Zambian HIV Guidelines:: Cotrimoxazole Prophylaxis

	Zambia HIV National Guidelines
	Introduction HIV Counseling and Testing Sexually Transmitted Infections (STIs) General Principles of Antiretroviral Therapy for Chronic HIV Infection in Adults and Adolescents When to Start ARV Therapy for Chronic HIV Infection in Adults and Adolescents Initial Regimen for ARV Therapy Adherence Baseline evaluation and Monitoring Calculations: Ideal Body Weight, Body Mass Index and Creatinine Clearance ARV Therapy for Individuals with Tuberculosis Co-Infection Adverse Effects and Toxicity Immune Reconstitution Inflammatory Syndrome (IRIS) Changing or Stopping ART Treatment Failure Stopping ARV Therapy Post Exposure Prophylaxis Cotrimoxazole Prophylaxis WHO Staging in Adults and Adolescents Nutrition Care and Support Palliative Care in HIV and AIDS
	Guide Editors
	Editor In Chief Joel E. Gallant, MD, MPH Pharmacology Editor Paul Pham, PharmD, BCPS Zambia Guideline Team Peter Mwaba MMed PhD FRCP Alywn Mwinga MMed Isaac Zulu MMed MPH Velepie Mtonga MMed Albert Mwango MBChB and Jabbin Mulwanda MMed FCS

Guidelines>Zambia HIV National Guidelines>

Cotrimoxazole Prophylaxis

04-28-2008

RECOMMENDATIONS FOR INFANTS AND CHILDREN

Initiation of cotrimoxazole (CTX) prophylaxis:
Begin CTX prophylaxis at 6 wks in all HIV-exposed infants (regardless of ARV history) and continue until HIV infection excluded
Children with presumed PCP or other symptomatic HIV disease should be treated and CTX prophylaxis continued until HIV infection definitively excluded
Infants with documented HIV infection:
-<1 yr: give CTX regardless of symptoms or CD4%
->1 yr: give CTX if Stage 2, 3, or 4 HIV or if CD4% <25%
History of treated PCP: give secondary CTX prophylaxis with same regimen used for primary prophylaxis
Discontinuation of CTX prophylaxis:
Discontinue when HIV infection definitively excluded (PCR or Ab negative) and at least 6 weeks after cessation of breast feeding
<5 years: Continue primary and secondary prophylaxis in HIV+ children regardless of immune recovery due to ART because of continued increased risk of bacterial infections.
>5 years: Can consider stopping CTX prophylaxis in accordance with adult/adolescent guidelines if on ART with good clinical and immune recovery, CD4 response, and secure supply of drugs.
Restart CTX if CD4% falls below the age-specific threshold for initiation or with new or recurrent WHO clinical Stage 2, 3, or 4 condition
Children with history of severe adverse reactions to CTX or other sulfa drugs: use dapsone 2 mg/kg following same guidelines apply
CTX may need to be discontinued for serious adverse events possibly due to CTX (extensive exfoliative rash, Stevens-Johnson syndrome, severe anemia or pancytopenia)

RECOMMENDATIONS FOR ADULTS AND ADOLESCENTS

Initiation of CTX Prophylaxis:
Patients with WHO Stage 2, 3 or 4 disease, regardless of CD4 count.
CD4 <350, regardless of clinical stage. If WHO Stage 2 and no CD4 count, initiate CTX.
Dose: 960 mg daily (800 mg SMX + 160 mg TMP).
Can be safely continued or initiated during pregnancy regardless of stage or during breastfeeding.
Patients with history of treated PCP should be treated with secondary CTX prophylaxis with same regimen used for primary prophylaxis
When starting both CTX and ART: start CTX first; initiate ART 2 weeks later if no adverse effects from CTX
Discontinuation of Primary or Secondary CTX Prophylaxis:
Stop CTX after immune recovery on ART: CD4 >350 for >6 months
Stop CTX for adverse drug reaction or drug toxicity such as jaundice, severe anaemia, pancytopenia or rash (extensive exfoliative dermatitis, Stevens-Johnson syndrome)
In absence of CD4 monitoring, no consensus; can consider discontinuation in patient on ART for >1 yr without stage 2, 3, 4 events, good adherence and secure ARV supply
Restart CTX if CD4 falls below threshold for initiation or with new or recurrent WHO clinical stage 2, 3, 4 condition
Monitor for potential side effects of CTX clinically every 3 months and manage accordingly (see Toxicity Grading Scale below); no specific lab monitoring required, but may be indicated depending on signs and symptoms. Most common side effects: bone marrow suppression, skin rash, hepatotoxicity

COTRIMOXAZOLE TOXICITY GRADING SCALE FOR ADULTS AND ADOLESCENTS Don't know why there's a line space between this title and the bulleted list.

Grade 1: Erythema. Continue CTX with careful and repeated observation and follow up. Provide symptomatic treatment, such as antihistamines, if available
Grade 2: Diffuse maculopapular rash, dry desquamation. Continue CTX with careful and repeated observation and follow up. Provide symptomatic treatment, such as antihistamines, if available
Grade 3: Vesiculation, mucosal ulceration. Discontinue CTX until adverse effect completely resolved (usually 2 weeks), then reintroduction or consider desensitization
Grade 4: Exfoliative dermatitis, Stevens-Johnson syndrome or erythema multiforme, moist desquamation. Permanently discontinue CTX.

TREATMENT OF OTHER INFECTIONS IN PATIENTS ON CTX PROPHYLAXIS

Bacterial infections: Use alternative antibiotic and continue CTX prophylaxis
PCP and toxoplasmosis: Stop CTX prophylaxis and treat infection, then restart prophylaxis after treatment course
Malaria: Treat with agent that does not include sulfadoxine-pyrimethamine, if possible

CTX DESENSITIZATION PROTOCOL (ADULTS AND ADOLESCENTS)

Day 1: 80 mg sulfamethoxazole (SMX) + 16 mg trimethoprim (TMP) (2 ml of oral suspension: 40 mg TMP + 200 mg SMX per 5 ml)
Day 2: 160 mg SMX + 32 mg TMP (4 ml of oral suspension)
Day 3: 240 mg SMX + 48 mg TMP (6 ml of oral suspension)
Day 4: 320 mg SMX+ 64 mg TMP (8 ml of oral suspension)
Day 5: 1 single-strength (480 mg) CTX tab (400 mg SMX + 80 mg TMP)
Day 6 and onwards: 2 single-strength CTX tabs or 1 double-strength tab (800 mg SMX + 160 mg TMP)

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