Side Effects

Antiretroviral drugs have significant side effects. The Food and Drug Administration has recognized this fact and in some cases requires prominent warnings to disclose the most serious side effects. This is commonly known as a "black box." Common black box warnings associated with antiretroviral drugs include:

Many antiretroviral drugs have been "fast tracked" out of a compassionate concern for the suffering public. Fast tracking limits the amount of study that can be done. Special populations such as women, pregnant women, elderly, children and people with co-morbidities have not been fully studied.

Further complicating the subject of antirertoviral therapy side effects is the fact that current treatment guidelines support combining ARTs to increase efficacy and limit the viral resistance. To date the safety of combining many antiretroviral drugs has not been thoroughly studied.

Caregivers need to assimilate safety data as it becomes available. We must remain vigilant for side effects both expected and unexpected. Contributing to the accumulation of drug safety data for antiretrovirals is possible through a number of Therapeutic Drug Monitoring Registries:

 


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The most serious side effects of antiretroviral drugs are described in "black box" warnings.

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Side effects associated with nucleoside analogue reverse transcriptase inhibitors (NRTIs):

All NRTIs are associated with lactic acidosis, hepatomegaly with stetosis and lipodystrophy. Lactic acidosis is a condition which causes damage to organs such as the liver and pancreas due to accumulation of excess lactic acid in blood and body tissues. Lactic acidosis results from the toxic effect of NRTIs on mitochondria. Damaged mitochondria become unable to metabolize lactic acid.

While lactic acidosis can be fatal if not treated, the initial symptoms of lactic acidosis can be quite mild. The most common symptoms of lactic acidosis include: fatigue, nausea, vomiting, abdominal pain and bloating, weight loss, increased heart rate, and shortness of breath. Muscle weakness or numbness in the feet or hands may also occur. Nausea and fatigue, that don’t resolve, are important signs of potential lactic acidosis. Because lactic acidosis can result in death, patients must be familiar with symptoms and bring them to their caregiver's attention ASAP.

Generic

Abbr:
Side Effects
Zidovudine
AZT

Minor
Nausea/Vomiting/ Diarrhea (N/V/D/HA), rash
Serious: confusion, pancreatitis, hepatotoxicity, neutropenia, anemia, lactic acidosis, neuropathy, thrombocytopenia in children, Stevens-Johnson syndrome or toxic epidermal necrolysis

Lamivudine
3TC

Minor
N/V/D/HA, dizziness, insomnia, myalgia, arthralgia, fever, weakness
Serious
Lactic acidosis, severe hepatomegaly w/ steatosis, pancreatitis (especially children)

Abacavir
ABC

Minor
N/V/D/HA, fever, skin rash
Serious
Hypersensitivity reaction, pharyngitis, dyspnea, neutropenia, hyperglycemia, hypertriglyceridemia, neutropenia, anemia, lactic acidosis, hepatomegaly w/ steatosis, lipodystrophy.


Stavudine
d4T
Minor: N/V/D/HA, skin rash, fever, chills
Serious: anemia, hepatotoxicity, pancreatitis, peripheral neuropathy
lactic acidosis, hepatomegaly w/ steatosis
Didanosine
ddI

Minor: N/V/D/HA, chills, fever, rash
Serious Pancreatitis, peripheral neuropathy, lactic acidosis, hepatomegally w/ steatosis, vision changes, dyslipidemia, lipodystrophy,severe

Tenofovir
TDF

Minor N/V/D/HA, dizziness, weakness
Serious SOB, weakness, renal failure, hepatotoxicity, lactic acidosis
pancreatitis, lipodystrophy

Zalcitabine
ddC
Minor: N/V/D/HA, anorexia, myalgia, arthralgia
Serious: Peripheral neuropathy, pancreatitis, lactic acidosis, hepatomegaly w/ steatosis, leukopenia, oral and esophageal ulcers, confusion, dementia, depression, lipodystrophy
Emtricitabine
FTC
Minor N/V/D/ HA, dizziness, insomnia, rash, skin discoloration
Serious lactic acidosis, neutropenia, hepatotoxicity w/ steatosis

