One study looked at the case of a year-old man with normal heart function, who began to experience heart problems, following interferon treatment. Another study , which was done in , looked at the effects of interferon on increasing risk of heart disease in people with lupus. The researchers found that all subjects, regardless of lupus, seemed to have increased signs of potential heart damage from using interferon.
At the same time, a study looked at the effects of interferon on the heart health of people with chronic hepatitis.
It found no significant negative effects. The authors suggested that interferon therapy might be used safely on people who did not have pre-existing heart disease. The connection between interferon and heart damage is not clearly understood, but it is worth being mindful of when someone is considering treatment. Anyone who is concerned, especially those with a history of heart disease, should discuss this with their doctor before starting interferon treatment. A review published in Digestive Diseases and Sciences , looked at four cases where people had received long-term interferon treatment.
In each case, interferon seemed to cause irreversible high blood pressure in people with hepatitis C. The authors noted that this particular issue was rare and had not previously been reported. But it was, nonetheless, a possible side effect of interferon to keep in mind. The study noted that the underlying risk factors and causes of this issue were unclear, but it occurred during a long course of interferon treatment.
Interferon is usually given by injection underneath the skin of the thigh or belly. The drug may also be given through a drip. In a study , interferon was given orally to see whether this would be effective in preventing chest infections.
Older research from found interferon to have no effect when taken by mouth. Before undergoing interferon treatment, people should have a lengthy and in-depth conversation with their doctor about what to expect, regarding side effects and symptoms. A doctor who knows about any side effects may be able to help address these with medication, adjust the treatment plan, or offer advice on counseling and other services.
Viremia occurs when a virus infects the bloodstream. In this article, learn about the types of viruses, symptoms, causes, and treatment. Tumefactive multiple sclerosis MS is a rare form of MS that involves a mass in the brain. Comparison: Pregnant women with the same diseases without IFN exposure. Outcomes: Pregnancy outcomes, including but not limited to live birth, spontaneous abortion, stillbirth, preterm delivery, maternal complications, and birth defects.
We excluded studies in which: 1 patients received other potentially teratogenic medications prior to or during pregnancy; 2 duplicate publications and publications including data from the same patients; and 3 published as conference, review, or abstract. Literature search was performed by two independent investigators MMZ and SF , as well as the data were strictly evaluated according to the inclusion and exclusion criteria.
Discrepancies were resolved by consulting with the third investigator JFL. The following information was collected using a customized data extraction form followed by cross-checking: first authors, published year, study region, study design, sample size, basic disease, obstetric history, period of pregnancy when exposed to IFN, duration of IFN exposure, the type and dose of IFN exposure, infant information, and maternal and fetal outcomes.
We set the possible pregnancy outcomes: live birth, spontaneous abortion, stillbirth, and preterm delivery. According to the European Medicines Agency EMA and Centers for Disease Control and Prevention CDC guidelines, a live birth was defined as any delivery resulting in viable neonates after 24 weeks of gestation; spontaneous abortion was defined as spontaneously ended pregnancy before 22 weeks of gestation according to EMA guidelines or 20 weeks of gestation according to CDC guidelines , including abortion, miscarriage, missed abortion, incomplete abortion, and early fetal death; stillbirth was defined as a fetal death occurring after 22 weeks of gestation according to EMA guidelines or 20 weeks of gestation according to CDC guidelines , further defined as fetal death or loss before or during delivery; and preterm delivery was defined as any delivery of viable neonates too early, before 37 weeks of gestation.
In this scale, studies were scored on the information of selection of study groups 0—4 stars , comparability 0—2 stars , and outcome ascertainment 0—3 stars. We also performed a proportion meta-analysis to calculate the pooled rate of each outcome in patients exposed to IFN, which was estimated using the number of events divided by the total number of pregnancies. The estimates were put in context with the general population using the published data. According to the differences of results and I 2 of the two methods, the random effect model or the fixed effect model was applied to combine the results of the studies.
Publication bias was calculated by visual funnel plot and assessed by Begg's test and Egger's test. As showed in the flowchart of study selection Figure 1 , our search strategy yielded 9, citations preliminarily. After removing duplications and other studies through reading the title and abstract, articles were then reviewed by full-text assessment, and 17 studies covering more than 10 countries United States, Italy, Germany, Canada, United Kingdom, France, Brazil, Japan, Sweden, Australia, European Economic Area and Global database were included in the final meta-analysis.
