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Prophylaxis of Opportunistic Infections. Part A: Module A2 Session 10. Objectives. Describe the prophylactic use of TMP/SMX and INH Describe the WHO recommendations for TMP/SMX and INH Understand when to prescribe prophylactic treatment, to whom and which regimen to use.

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part a module a2 session 10

Prophylaxis of

Opportunistic Infections

Part A: Module A2

Session 10

objectives
Objectives
  • Describe the prophylactic use of TMP/SMX and INH
  • Describe the WHO recommendations for TMP/SMX and INH
  • Understand when to prescribe prophylactic treatment, to whom and which regimen to use
objectives continued
Objectives, continued
  • Describe other preventive measures: 23-valent pneumococcal vaccine, antifungals, and hepatitis vaccine
  • Understand the purpose of secondary prevention and describe the relevant regimens
  • Discuss local and national guidelines regarding prophylaxis
prophylaxis for selected ois indications and treatment guidelines
Prophylaxis for Selected OIs: Indications and Treatment Guidelines
  • Overview
  • Prophylaxis/preventive measures
  • Secondary prevention
  • Necessary drugs and equipment
slide6
OI prevention in resource constrained countries occurs in a context that is very different than what exists in Europe, North America, etc.
  • Many HIV/AIDS patients in Africa do not survive long enough to develop OIs such as CMV or MAC
  • Resources are limited. For the majority of patients, no CD4 counts are available, which would otherwise enable care providers to monitor disease progression
  • HIV infection is often not diagnosed until the patient is at an advanced stage of disease
slide7

Common OIs in

Resource Constrained Countries

  • Tuberculosis: widespread
  • Pneumococcal disease: widespread
  • Non-typhoid salmonellosis: particularly East and West Africa, Thailand, and Cambodia
  • Cryptococcosis: particularly East and South Africa, Thailand and Cambodia
  • PCP: South Africa and Asia
  • Penicilliosis: Thailand
  • Bacterial infections
slide8

Some of the prevention measures recommended in the U.S. are not too expensive and may provide opportunities to prevent OIs in developing countries

  • TMP/SMX for PCP, cerebral toxoplamosis and various bacterial infections
  • INH for tuberculosis

Indications for prophylaxis in resource constrained countries include use of the WHO clinical stage, and, where possible, CD4 count and viral load.

slide9

Avoid unpasteurized dairy products, raw or undercooked eggs, meat, poultry, or fish (sources of salmonella)

  • Avoid undercooked or raw meat (source of toxoplasmosis)
  • If no safe water supply is available, patients and family should be advised to boil drinking water to avoid diarrheal diseases such as cryptosporidiosis
  • Moldy sugar cane or bamboo has been suggested as possible sources of Penicillium marneffei infection (in Thailand)

General Prevention Measures

cotrimoxazole tmp smx
Cotrimoxazole (TMP/SMX)
  • An effective prophylaxis against:
    • Various bacterial infections: Streptococcus pneumoniae, Salmonella species and Nocardia
    • Pneumocystis carinii
    • Toxoplasmosis
    • Isospora belli
    • Cyclospora

UNAIDS recommends that Cotrimoxazole be part of a minimum package of care for adults and children living with HIV/AIDS in Africa.

unaids who cotrimoxazole recommendations
UNAIDS/WHO Cotrimoxazole Recommendations

Candidates for cotrimoxazole prophylaxis should be

recruited from all levels of health care facilities, AIDS

service organizations and nongovernmental

organizations

Initial prescription of prophylaxis should be prescribed

by trained health care personnel

Counseling should be provided

unaids who cotrimoxazole recommendations13
UNAIDS/WHO Cotrimoxazole Recommendations

Prophylaxis should be offered to:

