This document provides guidelines for antiretroviral therapy in 2011. It outlines recommendations for treatment of adult/adolescent patients, treatment during pregnancy, and post-exposure prophylaxis. The guidelines classify recommendations as A (strong), B (moderate), or C (optional) based on the quality of evidence. They provide monitoring schedules before and after starting antiretroviral therapy. The guidelines also cover topics like when to start treatment, what drugs to start with, treatment of experienced patients, acute HIV infection, treatment of women/pregnant women, and management of HIV/HBV coinfection.

1. ANTIRETROVIRAL THERAPY
GUIDELINES 2011

2. OUTLINE
Guidelines for antiretroviral drugs in
 Adult and adolescent
 Pregnancy
 Post exposure prophylaxis

3. STRENGTH OF RECOMMENDATION QUALITY OF EVIDENCE
A. Strong recommendation I: One or more randomized trials with clinical
outcomes and/or validated laboratory
endpoints
B. Moderate recommendation for the II: One or more well-designed,
statement nonrandomized trials or
observational cohort studies with long-term
clinical
outcomes
C. Optional recommendation for the III: Expert opinion
statement

4. Laboratory Monitoring Schedule Prior and After Initiation of Antiretroviral Therapy
2–8 weeks
Follow- up ART
Entry post-ART Every 3–6 Every 6 Ever Treatment Clinicaly
before ART initiation or
into initiation or months months y 12 failure indicated
modification1
care modification mon
√ every 3–6 √ √ clinically stable patients
ths √ √
CD4 count months with
suppressed viral load, CD4
count can be monitored
√ every 3–6 months √ √2 √3 every √ √
Viral load 6–12 months
√ √4 √ √
Resistance
test
√
HLA- if considering
B*5701 ABC
√ √ √
Tropism
testing if considering a if considering a
testing CCR5 CCR5 antagonist
antagonist or for failure of
CCR5 antagonist-
Hepatitis B √ √ based regimen √
may repeat if
serology negative
baseline
Basic √ every 6–12 √ √ √ √
months
chemistry
AST,ALT √ every 6–12 √ √ √ √
months
,BIL
√ every 3–6 √ √ √ √
CBC months if on ZDV
√ if normal, √ √ √ √ √
Fasting annually consider 4–8 if abnormal if
lipid weeks after at last normal
starting new measurement at last
profile ART measure
√ if normal, √ √ √ ment √
Fasting annually if abnormal if normal at
glucose at last
measurement
last
measuremen
√ √ t √ √ √
Urinalysis7 if on TDF8
Pregnancy test √ √
if starting EFV

5. HIV drug-resistance testing
• HIV drug-resistance testing when they enter into care
regardless of initiation of ART (AIII). If therapy is deferred,
repeat testing at the time of ART initiation should be
considered (CIII).
• Genotypic testing is recommended as the preferred
resistance testing (AIII).
• HIV drug-resistance testing should be performed when
changing ARV regimens in persons with virologic failure
and HIV RNA levels >1,000 copies/mL (AI). In persons with
HIV RNA levels >500 but <1,000 copies/mL, testing may be
unsuccessful but should still be considered (BII).

6. HIV drug-resistance testing
•Drug-resistance testing in the setting of virologic failure
should be performed while the person is taking prescribed
ARV drugs or, if not possible, within 4 weeks after
discontinuing therapy (AII).
• Addition of phenotypic to genotypic testing is generally
preferred for persons with known or suspected complex
drug-resistance mutation patterns, particularly to protease
inhibitors (PIs) (BIII).
• Genotypic resistance testing is recommended for all
pregnant women prior to initiation of therapy (AIII) and for
those entering pregnancy with detectable HIV RNA levels
while on therapy (AI).

7. HLA-B*5701 SCREENING
• The Panel recommends screening for HLA-B*5701 before
starting patients on an abacavir (ABC)-containing regimen
to reduce the risk of hypersensitivity reaction (HSR) (AI).
• The positive status should be recorded as an ABC allergy
in the patient’s medical record (AII).
• When HLA-B*5701 screening is not readily available, it
remains reasonable to initiate ABC with appropriate
clinical counseling and monitoring for any signs of HSR
(CIII).

8. CORECEPTOR TROPISM ASSAYS
• Coreceptor tropism assay should be performed
whenever the use of a CCR5 inhibitor is being
considered (AI).

9. GOALS FOR ANTIRETROVIRAL
THERAPY (ART)
•Reduce HIV-associated morbidity and prolong the
duration and quality of survival,
•Restore and preserve immunologic function,
•Maximally and durably suppress plasma HIV viral
load and
•Prevent HIV transmission.

