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## Complete Summary

#### GUIDELINE TITLE

Ophthalmologic complications of HIV infection.

#### BIBLIOGRAPHIC SOURCE(S)

New York State Department of Health. Ophthalmologic complications of HIV
infection. New York (NY): New York State Department of Health; 2004 Jan.
14 p. \[17 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Ophthalmologic complications of human immunodeficiency virus (HIV)
infection:

-   Anterior segment complications including herpes zoster ophthalmicus,
    Kaposi\'s sarcoma of the lids and/or conjunctiva, microsporidia,
    molluscum contagiosum, and anterior uveitis

-   Neuro-ophthalmic complications of HIV infection

-   Retinal and choroidal manifestation of HIV infection:

    -   HIV-related retinal microangiopathy

    -   Infectious retinitis and choroiditis including
        cytomegalovirus (CMV) retinitis, progressive outer retinal
        necrosis, ocular toxoplasmosis, *Pneumocystis carinii*
        choroidopathy, and syphilis

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Allergy and Immunology\
Family Practice\
Infectious Diseases\
Internal Medicine\
Ophthalmology

#### INTENDED USERS

Advanced Practice Nurses\
Health Care Providers\
Nurses\
Physician Assistants\
Physicians\
Public Health Departments

#### GUIDELINE OBJECTIVE(S)

To provide guidelines for diagnosis and management of ophthalmologic
complications of human immunodeficiency virus (HIV) infection

#### TARGET POPULATION

Human immunodeficiency virus (HIV)-infected patients with ophthalmologic
complications

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Management of Cytomegalovirus (CMV) Retinitis**

1.  Retinal examination including ophthalmoscopy

2.  Referral to ophthalmologist

3.  Initiating highly active antiretroviral therapy (HAART) in
    antiretroviral (ARV)-naïve patients and re-evaluating ARV regimen in
    patients receiving HAART

4.  Valganciclovir induction and maintenance if retinitis is not
    sight-threatening

5.  Treatment of sight-threatening retinitis when immune reconstitution
    is likely: intravenous ganciclovir or foscarnet plus valganciclovir

6.  Treatment of sight-threatening retinitis when immune reconstitution
    is unlikely: combination of local and parenteral therapy plus
    ganciclovir implant plus valganciclovir

7.  Monitoring for progression or reactivation of CMV retinitis by
    examination and serial retinal photography

8.  Prophylaxis with oral ganciclovir and regular evaluations by
    ophthalmologist

**Management of Other Ophthalmologic Complications**

1.  Referral to ophthalmologist

2.  Intravenous acyclovir followed by oral valganciclovir for herpes
    zoster ophthalmicus

3.  For ocular toxoplasmosis: central nervous system evaluation; same
    treatment as that for central nervous system toxoplasmosis (e.g.,
    sulfadiazine, pyrimethamine, and leucovorin); alternative treatment:
    atovaquone  and/or azithromycin; maintenance therapy to prevent
    relapse

4.  Standard anti-pneumocystis therapy (e.g.,
    trimethoprim/sulfamethoxazole) for *Pneumocystis carinii*
    choroidopathy

5.  Intravenous penicillin G for syphilitic uveitis, chorioretinitis, or
    optic nerve disease

#### MAJOR OUTCOMES CONSIDERED

Efficacy and safety of treatment

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

AIDS Institute clinical guidelines are developed by distinguished
committees of clinicians and others with extensive experience providing
care to people with HIV infection. Committees\* meet regularly to assess
current recommendations and to write and update guidelines in accordance
with newly emerging clinical and research developments.

The Committees\* rely on evidence to the extent possible in formulating
recommendations. When data from randomized clinical trials are not
available, Committees rely on developing guidelines based on consensus,
balancing the use of new information with sound clinical judgment that
results in recommendations that are in the best interest of patients.

