Article

Once-daily antiretroviral therapy among treatment-experienced Muslim patients fasting for the month of Ramadan

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Abstract

Many countries with a considerable burden of human immunodeficiency virus (HIV) infection in Africa and Asia also have a substantial Muslim population. Anti-retroviral therapy (ART) has led to reductions in HIV morbidity and mortality in those areas. However, for ART to remain durably effective its provision should be adapted to local and religious customary practices such as Ramadan fasting. The fasting is often observed by Muslims with HIV infection and ART might be compromised by sub-optimal adherence during fasting as it precludes the ingestion of oral substances during the daytime and is often associated with an alteration of meals/sleeping patterns. We studied once-daily compared to twice-daily dosed ritonovir boosted lopinavir with fixed-dose tenofovir-emtricitabine once-daily among 17 heavily treatment-experienced stable FT patients in Nigeria. No changes in adherence, diarrhoea, CD4 cell counts, viral load, haematocrit, kidney, liver and lipid tests were observed. Effectiveness, safety and tolerability appeared unaffected by the changes.

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... Observing a similar adherence and sideeffects rates between the two groups and not noticing any impact on body weight and CD4 cell count, they concluded that fasting during Ramadan for HIV patients was safe. Yakasai and collaborators [9] replicated and confirmed these findings recruiting a sample of 17 heavily treatment-experienced stable patients (10 men) in Nigeria. They compared once-daily versus twice-daily dosed Ritonavir boosted Lopinavir with fixed-dose Tenofovir-Emtricitabine oncedaily. ...
... However, two patients (one being fully virologically suppressed) had post-Ramadan viral rebound with a significant decrease in CD4 cell count. In conclusion, summarizing the studies, clinicians can be provided with some useful suggestions [8,9]: ...
... The patient feels indeed himself/herself more active being involved in the religious activities, and less depressed and isolated [14]. Some studies have shown that religiosity can increase treatment adherence and compliance among HIV patients [8,9]. ...
... Observing similar adherence and side effect rates between the two groups and not noticing any impact on body weight and CD4 cell count, the researchers concluded that fasting during Ramadan for HIV patients was safe. Yakasai et al.[14]replicated and confirmed these findings in a sample of 17 heavily treatment-experienced stable patients (10 men) in Nigeria. They compared oncedaily to twice-daily dosed ritonavir-boosted lopinavir with fixed-dose tenofovir-emtricitabine once daily. ...
... Fasting enables the patient to be actively involved in the religious activities and less depressed and isolated[54]. Some studies have shown that religiosity can increase treatment adherence and compliance among HIV patients[12][13][14]. ...
Article
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Ramadan represents the fourth of the five pillars of the Islam creed. Although patients are exempted from observing this duty, they may be eager to share this moment of the year with their peers. However, there are no guidelines that can help physicians to address the concerns of patients with infectious diseases fasting in Ramadan. For this purpose, we performed a systematic review. We found 51 articles. Should summarize how many studies and/or articles included in the analysis Our main findings are that: 1) patients suffering from diabetes at risk of developing infectious complications should not fast; 2) Ramadan fasting has little impact on diarrheal patients; 3) HIV represents a challenge and ad hoc drug combinations should be recommended to patients, as well as they should be advised not to take fatty meals that could interfere with the treatment; 4) Ramadan has no effect on the effectiveness of anti-helminthic therapy; 5) patients with active ulcer should not fast, having a higher probability of developing complications.
... As far as cell-mediated immunity is concerned, it was shown in an in-vivo animal study that IF increased the bactericidal efficiency of macrophages. IFN-gamma has been shown to be upregulated during IF, and this cytokine has demonstrated anti-viral activity, although at this point, it is difficult to extrapolate this response to cover SARS-COV-2 as well [4,5]. ...