11. Initiating Antiretroviral Therapy in
Treatment- Naive Patients
• All patients with a history of an AIDS-defining illness or
with a CD4 count of <350 cells/mm3 (AI).
•ART is also recommended for patients with CD4 counts
between 350 and 500 cells/mm3 (A/B-II).
•ART should also be initiated, regardless of CD4 count, in
patients with the following conditions: HIVAN (AII) and HBV
coinfection when treatment of HBV is indicated (AIII).
•A combination ARV drug regimen is also recommended for
pregnant women who do not meet criteria for treatment
with the goal to prevent perinatal transmission (AI).
•Patients may choose to postpone therapy, and providers,
on a case-by-case basis, may elect to defer therapy based on
clinical and/or psychosocial factors.

12. What to Start
Preferred Regimens (Regimens with optimal
and durable efficacy, favorable tolerability and
toxicity profile, and ease of use)
A drug from column A should be combined with the drugs listed in column B
A B Remark
NNRTI NRT s
I • EFV/TDF/FTC co-formulated
• EFV TDF/FTC
• LPV/r (twice daily) ZDV/3TC preferred for pregnant women
Ritonavir-boosted PI
• ATV/r • ATV/r: 300/100 mg qd
TDF/FTC
• DRV/r • DRV/r: 800/100 mg qd
ITI
• RAL TDF/FTC • RAL: 400 mg bid

13. • Alternative Regimens (Regimens that
are effective and tolerable but have
potential disadvantages)
A drug from column A should be combined with the drugs listed in columnB
A B Remark
NNRTI NRTI s
• EFV ABC/3TC • ABC/3TC co-formulated
RPV (rilpivirine) TDF/FTC or ABC/3TC • TDF/FTC co-formulated
Ritonavir-boosted PI
• ATV/r ABC/3TC • ATV/r: 300/100 mg qd
• DRV/r • DRV/r: 800/100 mg qd
• LPV/r or FPV/r ABC/3TC or TDF/FTC • LPV/r: 400/100 mg bid or 800/200 mg
qd
ITI
ABC/3TC • RAL: 400 mg bid
• RAL

14. A drug from column A should be combined with the drugs listed in columnB
A B
NNRTI NRTI
EFV ZDV/3TC (CI)
Acceptable
NVP TDF/FTC or ZDV/3TC (CI) Regimens (CI)
NVP 90
ABC/3TC (CIII)
(C1)
(Regimens that may
RPV ZDV/3TC (CIII)
Ritonavir-boosted PI
be selected for some
ATV/r CI ZDV/3TC patients but are less
DRV/r CIII
LPV/r or FPV/r ZDV/3TC (CI)
satisfactory and
Regimens that may
CCR5 ANTAGONIST
be acceptable but
MVC ZDV/3TC (CI) or more definitive data
TDF/3TC or ABC/3TC (CIII) are needed)
ITI
ZDV/3TC (CIII)
RAL

15. Treatment Experienced Patient
• Expert advice is critical and should be sought.
• Drug-resistance testing should be obtained.
• To design a new regimen, the patient’s treatment history
and past and current resistance test results should be used
to identify at least two (preferably three) fully active
agents to combine with an optimized background ARV
regimen (AI).
• In general, adding a single, fully active ARV in a new
regimen is not recommended because of the risk of rapid
development of resistance (BII).

16. Treatment Experienced Patient
• In patients with a high likelihood of clinical progression
and limited drug options, adding a single drug may reduce
the risk of immediate clinical progression (CI).
• For some highly ART-experienced patients, maximal
virologic suppression is not possible. In this case, ART
should be continued (AI) with regimens designed to
minimize toxicity, preserve CD4 cell counts, and avoid
clinical progression.
• Discontinuing or briefly interrupting therapy strategy is
not recommended (AI).

17. ACUTE HIV INFECTION
• Diagnosis
• Clinical suspicion
• Negative or reactive EIA with negative or
indeterminate Western blot should be
followed by a HIV RNA levels
• Confirmatory HIV antibody test should be
performed over the next 3 months.

18. RECOMMENDATIONS
• Treatment should be considered optional at this time and
for those with seroconversion within last 6 months (CIII).
• All pregnant women with acute or recent HIV infection
should start a combination antiretroviral (ARV)regimen
(AI).
• If the decision is made to initiate therapy in a person with
acute HIV infection, genotypic resistance testing at
baseline will be helpful (AIII). If therapy is deferred,
genotypic resistance testing should still be performed
(AIII).
•Ritonavir (RTV)-boosted PI-based regimen should be used
if therapy is initiated before drug-resistance test results are

19. HIV-INFECTED WOMEN
• ART drugs having interactions with oral contraceptives should use
an additional or alternative contraceptive method (AIII).
e.g. E and N additional contraceptive method recommended,with
ATZ/r min 35 mcg of ethinyl estradiol is necessary,with other ritonavir
boosted PI ‘s an additional or alternative contraceptive method
recommended.
• Prevention of mother-to-child transmission (PMTCT).
• Genotypic resistance testing is recommended for all HIV-infected
persons, including pregnant women, prior to initiation of ART (AIII)
and for women entering pregnancy with detectable HIV RNA levels
while on therapy (AI).
• Efavirenz (EFV) should be avoided in a pregnant woman during the
first trimester (AIII).