\* Current committees include:

-   Medical Care Criteria Committee

-   Committee for the Care of Children and Adolescents with HIV
    Infection

-   Dental Standards of Care Committee

-   Mental Health Committee

-   Women\'s Health Committee

-   Substance Use Committee

-   Physician\'s Prevention Advisory Committee

-   Pharmacy Committee

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

All guidelines developed by the Committee are externally peer reviewed
by at least two experts in that particular area of patient care, which
ensures depth and quality of the guidelines.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Patients with CD4 counts \<50 cells/mm^3^ should be examined by an
ophthalmologist every 6 months. (Kuppermann et al., 1993; Whitly et al.,
1998)

Patients with visual disturbances or unremitting ocular symptoms,
regardless of CD4 cell count, should be evaluated by an ophthalmologist.
The severity of signs and symptoms should guide the clinician in
choosing whether to request emergency consultation.

Retinal examination in human immunodeficiency virus (HIV)-infected
patients should include indirect ophthalmoscopy through a dilated pupil
so the entire peripheral fundus can be evaluated.

The primary care clinician and the ophthalmologist should work in
conjunction to manage ocular opportunistic infections in HIV-infected
patients.

**[Anterior Segment Complications of HIV]{.underline}**

**Herpes Zoster Ophthalmicus**

The clinician should refer patients with herpes zoster ophthalmicus for
evaluation by an ophthalmologist because uveitis, corneal opacities, or
secondary glaucoma may develop. The retina should also be examined
because the infection can involve the posterior segment as well, which
is a medical emergency. See below: *Infectious* *Retinitis and
Choroiditis* for information on zoster retinitis (progressive outer
retinal necrosis).

*Treatment*

Clinicians should treat HIV-infected patients with herpes zoster
ophthalmicus with intravenous acyclovir (10 mg/kg) every 8 hours for 10
to 14 days. It should be administered at a constant rate for 1 hour to
prevent renal tubular damage. The course of intravenous acyclovir should
be followed by oral therapy with valganciclovir (1 g three times a day
\[tid\]) until lesions have healed.

**[Neuro-Ophthalmic Complications of HIV]{.underline}**

Patients with orbital and central nervous system opportunistic
infections and malignancies should undergo neurologic evaluation,
neuroimaging studies, and further evaluation by specialists.

Refer to Table 1 in the original guideline document for the list of
ocular disturbances associated with orbital and central nervous system
opportunistic infections, as well as which guideline to refer to for
recommendations concerning diagnosis and treatment.

**[Retinal and Choroidal Manifestations of HIV Infection]{.underline}**

**HIV-Related Retinal Microangiopathy**

*Diagnosis*

Patients who are suspected of having retinal microangiopathy but have
visual complaints should be re-evaluated serially to exclude an
alternative diagnosis.

**Infectious Retinitis and Choroiditis**

The primary care clinician and the ophthalmologist should work in
conjunction to manage infectious retinitis and choroiditis in
HIV-infected patients.

*Cytomegalovirus (CMV) Retinitis*

[Treatment of CMV Retinitis]{.underline}

Clinicians should initiate highly active antiretroviral therapy (HAART)
in antiretroviral (ARV)-naïve patients who present with CMV retinitis.

When patients who are receiving HAART present with CMV retinitis,
clinicians should re-evaluate the ARV regimen in an attempt to maximize
the effect of HAART on the immune system. However, CMV retinitis should
be treated with both HAART and specific antiviral treatment, which
varies depending on the immune status of the patient (refer to Figure 1
in the original guideline document for more information).

Because the ganciclovir implant does not start consistent delivery of
medication to the retina until the second week after placement, patients
should receive 2 weeks of an anti-CMV agent, such as intravenous
ganciclovir or oral valganciclovir, immediately following implant
placement.

When systemic therapy alone is indicated:

-   A 2- to 3-week induction period with one of the following should be
    used to stabilize CMV retinitis:

-   Typical first-line therapy options:

    -   Intravenous ganciclovir (5 mg/kg twice daily \[bid\] for 14 to
        21 days, then 5 mg/kg once daily \[qd\] for 21 days), or

    -   Oral valganciclovir (900 mg orally \[PO\] bid for 21 days, then
        900 mg PO qd).

-   Acceptable first-line therapy options in select cases (e.g.,
    long-standing previous prophylaxis with ganciclovir):

    -   Foscarnet (60 mg/kg IV every 8 hours or 90 mg/kg intravenously
        \[IV\] every 12 hours for 14 to 21 days, then 90 to 120 mg/kg IV
        every 12 hours), or

    -   Cidofovir (5 mg/kg IV once weekly for 2 weeks, then 5 mg/kg
        every 2 weeks; with probenecid, 2 g PO 3 hours before each
        cidofovir dose, 1 g PO at 2 hours and again at 8 hours post
        cidofovir dose)

The clinician should base the need for all maintenance regimens on the
patient\'s immune status. If patients have achieved immune
reconstitution with a CD4 count \>100 cells/mm^3^ for more than 6
months, discontinuation of maintenance therapy should be considered.