  • HIV positive adults (over age 13): all persons with symptomatic HIV (Stage II, III or IV); asymptomatic persons with CD4 count of 500 or less or total lymphocyte equivalent; pregnant women after 1st trimester
  • HIV exposed infants from 6 weeks of age: any child born to HIV infected mother; any child identified as HIV infected during the 1st year of life; any child older than 15 months who have had a PCP event, have symptomatic HIV disease, an AIDS defining illness or CD4 % less than 15
unaids who cotrimoxazole recommendations continued
UNAIDS/WHO Cotrimoxazole Recommendations, continued

Recommended drug dosages

Adults: 1 DS tablet or 2 SS tablets daily

(1DS=SMX 800 mg+TMP 160 mg; 1SS=SMX 400 mg+TMP 80 mg)

Children: Cotrimoxazole syrup administered 1/day, daily

Recommended dose is TMP 10 mg/kg,

SMX 50 mg/kg

If syrup is unavailable, may use crushed tablets.

Health professional may switch from syrup to tablet to ensure

ongoing access to medication.

oi prophylaxis
OI Prophylaxis

Duration of Treatment

Prophylaxis should be given life-long for

adults and children (>15 months)

oi prophylaxis continued
OI prophylaxis, continued

For infants < 15 months:

Prophylaxis should continue until HIV infection has been

reasonably ruled out and there is no further risk of

exposure

For children > 15 months:

Prophylaxis should be administered if child has

  • had a PCP event
  • has symptomatic HIV disease
  • has an AIDS-defining illness, or
  • has a CD4 percentage less than 15
oi prophylaxis cont d
OI prophylaxis, cont’d.

Criteria for Stopping Treatment (adults and children)

  • In the occurrence of severe cutaneous reactions such as fixed drug reaction andStevens Johnson syndrome, renal and/or hepatic failure, and severe hematological toxicity
  • If antiretroviral agents become available and when CD4 is greater than 500, prophylaxis can be stopped

Adverse Reactions

  • Adverse reactions are common
  • Every effort should be made to continue prophylaxis
  • Lower doses are less effective than the recommended daily DS tablet
oi prophylaxis continued18
OI prophylaxis, continued

Alternative Regimens

Dapsone 50 mg 2 x daily or 100 mg /day

In patients with CD4<100 and positive toxoplasma antibodies, pyrimethamine 50 mg weekly + folinic acid 25 mg weekly should be added to regimen

Pentamidine aerosols 300mg/month are more difficult to implement, less effective (PCP), effect not entirely understood (toxoplasmosis)

In cases of non-life threatening adverse reactions, treatment should be stopped for 2 weeks, then the patient should be re-challenged with TMP/SMX in a gradually increasing dose

oi prophylaxis continued19
OI prophylaxis, continued

Follow upProphylaxis should be used where regular follow-up of patients is possible

In adults, follow up should be every month and then every 3 months

Children should be evaluated on monthly basis

In adults and children, monitoring for toxicity, clinical events, and compliance to treatment should be undertaken.

Monitoring of adults should also include hemoglobin and white blood counts every 6 months, where possible and when clinically indicated

oi prophylaxis continued20
OI prophylaxis, continued

Monitoring Each country should develop an implementation and monitoring plan for Cotrimoxazole prophylaxis

Concurrent monitoring for clinical effectiveness is important, especially in areas where widespread resistance is present; in addition to prophylaxis investigation into new interventions is necessary

oi prophylaxis continued21
OI prophylaxis, continued

Evaluation Program evaluation and clinical effectiveness indicators will be developed by a task force led by UNAIDS. Could include surveillance for:

  • Background rates of OI and antimicrobial resistance
  • Changes in antimicrobial resistance
  • Acute and cumulative toxicities
oi prophylaxis continued22
OI prophylaxis, continued

Research Comparative studies to identify affordable alternative therapies

Further studies on dose and time of initiation

Willingness/ability to pay at the household level

Household income, savings, expenses impact

oi prophylaxis continued23
OI prophylaxis, continued

Cost TMP/SMX in the recommended dose of 1DS daily costs $US 60/year

Distribution Cotrimoxazole can be: Given through community clinics and home-care projects

