CD4 count 100 cells/ml. If positive, manage as per the cryptococcal meningitis screening algorithm HIV Drug Sensitivity Testing (DST) Not recommended as a baseline investigation

14 Test Initial Laboratory Evaluation Recommendation Hb (preferably FHG if available) Recommended If baseline Hb < 9.5 g/dl then AZT should be avoided Pregnancy status Pregnancy status should be determined for all women of reproductive age (based on history of last menstrual period, and if delayed then a urine pregnancy test should be performed) Urinalysis (for protein, glucose Recommended Creatinine Recommended Calculate Creatinine Clearance (CrCl): if CrCL 50 ml/min then TDF should be avoided

15 Test Initial Laboratory Evaluation Recommendation Glucose Recommended, but not mandatory at baseline and prior to initiation of ART RPR (syphilis serology) Recommended (for all PLHIV with a history of being sexually active) HBsAg Recommended If negative, patients should be immunized for HBV as soon as they achieve confirmed viral suppression Plasma lipid profile Recommended HCV Antibody test Recommended only for PWID or for patients with history of injection drug use, not mandatory prior to ART initiation ALT Not a recommended baseline investigation unless there is a specific clinical reason (e.g. patient with history of hepatitis, signs or symptoms of liver disease, etc)

16 HIV Entry into susceptible cells

17 Binding, fusion and entry Viral protease RNA RNA Proteins Viral protease Reverse transcriptase RT RNA DNA RT RNA DNA DNA Provirus Viral integrase

18 Classification NRTIs - inhibit reverse transcription by being incorporated into the newly synthesized viral DNA and preventing its further elongation. NNRTIs- inhibit reverse transcriptase directly by binding to the enzyme and interfering with its function PIs (Protease Inhibitors) - target viral assembly by inhibiting the activity of protease, an enzyme used by HIV to cleave nascent proteins, for final assembly of new virons

19 Classification Entry Inhibitors/Fusion inhibitors - interfere with binding, fusion and entry of HIV-1 to the host cell by blocking one of several targets maraviroc & enfurvitide Integrase Inhibitors - inhibit the enzyme integrase which is responsible for integration of viral DNA into the DNA of the infected cell Raltegravir Maturation inhibitors - inhibit the last step in gag processing in which the viral capsid polyprotein is cleaved, thereby blocking the conversion of the polyprotein into the mature capsid protein (p24) Bevirimat & vivecon

20 Timing of ART initiation Anza Sasa- Based on the START study and WHO recommendations Same day ART initiation for following populations: -Pregnant and breastfeeding women -Infants -Positive partner of a discordant partnership Patient preparedness assessment to be conducted Guidance on adherence support for same day initiation and continued follow up included

21 ART for all PLHIV Age Preferred Regimen 2 weeks-4weeks AZT/3TC/LPV/r 4 weeks - < 3 years ABC + 3TC + LPV/r 3-15 years (< 35 kg body weight) ABC + 3TC + EFV 3-15 years ( 35 kg body weight) TDF + 3TC + EFV > 15 years TDF + 3TC + EFV PWID TDF + 3TC + ATV/r

22 Possibly we get samples of each formulation***

23 2 nd line ART Age/Scenario First-line ART Second-line ART 2 weeks - < 3 years ABC (or AZT) + 3TC + LPV/r DRT-based second-line line 2 ABC + 3TC + NVP (or RAL) AZT + 3TC + LPV/r 3-15 years ( 35 kg body weight) > 15 years HIV/HBV co-infection AZT + 3TC + EFV (or RAL) TDF (or ABC) + 3TC + EFV (or NVP) TDF (or ABC or AZT) + 3TC + LPV/r (or ATV/r) ABC + 3TC + LPV/r AZT + 3TC + ATV/r (or LPV/r) 3 DRT-based 2nd line AZT + 3TC + EFV (or NVP) TDF + 3TC + ATV/r (or LPV/r) 3 TDF (or ABC) + 3TC + EFV (or NVP) AZT + 3TC + EFV (or NVP) TDF (or ABC) + 3TC + DTG TDF (or ABC or AZT) + 3TC + ATV/r (or LPV/r) AZT + 3TC + ATV/r TDF + 3TC + ATV/r AZT + 3TC + ATV/r DRT based regimen

24 3 RD LINE This will be discussed as we discuss ART resistance and Management.

