Guidelines for HIV care and treatment

1. National guidelines for HIV care and treatment 2021
Dr Shoebul Haque
PG Resident
Department of Pharmacology & Therapeutics
King George’s Medical University, Lucknow
Email:- shoeb_ulhaque@yahoo.com

2. Objectives
• Definitions
• National AIDS Control Organization (NACO)
• Aim of National Guidelines
• Rapid ART initiation algorithm in PLHIV
• IRIS Management
• Package of Advanced HIV Disease Management
• PPTCT and ART in Pregnant Women
• Treatment of HIV and Hepatitis Coinfected Patients
• ART in PLHIV with TB Co-infection
• Recommended PEP regimens

3. Definitions
• Advanced HIV disease in
adults, adolescents and
children more than 5
years of age
Advanced HIV disease is defined as CD4 cell
count <200 cells/mm3 or WHO stage 3 or 4
event
• Advanced HIV disease in
children less than 5
years of age
All children less than 5 years infected with
HIV (who are not already receiving ART and
clinically stable) are considered to have
advanced disease

4. Definitions
• Antiretroviral
therapy
Use of a combination of at least three
antiretroviral drugs from different classes to
inhibit the replication of HIV and reduce viremia
to undetectable levels
• AIDS AIDS is defined as the occurrence of life-threatening
opportunistic infections (OIs), malignancies,
neurological diseases and other specific illnesses in
patients with HIV infection and CD4 counts

5. Definitions
• First line ART Initial regimen prescribed for an ART-naive patient
• Alternate first line
ART
Recommended regimen where the preferred first
line ARV regimen cannot be used
• Second line ART Subsequent regimen used in sequence immediately
after first line therapy has failed
• Third line ART Subsequent regimen used in sequence immediately
after second line therapy has failed

6. National AIDS Control Organization (NACO)
• To respond to the challenge, the Government of India established the
National AIDS Committee in 1986
• Establishment of National AIDS Control Organization (NACO) in 1992 to
oversee the policies for prevention and control of the HIV infection

7. National AIDS Control Programme (NACP)
• The first phase of the National AIDS Control Programme (NACP) started in
1992 and lasted until 1999 followed by
• NACP-II (2000–2005),
• NACP-III (2006–2011),
• NACP-IV (2012–2017)

8. NACP- V (2021–2026)
• In the current phase of NACP-V (2021–2026): The focus is on ensuring
PLHIV survive longer and lead productive lives
• This will be achieved through improving retention in HIV care and
adherence to ART
• The current strategic plan aims to achieve zero new infections, zero AIDS-
related deaths and zero discrimination for paving the way for an end of
AIDS by 2030

9. India’s ART programme
• The Government of India launched the free ART initiative on 1 April 2004 in
eight tertiary-level hospitals
• Currently, HIV care services are being delivered through a network of 620
ART centers
• India’s ART programme is the second largest globally and one of the best
public health programmes providing HIV care services

10. National Guidelines on HIV Care and Treatment
The current guidelines are being finalized based on the recommendations of
• The Technical Resource Group for ART
• Government of India, WHO and other UN agencies
• Pharmaceutical industries
• Non-governmental organizations (NGOs)
• India is committed to achieving the “End of AIDS as a public health threat”
by 2030

11. Aim of National Guidelines
• Harmonize treatment practices across the public and the private sectors
• Consolidate various existing guidelines and incorporate recommendations
for all age groups, genders and populations
• Provide standardized guidelines for prevention, screening, diagnosis and
management of common OIs among PLHIV

12. Goals of ART
• Clinical goals Increased survival and improvement in quality of life
• Virological goals Greatest possible sustained reduction in viral load
• Immunological
goals
Immune reconstitution, both quantitative and
qualitative
• Therapeutic goals Rational sequencing of drugs in a manner that
maintain future treatment options, limiting drug
toxicity and facilitating adherence
• Preventive goals Reduction of HIV transmission by suppression of viral
load

13. Principles of Antiretroviral Therapy
1. Block binding of HIV to the target cell (Fusion Inhibitors and CCR-5 co-receptor
blockers)
2. Block the viral RNA cleavage and one that inhibits reverse transcriptase (RTIs)
3. Block the enzyme integrase, which helps in the pro-viral DNA being
incorporated into the host cell chromosome (Integrase Inhibitors)
4. Block the RNA to prevent viral protein production
5. Block enzyme protease (Protease Inhibitors)
6. Inhibit the budding of virus from host cells