  -----------------------------------------------------------------------
  **Table\                       
  Choosing the Treatment         
  Modality for CMV Retinitis**   
  ------------------------------ ----------------------------------------
  **Consideration**              **Effect on Treatment Choice**

  The location and extent of CMV If the patient has sight-threatening CMV
  retinitis (i.e., sight         retinitis or bilateral disease,
  threatening or peripheral) and parenteral therapy should be used.
  the status of the fellow eye   

  Whether the disease is newly   If the patient is experiencing a
  diagnosed or relapsed          relapse, combination therapy with two
                                 parenteral agents has produced the best
                                 results.

  The immune status of the       The immune status of the patient will
  patient                        determine whether an implant is required
                                 (see Figure 1 in the original guideline
                                 document).

  Whether the patient is HAART   HAART should be initiated in naïve
  naïve or whether HAART has     patients, and the regimen should be
  failed                         optimized in patients with failing
                                 HAART.

  The presence of other          For example, for patients actively using
  conditions that can affect     drugs, the implant may facilitate
  medication choice              treatment.

  Other medications with         Overlapping toxicities may help decide
  overlapping toxicities         between ganciclovir versus foscarnet.
                                 For example, if a patient has
                                 neutropenia that is unlikely to resolve,
                                 ganciclovir should be avoided.

  Adherence to follow-up         For patients with poor adherence, the
                                 implant may facilitate treatment.

  Patient\'s preference and      Quality-of-life issues may sway a
  quality-of-life concerns       patient away from parenteral therapy.
  -----------------------------------------------------------------------

[Reactivation of Progression of CMV Retinitis]{.underline}

During therapy, the ophthalmologist should monitor for progression or
reactivation of retinitis by examination and serial retinal photography.

[Prophylaxis for CMV Retinitis]{.underline}

Patients receiving oral ganciclovir prophylaxis or therapy for
extraocular CMV should be evaluated every 3 months by an ophthalmologist
because treatment may mask the development of symptoms of retinitis.

*Ocular Toxoplasmosis*

[Treatment]{.underline}

Clinicians should perform a central nervous system evaluation in
patients with ocular toxoplasmosis.

Therapy for ocular toxoplasmosis should be the same as that for central
nervous system toxoplasmosis. Atovaquone and/or azithromycin can be
considered for patients in whom standard therapy fails or may not be
used (e.g., allergies to sulfa or clindamycin).

Clinicians should continue maintenance therapy to prevent relapse of
toxoplasmosis lesions.

*Pneumocystis carinii Choroidopathy*

[Treatment]{.underline}

Because ocular *Pneumocystis carinii* is a manifestation of disseminated
pneumocystosis, clinicians should initiate standard anti-pneumocystis
therapy.

*Syphilis*

[Diagnosis and Treatment]{.underline}

Clinicians should treat patients with syphilitic uveitis,
chorioretinitis, or optic nerve disease for neurosyphilis. The treatment
of ocular syphilis optimally will include 2 weeks of intravenous
penicillin G.

#### CLINICAL ALGORITHM(S)

An algorithm is provided in the original guideline document for
Initiation of Treatment for CMV Retinitis.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=10971)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each
recommendation.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate diagnosis and treatment of ophthalmologic complications
associated with human immunodeficiency virus (HIV) infection

#### POTENTIAL HARMS

**Adverse Effects of Medications**

-   *Ganciclovir*: Neutropenia, thrombocytopenia, gastrointestinal (GI)
    symptoms, diarrhea, nausea, anemia, development of resistance

-   *Valganciclovir*: GI symptoms, neutropenia, anemia, thrombocytopenia

-   *Foscarnet*: Nephrotoxicity, hypomagnesemia, hypocalcemia,
    hypokalemia, penile and genital ulcers in uncircumcised men
    receiving high doses with poor hydration prior to treatment