Integrated into counseling activities, favoring the regular follow up of the PLH/A by a counselor at the same time as the cotrimoxazole prescription is renewed

isoniazid inh
Isoniazid (INH)
  • HIV infection is the strongest known risk factor the progression of latent TB infection to active TB
  • In countries with high TB prevalence, between 2.4% and 7.5% of HIV-infected adults may develop active TB each year
  • The mechanisms include reactivation of latent infection and/or a re-infection with Mycobacterium tuberculosis, characterized by a rapid progression towards active disease and a rapid progression of primary infection
isoniazid inh continued
Isoniazid (INH), continued
  • Before the AIDS epidemic, preventive therapy for tuberculosis was never recommended in developing countries except for breast-feeding infants of mothers with PTB, or children < 5 years old living with infectious persons
  • Preventive therapy as a public health strategy is now being reconsidered because of the high incidence of TB in HIV-positive patients in developing countries
  • In the pre-AIDS era, several placebo-controlled trials in the USA and Europe demonstrated the efficacy of INH prevention in PPD-positive persons, which is believed to be at least 60%
  • The cost of this drug is about $US 60 per year
isoniazid inh continued26
Isoniazid (INH), continued
  • WHO Recommendations: Preventive therapy (PT) against tuberculosis in people living with HIV
    • Several large randomized controlled trials have now demonstrated that PT is effective in preventing TB in individuals dually infected with HIV and M. tuberculosis
    • However, studies of feasibility of PT demonstrate that the process required to target appropriate individuals, to exclude active TB, to deliver PT, and to achieve compliance is complex and inefficient
who isoniazid recommendations
WHO Isoniazid Recommendations

Prerequisites The following should be in place before a PT service is considered:

  • Adequate capacity for HIV counseling
  • Sufficiently trained health care staff
  • Linkage between HIV care and TB control services
  • TB treatment services that have a high probability of curing cases of TB identified through the PT service (defaulter and failure rate <10%)
who isoniazid recommendations continued
WHO Isoniazid Recommendations, continued

Recommendations to Governments

1. Preventive therapy against tuberculosisshould be part of a package of care for people living with HIV/AIDS

2. Preventive therapy should only be used in settings where it is possible to exclude active TB cases and to ensure appropriate monitoring and follow-up

who isoniazid recommendations continued29
WHO Isoniazid Recommendations, continued
  • Information about tuberculosis, including preventive therapy, should be made available to people with HIV
  • Preventive therapy should be provided from within settings that include established voluntary counseling and testing (VCT) services for HIV
who isoniazid recommendations continued30
WHO Isoniazid Recommendations, continued

5. The priority for TB control programmes continues to be the detection and cure of infectious tuberculosis cases

6. National authorities must regulate the procurement and supply of tuberculosis drugs in order to prevent the development of drug resistance

who isoniazid recommendations continued31
WHO Isoniazid Recommendations, continued

Those who test positive for HIV should receive

  • Counseling on tuberculosis:

People living with HIV are at risk ofdeveloping TB. They should be given health education and encouraged to seek early diagnosis and treatment of cough and other symptoms suggestive of TB.

2) Screening for active TB:

PT is inadequate treatment for active TB and could lead to the development of drug resistance if taken in such cases. Active TB should therefore be excluded before PT is started.

Do chest x-ray before considering PT.

who isoniazid recommendations continued32
WHO Isoniazid Recommendations, continued

Target those most PT is recommended for PPD-positive HIV- likely tobenefit infected individuals who do not have activeTB

In some settings it may not be feasible to perform PPD testing. Under these circumstances the following individuals may still be considered for preventive therapy if they are infected with HIV:

  • Those living in population with high TB prevalence
  • Health care workers
  • Household contacts of TB patients
  • Prisoners
  • Miners
  • Other groups at high risk of TB
who isoniazid recommendations continued33
WHO Isoniazid Recommendations, continued

INH alone is the recommended drug regimen forpreventive therapy to those without active tuberculosis

Trials using combination treatment report higher

rates of adverse drug reaction

Isoniazid may be given as a daily, self-administered therapy for 6 months at a dose of 5 mg/kg to a maximum of 300 mg.