N/V/D/HA - Nausea/vomiting/diarrhea/headache


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All NRTIs are associated with lactic acidosis, hepatomegaly with stetosis and lipodystrophy.
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Abacavir is an NRTI that can cause an allergic response ranging from rash to severe hypersensivity reaction.
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Side effects associated with protease inhibitors (PIs):

Protease Inhibitors are an important part of the HAART protocols. Current ART guidlines discourage the use of PIs as a monotherapy. Therefore, the severity of PI side effects will vary depending upon the combined drug regimen. The most common side effects attributed to protease inhibitors are: nausea, diarrhea, and other gastrointestinal problems, lipodystrophy, hepatotoxicity, hyperglycemia, hyperlidemia, coagulopathy.

Because protease inhibitors also affect an enzyme system in the liver that metabolizes drugs, they produce a number of other side effects when they interact with other medications. PIs may also elevate triglyceride levels and alter glucose metabolism.

The alterations in glucose metabolism may progress to Type 2 diabetes. PI induced hyperglycemia can exacerbate gestational diabetes.

PIs
Side Effects
Saquinavir Seizure
Depression
Hepatotoxicity
Photosensitivity
Hyperglycemia
Thrombocytopenia
Acute myeloblastic leukemia
N/V/D/HA
Rash, Steven Johnson Syndrome
Ritonavir Siezures
Pharyngitis
Bronchospasm
Renal failure
Hypersensitivity
Hyperlipidemia
N/V/D/HA
Loss of appetite
Fatigue
Oral Parasthesia
Lipodystrophy
Hepatotoxicity
Anemia
Indinavir

Rash, Steven Johnson Syndrome
Kidney stones
Visual disturbances
Insomnia
N/V/D/HA
Ketoacidosis
Lipodystrophy
Hyperglycemia

Thrombocytopenia

Lopinavir

N/V/D/HA
Insomnia
Weakness
Hepatotoxicity
Pancreatitis
Rash
Lipodystrophy
Hyperglycemia

Atazanavir

Hyperbilirubinemia, Lipodystrophy,Hyperglycemia
fever, arthralgia, depression, insomnia, dizziness,
N/V/D/HA, paresthesia
Rash, Steven Johnson Syndrome
Prolonged P-R interval
1st degree AV block
2nd degree AV Block,

Amprenavir
(Discontinued by manufacturer 10/07)

Hyperglycemia
Fatigue
Appetite loss
Rash (severe)
N/V/D/HA
Lipodystrophy
Circumoral parestheias
Anemia

Fosamprenavir N/V/D/HA
paresthesia
Rash, Steven-Johnson syndrome
Lipodystrophy
Neutropenia
Anemia
Hyperglycemia

 

Side effects associated with nonnucleoside reverse transcriptase inhibitors (NNRTIs):

This group of medications are relatively well tolerated. Skin rash is a major side effect of all drugs in this group.

NNRTI
Side Effects
Efavirenz
  • Common - dizziness, altered dreams,
    sleeplessness, trouble concentrating
    , rash
  • Rare - hepatotoxicity, congenital defects.
Nevirapine
  • Common - hepatotoxicity, rash
  • Rare - severe to fatal hepatotoxicity, Stevens-Johnson syndrome or toxic epidermal necrolysis , peripheral neuropathy, women are at higher risk for adverse effects
Delavirdine
  • Common - moderate rash, fever, myalgia, arthralgia
  • Rare - toxic epidermal necrolysis, hepatotoxicity

Side effects associated with fusion inhibitors:

Enfuvirtide (Fuzeon) is used in combination with other medication. It has not been studied in pregnant women.

FI
Side Effects
Enfuvirtide
  • Common - injection site reaction, peripheral neuropathy, shortness of breath, pneumonia, neutropenia
  • Rare - rash, fever, nausea, hypotension, hepatotoxicity

Side effects associated with entry inhibitors:

Entry inhibitor
Side Effects
Maraviroc
  • Common - (> 5%) diarrhea, nausea, abdominal pain, asthenia, vomiting, headache, and dyspepsia.
  • Rare - hepatotoxicity

 



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