14. Considerations before Initiation of ART
1. Informed consent should be obtained from the patient or from the
caregiver
2. Treatment should be started based on the person’s informed decision and
preparedness to initiate ART
3. Caregivers must be counselled and trained to support treatment
adherence
4. All patients with clinical stages 3 and 4 and those with CD4 less than 350
cells/mm3 need to be put on CPT

15. Considerations before Initiation of ART
5. ART should not be started in the presence of an active OI
• In general, OIs should be treated or stabilized before commencing ART
• Mycobacterium Avium Complex (MAC) and Progressive Multifocal
Leukoencephalopathy (PML) are exceptions in which commencing ART may
be the preferred treatment

16. Key questions pertaining to ART:
1. When to start treatment?
2. Which and how many agents to use?
3. Choice of optimal regimen
4. How to monitor the therapy?
5. How long to give therapy?
6. When to change therapy and to what?

17. Current NACO Guidelines on When to start ART?
• All persons diagnosed with HIV infection should be initiated on ART
regardless of the CD4 count or WHO Clinical Stage or age group or
population sub-groups
• The current recommendation to TREAT ALL, regardless of the clinical stage
or CD4 count is in the National Programme since 2017

18. What to Start?: Antiretroviral Therapy Regimens
• Fixed-dose combinations (FDCs) of ARVs are preferred because they are
easy to prescribe and easy for patients to take
• National experience has shown that regimens with FDCs are more
acceptable, well tolerated and adequately complied with

19. Recommended Choice of First-Line Regimen
• In consideration of the WHO guidelines and based on recommendations of
NACO Technical Resource Group
• It has been decided to include DTG-containing regimens as the preferred
first-line treatment for HIV-positive adults, adolescents and children
(weighing more than 20 kg/age more than 6 years)
• under the NACP since July 2020

20. Dolutegravir why Recommended?
1. High genetic barrier: It is highly potent and has high genetic barrier
2. Rapid viral suppression: It has been found to reduce the viral copies to
<50 copies/ml within 4 weeks
3. Fewer toxicities and side effects: lesser allergic reactions and chances of
neuropsychiatric events compared to NNRTI-based regimens
4. Minimal drug interactions
5. Effective against HIV-2

21. Basic Principle for first-line ART
• The first-line ART essentially comprises of a NRTI backbone, preferably Non-
Thymidine (Tenofovir plus Lamivudine) and one INSTI, preferably DTG
Tenofovir (TDF 300 mg) + Lamivudine (3TC 300 mg) + Dolutegravir
(DTG 50 mg) regimen (TLD) as FDC in a single pill once a day
(at a fixed time every day as per patient’s convenience)

22. Alternate first-line ART in adults and Adolescents
CONDITION ALTERNATE FIRST-LINE REGIMEN
• PLHIV with body
weight <30 kg
ABC 600 mg + Lamivudine 300mg, one tablet + DTG (50
mg)
once daily in the morning or any fixed time every day
• All patients with high
serum creatinine
values (Calculate
Creatinine clearance)
ABC 600 mg OD, Lamivudine (as per creatinine clearance)
and DTG 50 mg once daily in the morning or any fixed time

23. Alternate first-line ART in adults and Adolescents
CONDITION ALTERNATE FIRST-LINE REGIMEN
• PLHIV on
Rifampicin-
containing ATT
regimen
Tenofovir (300 mg) + Lamivudine (300 mg) + Dolutegravir (50 mg)
FDC one tablet once daily (in the morning or any fixed time every
day)
+
Additional dose of DTG 50 mg to be provided (12 hours after taking
their regular dose) until 2 weeks after completion of ATT
• Women of
childbearing
potential who do
not wish to take
DTG-based ART
Tenofovir (300 mg) + Lamivudine (300 mg) + Efavirenz (600mg)

24. General Guidance
• A single pill of TLD should be taken preferably at bedtime, where additional
dose of DTG is indicated should be taken preferably in the morning
• Patients with severe Diabetes and Hypertension should be monitored more
closely for TDF toxicity
• Patients starting on DTG should be monitored for blood glucose (six
monthly) and weight gain (on monthly visits)
• Appropriate physical activity should be advised to prevent weight gain

25. Rapid ART initiation algorithm in PLHIV
DAY 1
Symptoms
screening
• Cough
• Fever
• weight loss
• night sweats
Physical
examination Signs
& serious illness
1. Temperature ≥39°C
2. Respiratory rate
>30/min
3. Heart rate >120/min
4. Altered mental status
Comorbid
conditions
Readiness
assessment
Appropriate diagnosis, management/ Expert consultation/ Referral, if required
Cont.
No No No
Yes, for
any
symptoms
Yes, for
any
symptoms
Yes, for any
comorbid
condition
ART initiation as soon as appropriate action has been taken (as per NACO guidelines)