20. Perinatal guidelines
• Combined antepartum, intrapartum, and infant ARV
prophylaxis is recommended to prevent perinatal
transmission (AI).
• Antepartum ART –
Start as soon as possible for own health
After first trimester if not for own health (AI)
• Adding single-dose intrapartum/newborn nevirapine to
the standard ARV regimens is not recommended(AI).
• If an ARV drug regimen is stopped acutely for severe
toxicity, severe pregnancy-induced hyperemesis , all ARV
drugs should be stopped and reinitiated at the same
time (AIII).

21. Perinatal guidelines
• When HIV is diagnosed late in pregnancy, ARV should be initiated
pending results of resistance testing (BIII).
• Breastfeeding is not recommended for HIV infected women including
those receiving ART(AII).
• Regarding continuation of the ARV regimen for therapeutic indications
after delivery are the same as for non pregnant individuals.(AIII)
(promise trial underway).
• Discontinuation postnatal,
Ideally all drugs should be stopped simultaneously.
If NNRTI based regimens,
1) continue the dual-NRTI back- bone for 7 days.
2) If efavirenz-based NNRTI continue other ARV agents for
up to 30 days
3) alternatively replace the NNRTI with PI then to discontinue all the
drugs at the same time.

22. CLINICAL SCENARIO RECOMMENDATIONS
HIV-infected Women:
pregnant women • Perform HIV ARV drug-resistance and repeat after initiation of therapy if viral
who are ARV naive suppression is suboptimal.
and do not require • Prescribe combination ARV drug prophylaxis (i.e., at least 3 drugs) to prevent
treatment for their perinatal transmission.
own health • Delayed initiation of prophylaxis until after the first trimester of
pregnancy can be consid- ered in women who are receiving ARV drugs solely
for prevention of perinatal transmission, but earlier initiation of prophylaxis
may be more effective in reducing perinatal transmission of HIV.
•Avoid use of efavirenz or other potentially teratogenic drugs in the first
trimester.
•use one or more NRTIs with good transplacental passage as a component of
the ARV regimen.
• Continue ARV prophylaxis regimen during the intrapartum period (zidovudine
given as con- tinuous infusiona during labor while other ARV agents are
continued orally).
• Schedule cesarean delivery at 38 weeks of gestation if plasma HIV RNA
remains >1,000 copies/mL near the time of delivery.
Infants:
• Start zidovudine as soon as possible after birth and administer for 6 weeks

23. HIV-infected Women:
pregnant women • Obtain full ARV drug history, including prior resistance testing, and evaluate
who are ARV need for ART
experi- enced but for maternal health.
not currently re- • Test for HIV ARV drug resistance before reinitiating ARV drugs & retest after
ceiving ARV drugs initiating combination ARV regimen if viral suppression is suboptimal.
Infants:
• Start zidovudine as soon as possible after birth and administer for 6 weeks.b
HIV-infected Women: Give zidovudine as continuous infusion during labor.
women who have Infants: prophylaxis with a combination ARV drug regimen started as close to
received no ART the time of birth as possible. Zidovudine given for 6 weeks combined with 3
before labor doses of nevirapine in the first week of life ( at birth, 48 hours later,& 96
hours after second ).
Infants born to HIV- Prophylaxis with a combination ARV drug regimen started as close to the
infected women time of birth.
who have received
no ART before or
during labor

24. Concordant and Serodiscordant
Couples
•For serodiscordant couples who want to conceive, expert consultation is
recommended (AIII).
•Partners should be screened and treated for genital tract infections
before attempting to conceive (AII).
•HIV-infected female with an HIV-uninfected male partner,
- artificial insemination (AIII).
•For HIV-infected men with an HIV-uninfected female partner,
donor sperm from an HIV-uninfected male for insemination
the use of sperm preparation techniques coupled with either intrauterine
insemination, in vitro fertilization, or intracytoplasmic sperm injection (AII).
•In a serodiscordant couple who wishes to conceive,
Initiation of ART for the HIV-infected partner is recommended if
the infected partner has a CD4 count ≤550 cells/mm3 (AI).
with CD4 counts >550 cells/mm3, initiation of ART could be
considered (BIII).