Article
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Ramadan is the holy month in the Islamic calendar marked by many social and behavioral changes in Muslim societies. The ongoing COVID-19 pandemic raises concerns about the effect of Ramadan on COVID-19 and vice-versa. The global fight against COVID-19 can only be effective if measures taken for its attenuation are in sync with accepted evidence and the same is communicated to the population at large. Muslims comprise one-fourth of the world's population and have their presence in every nook and corner of human civilization, and they celebrate Ramadan across the world with intermittent fasting (IF) from dawn to dusk with the duration ranging from 12-20 hours, depending on the latitude of the place. During this period, no food, drink, or smoking is allowed. The beginning and end of IF are marked by a gathering of family and friends to partake of common food and some portions of the night are devoted to prayers [1]. There have been multiple studies in the past evaluating the effect of fasting on immunity, infection, and dehydration. Whereas a few of them showed impaired immunity, a majority highlighted otherwise. The combined effects of IF and sleep deprivation led to a decrease in IgG level, salivary IgA levels, and creatinine clearance, along with poorer control of auto-immune diseases due to an increase in auto-antibodies like anti-dsDNA in fasting cohorts [2, 3]. Though a majority of the studies indicates that fasting is associated with no decline in immunity, some studies show it to augment immunity. These studies have mainly delved into the levels of cytokines in the body. It has been shown consistently that IF was associated with a decrease in proinflammatory cytokine levels like IL-6, IL-1B, and TNF-alpha. In addition, loss of weight and adipose tissue due to IF in Ramadan was naturally associated with a better cytokine profile. As far as cell-mediated immunity is concerned, it was shown in an in-vivo animal study that IF increased the bactericidal efficiency of macrophages. IFN-gamma has been shown to be upregulated during IF, and this cytokine has demonstrated anti-viral activity, although at this point, it is difficult to extrapolate this response to cover SARS-COV-2 as well [4, 5]. The course of COVID-19 in severe cases has been marked by a cytokine storm; therefore, it is essential to understand the effect of IF on oxidative stress. It has been shown in both cytokine-based and gene-based studies that IF has been associated with an overall decrease in oxidative stress [6]. Fasting during the day, especially in summer in the northern hemisphere and tropical countries may result in dehydration. In addition, dehydration can theoretically lead to a decreased mucociliary activity, which can impair the removal of noxious agents from the respiratory tract. However, most research has shown that IF in Ramadan is associated with increased pre-and post-fasting fluid intake, effectively attenuating any total decline in fluid intake. Moreover, the increased concentrating ability of the kidneys particularly late into the fasting contributes to effective maintenance of fluid volume without any detriment to the general health [7]. Despite a volume of research on the subject, the final word in terms of Ramadan-induced immune-modulation has not been spoken, with some studies also showing adverse effects related to ritualistic IF. It mostly boils down to how an individual manages his/her diet, sleep, and exercise schedule during the month of Ramadan. In addition, because Ramadan rotates through different seasons, and because daylight hours differ based on latitude, the period of fasting varies. This is
... As far as cell-mediated immunity is concerned, it was shown in an in-vivo animal study that IF increased the bactericidal efficiency of macrophages. IFN-gamma has been shown to be upregulated during IF, and this cytokine has demonstrated anti-viral activity, although at this point, it is difficult to extrapolate this response to cover SARS-COV-2 as well [4,5]. ...
... [21] Interestingly, in Muslim fasting HIV patients, the change of twice-daily dose of antivirals to once-daily dosed had no significant changes on CD4 cell counts, viral load, or disease state in comparison with the twice-daily dose therapy for non-fasting patients. [22] The results of a comprehensive systematic review showed that fasting during Ramadan was associated with mild transient changes in the immune system, which return to the basal pre-Ramadan status shortly afterward. [23] Fasting also has some effects on pathogen defense mechanisms and adaptive/innate immune responses. ...
Article
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Almost all religions recommend periods of fasting. Many adult Muslims fast during the holy month of Ramadan each year. Ramadan fasting as a type of intermittent fasting is a non-pharmacological intervention refining the overall health. This year, Ramadan is coincided with coronavirus disease 2019 (COVID-19) outbreak making it one of the most challenging fasting periods for Muslims in the world. There is no solid direct evidence to suggest any adverse effect of Ramadan fasting during the COVID-19 pandemic in healthy individuals. However, there are exemptions in Ramadan Fasting and those at risk of health issues should not fast. COVID-19 is a new disease and there is limited studies concerning its risk factors. The purpose of this review was shedding more light on the potential mechanisms involved in influence of practice of fasting in all forms, including Ramadan fasting on the vulnerability to infection.