The main characteristics of the included studies for meta-analysis are detailed in Table 1. The quality of the eight cohort studies was assessed with NOS scores, whereas four studies were at a low risk of bias Supplementary Table.
In total, 3, pregnancies were included for final analysis, among which 2, pregnancies were exposed to IFN before conception or during pregnancy and 1, were not exposed to IFN. As presented in Table 2 , all of those pregnant women navigated safely throughout the pregnancy and no birth defects were reported associated with IFN exposure.
Table 2. In line with our expectations, the majority of the outcomes were normal live births. As shown in Figure 2 , the prevalence of live birth was The analysis showed no increased risk of stillbirth OR 0. Furthermore, the studies yielded a pooled prevalence of 5. Figure 2. All 17 studies reported the incidence of live birth with a total of 2, pregnancies with IFN exposure, the pooled rate was Figure 3. Meta-analysis of pregnancy outcomes after IFN exposure.
The pooled estimates showed no increased risk of spontaneous abortion OR 1. Among a total of 2, infants in proportion meta-analysis from 17 studies reporting spontaneous abortion and stillbirth as outcome measures, presented spontaneous abortion, yielding a pooled estimate of 9. From the seven studies reporting data on any maternal complications, 67 events were observed in pregnancies, and the pooled rate was 6. Nine studies reported the incidence of birth defects including any birth defects and major birth defects , a total of 18 and 56 cases of birth defects out of and live births in the two groups were reported, respectively.
The results showed that there was no obvious distinction in risk of birth defects OR 0. In addition, the pooled estimate of birth defects was 0.
Studies included for the final analysis were also graphically assessed for any potential publication bias through a funnel plot Supplementary Figure. The studies were plotted with the estimated effect on the horizontal axis and the standard error of the estimated effect on the vertical axis. Studies with a smaller sample scatter more widely at the bottom of the graph, while larger studies are closer to the true effect of the intervention and are positioned in the upper part of the diagram.
In the absence of a publication bias, the plot should look symmetric. Since be cloned and large-scale produced, type I IFNs have been successfully applied as therapies in patients suffering from various diseases 44 — Although there are scant published data discussing the safety in pregnant women with chronic HBV infection, IFN has been recommended widely in MS, ET, chronic myeloid leukemia, multiple myeloma, and others 46 — In this meta-analysis including the most comprehensive and up-to-date research on the safety of INF exposure in pregnant women, we found that exposure to type I IFNs during pregnancy did not adversely affect pregnancy or infant outcomes.
In these meta-analysis enrolled 3, pregnancies, the pooled estimate of live birth was When further compared with pregnant women with the same diseases unexposed to IFN, there was no significant difference, suggesting no evidence of the adverse effect on live birth.
This similarity has also been presented in other systematic literature reviews and observational studies 50 , In view of these available research results, IFN exposure displays no adverse impact on successful pregnancy.
In line with the general pregnancy population, spontaneous abortion is the primary adverse outcome in the current investigation. A pooled rate of 9.
In addition, as presented in Figure 3 , the prevalence of stillbirth and preterm delivery remained within the ranges reported in the general population Moreover, the risks of these adverse pregnancy outcomes were not increased after exposure to IFNs in pregnant women with the same diseases.
Several clinical trials and reviews have previously evaluated the safety profile of IFN in pregnant women, the majority of the exposure was during the first trimester 22 , 51 , A bit higher rates of spontaneous abortions, lower birthweight 20 , 21 , and shorter mean birth length were presented in observational cohorts with a small sample size 20 , 21 , Whereas, these negative pregnancy outcomes were not demonstrated with IFN exposure in systematic reviews and clinical cohorts with large samples 22 , 34 , In the enrolled studies, there were 67 maternal adverse events reporting from 7 cohorts, and pooled analysis did not show an increased risk of maternal complications in pregnant women exposed to IFN.
These findings align with the previous meta-analysis concerning the IFN exposure in pregnant women with myeloproliferative neoplasms, and are consistent with the worldwide prevalence Whereas, some IFN-associated adverse events, including general fatigue, hair loss, and IFN-associated autoimmune diseases, as well as other maternal complications including pre-eclampsia, gestational diabetes, were not sufficiently evaluated in the current analysis.