25. HIV/HBV Coinfection in
pregnancy
•Screening for hepatitis B virus (HBV) infection is
recommended (AII).
•HBV vaccine should be administered if negative
for hepatitis B (AII).
•consultation with an expert in HIV and HBV is
recommended (AIII).
•All pregnant women with HIV/HBV coinfection
should receive a combination ARV drug regimen
with two drugs active against both HIV and HBV
(AII). Tenofovir plus lamivudine or emtricitabine is
the preferred (AI).

26. HIV/HBV Coinfection in pregnancy
• If ARV drugs are discontinued postpartum , frequent
monitoring of liver function tests for exacerbation
of HBV infection is recommended, with prompt
reinitiation of treatment for both HIV and HBV if a
flare is suspected (BIII).
• liver transaminases should be assessed 1 month
following initiation of ARV drugs and at least every 3
months thereafter (BIII).
• Within 12 hours of birth, infants born to women with
HBV infection should receive
hepatitis B immune globulin (HBIG)
first dose of the HBV vaccine series (AI).

27. HIV/HCV Coinfection in Pregnancy
•Screening for hepatitis C virus infection is recommended (AIII).
•Interferon alfa not recommended and ribavirin is contraindicated
during pregnancy (AIII).
•Recommendations for ARV drug use during pregnancy are the same
for women who have chronic HCV as for those without HIV/HCV
coinfection (BIII).
•Decisions of mode of delivery should be based on standard
obstetric and HIV-related indications alone (BIII).
•Infants born to women with HIV/HCV coinfection should be
evaluated for HCV infection with anti-HCV antibody testing after age
18 months (AII). Infants with a positive anti-HCV antibody should
undergo confirmatory HCV RNA testing. If earlier diagnosis is
indicated or desired, HCV RNA virologic testing between ages 3 and
6 months can be performed (AIII).

28. HIV-2 Infection and Pregnancy
• A regimen with TWO NRTIS AND A BOOSTED PI currently is
recommended because they have SIGNIFICANT CLINICAL DISEASE
OR CD4 COUNTS <500 CELLS/MM3 (AIII).
• Based on available data on safety in pregnancy,ZDV+3TC+LPV/r
would be preferred (AIII).TDF+3TC/FTC+LPV/r can be considered as
an alternative (BIII).
• Optimal PROPHYLACTIC regimens have not been defined
following approaches:
• A boosted PI-based regimen (two NRTIs plus lopinavir/ritonavir)
for prophylaxis, with the drugs stopped postpartum(BIII); OR
Zidovudine prophylaxis alone during pregnancy and intrapartum
(BIII).
• NNRTIs AND ENFUVIRTIDE are not active against HIV-2 (AIII).
• Infants should receive 6-WK AZT prophylactic regimen (BIII).

29. Monitoring in Pregnancy
• CD4 count should be monitored at the initial visit (AI)
and at least every 3 monthly (BIII).Monitoring of CD4
count may be performed every 6 months in patients on
ART for more than2–3 years & have sustained viral
suppression (BIII)
• Plasma HIV RNA levels should be monitored at the initial
visit (AI); 2–4 weeks after initiating (or changing)
antiretroviral (ARV) drug regimens (BI); monthly until
RNA levels are undetectable (BIII); and then at least
every 3 months (BIII). HIV RNA levels also should be
assessed at approximately 34–36 weeks’ gestation to
inform decisions about mode of delivery (AIII).

30. Management of Antiretroviral Drug
Resistance during Pregnancy
• Women who have documented zidovudine
resistance and are on regimens that do not
include zidovudine for their own health should
still receive intravenous zidovudine during labor
whenever possible, along with their established
antiretro- viral (ARV) regimens (AII).
• In women who are receiving a stavudine-
containing regimen, the drug should be
discontinued during labor while intra-venous
zidovudine is being administered (AII).

31. HBV/HIV COINFECTION
•ART should be initiated with the combination of
TDF + FTC or TDF + 3TC backbone of a fully
suppressive antiretroviral (ARV) regimen (AI).
•If TDF cannot safely be used, the alternative
recommended HBV therapy is entecavir in addition
to a fully suppressive ARV regimen (BI).

32. HBV/HIV COINFECTION
• Entecavir has activity against HIV; its use for HBV
treatment without ART in patients with dual
infection may result in the selection of the M184V
mutation that confers HIV resistance to 3TC and
FTC (AII).
• If ART needs to be modified due to HIV virologic
failure and the patient has adequate HBV
suppression, the ARV drugs active against HBV
should be continued for HBV treatment in
combination with other suitable ARV agents to
achieve HIV suppression (AIII).