... A study that was conducted on Muslim patients infected with the human immunodeficiency virus (HIV) showed the absence of any negative impact of RIF on modifying the frequency of antiretroviral therapy. [34] In this study, fasting HIV patients on antiretroviral therapy were shifted from twice-daily dosed to once-daily dosed without significant changes in cluster differentiation of CD4 cell counts, viral load, or hematocrit levels in comparison with the twice-daily dose therapy in the non-fasting patients. ...
Article
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With the growing pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome (SARS)-related coronavirus (SARS-CoV-2) infection, a parallel growing interest arose concerning the preventive therapies, dietary behaviors, and remedies that may boost the immunity of against SARS-CoV-2 infection. Further, as Ramadan intermittent religious fasting that is practiced by about one and a half billion people throughout the globe is coincide this year with COVID-19 pandemic, a growing debate rose concerning the expected impact of fasting during Ramadan month and the associated dietary and lifestyle behaviors on the body's immunity against the pandemic infection. Published literature was searched to find out how intermittent fasting and its model of Ramadan affect the various aspects related to the body's immunity against microbial infections. Intermittent fasting was found to impact immunity by changing different related elements, including oxidative stress and inflammation, metabolism, body weight, and body composition. Dietary and lifestyle modifications during Ramadan month and their impact on immunity, such as water intake and hydration status, sleep duration and timing, caloric intake and mealtime, and social and religious activities, were addressed. Further research is warranted to figure out how intermittent fasting during Ramadan affects immunity against SARS-CoV-2 infection.
... A study that was conducted on Muslim patients infected with the human immunodeficiency virus (HIV) showed the absence of any negative impact of RIF on modifying the frequency of antiretroviral therapy. [34] In this study, fasting HIV patients on antiretroviral therapy were shifted from twice-daily dosed to once-daily dosed without significant changes in cluster differentiation of CD4 cell counts, viral load, or hematocrit levels in comparison with the twice-daily dose therapy in the non-fasting patients. ...
Article
Full-text available
With the growing pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome (SARS)-related coronavirus (SARS-CoV-2) infection, a parallel growing interest arose concerning the preventive therapies, dietary behaviors, and remedies that may boost the immunity of against SARS-CoV-2 infection. Further, as Ramadan intermittent religious fasting that is practiced by about one and a half billion people throughout the globe is coincide this year with COVID-19 pandemic, a growing debate rose concerning the expected impact of fasting during Ramadan month and the associated dietary and lifestyle behaviors on the body's immunity against the pandemic infection. Published literature was searched to find out how intermittent fasting and its model of Ramadan affect the various aspects related to the body's immunity against microbial infections. Intermittent fasting was found to impact immunity by changing different related elements, including oxidative stress and inflammation, metabolism, body weight, and body composition. Dietary and lifestyle modifications during Ramadan month and their impact on immunity, such as water intake and hydration status, sleep duration and timing, caloric intake and mealtime, and social and religious activities, were addressed. Further research is warranted to figure out how intermittent fasting during Ramadan affects immunity against SARS-CoV-2 infection.
... In HIV patients on antiretroviral therapy, once-daily compared to twice daily dose therapy in fasting patients was not shown to lead to any significant changes in cluster differentiation 4 cell counts, viral load, or hematocrit levels (41). ...