26. Rapid ART initiation algorithm in PLHIV
Cont.
Day 1 Preferably Within 3−5 days preferably
Initiate ART- Preferably same
day (if patient is ready)
• ART to be dispensed for one
month
• Concurrently send samples
for CD4 count and other
baseline investigations as
per NACO guidelines
Follow up
• Review test result: If test reports are
not normal, PLHIV to be called back
to ART center
• ART counsellor to call all patients &
ask about general wellbeing of
patients within 2 weeks of ART
initiation

27. Monitoring and follow-up schedule for patients on ART
Monitoring Tool When to Monitor
• Body weight Height / length in
children
Every visit
• Treatment adherence Every visit
• 4-symptom TB screening Every visit
• Screening for common NCD;
Hypertension, Diabetes mellitus
Every 6 months or symptom directed
• Laboratory evaluation Every 6 months or symptom directed
• CD4 Count CD4 must be done every 6 months
• Viral load At 6 months, 12 months and then every
12 months

28. Laboratory monitoring of individual ARV drugs

29. • Virological suppression in the context of the national programme means a
plasma viral load of less than 1000 copies/ml after at least 6 months on ART

30. Stable Adults and adolescents (>10 years)
Definition
PLHIV shall be termed ‘stable’ if they fulfil all the following criteria:
1. On ART for at least 6 months
2. No adverse effects of ART that require regular monitoring
3. No current illness/OI/medical condition that requires management
4. Suppressed plasma viral load

31. Immune Reconstitution Inflammatory Syndrome
Definition
• “The worsening of signs and symptoms due to known infections” or “the
development of disease due to occult infections that result from an
inflammatory response by a reinvigorated immune system following the
initiation of ART”

32. IRIS Management
1. Mild form (with ongoing ART): Observation
2. Localized IRIS (with ongoing ART): Local therapy such as minor surgical
procedures for lymph node abscesses (drainage)
3. Most of the situations (with ongoing ART): Antimicrobial therapy is
required to reduce and to eliminate the triggering pathogen

33. IRIS Management
• Short-term therapy with corticosteroids or NSAIDS can be given to reduce the
inflammation:
Temporary cessation of ART must be considered, only if potentially life-
threatening forms of IRIS develop

34. Definition of advanced HIV disease
• For adults and adolescents, and children older than 5 years, advanced HIV
disease is defined as CD4 cell count <200 cells/mm3 or WHO stage 3 or 4
event
• Includes both ART-naive individuals and those who interrupt treatment and
return to care
• All children younger than 5 years of age (who are not already receiving ART
and clinically stable) with HIV are considered as having advanced HIV
disease

35. PPTCT and ART in Pregnant Women
• The Prevention of Parent to Child Transmission (PPTCT) programme is being
implemented under NACP to achieve the goal of Elimination of Mother To
Child Transmission (EMTCT)
• In 2020, 81,430 children are estimated to be living with HIV accounting for
3.5% of the estimated 23,18,738 PLHIV in India

36. Four-Pronged strategy for PPTCT
4

37. ART for Pregnant Women under the National Programme
• It is recommended to provide lifelong ART for all pregnant and breastfeeding
women living with HIV
• All pregnant women living with HIV receive a ‘Fixed Drug Combination (FDC)’
triple-drug ART regimen regardless of CD4 count or clinical stage
• Presently as per national guidelines, TLD is the preferred regimen for pregnant
women

38. ARV for Exposed Infant
• ARV Prophylaxis is advised to the infant based on the risk of HIV
transmission
• Single-drug ARV Prophylaxis is advised in infants with low risk for HIV
transmission for 6 weeks (regardless of type of feeding)
• Dual-drug ARV Prophylaxis is advised in infants with high risk for HIV
transmission
• The duration of which depends on the type of feeding (for 6 weeks if on
replacement feeding and 12 weeks if on breastfeeding)

39. ART regimen in pregnant and breastfeeding women with HIV
Target Population Preferred ART
Regimen
Remark
• Pregnant or
breastfeeding
women with
HIV
Tenofovir +
Lamivudine +
Dolutegravir
TDF + 3TC + DTG
(TLD)
• FDC of TDF (300 mg) + 3TC (300 mg) +
DTG (50 mg)
• To be given once daily
• Including HIV-1, HIV-2, HIV-1 & 2,
women exposed to single-dose NVP in
the past and co-infected with TB or
Hepatitis
• Pregnant women with HIV should be
educated about the benefits and risks of
DTG to help informed choice

