Side Effects of nelfinavir: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Main Research Findings

Nelfinavir, an HIV protease inhibitor, may cause intestinal epithelial impairment, but the adverse effects could be mitigated by alanyl-glutamine supplementation. 8 This study also investigated the protective effects of alanyl-glutamine against nelfinavir-induced epithelial impairment in IEC-6 cells and in mouse intestinal mucosa.

The study 6 compared the side effects of different treatment regimens for nonoccupational post-exposure prophylaxis (NPEP) for HIV. They found that a triple nucleoside-nucleotide regimen (TDF-3TC-d4T) had a lower incidence of intolerable side effects compared to protease inhibitor- and zidovudine-based regimens.

Nelfinavir can also suppress insulin signaling and nitric oxide production in endothelial cells, which may contribute to cardiovascular disease. 9 examined the effects of nelfinavir on insulin-induced NO production in human aortic endothelial cells (HAECs), and found that it suppresses Akt phosphorylation, leading to decreased NO production. Thiazolidinediones, peroxisome proliferator-activated receptor-gamma agonists, were found to ameliorate these negative effects.

Reasons for Side Effects

Nelfinavir, as an HIV protease inhibitor, works by inhibiting the HIV protease enzyme, which is crucial for the virus to replicate. However, this medication can also interact with other enzymes and proteins in the body, potentially causing side effects.

Common Side Effects

Gastrointestinal

Nelfinavir can cause gastrointestinal side effects, especially diarrhea. mentions diarrhea as one of the side effects associated with nelfinavir treatment. 16 investigated the potential benefits of nutritional co-therapies like probiotics, soluble fiber, and L-glutamine in reducing diarrhea caused by nelfinavir or lopinavir/ritonavir. Additionally, 22 suggests that nelfinavir administration to children may lead to gastrointestinal side effects.

Metabolic

Nelfinavir may cause metabolic side effects such as insulin resistance, dyslipidemia, lipodystrophy, and atherosclerosis. 14 discusses the link between HIV protease inhibitors (HPIs) and these metabolic issues, highlighting the role of nelfinavir in inhibiting GLUT4-mediated glucose transport and disrupting insulin signaling. 13 investigated the therapeutic effects of black seed oil from Nigella sativa in mitigating chronic HAART-induced hyperinsulinemia in rats, suggesting potential benefits in addressing metabolic side effects.

Liver

Nelfinavir may cause liver side effects. 11 explores the potential association between nelfinavir's inhibition of organic anion transporting polypeptides 1B1 and 1B3 (OATP1B1 and OATP1B3) and hyperbilirubinemia, a condition that can indicate liver dysfunction.

Kidney

Nelfinavir may cause kidney side effects. 3 identifies renal complications as a potential side effect of nelfinavir treatment, particularly in children. Regular monitoring of kidney function is crucial to manage this potential issue.

Skin

Nelfinavir may cause skin side effects such as alopecia. 23 reports a case of alopecia totalis in an HIV-positive patient who was taking lopinavir/ritonavir, suggesting the potential for hair loss associated with nelfinavir. A serious incident involving the contamination of nelfinavir tablets with ethyl methanesulfonate (EMS) occurred in 2007. 19 details the global recall of nelfinavir due to the potential health risks posed by EMS. Any skin abnormalities while taking nelfinavir should be reported to a doctor immediately.

Nervous System

Nelfinavir may affect the nervous system. 5 indicates that nelfinavir accelerates glutathione export from cultured rat neurons, suggesting a potential impact on brain GSH metabolism. While further research is needed, this study highlights the possibility of neuro-related side effects associated with nelfinavir.

Countermeasures for Side Effects

Gastrointestinal

Dietary and nutritional therapies can help mitigate gastrointestinal side effects. 16 suggests that probiotics, soluble fiber, and L-glutamine may be beneficial in reducing diarrhea associated with nelfinavir or lopinavir/ritonavir.

Metabolic

Maintaining a healthy lifestyle with a balanced diet and regular exercise is recommended to address metabolic side effects associated with nelfinavir. 14 emphasizes the importance of managing insulin resistance, dyslipidemia, lipodystrophy, and atherosclerosis through lifestyle modifications. 13 investigates the potential of black seed oil from Nigella sativa in mitigating chronic HAART-induced hyperinsulinemia in rats.

Liver

Regular liver function tests are essential for monitoring liver health and detecting any potential issues related to nelfinavir treatment. 11 suggests a possible link between nelfinavir and hyperbilirubinemia, highlighting the importance of liver function monitoring.