Article
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Ramadan is the ninth month of the Islamic lunar calendar and is observed by Muslims as a month of fasting. All Muslim adults are expected to fast; nevertheless certain subgroups, including sick, frail subjects, and pregnant women, among others, are exempted. Ramadan fasting has been shown to impact on body systems in different manners. The influence of Ramadan fasting on immune system regulation remains elusive; however, immune system changes, such as the modulation of body response to various infectious, stressful, and other harmful events, are of great interest during fasting. In this paper, we performed an extensive systematic literature review of different scholarly databases (ISI/Web of Science, Scopus, PubMed,/MEDLINE, Google Scholar, Directory of Open Access Journals, EbscoHOST, Scirus, Science Direct, the Cochrane Library, and ProQuest), using the following key words: “fasting,” “Ramadan,” “Islam,” and “immunity.” Conclusions drawn from these findings included: (1) Ramadan fasting has been shown to only mildly influence the immune system and the alterations induced are transient, returning to basal pre-Ramadan status shortly afterward. (2) Ramadan fasting during the second trimester of pregnancy was shown to be safe and did not result in negative fetal outcomes, or maternal oxidative status alterations. (3) In cardiac patients, Ramadan fasting can have beneficial effects including lipid profile improvement and alleviation of oxidative stress. (4) In asthmatic patients as well as in patients with human immunodeficiency virus/acquired immunodeficiency syndrome and autoimmune disorders, fasting was safe. (5) In psychiatric patients, such as those suffering from schizophrenia, fasting could increase immunologic markers. (6) Fasting Muslim athletes who maintain intensive training schedule during Ramadan showed fluctuations of immunologic markers.
... In HIV patients on antiretroviral therapy, once-daily compared to twice daily dose therapy in fasting patients was not shown to lead to any significant changes in cluster differentiation 4 cell counts, viral load, or hematocrit levels (41). ...
Chapter
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Ramadan is the ninth month of the Islamic lunar calendar, and is observed by Muslims as a month of fasting. The observance of Ramadan is considered one of the five pillars of Islam. During daylight hours, muslins abstain from eating any food, drinking any liquids, smoking and engaging in any sexual activity. All Muslim adults are expected to fast, nevertheless certain subgroups are exempted including the sick, frail and pregnant women among others. Although Ramadan is observed by approximately 1.8 billion Muslims worldwide, guidelines and protocols that address fasting concerns of patients are lacking. Moreover, the influence of Ramadan fasting on immune system regulation remains elusive. In this paper, we performed an extensive systematic literature review of ISI Web of Science (WoS), Scopus, MEDLINE/PubMed, Google Scholar, DOAJ, EbscoHOST, Scirus, Science Direct, the Cochrane Library and ProQuestusing using the following key words: "fasting," "Ramadan," "Islam," and "immunity." Conclusions drawn from these findings included: 1- Ramadan fasting has been shown to only mildly influence the immune system and the alterations are transient and return to basal pre-Ramadan status. 2- Ramadan fasting during the second trimester of pregnancy was shown to be safe and did not result in negative fetal outcomes, or maternal oxidative status alterations. 3- Ramadan fasting was documented to improve glycemic control and lipid profile, and had positive effects on patients suffering from metabolic disorders. 4- In cardiac patients, Ramadan fasting can have beneficial effects including lipid profile improvement and alleviation of oxidative stress. 5- Fasting athletes who maintain intensive training schedule show decreased performance due to high demand.
... Although Muslims who are ill are exempted from these regulations, many HIV-infected patients are reluctant to give up fasting, and this may have clinical implications (Güven, 2004). Habib et al. (2009) argued that a 4-h discrepancy in dosing time (i.e., taking drugs at 5AM and 9PM during Ramadan rather than at regular 12-h intervals) poses no risk of diminished drug efficacy for the patient, joining Yakasai et al. (2011) in arguing that ART must adapt to Islamic practices to be successful. Habib et al. (2010) found that HIV-positive Nigerians on the Hajj pilgrimage to Mecca in Saudi Arabia faced various challenges to ART and had poorer adherence than a comparable cohort of Muslims traveling domestically within Nigeria. ...
... Drug compliance during Ramadan generally tends to fall, as noticed by some scholars (68)(69)(70). ...
Article
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Ramadan fasting represents one of the five pillars of the Islam creed. Even though some subjects (among which patients) are exempted from observing this religious duty, they may be eager to share this particular moment of the year with their family and peers. However, there are no guidelines or standardized protocols that can help physicians to properly address the issue of patients with cancer fasting in Ramadan and correctly advising them. Moreover, in a more interconnected and globalized society, in which more and more Muslim patients live in the Western countries, this topic is of high interest also for the general practitioner. For this purpose, we carried out a systematic review on the subject. Our main findings are that: 1) very few studies have been carried out, addressing this issue; 2) evidence concerning quality of life and compliance to treatment is contrasting and scarce; 3) generally speaking, few patients ask their physicians whether they can safely fast or not. For these reasons, further research should be performed, given the relevance and importance of this topic.
