Pharm, Apt. Side effects that occurred in antiretroviral use may result in reduced patient compliance in taking medication so that the expected therapeutic outcomes will not be achieved. Sardjito Yogyakarta year period from to This study used a cross-sectional research design and the datas were collected retrospectively from patients' medical record files who meet the inclusions and exclusions criteria.

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Nominations should be submitted to Alice Pau, Pharm. For more information on the community representative nomination requirements, please read this news announcement. The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations. Adverse effects have been reported with all antiretroviral ARV drugs and, in the earlier era of combination antiretroviral therapy ART , adverse effects were among the most common reasons for switching or discontinuing therapy and for medication nonadherence.

However, the long-term complications of ART can be underestimated because most clinical trials use highly specific inclusion criteria which exclude individuals with certain underlying medical conditions, and the duration of participant follow-up is relatively short. As ART is now recommended for all patients regardless of CD4 T lymphocyte CD4 cell count, and because therapy must be continued indefinitely, the focus of patient management has evolved from identifying and managing early ARV-related toxicities to individualizing therapy to avoid long-term adverse effects, including diabetes and other metabolic complications, atherosclerotic cardiovascular disease, kidney dysfunction, bone loss, and weight gain.

To achieve and sustain viral suppression over a lifetime, both long-term and short-term ART toxicities must be anticipated and managed. Information on the adverse effects of ARVs is outlined in several tables in the guidelines.

Table Because these effects may persist long after discontinuation of ddI or d4T, and patients may still present with these long-lasting toxicities, the drugs remain listed among the ARVs associated with these two effects. Refer to the product labels or to the July 10, , version of the guidelines found in the archived guidelines section of AIDS info for information regarding the adverse effects associated with these older ARVs.

This table focuses on ARV-associated adverse effects that a patient may experience as a result of taking an ARV regimen. For information regarding potential adverse effects of ARVs on fetuses and newborns when certain ARVs are taken around the time of conception or during pregnancy, refer to Table 6b and to the Perinatal Guidelines. See Appendix B, Tables 3 - 9 for additional information listed by drug.

Some patients experience treatment-limiting toxicities associated with ART. In these cases, ART must be modified. ART-associated adverse events can range from acute and potentially life-threatening to chronic and insidious. Serious life-threatening events e. Toxicities that are not life-threatening e. Other chronic, non—life-threatening adverse events e. Management strategies must be individualized for each patient.

Switching a patient from an effective ARV agent or regimen to a new agent or regimen must be done carefully and only when the potential benefits of the change outweigh the potential risks of altering treatment. The fundamental principle of regimen switching is to maintain viral suppression.

When selecting a new agent or regimen, providers should be aware that drug resistant viruses previously acquired or selected, even those not detected by past genotypic resistance testing, are archived in HIV reservoirs.

The resistant virus, even if absent from subsequent resistance test results, may reappear under selective drug pressure. See Optimizing Antiretroviral Therapy section for further discussion. It is critical that providers review the following information before implementing any treatment switch:. In some cases, medication costs may also be a factor to consider before switching treatment. Signs and symptoms of comorbidities, adverse effects of concomitant medications, or HIV itself may mimic adverse effects caused by ART.

Therefore, clinicians should investigate all potential causes for an adverse event. In the case of a severe adverse event, it may be necessary to discontinue or switch ARVs pending the outcome of such an investigation. For the first few months after an ART switch, the patient should be closely monitored for any new adverse events.

Table 18 lists several major ART-associated adverse events and the options for appropriate switches between agents in an ARV regimen. The table focuses on the ARVs most commonly used in the United States and lists substitutions that are supported by ARV switch studies, the findings of comparative ARV trials and observational cohort studies, or expert opinion.

Switching agents in an effective ARV regimen should be done carefully and only when the potential benefits of the change outweigh the potential risks of altering treatment.

This table focuses on ARV-associated adverse effects that patients may experience as a result of a current ARV regimen. For information regarding ARV choices to use in individuals of childbearing potential and during pregnancy to avoid potential ARV adverse effects on fetuses and newborns refer to Table 6b and to the Perinatal Guidelines.

PDF documents can be viewed with the free Adobe Reader. Please enable Javascript in your Browser to experience full features of this website. Department of Health and Human Services. Search Search. Table of Contents. What's New in the Guidelines? Brief Version. Full Version. Limitations to Treatment Safety and Efficacy Adverse Effects of Antiretroviral Agents Last Updated: December 18, ; Last Reviewed: December 18, Adverse effects have been reported with all antiretroviral ARV drugs and, in the earlier era of combination antiretroviral therapy ART , adverse effects were among the most common reasons for switching or discontinuing therapy and for medication nonadherence.