Kidney

Regular kidney function tests are crucial for early detection and management of potential kidney complications associated with nelfinavir treatment. 3 highlights the occurrence of renal complications in some patients taking nelfinavir, especially children.

Skin

Consult a doctor immediately if you experience any skin abnormalities while taking nelfinavir. 23 discusses a case of alopecia totalis related to lopinavir/ritonavir, highlighting the importance of seeking medical advice for skin issues. The global recall of nelfinavir in 2007 due to contamination with EMS 19 underscores the critical need for vigilance and prompt medical attention for any adverse reactions.

Nervous System

Consulting a doctor is essential if you experience any nervous system side effects while taking nelfinavir. 5 suggests a potential impact of nelfinavir on brain GSH metabolism, emphasizing the need for medical evaluation for any neurological symptoms.

Comparison of Studies

Commonalities of Studies

Several studies indicate that nelfinavir, while effective in treating HIV, can cause a range of side effects, including gastrointestinal issues, metabolic problems, and potential impacts on the liver, kidneys, skin, and nervous system.

Differences of Studies

The specific side effects and their prevalence can vary depending on the study population, treatment regimen, and other factors.

Points to Note for Applying to Real Life

Nelfinavir is a valuable medication for treating HIV, but it's crucial to be aware of its potential side effects and to discuss any concerns with your doctor. It's essential to follow your doctor's instructions carefully and seek medical attention immediately if you experience any adverse reactions.

Limitations of Current Research

While there is research on the side effects of nelfinavir, further investigation is needed, especially regarding long-term effects. Additionally, individual responses to nelfinavir can vary significantly, making it challenging to establish universally applicable findings.

Future Research Directions

Long-term studies are essential to comprehensively understand the side effects of nelfinavir. Research tailored to individual patient characteristics, such as genetic predisposition and lifestyle factors, is also important. Furthermore, developing new therapies to mitigate or prevent these side effects is a crucial area for future research.

Conclusion

Nelfinavir is an effective medication for HIV treatment, but it's essential to be aware of its potential side effects and to discuss any concerns with your doctor. While current research provides valuable insights, further studies are needed to gain a deeper understanding of nelfinavir's long-term effects and to develop strategies to minimize its side effects. Maintaining open communication with your doctor and following their instructions carefully are crucial for safe and effective treatment.

Literature analysis of 25 papers
Positive Content
19
Neutral Content
1
Negative Content
5
Article Type
5
0
0
3
25
1.

Systems Pharmacology Identifies an Arterial Wall Regulatory Gene Network Mediating Coronary Artery Disease Side Effects of Antiretroviral Therapy.

Author: FradesItziar, ReadheadBen, AmadoriLetizia, KoplevSimon, TalukdarHusain A, CraneHeidi M, CranePaul K, KovacicJason C, DudleyJoel T, GiannarelliChiara, BjörkegrenJohan L M, PeterInga

Increased CAD risk

Ritonavir, nelfinavir, and saquinavir, three commonly used ARTs, were found to alter the activity of AR-RGN, a regulatory gene network promoting foam cell formation and risk of CAD.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Nelfinavir and nevirapine side effects during pregnancy.

Author: TimmermansSarah, TempelmanClaire, GodfriedMieke H, NellenJeanine, DielemanJeanne, SprengerHerman, SchneiderMargriet Ee, de WolfFrank, BoerKees, van der EndeMarchina E,

HIV transmission reduction
Gastrointestinal symptoms
Hepatotoxicity
Hyperglycemia

Nelfinavir- or nevirapine-containing HAART regimens during pregnancy are well tolerated. Side effects of antiretroviral therapy are more frequent in pregnant than in non-pregnant women.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

[Highly active antiretroviral therapy (HAART) in HIV-positive pregnant women in the Netherlands, 1997-2003: safe, effective and with few side effects].

Author: TempelmanC, TimmermansS, GodfriedM H, DielemanJ P, BoerK, van der EndeM E

HIV treatment
Gastrointestinal side effects
Hepatotoxicity
Rash

HAART regimens containing nelfinavir or nevirapine were safe, effective, and well tolerated in HIV-infected pregnant women.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Dutch

5.

Antiretroviral protease inhibitors accelerate glutathione export from viable cultured rat neurons.

Author: BrandmannMaria, HohnholtMichaela C, PettersCharlotte, DringenRalf

Altered GSH metabolism

Antiretroviral protease inhibitors, commonly used for HIV treatment, can increase the export of glutathione (GSH) from neurons, potentially leading to altered brain GSH metabolism. This effect was observed with indinavir, nelfinavir, lopinavir, and ritonavir, and was mediated by the multidrug resistance protein 1.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

The use of a triple nucleoside-nucleotide regimen for nonoccupational HIV post-exposure prophylaxis.