These individuals should be seen monthly and given 1-month supply of medication at each visit.

who isoniazid recommendations continued34
WHO Isoniazid Recommendations, continued

Compliance may be improved by giving anadditional 2-week emergency buffer supply to be used if the individual has to defer his or her monthly review.

Rifampicin-containing regimens are not recommended in order to eliminate the risk of promoting rifampicin resistance through inadequate screening procedures or by misuse of the tablets.

who isoniazid recommendations continued35
WHO Isoniazid Recommendations, continued

ContraindicationsPreventive therapy is contraindicated into PTpatients with active tuberculosis and in patients with active (chronic or acute) hepatitis

Active tuberculosis must be excluded before beginning preventive therapy

Isoniazid should be given with caution to individuals who consume alcohol daily

conclusions
Conclusions
  • Programs with Cotrimoxazole prevention for PLHA must show proof of good patient compliance and have strategies in place to follow-up defaulters
  • INH prophylaxis is recommended for all known HIV-infected persons,without performing a PPD test:
    • Active TB has to be excluded before starting PT
    • That is, only asymptomatic PLHA who are in WHO clinical stage 1 and 2 and who have a negative chest X-ray will be considered for PT
    • Patients who have are in clinical stage 3 with no other symptoms might also be candidates for starting preventive therapy
conclusions continued
Conclusions, continued
  • Dose of INH: 5 mg/kg, with a maximum of 300 mg daily, for a duration of 6 months. (WHO guidelines)
  • All projects that face difficulties in the control of TB should not start INH preventive therapy on a routine basis
  • Projects that want to implement PT should have close working relationships between HIV and TB services. The programmes need qualified staff for counseling, a high cure rate for TB and a low defaulter rate (<10%) 
  • All projects, except pilot projects in HIV/AIDS care, should follow the national guidelines
  •  Prophylactic Treatment as Recommended in the U. S. in appendix C
other preventive measures
Other Preventive Measures

23-valent pneumococcal vaccine

  • HIV infected at increased risk of invasive pneumococcal disease caused by streptococcus pneumoniae

Antifungals

  • In some regions with an unusual high incidence of cryptococcal meningitis or P. marneffei, primary prophylaxis with fluconazole or itraconazole might be considered

Hepatitis B vaccination

  • HIV-infected patients have a higher risk of hepatitis B because of common risk factors. Patients who are HIV-positive are more likely to develop chronic hepatitis
slide40

Tuberculosis

Tuberculosis

  • Until now, secondary prevention for TB has not been advocated
  • Extended therapy (beyond 6-9 months) has been shown to reduce the incidence of relapse, but showed no benefit in terms of survival
  • Although no firm recommendation can be made, the results of a Haiti study favors use of secondary INH prophylaxis in patients who had symptomatic HIV disease before the initial diagnosis and treatment of TB
slide41

PCP

PCP

  • TMP/SMX: 1 DS daily is the recommended dose. Tolerance is improved with lower doses
slide42

Fungal Infections

Fungal Infections

  • P. marneffei: Itraconazole 200 mg daily
  • Cryptococcus neoformans: Fluconazole 200 mg daily (1st choice), amphotericin B, IV, 1/week, or fluconazole 200 mg 3 x weekly
  • Oral Thrush/ Fluconazole 100-200 mg Oesophageal candidiasis daily only if :recurrences are severe and frequent
  • Toxoplasmosis: TMP/SMX 1DS daily
  • Mucocutaneous Acyclovir 200mg 3 x daily or

Herpes Simplex: acyclovir 400 mg 2 x daily

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