Several factors may predispose individuals to adverse effects of ARV medications, such as: Concomitant use of medications with overlapping and additive toxicities. Comorbid conditions that increase the risk of adverse effects.

Certain ARVs may exacerbate pre-existing conditions, for example, psychiatric disorders may be exacerbated by EFV, rilpivirine, and, infrequently, by integrase strand transfer inhibitors. See Appendix B, Tables 3 - 9 for additional information listed by drug Table Osteomalacia may be associated with renal tubulopathy and urine phosphate wasting.

Risk factors include pre-existing heart disease and concomitant use of medications that may cause PR prolongation. Absolute risk greatest in patients with traditional CVD risk factors. Median onset is 42 months after ARV initiation.

Fulminant hepatitis leading to death or hepatic failure requiring transplantation have been reported. NVP : Severe hepatotoxicity associated with skin rash or hypersensitivity.

A 2-week NVP dose escalation may reduce risk. NVP should never be used for post-exposure prophylaxis. All PIs : Drug-induced hepatitis and hepatic decompensation have been reported. HSR Symptoms in Order of Descending Frequency : Fever, rash, malaise, nausea, headache, myalgia, chills, diarrhea, vomiting, abdominal pain, dyspnea, arthralgia, and respiratory symptoms Symptoms worsen with continuation of ABC.

NVP : Hypersensitivity syndrome of hepatotoxicity and rash that may be accompanied by fever, general malaise, fatigue, myalgias, arthralgias, blisters, oral lesions, conjunctivitis, facial edema, eosinophilia, renal dysfunction, granulocytopenia, or lymphadenopathy.

Overall, risk is higher for women than men. A 2-week dose escalation of NVP reduces risk. Some symptoms may subside or diminish after 2—4 weeks. Bedtime dosing and taking without food may reduce symptoms. Risk factors include psychiatric illness, concomitant use of agents with neuropsychiatric effects, and genetic factors. RPV : Inhibits Cr secretion without reducing renal glomerular function. ATV : Stone or crystal formation. Adequate hydration may reduce risk.

Click here to view this table. Switching from TDF to alternative ARV agents has been shown to increase bone density, but the clinical significance of this increase remains uncertain. The long-term impact of TAF on patients with osteopenia or osteoporosis is unknown; close clinical monitoring is recommended in this setting. However, this association has not been seen with ATV. Further study is needed.

GI effects are often transient and do not warrant ARV substitution unless they are persistent and intolerable. However, traditional risk factors for insulin resistance may be stronger risk factors than the use of any PI. Lipoatrophy Peripheral lipoatrophy loss of subcutaneous fat of the limbs, face, and buttocks is associated with prior thymidine analog d4T and ZDV use.

Despite switching from these ARVs, fat recovery remains slow may take years and incomplete. Lipohypertrophy Accumulation of visceral, truncal, dorsocervical, and breast fat has been observed during ART, particularly during use of older PI-based regimens e. There is no clinical evidence that switching to another first line regimen will reverse lipohypertrophy.

In most patients, EFV-related CNS effects subside within 4 weeks after initiation of the drug, but in some patients, ataxia or encephalopathy may appear months to years after EFV-initiation. Persistent or intolerable effects should prompt substitution of EFV. INSTIs are associated with insomnia. Depression and suicidality have been infrequently reported with INSTI use, primarily in patients with pre-existing psychiatric conditions.

For more severe reactions, change to an alternative boosted PI or an agent from another drug class. TDF may cause tubulopathy. The long-term impact of TAF on patients with pre-existing renal disease, including overt proximal tubulopathy, is unknown, and close clinical monitoring is recommended in this setting. This effect does not affect glomerular filtration.

ATV : Cholelithiasis and kidney stones may present concurrently. GI intolerance e. ZDV : Steatosis. EFV : Most cases relate to an increase in transaminases. ATV : Jaundice due to indirect hyperbilirubinemia. Hypersensitivity Reaction Excluding rash alone or Stevens-Johnson syndrome.

RPV : Depression, suicidality, sleep disturbances DOR : Sleep disorders and disturbances, dizziness, altered sensorium; depression and suicidality and self-harm. Weight gain has been associated with initiation of ART and subsequent viral suppression. Calculi Nephrolithiasis and cholelithiasis. Cardiovascular Events Myocardial infarction, ischemic stroke.


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