Author: WinstonA, McAllisterJ, AminJ, CooperD A, CarrA

Reduced side effects

This study compared the side effects and completion rates of nonoccupational post-exposure prophylaxis (NPEP) regimens using tenofovir-lamivudine-stavudine (TDF-3TC-d4T) to previous regimens.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

7.

Therapeutic drug monitoring of HIV protease inhibitors using high-performance liquid chromatography with ultraviolet or photodiode array detection.

Author: LeibenguthP, Le GuellecC, BesnierJ M, BastidesF, MacéM, GaudetM L, Autret-LecaE, PaintaudG

HIV treatment

This study explores the potential benefits of therapeutic drug monitoring for HIV protease inhibitors, aiming to optimize treatment effectiveness and minimize side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Protective effects of alanyl-glutamine supplementation against nelfinavir-induced epithelial impairment in IEC-6 cells and in mouse intestinal mucosa.

Author: Braga-NetoManuel B, OliveiraBruna M C, RodriguesRaphael S, NoronhaFrancisco J, LeitaoRenata F, BritoGerly A C, LimaAldo A, GuerrantRichard L, WarrenCirle A

HIV treatment
Diarrhea

This study evaluated the effects of nelfinavir (NFV), an HIV PI, and of alanyl-glutamine (AQ) supplementation, on intestinal cell migration, proliferation, apoptosis and necrosis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Low efficacy and high frequency of adverse events in a randomized trial of the triple nucleoside regimen abacavir, stavudine and didanosine.

Author: GerstoftJan, KirkOle, ObelNiels, PedersenCourt, MathiesenLars, NielsenHenrik, KatzensteinTerese L, LundgrenJens D

Viral load reduction
Side effects

The A/S/D regimen had a low efficacy and a high frequency of adverse events and cannot be recommended.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

HIV postexposure prophylaxis for children and adolescents.

Author: BablF E, CooperE R, DamonB, LouieT, KharaschS, HarrisJ A

HIV prevention
Financial concerns
Noncompliance
Side effects

HIV postexposure prophylaxis (PEP) in the nonoccupational setting for children and adolescents presents a medical and management challenge, and requires a coordinated effort.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Therapeutic effects of Nigella sativa on chronic HAART-induced hyperinsulinemia in rats.

Author: ChandraSurabhi, MurthySubramanyam N, MondalDebasis, AgrawalKrishna C

Insulin resistance suppression

Prolonged use of highly active antiretroviral therapy (HAART) is linked to insulin resistance. This study investigated the protective effects of black seed oil (BSO) in rats treated with HAART. BSO was found to reduce hyperinsulinemia and prevent the reduction of pancreatic islet size observed in HAART-treated rats.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

14.

Cellular mechanisms of insulin resistance, lipodystrophy and atherosclerosis induced by HIV protease inhibitors.

Author: RudichA, Ben-RomanoR, EtzionS, BashanN

Atherosclerosis
Dyslipidaemia
Insulin resistance
Lipodystrophy

This study explores the cellular mechanisms by which HIV protease inhibitors (HPIs) contribute to insulin resistance, dyslipidemia, lipodystrophy, and atherosclerosis. It discusses the roles of impaired glucose transport, defective insulin signaling, disrupted adipogenesis, and increased free radical production.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

The efficacy of combined zidovudine and lamivudine compared with that of combined zidovudine, lamivudine and nelfinavir in asymptomatic and early symptomatic HIV-infected children.

Author: MoolasartPikul, LikanonsakulSirirat

HIV treatment

This study compared the efficacy of two treatment regimens, double-drug therapy (ZDV+3TC) and triple-drug therapy (ZDV+3TC+NFV), in 25 HIV-infected children over 6 months. Although the triple-drug therapy showed higher median weight increase (24% vs. 2%), CD4-cell count increase (94.5% vs. 9.4%), and viral load reduction (1.2 log10; 20.8% vs. 0.72 log10; 13.8%), these differences were not statistically significant. Both regimens were well tolerated, with no side effects or deaths.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Probiotics, soluble fiber, and L-Glutamine (GLN) reduce nelfinavir (NFV)- or lopinavir/ritonavir (LPV/r)-related diarrhea.

Author: HeiserCarla R, ErnstJudith A, BarrettJames Tom, FrenchNeel, SchutzMalte, DubeMichael P

Improved quality of life
Improved treatment durability
Diarrhea
GI side effects

This study assessed the impact of nutritional co-therapies known to reduce diarrhea in HIV-positive men treated with nelfinavir (NFV)- or lopinavir/ritonavir (LPV/r)-containing regimens.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

17.