33. HCV/HIV COINFECTION
• ART should be started in HCV/HIV-coinfected
persons in accordance with the Panel’s
recommendation for initiating ART in ART-naïve
patients.
• Patients receiving or considering therapy with
ribavirin should avoid ddI, d4T, and ZDV.
• Patients should be monitored by following alanine
aminotransferase (ALT) and aspartate
aminotransferase (AST) levels at 1 month and
then every 3 months after initiation of ART.

34. MYCOBACTERIUM TUBERCULOSIS
DISEASE WITH HIV COINFECTION
• All HIV-infected patients with diagnosed active TB
should be treated with ART (AI).
• For patients with CD4 count <200 cells/mm3, ART
should be initiated within 2–4 weeks of starting TB
treatment (AI).
• For patients with CD4 count 200–500 cells/mm3,
the Panel recommends initiation of ART within 2–4
weeks, or at least by 8 weeks after commencement
of TB therapy (AIII).

35. MYCOBACTERIUM TUBERCULOSIS
DISEASE WITH HIV COINFECTION
• For patients with CD4 count >500 cells/mm3,
most Panel members also recommend starting ART
within 8 weeks of TB therapy (BIII).
• If a protease inhibitor (PI)-based regimen is used,
rifabutin is the preferred rifamycin (AII).
• Coadministration of rifampin and PIs (with or
without ritonavir boosting) is not recommended
(AII).

36. IMPROVING ADHERANCE
Strategies to Improve Adherence to Antiretroviral Therapy
Strategies Examples
multidisciplinary approach accessible, • Nurses, social workers, pharmacists, and medication managers
trusting health care team
Establish readiness to start ART Counseling sessions
Identify potential barriers to adherence • Psychosocial issues • Active substance abuse or at high risk of relapse
prior to starting ART • Low literacy level • Busy daily schedule and/or travel away from home
• Lack of disclosure of HIV diagnosis • Skepticism about ART
• Lack of prescription drug coverage
Provide resources for the patient • Referrals for mental health and/or substance abuse treatment
• Resources to obtain prescription drug coverage
• Pillboxes
Involve the patient in antiretroviral (ARV) • For each option, review potential side effects, dosing frequency, pill
regimen selection burden, storage requirements, food requirements, and consequences
of nonadherence
Assess adherence at every clinic visit • Use a simple checklist the patient can complete in the waiting room
• Have other members of the health care team also assess
adherance
• Ask the patient open-ended questions (e.g., In the last 3 days,
please tell me how you took your medicines.)
Identify the type of nonadherence • Failure to fill the prescription(s)
• Failure to take the right dose(s) at the right time(s)
• Nonadherence to food requirements
Identify reasons for nonadherence • Adverse effects from medications
Assess and simplify regimen, if possible • Complexity of regimen (pill burden, dosing frequency)
• Difficulty swallowing large pills• Forgetfulness
• Failure to understand dosing instructions

37. Post exposure Prophylaxis
• The first dose of PEP should be administered
within the first 72 hours of exposure and the risk
evaluated as soon as possible.
• Special leave from work should be considered for
a period of time eg. 2 weeks (initially) then, as
required based on assessment of the exposed
person’s mental state, side effects and
requirements.

38. PEP is not indicated
• if the exposed person is HIV-positive from a previous
exposure;
• in chronic exposure;
• if the exposure does not pose a risk of transmission, that
is, after: exposure of intact skin to potentially infectious
body fluids, sexual intercourse using a condom that
remains intact
• any exposure to non-infectious body fluids (such as
faeces, saliva, urine and sweat)
• if the exposure occurred more than 72 hours previously.

39.  If the skin is broken following an injury with a used
needle or sharp instrument, the following is
recommended.
Do not squeeze or rub the injury site.
Wash the site immediately using soap or a mild disinfectant
solution that will not irritate the skin. WHO recommends
the use of a chlorhexidine gluconate solution.
If running water is not available, clean the site with a gel or
other hand-cleaning solution
Do not use strong solutions, such as bleach or iodine,
 After a splash contacts unbroken skin, do the following.
Wash the area immediately.
If running water is not available, clean the area with a gel or
other hand- rub solution, whatever is customarily available.
Do not use strong disinfectants.

40.  After a splash contacts the eye, do the following
• Irrigate the exposed eye immediately with water or
normal saline.
• Sit in a chair, tilt the head back and have a colleague
gently pour water or normal saline over the eye, pulling
the eyelids up and down to make sure the eye is cleaned
thoroughly.
• If contact lenses are worn, leave these in place while
irrigating the eye, as they form a barrier over the eye and
will help protect it. Once the eye has been
cleaned, remove the contact lenses and clean them in the
normal manner. This will make them safe to wear again.
 After a splash contacts the mouth, do the following
• Spit the fluid out immediately.
• Rinse the mouth thoroughly, using water or saline, and
spit again. Repeat this process several times..