... Muslim respondents were less likely to have accurate beliefs about benefits of ART/clinical care; a finding requiring further investigation. This result might reflect lower penetration of HIV-related information within the Muslim community or lower health-seeking behavior [45], possibly associated with concerns about ingestion of medication during the fasting month of Ramadan, when meal and sleeping times are altered [20,46]. ...
Article
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To better understand patient beliefs, which may influence adherence to HIV care and treatment, we examined three dimensions of beliefs among Ethiopian adults (n = 1177) initiating antiretroviral therapy (ART). Beliefs about benefits of ART/HIV clinical care were largely accurate, but few patients believed in the ability of ART to prevent sexual transmission and many thought Holy Water could cure HIV. Factors associated with lower odds of accurate beliefs included advanced HIV, lack of formal education, and Muslim religion (benefits of ART/clinical care); secondary or university education and more clinic visits (ART to prevent sexual transmission); and pregnancy and Orthodox Christian religion (Holy Water). Assessment of patient beliefs may help providers identify areas needing reinforcement. In this setting, counselors also need to stress the benefits of ART as prevention and that Holy Water should not be used to the exclusion of HIV care and ART.
... Drug compliance during Ramadan generally tends to fall, as noticed by some scholars [9][10][11]. Other authors, such as Zeeneldin and coauthors [12], however, have found that Ramadan fasting does not impair patient's adherence to treatment. ...
Chapter
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... Religious beliefs are complex cultural concepts and influenced patients' treatment with antiretrovirals in our sample of study; this has been reported elsewhere [19,41,42]. The Ethiopian Orthodox Church does not allow eating until midday every Wednesday and Friday, as well as in fasting seasons such as Flseta and Worha-Tsom. ...
Article
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Antiretroviral therapy (ART) has been life saving for hundreds of thousands of Ethiopians. With increased availability of ART in recent years, achievement of optimal adherence and patient retention are becoming the greatest challenges in the management of HIV/AIDS in Ethiopia. However, few studies have explored factors influencing medication adherence to ART and retention in follow-up care among adult Ethiopian HIV-positive patients, especially in the Amhara region of the country, where almost one-third of the country's ART is prescribed. The aim of this qualitative study was to collect such data from patients and healthcare providers in the Amhara region of Ethiopia. Semi-structured interviews were conducted with 24 patients, of whom 11 had been lost to follow-up and were non-persistent with ART. In addition, focus group discussions were performed with 15 ART nurses and 19 case managers. All interviews and focus groups were audio-recorded, transcribed, and coded for themes and patterns in Amharic using a grounded theory approach. The emergent concepts and categories were translated into English. Economic constraints, perceived stigma and discrimination, fasting, holy water, medication side effects, and dissatisfaction with healthcare services were major reasons for patients being non-adherent and lost to follow-up. Disclosure of HIV status, social support, use of reminder aids, responsibility for raising children, improved health on ART, and receiving education and counseling emerged as facilitators of adherence to ART. Improving adherence and retention requires integration of enhanced treatment access with improved job and food security. Healthcare providers need to be supported to better equip patients to cope with the issues associated with ART. Development of social policies and cooperation between various agencies are required to facilitate optimal adherence to ART, patient retention, and improved patient outcomes.
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Resumo Dentre os fatores associados à adesão à Terapia Antirretroviral (TARV) em pessoas vivendo com HIV, destaca-se a religiosidade/espiritualidade (R/E). O objetivo deste estudo foi apresentar as evidências disponíveis sobre a relação entre a dimensão da R/E e a adesão aos antirretrovirais. Realizou-se uma revisão integrativa de literatura com buscas nas bases/bibliotecas CINAHL, LILACS, PePSIC, PsycINFO, PubMed, SciELO, Scopus e Web of Science. Foram selecionados artigos empíricos publicados entre janeiro de 2008 e junho de 2019, sendo recuperados 49 estudos após a aplicação dos critérios de inclusão/exclusão. Encontraram-se associações positivas, negativas e neutras entre R/E e adesão à TARV, evidenciando que a R/E é uma dimensão psicossocial que pode ser preditora da adesão aos antirretrovirais. O sentido dessa influência, no entanto, ainda não é um consenso na literatura científica. Recomenda-se que essas influências sejam compreendidas a partir de elementos contextuais dessa população e não apenas de marcadores pessoais.