40. Pregnant women presenting in active labour
Maternal Status Intra-partum Post-partum
Presenting in active
labor, no prior ART
Initiate TLD
TDF (300 mg) +
3TC (300 mg) +
DTG (50 mg)
Continue TLD
TDF (300 mg) +
3TC (300 mg) +
DTG (50 mg)
• Labour room nurse will offer bedside counselling and HIV
screening test
• If the woman consents, screen for HIV using the ‘Whole Blood
Finger Prick Test’ in delivery room or labour ward

41. HIV risk assessment of infants born to HIV-infected mothers and
infant ARV Prophylaxis options
HIV Risk Status Option for ARV Prophylaxis
Low-risk infants
• Infants born to mothers
with suppressed viral
load (<1000 copies/ml)
done any time after 32
weeks of pregnancy up
to delivery
1. Syrup Nevirapine (NVP) or
2. Syrup Zidovudine (in situations where NVP will
not be effective)
• Infant born to a mother with confirmed HIV-2 or HIV-1 and
HIV-2 combined infections
• Infant born to a mother who is on PI-based ART regimen
due to treatment failure
• Duration of ARV prophylaxis: From birth till 6 weeks of age

42. HIV risk assessment of infants born to HIV-infected mothers and
infant ARV Prophylaxis options
HIV Risk Status Option for ARV Prophylaxis
High-risk infants
• Infants born to HIV-positive mother not
on ART
• Maternal viral load not done after 32
weeks of pregnancy till delivery
• Maternal viral load not suppressed
between 32 weeks of pregnancy till
delivery
• Mother newly identified HIV positive
within 6 weeks of delivery
Options for dual prophylaxis:
• Syrup NVP + Syrup Zidovudine
Duration of Dual ARV Prophylaxis:
• In case of Exclusive Replacement Feeding
(ERF): From birth till 6 weeks of age
• In case of Exclusive Breastfeeding (EBF):
From birth till 12 weeks of age

43. Dose of syrup Nevirapine (10 mg/ml)
Infant Age Daily Dosing
Birth* to 6 weeks
• Birth weight 2000–2500 g
• Birth weight >2500 g
10 mg (1 ml) once daily
15 mg (1.5 ml) once daily
>6 weeks – up to 6 months 20 mg (2 ml) once daily
>6 months – up to 9 months 30 mg (3 ml) once daily
>9 months – until breastfeeding ends 40 mg (4 ml) once daily

44. Dose of syrup Zidovudine (10 mg/ml)
Infant Birth
Weight
Zidovudine Daily
Dosage (in mg)
Zidovudine Daily
Dosage (in ml)
Duration
2000–2500 g 10 mg/dose twice daily 1.0 ml twice daily 6 weeks
>2500 g 15 mg/dose twice daily 1.5 ml twice daily 6 weeks

45. ART in PLHIV with TB Co-infection
Patient
details
Timing of ART in Relation to Initiation of TB
Treatment
ART
Recommendations
• HIV-TB
coinfected
patients
• ART should be started as soon as possible within
two weeks of initiating TB treatment, regardless of
CD4 cell count, (except when signs and symptoms
of meningitis are present)
• Among PLHIV with TB meningitis, ART should be
delayed for at least 4 weeks (and initiated within 8
weeks) after treatment for TB meningitis is initiated
• Corticosteroids should be considered as adjuvant
treatment for TB meningitis
• Appropriate ART
regimen
*WHO Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring, July 2021

46. HIV-VL Co-infection -Treatment
• HIV-VL Co
infection
Treatment
Current guidelines—recommend liposomal amphotericin B
(L-AmB) as preferred treatment in HIV-VL co infection
L-AmB - 4 mg/kg/day on days 1–5, 10, 17, 24, 31, and 38

47. Treatment of HIV and Hepatitis B Coinfected Patients
• All HIV-positive patients with HBV co-infection should start dual anti-HIV
and HBV therapy irrespective of CD4 count and HBV viral load
• The recommended NRTI drugs for ART – TDF with 3TC or FTC –
• Fortunately, TDF, a drug widely included in ART regimens, is also the most
effective drug for long‐term treatment of HBV

48. Treatment of HIV and Hepatitis B Coinfected Patients
• HIV treatment among people coinfected with HBV without using TDF in
the regimen may lead rarely to flares of HBV
• Abrupt treatment discontinuation of TDF or 3TC may be associated with
HBV reactivation, hepatic flares