41. Criteria for treatment
with two NRTI inhibitors
• HIV status of the source person is unknown; and
• background prevalence of resistance to antiretroviral
therapy in the community is less than 15%; and
• source person has never used antiretroviral therapy;
or
• source person is unlikely to have HIV infection resistant
to antiretroviral therapy , based on antiretroviral therapy
and adherence history.
Preferred regimens Alternative regimens
zidovudine + lamivudine tenofovir +
lamivudine

42. Criteria for treatment
with two NRTI + bPI
•source person is HIV positive, taking antiretroviral therapy
and is known to have signs of, personal history of or proven
antiretroviral therapy resistance; or
•source person’s HIV status is unknown;
the background prevalence of resistance to antiretroviral
therapy in the community exceeds 15%.

43. Categories of exposure
category Definition and example
Mild mucous membrane/non-intact skin with small
exposure volumes E.g. : a superficial wound (erosion of the
epidermis) with a plain or low calibre needle, or
contact with the eyes or mucous membranes,
subcutaneous injections following small-bore
needles
Moderate mucous membrane/non intact skin with large
exposure volumes Or percutaneous superficial exposure with
solid needle
E.g. : cut or needle stick injury penetrating gloves
severe percutaneous with large volume e.g. :needle (>18 G)
exposure with visibly blood;deep wound (haemorrhagic
wound or very painful) ;volume of blood;previously
used intravenously or intra-arterially line .

44. HIV transmission risk : different
routes
Blood transfusion 90–95%
•
Perinatal HIV transmission risk of
20–40%
Sexual intercourse 0.1 to 10%
Vaginal 0.05–0.1%
Anal 0.065–0.5%
Oral 0.005–0.01%
Injecting drugs use 0.67%
Needle stick exposure 0.3%
Mucous membrane splash to eye, oro- 0.09%
nasal
tears, sweat, saliva, urine and faeces Noninfectious unless contaminated
exposure with visible blood
Needle-stick exposure HBV is
9–30% & for HCV is 1–10%

45. HIV POST-EXPOSURE PROPHYLAXIS EVALUATION
EXPOSURE HIV+ & HIV+ &
HIV STATUS UNKNOWN
ASYMPTOMATIC CLINICALLY
SYMPTOMATIC
MILD CONSIDER 2-DRUG START 2- DRUG USUALLY NO PEP OR CONSIDER 2-DRUG PEP
MODERAT START 2-DRUG START 3-DRUG USUALLY NO PEP OR CONSIDER 2-DRUG PEP
E
SEVERE START 3-DRUG START 3-DRUG USUALLY NO PEP OR CONSIDER 2-DRUG PEP
pep regimens to be prescribed by health centers
preferred alternative
2-drug regimen 1st choice: 2nd choice:
(basic pep regimen) Zidovudine (AZT) + Lamivudine Stavudine (d4T) + Lamivudine (3TC)
(3TC)
3-drug regimen (expanded regimen) -consult expert for starting 3rd drug eg LPV/r, NLF or IND

46. NACO: WHAT IS DIFFERENT?
• Plasma viral load: A baseline PVL is not necessary.
With optimum adherence and a potent regimen,
undetectable levels should be achieved at 6
months after ART initiation.
• All patients should undergo at least two
counselling sessions before the initiation of ART.
• TDF + 3TC + (NVP or EFV): if toxicity or other
contraindications to AZT or d4T.
• ‘triple NRTI approach’ will not be used in the
National programme until further data is
available globally

47. Intolerance to both ZDV and d4T : in this
case, TDF+3TC as fixed dose combination will be
provided, after consultation with the SACEP. Drug
supply mechanism to be decided.
Intolerance to both NVP and EFV: in this
case, ATV/r as a substitution ARV will be provided
upon review and approved by the SACEP. The
patient shall be managed and provided ATV/r by
the COE for at least 6 months and then
transferred back to the referring ART center.

48. FAILURE
• Clinical, immunological and virological definitions of
treatment failure for first-line regimen.
>5000
• Certain WHO clinical stage 3 conditions like pulmonary TB
, severe bacterial infections indicate treatment failure and
second line ART considered.
• Some stage 4 conditions TB lymph nodes &
plueral, recurrent bacteria pneumonia , oesophageal
candidiasis may not indicate Rx failure and 2nd line should
not be cosidered.