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Background: Muslim cancer patients and healthcare professionals face several challenges about the necessity of fasting and its possible side effects during the holy month of Ramadan. We aimed to study the prevalence of fasting among cancer patients during Ramadan and opinions of health care professionals about fasting among cancer patients in Iran. Methods: We conducted a cross-sectional survey during the Ramadan (July-August) in 2013. Participants were 620 cancer patients and, 187 healthcare professionals in several cancer clinics from different provinces of Iran. We used self-administered questionnaires and collected data from patients, and healthcare professionals to collect data. We performed descriptive analysis by using Stata statistical software. Results: Out of 620 patients who participated in this study, 428 (69%) were women. 76 (13%) of patients had fasted for at least a day during Ramadan and, from which 41 (7%) had fasted whole months because of their religious belief. Among patients who had refrained from fasting, the reasons were lack of sufficient physical strength (403, 65%), excessive thirst (141, 23%). 275 (44%) of participants had consulted with their physician about fasting. We found that more than 50% of physicians advised against fasting for patients following surgery, pre-operation, recent hospitalization, and consumption of oral or intravenous chemotherapy. Most of the healthcare professionals (68%) believed that cancer survivors could not fast even if they have no signs or symptoms or side-effects after the treatment. Conclusion: Although most of the cancer patients refrain from fasting, some cancer patients practice fasting and face challenges during the holy month of Ramadan in Iran. Most patients consult about fasting in Ramadan with their doctor who has variable opinions about this issue. Development of guidelines for healthcare professional and cancer patients regarding Ramadan fasting is needed.
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Background: Traditional, complimentary and alternative medicines (TCAMS) are increasingly being promoted by various Sub-Saharan African governments as a promising health resource in the control and amelioration of HIV/AIDS. The accessibility and cultural acceptability of both herbal medicines and faith healing and the scarcity of antiretroviral treatment (ART) in many communities have made them a favorite treatment option for people living with HIV (PLHIV). Objectives: This paper reviews the literature on the utilization and potential contribution of plant medicines and faith healing for treatment of HIV and opportunistic infections in Ethiopia. Methods: The published and unpublished literature on TCAM, faith healing and HIV/AIDS was reviewed from online sources and several bibliographies. Results and Discussion: Several studies indicate that both plant medicines and faith healing are widely used in Ethiopia for the treatment of HIV-related illness due to the long history, prevailing illness perceptions and religious beliefs. Primary phytochemical tests have identified several plant species with anti-HIV, anti-mycobacterial and anti-protozoal properties but their development as safe and effective medicines will require extensive toxicological and pharmacological drug interaction studies. Increasing evidence of positive outcomes of faith healing involving holy water and prayer reported by PLHIV, particularly spiritual and mental benefits, has potential application for chronic patient care but needs further study. Conclusion and Recommendations: Prevailing and evolving indigenous practices indicate the need for the implementation of appropriate policies and guidelines for the development of safe and effective herbal medicines and the integration of traditional medicine into the health services. Several areas requiring further study are identified.