It is thought that the main concern of the included studies contributes to whether or not it is reported.
Furthermore, the reporting bias may also be due to the missing data associated with retrospective studies. As the main concern among hepatologists about IFN exposure during pregnancy, the pooled estimate of birth defects was 0. Whereas, there have been reports that expression of type I IFNs is constitutive in placental, regulating the immune balance between mother and fetus during gestation 59 , Finally, among the 18 cases with birth defects, no consistent pattern of developmental abnormalities was identified, which suggests that there is no evidence of signal suggesting exposure to type I IFN resulting in birth defects.
Although only case reports were retrieved in pregnant women with viral hepatitis, there were cohorts presenting outcomes from patients with other myeloproliferative diseases. Overall, the current meta-analysis presents a comprehensive assessment of the safety in pregnancies with exposure to type I IFNs and provides references for clinical decisions in unintended pregnancies during IFN treatment.
There are inevitable limitations in the present meta-analysis. First, the included studies in this research were retrospective cohorts and case—control observations, and none were randomized controlled trials. However, from an ethical point of view, it is ethically unacceptable to perform ideal randomized controlled trials in such a special population. In addition, during the process of literature inclusion, we conducted a rigorous quality assessment of the included cohort studies according to NOS, and only those with moderate quality were included in this meta-analysis.
Due to the particularity of the study population and intervention conditions, it is difficult to conduct higher-quality studies in the future. Second, there were only case reports about pregnant women with viral hepatitis, and only a few cohorts were eligible for meta-analysis. Another limitation of the current meta-analysis is the potential for under-reporting due to retrospective studies.
Whereas, prospective observational studies or registries require many years to reach a sample size that afford the statistical power to detect a difference in the relevant risk compared with the general population or untreated patients.
Furthermore, due to dose and duration of IFN exposure in every single case was unavailable, we could not determine the association of adverse pregnancy outcomes with higher doses or longer duration of IFN exposure. Nevertheless, this systematic review with comprehensive evaluation of type I IFNs could provide references for hepatologists to make a strategic clinical decision.
Taken together, the current analysis presented a comprehensive assessment of the safety of IFN exposure during pregnancy. Despite the low-to-moderate quality of the enrolled studies in this analysis, there is no evidence of signal suggesting termination of pregnancy after exposure to IFN prior to or during pregnancy. However, as with all drugs used in pregnancy, it should be encouraged and supported to collect data on birth outcomes to further assess any potential risk of adverse outcomes.
MZ, SF, and DR: Study design, study identification, data collection and extraction, quality assessment, data analysis and interpretation, and manuscript drafting. YC: Study design, data analysis, interpretation, and critical review of the manuscript. TC, YZ, and JL: Study concept, study design, data analysis, interpretation of data, manuscript drafting and revision, quality control of algorithms, and study supervision.
The types of interferons that were used to treat hepatitis C included:. All three of these drugs are injected under the skin.
This is called a subcutaneous injection. These types of interferons were often used with ribavirin. Interferons work in a few ways. For one, they change the way white blood cells destroy invading cells. Interferons also help stop the spread of hepatitis C. Hepatitis C spreads by multiplying, or copying, its cells.
Interferons would help stop the virus from multiplying, which helped slow the spread of the virus. This is one reason why these drugs can cause many side effects. Until recently, treatments for hepatitis C focused on interferons and ribavirin. These drugs were used in an attempt to cure the hepatitis C infection.
However, they were only effective some of the time. Effective treatment with these medications would prevent liver disease and cirrhosis scarring of the liver. In addition, effective treatment would decrease the risk of liver cancer and help prevent liver failure.
In recent years, DAAs have become available, and they have a cure rate of up to 99 percent. These drugs require a shorter treatment time and typically have fewer side effects than interferons.
The type of DAA your doctor might prescribe would depend on your insurance coverage and the type of hepatitis C you have. Some examples of DAAs include:.
To find out more about the long-term side effects of interferon use for treating hepatitis C, talk with your doctor. They can also offer ways to help ease your symptoms. For instance, they may change your dosage or switch you to a different drug. Whatever the cause of your symptoms, working with your doctor and sticking to your prescribed hepatitis C treatment plan can help you manage your condition and feel your best.
New treatments over the past few years mean that Hep C today is much more manageable than it was in the past. Learn about new treatments and costs.
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