49. Procedure for second line ART
Counsel patient & Reinforce adherence to 1st line
ART while waiting for SACEP(State AIDS Clinical
Expert Panel) review.
Send all patient informationto SACEP/COE by courier.
• Refer to SACEP for appointment dates by email - inform
patient of date and to attend in person.
• All patient who require 2nd line ART will be reviewd by
SACEP irrespective of from where they took 1st line.
• SACEP will document its decision ie
Provide 2nd line ART, Not eligible for 2nd line ART, Re-
evaluate
• Patient should undergo minimum of 3 counseling
sessions for treatment readiness.
• The NACO second line regimen (TDF + 3TC + ATV/R)

50. Co-trimoxazole prophylaxis recommendations
Commencing Cd4 not available Cd4 available
primary CpT WHO clinical Any WHO clinical stage and Cd 4 <200 cells/mm3 or
stage Any WHO clinical stage, Cd 4 <350 cells/mm3 and if
3 or 4 (This patient is symptomatic or
includes all WHO stage 3 or 4 irrespective of CD4 count
Timing the initiation patients with
Start co-trimoxazole prophylaxis first.
of co-trimoxazole in TB) ART about two weeks later if the patient can tolerate co-trimoxazole
Start
relation to initiating and has no symptoms of allergy (rash, hepatotoxicity)
ART
patients allergic Dapsone 100 mg per day, if available
to sulpha-based
medications
Monitoring No specific laboratory monitoring is required in patents receiving co-

51. Recommended schedule for starting and stopping oI prophylaxis
opportunisti primary prophylaxis drug of choice discontinue primary discontinue
c infection indicated when Cd4 prophylaxis when secondary
is Cd4 is prophylaxis when
Cd4 is
PCP < 200 TMP-SMX 1 DS od >200
Toxoplasmosis < 100 TMP-SMX 1 DS od >200
CMV retinitis Not indicated Secondary: oral Not applicable >100
ganciclovir
Cryptococs Not indicated Secondary: Not applicable >100
meningitis fluconazole
Oral & oesophageal Not indicated Not applicable Not applicable Not indicated
candidiasis
• Co-trimoxazole desensitization
Desensitization can be attempted two weeks after a
non-severe co-trimoxazole reaction.
successful and safe in approximately 70% cases.

52. WHO : WHATS DIFFERENT ?
• It is recommended to treat all patients with WHO clinical
stage 3 and 4 irrespective of CD4 count.(Strong
recommendation, low quality of evidence)
• Start one of the following regimens in ART-naive individuals
eligible for treatment.
• AZT + 3TC + EFV
• AZT + 3TC + NVP
• TDF + 3TC (or FTC) + EFV
• TDF + 3TC (or FTC) + NVP
(Strong recommendation, moderate quality of evidence)

53. Triple nucleoside regimens AZT + 3TC + ABC
or A ZT + 3TC + TDF should be used for
individuals who are unable to tolerate or have
contraindications to NNRTI- based regimens,
particularly in the following situations:
• HIV/ TB coinfection;
• pregnant women;
• chronic viral hepatitis B;
• HIV-2 infection.
(Conditional recommendation, low quality of
evidence)

54. WHEN TO SWITCH THERAPY?
• Where available, use viral load ( VL) to confirm
treatment failure.(Strong recommendation, low
quality of evidence)
• Where routinely available, use VL every 6 months
to detect viral replication.
(Conditional recommendation, low quality of
evidence)
• A persistent VL of >5000 copies/ml confirms
treatment failure.(Conditional recommendation,
low quality of evidence)

55. THIRD-LINE REGIMENS
• Include new drugs likely to have anti-HIV
activity, such as integrase inhibitors and
second-generation NNRTIs and
PIs.(Conditional recommendation, low quality
of evidence)
• Patients on a failing second-line regimen with
no new ARV options should continue with a
tolerated regimen.(Conditional
recommendation, very low quality of evidence)

57. WHO PERINATAL GUIDELINES
Maternal AZT + infant ARV prophylaxis Maternal triple ARV prophylaxis
(Option A) (Option B)
Mother Mother
Antepartum twice-daily AZT starting at 14 ARV prophylaxis starting 14 weeks of
weeks of gestation. At onset of labour, sd-NVP gestation and continued until delivery, or, if
and initiation of twice daily AZT + 3TC for 7 breastfeeding, continued until 1 week after
days postpartum. all infant exposure to breast milk has
If maternal AZT was provided for >4 weeks
ended. AZT + 3TC +LPV/r
antenatally, omit sd-NVP and
AZT + 3TC + ABC
AZT + 3TC tail ; in this case, continue
maternal AZT during labour and stop at AZT + 3TC + EFV
delivery). TDF + 3TC (or FTC) + EFV
Infant Infant
For breastfeeding infants:Daily NVP from birth Irrespective of mode of infant feeding
for min of 4 to 6 weeks, and until 1 week after Daily NVP or twice daily AZT from birth
all exposure to breast milk has ended. until 4 to 6 weeks of age.
Infants receiving replacement feeding only:
Daily NVP or sd-NVP + twice-daily AZT from
birth until 4 to 6 weeks of age.