Misfolded proteins: from little villains to little helpers in the fight against cancer.

Author: BrüningAnsgar, JückstockJulia

Cancer Cell Killing
Severe Side Effects

This review discusses new therapeutic strategies for treating cancer that focus on targeting protein homeostasis. Many cancer cells have abnormal protein expression, which can be exploited for therapeutic purposes. Drugs that disrupt protein folding, proteasome function, and autophagy are being investigated as potential cancer treatments.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

[Attitude of the clinican toward adverse effects of protease inhibitors].

Author: NicolB, ChampagneX, BreuxJ P, PasdeloupT, RemblierC, PéraultM C, VandelB

AIDS treatment
gastrointestinal effects
metabolic effects
neurological effects
renal effects

Protease inhibitors (PIs), used for treating HIV/AIDS, can cause various side effects. While some side effects are tolerable and regress spontaneously, others require stopping the PI.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : French

19.

EMS in Viracept--the course of events in 2007 and 2008 from the non-clinical safety point of view.

Author: MüllerLutz, SingerThomas

HIV Treatment
Contamination

Viracept (nelfinavir), an HIV protease inhibitor, was globally recalled due to contamination with ethyl methanesulfonate, a mutagen, carcinogen, and teratogen. Risk assessment concluded that the levels of contamination did not pose a health risk to affected patients.

Historical ArticleA research paper that analyzes past events and developments using primary sources and examines them from a historical perspective.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

20.

Resistance profiles and adherence at primary virological failure in three different highly active antiretroviral therapy regimens: analysis of failure rates in a randomized study.

Author: RøgeB T, BarfodT S, KirkO, KatzensteinT L, ObelN, NielsenH, PedersenC, MathiesenL R, LundgrenJ D, GerstoftJ

Resistance mutations
Treatment interruption

Treatment interruption or poor adherence was the main cause of primary virological failure in patients on highly active antiretroviral therapy (HAART). Resistance mutations were prevalent in patients failing on regimens containing non-nucleoside reverse transcriptase inhibitors (NNRTIs) and nucleoside reverse transcriptase inhibitors (NRTIs), but not in those failing on boosted saquinavir.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

21.

Virological efficacy and plasma drug concentrations of nelfinavir plus saquinavir as salvage therapy in HIV-infected patients refractory to standard triple therapy.

Author: ReiserM, SalzbergerB, StiepelA, HoetelmansR, DiehlV, FätkenheuerG

Treat HIV infection
Diarrhea

In patients refractory to standard triple therapy, the combination of nelfinavir and saquinavir showed a short-term virological efficacy in only a minority of patients. Although CD4 counts were significantly increased, plasma saquinavir concentrations could not be increased by dose escalation.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

22.

Efficacy of highly active antiretroviral therapy in HIV-1 infected children.

Author: van RossumAnnemarie M C, FraaijPieter L A, de GrootRonald

HIV-1 treatment
Gastrointestinal side effects
Lipid abnormalities

This review examines paediatric clinical studies using HAART for HIV-1 infection. Virological response rates were variable, while immunological response rates were more uniform. Side effects were generally mild and transient.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

23.

Alopecia induced by lopinavir plus ritonavir therapy in an HIV patient.

Author: ChrysosGeorge, MikrosSotirios, KokkorisStelios, PastelliAndroula, KontochristopoulosGeorge

HIV treatment
Alopecia
Lopinavir/ritonavir side effects

Lopinavir/ritonavir, an antiretroviral medication used to treat HIV infection, is associated with several side effects. This report describes a case of alopecia totalis (complete hair loss) in a 62-year-old man who was treated with lopinavir/ritonavir. The alopecia resolved when the patient was switched to nelfinavir.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

24.

A randomized trial comparing the efficacy and tolerability of two HAART strategies at two years in antiretroviral naive patients.

Author: MallolasJ, BlancoJ L, PichJ, ArnaizJ A, PeñaJ M, DalmauD, de LazzariE, OchoaA, VidalF, RibasM A, SeguraF, PedrolE, FloresJ, CrucetaA, VareaS, MiróJ M, MartínezE, GatellJ M

ARV treatment
HAART efficacy
Side effects
Treatment failure

This study compared the long-term effectiveness of two antiretroviral (ARV) treatment strategies in HIV-infected patients. The two strategies involved starting with either a nelfinavir-based HAART regimen or a nevirapine-based HAART regimen. The study aimed to determine the optimal long-term treatment strategy for patients not previously treated.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

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