Table 15c. Antiretroviral Therapy–Associated Adverse Effects and Management Recommendations—Gastrointestinal Effects

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Table 15c. 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 All ARV drugs, but most notably RTV-boosted PIs Onset:
  • Early
Presentation:
  • Nausea and emesis, both of which may be associated with anorexia and/or abdominal pain.
Varies by ARV agent; generally <15% Unknown Instruct patient to take PIs with food.

Monitor for weight loss and ARV adherence.
Reassure patient that these adverse effects generally improve over time (usually in 6–8 weeks).

Consider switching to ARV drugs with smaller tablet sizes (see Appendix A, Table 2).

Provide supportive care.

In extreme or persistent cases, use antiemetics or switch to another ARV regimen.
Diarrhea All ARV drugs, but most notably RTV-boosted PIs Onset:
  • Early
Presentation:
  • More frequent bowel movements and stools that are generally soft.
Varies by ARV agent; generally <15% Unknown Monitor for weight loss and dehydration. In prolonged or severe cases, exclude infectious or noninfectious (e.g., lactose intolerance) causes of diarrhea.

Reassure patient that this adverse effect generally improves over time (usually in 6–8 weeks). Consider switching to another ARV regimen in persistent and severe cases.

Treatment data in children are lacking; however, the following strategies may be useful when the ARV regimen cannot be changed:
  • Modifying the diet
  • Using bulk-forming agents (e.g., psyllium)
  • Using antimotility agents (e.g., loperamide)
  • Using crofelemer, which is approved by the FDA to treat ART-associated diarrhea in adults aged ≥18 years; no pediatric data are available.
Pancreatitis Rare, but may occur with NRTIs or RTV-boosted PIs Onset:
  • Any time, usually after months of therapy
Presentation:
  • Emesis, abdominal pain, elevated amylase and lipase levels (asymptomatic hyperamylasemia or elevated lipase do not in and of themselves indicate pancreatitis)
<2% Use of concomitant medications that are associated with pancreatitis (e.g., TMP-SMX, pentamidine, ribavirin)

Hypertriglyceridemia

Advanced HIV infection

Previous episode of pancreatitis

Alcohol use
Measure serum amylase and lipase concentrations if persistent abdominal pain develops. Discontinue offending agent and avoid reintroduction.

Manage symptoms of acute episodes.

If pancreatitis is associated with hypertriglyceridemia, consider using interventions to lower TG levels.
Key: ART = antiretroviral therapy; ARV = antiretroviral; FDA = Food and Drug Administration; NRTI = nucleoside reverse transcriptase inhibitor; PI = protease inhibitor; RTV = ritonavir; TG = triglyceride; TMP-SMX = trimethoprim sulfamethoxazole