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Introduction Clinical outcome is an important determinant of programme success. This study aims to evaluate patients’ baseline characteristics as well as level of care associated with lost to follow-up (LTFU) and mortality of patients on antiretroviral treatment (ART). Methods Retrospective cohort study using routine service data of adult patients initiated on ART in 2007 in 10 selected hospitals in Nigeria. We captured data using an electronic medical record system and analyzed using Stata. Outcome measures were probability of being alive and retained in care at 12, 24 and 36 months on ART. Potential predictors associated with time to mortality and time to LTFU were assessed using competing risks regression models. Results After 12 months on therapy, 85% of patients were alive and on ART. Survival decreased to 81.2% and 76.1% at 24 and 36 months, respectively. Median CD4 count for patients at ART start, 12, 18 and 24 months were 152 (interquartile range, IQR: 75 to 242), 312 (IQR: 194 to 450), 344 (IQR: 227 to 501) and 372 (IQR: 246 to 517) cells/µl, respectively. Competing risk regression showed that patients’ baseline characteristics significantly associated with LTFU were male (adjusted sub-hazard ratio, sHR=1.24 [95% CI: 1.08 to 1.42]), ambulatory functional status (adjusted sHR=1.25 [95% CI: 1.01 to 1.54]), World Health Organization (WHO) clinical Stage II (adjusted sHR=1.31 [95% CI: 1.08 to 1.59]) and care in a secondary site (adjusted sHR=0.76 [95% CI: 0.66 to 0.87]). Those associated with mortality include CD4 count <50 cells/µl (adjusted sHR=2.84 [95% CI: 1.20 to 6.71]), WHO clinical Stage III (adjusted sHR=2.67 [95% CI: 1.26 to 5.65]) and Stage IV (adjusted sHR=5.04 [95% CI: 1.93 to 13.16]) and care in a secondary site (adjusted sHR=2.21 [95% CI: 1.30 to 3.77]). Conclusions Mortality was associated with advanced HIV disease and care in secondary facilities. Earlier initiation of therapy and strengthening systems in secondary level facilities may improve retention and ultimately contribute to better clinical outcomes.
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Annual fasting during the month of Ramadan is observed in Muslim countries, some of which have widespread HIV infection. We studied treatment adherence and customary practices among 142 fasting 'FT' and 101 non-fasting 'NFT' patients on anti-retroviral therapy (ART) in Nigeria. Adherence on ART among FT and NFT patients was similar during Ramadan, 96% and 98%, and ever since commencement of ART, 80% and 88%, respectively. FT patients altered their typical daily behaviors by advancing morning and delaying evening doses thereby prolonging dosing intervals, eating heavier meals pre-dawn and on breakfast at sunset (78%), and changing or reducing their sleeping and waking times (40%). This preliminary study suggests that adherence and drug taking frequency appear uncompromised in FT HIV infected patients on ARVs.
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Demands for the introduction of antiretroviral therapy into Africa have been growing over the past few years. On the face of it, the availability of antiretroviral therapy at what seems to be an affordable price is good news. The treatment can produce dramatic clinical improvements in people with symptomatic HIV disease and, when used optimally, can delay the progression of disease. However, the potential short term gains from reducing individual morbidity and mortality may be far outweighed by the potential for the long term spread of drug resistance if the experience of adherence to treatment for tuberculosis is repeated. Without due forethought and planning, antiretroviral therapy is likely to be introduced to Africa in a random and haphazard way, with inconsistent prescribing practices and poor monitoring of therapy and adherence. This risks the rapid development and transmission of drug resistance.
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Lopinavir/ritonavir (LPV/r)-dosed twice daily has demonstrated durable efficacy in antiretroviral-naive and protease inhibitor (PI) -experienced patients. Study M05-730 compared LPV/r tablets dosed once daily vs. twice daily in antiretroviral-naive subjects. Six hundred sixty-four subjects were randomized to LPV/r soft gel capsules (SGCs) once daily, SGC twice daily, tablets once daily, and tablets twice daily, all with tenofovir and emtricitabine once daily. At week 8, all SGC-treated subjects were switched to tablets, maintaining randomized dose frequency. The primary efficacy analysis used an intent-to-treat, noncompleter = failure approach to assess noninferiority of the LPV/r once-daily group compared with the twice-daily group. At week 48, 77% of once-daily-dosed subjects vs. 76% of twice-daily-dosed subjects had HIV-1 RNA <50 copies per milliliter (P = 0.715; 95% confidence interval for difference: 5% to 8%). Response rates were numerically similar between the once-daily and twice-daily groups among subjects with baseline HIV-1 RNA > or = 100,000 copies per milliliter (75% once daily vs. 74.6% twice daily; P > 0.999) or when analyzed by baseline CD4+ T-cell count (<50, 50 to <200, and > or = 200 cells/mm3). Rates of discontinuation and adverse events, including diarrhea, were similar between arms. Among subjects with protocol-defined virologic rebound through week 48, no new PI resistance mutations were detected. At 48 weeks, the antiviral response in the LPV/r once-daily group was noninferior to the twice-daily group when coadministered with tenofovir and emtricitabine in antiretroviral-naive subjects. Efficacy was comparable between the once-daily and twice-daily groups regardless of baseline HIV-1 RNA or CD4+ T-cell count. Safety and tolerability of once-daily and twice-daily dosing was also comparable. No new PI resistance mutations were detected upon virologic rebound.