-   Cidofovir: Vomiting, nausea, rash, headache, anorexia, anemia,
    severe uveitis, irreversible hypotony, neutropenia

-   Oral ganciclovir: Neutropenia, diarrhea, anemia, thrombocytopenia

-   Intraocular ganciclovir implant: Temporary loss of functional visual
    acuity after surgery, risk of early retinal detachment,
    endophthalmitis

-   Fomivirsen: Ocular inflammation (uveitis, vitritis), increased
    intraocular pressure, pigmentary retinopathy

Refer to Table 3 in the original guideline document for more information
about these drugs and their combinations.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

-   *Ganciclovir* should be avoided in patients with neutropenia that is
    unlikely to resolve

-   *Cidofovir* and *foscarnet* should be avoided in patients with renal
    insufficiency (creatinine clearance \<55; creatinine \>1.5) and
    should not be used concomitantly with other nephrotoxic agents.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

The AIDS Institute\'s Office of the Medical Director directly oversees
the development, publication, dissemination and implementation of
clinical practice guidelines, in collaboration with The Johns Hopkins
University, Division of Infectious Diseases. These guidelines address
the medical management of adults, adolescents and children with HIV
infection; primary and secondary prevention in medical settings; and
include informational brochures for care providers and the public.

**Guidelines Dissemination**

Guidelines are disseminated to clinicians, support service providers and
consumers through mass mailings and numerous AIDS Institute-sponsored
educational programs. Distribution methods include the HIV Clinical
Resource website, the Clinical Education Initiative, the AIDS
Educational Training Centers (AETC) and the HIV/AIDS Materials
Initiative. Printed copies of clinical guidelines are available for
order from the NYSDOH Distribution Center for providers who lack
internet access.

**Guidelines Implementation**

The HIV Clinical Guidelines Program works with other programs in the
AIDS Institute to promote adoption of guidelines. Clinicians, for
example, are targeted through the Clinical Education Initiative (CEI)
and the AIDS Education and Training Centers (AETC). The CEI provides
tailored educational programming on site for health care providers on
important topics in HIV care, including those addressed by the HIV
Clinical Guidelines Program. The AETC provides conferences, grand rounds
and other programs that cover topics contained in AIDS Institute
guidelines.

Support service providers are targeted through the HIV Education and
Training initiative which provides training on important HIV topics to
non-physician health and human services providers. Education is carried
out across the State as well as through video conferencing and audio
conferencing.

The HIV Clinical Guidelines Program also works in a coordinated manner
with the HIV Quality of Care Program to promote implementation of HIV
guidelines in New York State. By developing quality indicators based on
the guidelines, the AIDS Institute has created a mechanism for
measurement of performance that allows providers and consumers to know
to what extent specific guidelines have been implemented.

Finally, best practices booklets are developed through the HIV Clinical
Guidelines Program. These contain practical solutions to common problems
related to access, delivery or coordination of care, in an effort to
ensure that HIV guidelines are implemented and that patients receive the
highest level of HIV care possible.

#### IMPLEMENTATION TOOLS

Clinical Algorithm\
Personal Digital Assistant (PDA) Downloads

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

New York State Department of Health. Ophthalmologic complications of HIV
infection. New York (NY): New York State Department of Health; 2004 Jan.
14 p. \[17 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2004 Jan

#### GUIDELINE DEVELOPER(S)

New York State Department of Health - State/Local Government Agency
\[U.S.\]

#### SOURCE(S) OF FUNDING

New York State Department of Health

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [New York State Department of
Health AIDS Institute Web
site](http://www.hivguidelines.org/Content.aspx?pageID=257).

#### AVAILABILITY OF COMPANION DOCUMENTS

This guideline is available as a Personal Digital Assistant (PDA)
download from the [New York State Department of Health AIDS Institute
Web site](http://hivguidelines.org/Content.aspx?pageID=257).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on September 10, 2007.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is
copyrighted by the guideline developer. See the [New York State
Department of Health AIDS Institute Web
site](http://www.hivguidelines.org/Content.aspx?pageID=451) for terms of
use.

### DISCLAIMER

#### NGC DISCLAIMER

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Readers with questions regarding guideline content are directed to
contact the guideline developer.

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Date Modified: 11/3/2008