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Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

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Management of Medication Toxicity or Intolerance

Gastrointestinal Effects

Last Updated: April 27, 2017; Last Reviewed: April 27, 2017

Table 13c. Antiretroviral-Therapy-Associated Adverse Effects and Management Recommendations—Gastrointestinal Effects
Adverse Effects Associated ARVs Onset/Clinical Manifestations Estimated Frequency Risk Factors Prevention/Monitoring Management
Nausea/ Vomiting Principally ZDV and PIs, but can occur with all ARVs and COBI Onset:
  • Early
  • Nausea, emesis—may be associated with anorexia and/or abdominal pain
Varies with ARV agent; 10% to 30% in some series Unknown Instruct patient to take PIs with food.

Monitor for weight loss, ARV adherence.
Reassurance—generally improves over time (usually 6–8 weeks)

Supportive care.

Antiemetics may be useful in extreme or persistent cases.
Diarrhea PIs (particularly NFV, LPV/r, FPV/r), buffered ddI, INSTIs (mild) Onset:
  • Early
  • Generally soft, more frequent stools
Varies with ARV agent; 10% to 30% in some series Unknown Monitor for weight loss, dehydration. Exclude infectious causes of diarrhea if prolonged or severe.

Reassurance—generally improves over time (usually 6–8 weeks)

Although treatment data in children are lacking, potentially useful modalities include:
  • Dietary modification
  • Calcium carbonate (should not be used with DTG)
  • Bulk-forming agents (psyllium)
  • Antimotility agents (loperamide)
  • Crofelemer is FDA-approved for treatment of ART-associated diarrhea in adults, but not in children.
Pancreatitis ddI, d4T (especially concurrently), boosted PIs

Reported, albeit rarely, with most ARVs.
  • Any time, usually after months of therapy
  • Emesis, abdominal pain, elevated amylase and lipase (asymptomatic hyperamylasemia or elevated lipase do not in and of themselves indicate pancreatitis).
<2% in recent series Use of concomitant medications associated with pancreatitis (e.g., TMP-SMX, pentamidine, ribavirin)


Advanced disease

Previous episode of pancreatitis

Alcohol use
Avoid use of ddI in patients with a history of pancreatitis. Discontinue offending agent—avoid reintroduction.

Manage symptoms of acute episode.

If associated with hypertriglyceridemia, consider interventions to lower TG levels.
Key to Acronyms: ART = antiretroviral therapy; ARV = antiretroviral; COBI = cobicistat; d4T = stavudine; ddI = didanosine; DTG = dolutegravir; FDA = Food and Drug Administration; FPV/r = fosamprenavir/ritonavir; INSTI = integrase strand transfer inhibitor; LPV/r = lopinavir/ritonavir; NFV = nelfinavir; PI = protease inhibitor; RTV = ritonavir; TDF = tenofovir disoproxil fumarate; TG = triglyceride; TMP-SMX = trimethoprim sulfamethoxazole; ZDV = zidovudine


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