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The use of antiretroviral therapy has improved the quality of life and has increased the survival of HIV-infected individuals. However, the rapid rate of virus mutation and subsequent emergence of drug-resistant HIV variants threaten the longer-term efficacy of HIV treatment. The initial regimen provides the greatest chance for lasting suppression of viral load. Appropriate selection of the initial antiretroviral regimen is critical. The growing number of drug classes allows healthcare providers to individualize treatment regimens. Factors influencing the selection of first-line therapy include baseline viral load and CD4 count, drug pharmacokinetics, potency, tolerability, safety, resistance and salvageability. Characteristics likely to affect adherence, such as regimen complexity and pill burden, must also be considered, as poor adherence is the most common cause of treatment failure. The selection of the initial regimen requires consideration of several factors. Drugs from new classes as well as new drugs from existing classes with favorable resistance and side effect profiles are in various stages of development. Many of these drugs will enhance available options for initial therapy.
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Diurnal variation in plasma concentrations of nelfinavir and ritonavir has previously been described. Plasma concentrations of 29 pharmacokinetic profiles with indinavir, amprenavir and saquinavir were evaluated, and a statistically significant median difference of 57.6% was found between morning and evening, with the morning C-through being higher than the evening C-through.Consequently, a change in dosing intervals might result in more balanced plasma protease inhibitor concentrations, thereby decreasing toxicity and the risk of virological failure.
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To compare the pharmacokinetics of lopinavir/ritonavir (LPV/r) 800/200 mg administered once daily in the morning compared with the evening. This was a randomized, two-way, cross-over study in HIV+ subjects. In each subject the pharmacokinetics of each drug were characterized after 2 weeks of LPV/r 800/200 mg administered once daily at 08.00 h and 19.00 h. On study days, LPV/r was taken with a standardized meal (800 kCal, 25% from fat) after fasting for at least 5 h. LPV/r concentrations were measured by LC-MS/MS, and the data were analyzed by noncompartmental pharmacokinetic analysis. Fourteen subjects completed the study (all men, mean age/weight 44 year/81 kg). The median (interquartile range) LPV AUC(0,24 h), maximum plasma concentration (C(max)) and concentration at the end of the dosing interval (C(24 h)) after am and pm dosing was, respectively, 143 (116-214) mg l(-1) h, 12.8 (10.3-17.2) mg l(-1), 1.34 (0.58-3.25) mg l(-1), and 171 (120-232) mg l(-1) h, 12.9 (8.22-16.3) mg l(-1), 1.15 (0.59-1.98) mg l(-1). The geometric mean ratio (GMR, am : pm) and 95% CI of the LPV AUC(0,24 h), C(max), and C(24 h) was 0.91 (0.79, 1.06), 1.11 (0.94, 1.32), and 1.19 (0.72, 1.96), respectively. The median ritonavir C(max) after am and pm dosing was 1.05 and 0.90 mg l(-1), respectively. The GMR (95% CI) of the RTV AUC(0,24 h), C(max), and C(24 h) was 0.93 (0.80, 1.08), 1.27 (1.00, 1.63), and 1.04 (0.68, 1.60), respectively. Administration of LPV/r in a once-daily regimen was generally well tolerated. No differences were observed in the pharmacokinetics of LPV/r after am or pm dosing with food, which suggests that this once daily combination, can be taken in the morning or evening. Such flexibility in dosing may improve adherence.