25 Laboratory Monitoring Routine monitoring of treatment response in adolescents and adults- perform at 6 months and 12 months after initiation of ART, and if suppressed (VL<1000 copies/ml), annually thereafter. Routine monitoring for infants and children below 18 months at baseline, 6 months and 12 months after initiation of ART, then annually thereafter if stable and suppressed. Targeted VL for patients with suspected treatment failure Targeted VL when considering regimen change or single drug substitutions in patients who have been on ART for at least 6 months.

26 Drug Resistance Testing Proposed recommendations Baseline DRT not recommended Rationale Baseline DRT is not cost effective Should be reserved for surveillance purposes (general and special populations e.g. discordant couples, in context of PMTCT ) All patients (adults and children) failing first line PI regimen require DRT To determine usefulness of PI in 2 nd line All patients failing 2 nd line ART For regimen selection

27 Hepatitis B/HIV Co-infection HIV and HBV have shared transmission routes HBV/HIV coinfection associated with rapid HIV disease progression and poor HIV treatment outcomes Acute HBV infection in HIV associated with increased risk of chronicity, reduced chances of spontaneous clearance, higher rates of replication and reactivation Increased incidence of chronic liver disease, cirrhosis and hepatocellular carcinoma (HCC) Increased incidence of direct hepatotoxicity ART-related immune reconstitution hepatitis

28 Hepatitis B/HIV Co-infection Screening -All HIV positive using HBsAg, as part of initial screening. Prevention-HBV Vaccination & general IPC ;Use of personal protective equipment, medical waste management HBV vaccination reduces the risk of new (incident) HBV infection in HIV positive & reduces the risk of new infections becoming chronic. Vaccine -IM schedule 0,1,2, and 6 months

29 Other indications for Hepatitis B screening Other household contacts or sexual contacts PWID MSM, Sex workers Unvaccinated Health care providers 29

30 Hepatitis B/HIV Co-infection Treatment 1 st line-tdf + 3TC + EFV Treatment 2 nd line -AZT + TDF + 3TC (or FTC) + ATV/r (or LPV/r or DTG or RAL) Monitoring PLHIV therapy monitoring applys Stopping treatment or treatment interruptions-tdfbased ART should not be stopped abruptly to avoid risk of hepatitis flare

31 Hepatitis C/HIV Co-infection Prevalence of HCV infection is high in PWID (10-30%). General population and PLHIV is low <3 % HIV/HCV infection is associated with; -Rapid progression of liver fibrosis - Higher risk of deteriorating liver disease even in the presence of controlled HIV disease - Worsened hepatotoxicity as a result of ART and other drugs

32 Hepatitis C/HIV Co-infection Screening- HCV serology should be offered to individuals at risk of HCV infection.- PWID, Sex workers, MSM Prevention- General measures for prevention of blood-borne infections Treatment- direct acting antiviral therapies (DAAs) HCV genotype important for selecting DAAs

33 Recommended DAA for the Treatment of HCV DAA- Direct Acting Antivirals Daclatasvir (60 mg) + Sofosbuvir(400 mg) 12 weeks Elbasvir (50 mg + Grazoprevir(100 mg) 12 weeks Ledipasvir (90 mg) + Sofosbuvir(400 mg) 12 weeks

34 References Kenya National HIV/AIDS guidelines 2016www.nejm.org/doi/full/ /NEJMoa HIV Medicine 2007 By Hoffmann-Rockstroth-Kemp Nelsons Textbook of Pediatrics

35 Acknowledgements KPA NASCOP /MOH CDC CHS-KENYA

36 Thank you! Centre for Health Solutions 36