58. Previous ARV exposure for PMTCT Recommendations for initiation of
ART when needed for treatment
of HIV for maternal health
SdNVP (+/- antepartum A ZT ) Initiate a non-NNRTI regimen
with no A ZT/3TC tail in last 12 PI preferred over 3 NRTI
months
sdNVP (+/- antepartum A ZT ) Initiate an NNRTI regimen
with an A ZT/3TC tail in last 12 If possible, check viral load at 6
months months and if >5000 copies/ml,
switch to second- line ART with PI
sdNVP (+/- antepartum A ZT ) with or Initiate an NNRTI regimen
without an A ZT/3TC tail over 12 months If possible, check viral load at 6
ago months and if >5000 copies/ml,
switch to second- line ART with PI
Option A Initiate an NNRTI regimen
Antepartum A ZT (from as early as 14 If possible, check viral load at 6
weeks of gestation) months and if >5000 copies/ml,
sdNVP at onset of labour* switch to second- line ART with PI
A ZT + 3TC during labour and If no sdNVP was given, start
standard NNRTI (viral load does not
delivery* A ZT + 3TC tail for 7 days
need to be checked unless clinically
postpartum*
indicated as no sdNVP received)
* sd-NVP and A ZT + 3TC can be
All triple ARV regimens (including Option Initiate standard NNRTI regimen
omitted if mother receives >4 weeks of
B), irrespective of duration of exposure If EFV-based triple ARV was used for
A ZT
and time since exposure prophylaxis and no tail (A ZT + 3TC; or
antepartum
Option B TDF+ 3TC; or TDF + FTC) was given
Triple ARV from 14 weeks gestation when triple ARV was discontinued
until after all exposure to breast milk after cessation of breastfeeding (or
has ended A ZT + 3TC + LPV/r delivery if formula feeding), check
A ZT + 3TC + ABC viral load at 6 months and if >5000
A ZT + 3TC + EFV copies/ml, switch to second-line ART
TDF + [3TC or FTC] + EFV with PI.

59. WHO clinical staging of HIV disease in adults and adolescents
Clinical stage 1
Asymptomatic
Persistent generalized lymphadenopathy
Clinical stage 2
Moderate unexplained weight loss (<10% of measured body wt)
Recurrent RTI (sinusitis,tonsillitis,otitis media, pharyngitis)
Herpes zoster
Angular cheilitis
Recurrent oral
ulceratio
Papular pruritic
eruptio
Seborrhoeic
dermatitis
Fungal nail
infections
Clinical stage
3
Unexplained severe weight loss (over 10% of presumed or measured body weight)
Unexplained chronic diarrhoea for longer than 1 month
Unexplained persistent fever (intermittent or constant for > 1
month)
Persistent oral candidiasis
Oral hairy leukoplakia
Pulmonary tuberculosis
Severe bacterial infections (e.g. pneumonia, empyema, meningitis,
pyomyositis, bone or joint infection, bacteraemia, severe pelvic
inflammatory disease)
Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis
Unexplained anaemia (below 8 g/dl ), neutropenia (below 0.5 x 10 9 /l)
and/or chronic thrombocytopenia (below 50 x 10 9 /l)

60. Clinical stage 4
HIV wasting syndrome
pcp pneumonia
Recurrent severe bacterial
pneumonia
Chronic herpes simplex infection (orolabial, genital or anorectal of more
than 1 month’s duration or visceral at any site)
Oesophageal candidiasis ( trachea, bronchi or lungs)
Extrapulmonary tuberculosis
Kaposi sarcoma
Cytomegalovirus disease (retinitis or infection of other organs, excluding
liver, spleen and lymph nodes)
Central nervous system toxoplasmosis
HIV encephalopathy
Extrapulmonary cryptococcosis
Disseminated nontuberculous
mycobacteria infection
Progressive multifocal
leukoencephalopathy
Chronic cryptosporidiosis
Chronic isosporiasis
Disseminated mycosis (histoplasmosis,
coccidiomycosis)
Recurrent septicaemia (including nontyphoidal
Salmonella)
Lymphoma (cerebral or B cell non-Hodgkin)
Invasive cervical carcinoma
Atypical disseminated leishmaniasis
Symptomatic HIV-associated nephropathy or HIV-associated cardiomyopathy