49. Treatment of HIV and Hepatitis B Coinfected Patients
• Preferred Regimen  TDF + 3TC + DTG (TDF may be replaced by ABC in case
of TDF toxicity)
 However, in such cases, Entecavir is needed for
managing hepatitis B
• Hepatic Flares  HBV flares on ART start soon after the initiation of ART
is a manifestation of IRIS
 Discontinuation of 3TC and TDF may also result in
hepatic flares

50. PRE-EXPOSURE PROPHYLAXIS OF HIV INFECTION
Drug regimen
Tenofovir 300 mg daily ± Emtricitabine 200 mg daily
Key risk groups
Men who have sex with men
Sex workers
Injection drug users
Transgender people
Uninfected partner of heterosexual serodiscordant couples

51. Recommended PEP regimens
• The first dose of PEP should be administered immediately (within 2 hours)
and preferably within 72 hours of exposure
• Healthcare personnel should be counselled about the safety of the PEP
drugs
• Duration of PEP is 28 days, regardless of PEP regimen

52. Recommended PEP regimens
Exposed Person Preferred Regimen for PEP Drugs and Dosages
• Adolescents and Adults (>10
years of age and >30 kg
weight)
Tenofovir (300 mg) +
Lamivudine (300 mg) +
Dolutegravir (50 mg)
(FDC: One tablet OD)
• Children (>6 years of age and
>20 kg weight)
Zidovudine +
Lamivudine +
Dolutegravir (50 mg) (One tablet OD)
• Children (<6 years of age or
<20 kg weight)
Zidovudine +
Lamivudine +
Lopinavir/ritonavir (Dosage as per weight band)

53. HIV and Hepatitis C Co-infection
• The following drugs are currently available under the NVHCP for management
of hepatitis C:
1. Sofosbuvir (SOF)
2. Velpatasvir (VEL)
3. Daclatasvir (DCV)
4. Ribavirin
• In general, clinical stabilization of HIV disease with ART is advisable before
starting treatment for HCV
• Especially for people with advanced immunosuppression (CD4 count below 200
cells/mm3 )

54. Management approach in HIV–HCV co-infection
PLHIV confirmed with chronic HIV infection (Detected HCV antibodies and HCV RNA)
Undertake baseline investigations — APRI, FIB4 and elastography, if available
Perform HCV RNA 12 weeks after completion of treatment
Patient does not have cirrhosis
Patient has cirrhosis
(compensated child Pugh A)
Treat with SOF + DCV for 12
weeks
Treat with SOF + VEL for 12
weeks
HCV RNA not detected HCV RNA detected
Treatment completed
Refer to higher center for
further management

55. Management approach in HIV–HCV co-infection
Regimen
type
Category of patients Regimen recommended Duration of
Treatment
I Patient without cirrhosis
(uncomplicated)
Sofosbuvir (400 mg) + Daclatasvir
(60 mg)
84 days
(12 weeks)
II Patient with cirrhosis compensated
(Child-Pugh A)
Sofosbuvir (400 mg) + Velpatasvir
(100 mg)
84 days
(12 weeks)
III Patient with cirrhosis decompensated
(Child-Pugh B and C)
Sofosbuvir (400 mg) +
Velpatasvir (100 mg) & Ribavirin
600-1200 mg)
84 days
(12 weeks)
In Ribavirin-intolerant patients
Sofosbuvir (400 mg) + Velpatasvir
(100 mg)
168 days
(24 weeks)

56. Management of clinical conditions before ART initiation
Clinical Picture Action
• Any undiagnosed active
infection with fever
Diagnose and treat first; start ART when stable
• Pneumocystis pneumonia Treat PCP first; start ART when PCP treatment is completed
• Malaria Treat malaria first; start ART when treatment is completed
• Drug reaction Do not start ART during an acute drug reaction
• Acute diarrhoea which may
reduce absorption of ART
Diagnose and treat first; start ART when diarrhoea is
stabilized or controlled
• Cytomegalovirus infection
(CMV)
Treat CMV; start ART after induction phase of treatment for
CMV
• Bacterial pneumonia Treat pneumonia first; start ART when treatment is
completed

57. PLHIV (People living with HIV)
• The shorter or longer oral MDR-TB regimen can be used in PLHIV
• In PLHIV with pulmonary MDR/RR-TB, drug-drug interactions between anti-
TB and ART medicines potentially overlap
E.g.
• Mfx and Cfz or
• Efavirenz and Bdq may potentially increase the risk of Bdq related adverse
events

58. References
• National Guidelines for HIV care and Treatment in India-2021
• National AIDS Control Organization (2021) New Delhi: NACO, Ministry of
Health and Family Welfare, Government of India

59. THANK-YOU