Browsing by Author "Merry, Concepta"
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Item Antiretroviral therapy in developing countries: pharmacologic considerations(Current Opinion in HIV and AIDS, 2008) Lamordea, Mohammed; Byakika-Kibwika, Pauline; Merry, ConceptaThe roll-out of antiretroviral drugs in developing countries has become the largest and most ambitious pharmacology project in history. About 2 million people in developing countries now have access to life-saving antiretrovirals, approximately 28% of those in need [1]. Among treated patients, comparable response rates to those seen in western countries have been demonstrated in the first few years of antiretroviral therapy [2]. It is important to sustain these successes by the efficient use of acceptable, efficacious and minimally toxic regimens.Item Artemether-Lumefantrine Combination Therapy for Treatment of Uncomplicated Malaria: The Potential for Complex Interactions with Antiretroviral Drugs in HIV-Infected Individuals(Malaria Research and Treatment, 2011) Byakika-Kibwika, Pauline; Lamorde, Mohammed; Mayanja-Kizza, Harriet; Khoo, Saye; Merry, Concepta; Van geertruyden, Jean-Pierre Van geertruyden4Treatment of malaria in HIV-infected individuals receiving antiretroviral therapy (ART) poses significant challenges. Artemetherlumefantrine (AL) is one of the artemisisnin-based combination therapies recommended for treatment of malaria. The drug combination is highly efficacious against sensitive and multidrug resistant falciparum malaria. Both artemether and lumefantrine aremetabolized by hepatic cytochrome P450 (CYP450) enzymes which metabolize the protease inhibitors (PIs) and nonnucleoside reverse transcriptase inhibitors (NNRTIs) used forHIV treatment. Coadministration of NNRTIs and PIs with AL could potentially cause complex pharmacokinetic drug interactions. NNRTI by inducing CYP450 3A4 enzyme and PIs by inhibiting CYP450 3A4 enzymes could influence both artemether and lumefantrine concentrations and their active metabolites dihydroartemisinin and desbutyl-lumefantrine, predisposing patients to poor treatment response, toxicity, and risk for development of resistance. There are scanty data on these interactions and their consequences. Pharmacokinetic studies to evaluate these interactions in the target populations are urgently needed.Item Building clinical pharmacology laboratory capacity in low- and middle-income countries: Experience from Uganda(African Journal of Laboratory Medicine, 2023) Omali, Denis; Buzibye, Allan; Kwizera, Richard; Byakika-Kibwika, Pauline; Namakula, Rhoda; Matovu, Joshua; Mbabazi, Olive; Mande, Emmanuel; Sekaggya-Wiltshire, Christine; Nakanjako, Damalie; Gutteck, Ursula; McAdam, Keith; Easterbrook, Philippa; Kambugu, Andrew; Fehr, Jan; Castelnuovo, Barbara; Manabe, Yukari C.; Lamorde, Mohammed; Mueller, Daniel; Merry, ConceptaResearch and clinical use of clinical pharmacology laboratories are limited in low- and middle-income countries. We describe our experience in building and sustaining laboratory capacity for clinical pharmacology at the Infectious Diseases Institute, Kampala, Uganda. Intervention: Existing laboratory infrastructure was repurposed, and new equipment was acquired. Laboratory personnel were hired and trained to optimise, validate, and develop in-house methods for testing antiretroviral, anti-tuberculosis and other drugs, including 10 high-performance liquid chromatography methods and four mass spectrometry methods. We reviewed all research collaborations and projects for which samples were assayed in the laboratory from January 2006 to November 2020. We assessed laboratory staff mentorship from collaborative relationships and the contribution of research projects towards human resource development, assay development, and equipment and maintenance costs. We further assessed the quality of testing and use of the laboratory for research and clinical care. Lessons learnt: Fourteen years post inception, the clinical pharmacology laboratory had contributed significantly to the overall research output at the institute by supporting 26 pharmacokinetic studies. The laboratory has actively participated in an international external quality assurance programme for the last four years. For clinical care, a therapeutic drug monitoring service is accessible to patients living with HIV at the Adult Infectious Diseases clinic in Kampala, Uganda. Recommendations: Driven primarily by research projects, clinical pharmacology laboratory capacity was successfully established in Uganda, resulting in sustained research output and clinical support. Strategies implemented in building capacity for this laboratory may guide similar processes in other low- and middle-income countries.Item Cardiac Conduction Safety during Coadministration of Artemether-Lumefantrine and Lopinavir/Ritonavir in HIV-Infected Ugandan Adults(Chemotherapy research and practice, 2011) Byakika-Kibwika, Pauline; Lamorde, Mohammed; Lwabi, Peter; Nyakoojo, Wilson B.; Okaba-Kayom, Violet; Mayanja-Kizza, Harriet; Boffito, Marta; Katabira, Elly; Back, David; Khoo, Saye; Merry, ConceptaWe aimed to assess cardiac conduction safety of coadministration of the CYP3A4 inhibitor lopinavir/ritonavir (LPV/r) and the CYP3A4 substrate artemether-lumefantrine (AL) in HIV-positive Ugandans. Methods. Open-label safety study of HIV positive adults administered single-dose AL (80/400 mg) alone or with LPV/r (400/100 mg). Cardiac function was monitored using continuous electrocardiograph (ECG). Results. Thirty-two patients were enrolled; 16 taking LPV/r -based ART and 16 ART naıve. All took single dose AL. No serious adverse events were observed. ECG parameters in milliseconds remained within normal limits. QTc measurements did not change significantly over 72 hours although were higher in LPV/r arm at 24 (424 versus 406; P = .02) and 72 hours (424 versus 408; P = .004) after AL intake. Conclusion. Coadministration of single dose of AL with LPV/r was safe; however, safety of six-dose AL regimen with LPV/r should be investigated.Item Drug–drug interactions between antiretrovirals and drugs used in the management of neglected tropical diseases: important considerations in the WHO 2020 Roadmap and London Declaration on Neglected Tropical Diseases(Lippincott Williams & Wilkins, 2020) Sedena, Kay; Khooa, Saye; Backa, David; Prevattb, Natalie; Lamorde, Mohammed; Byakika-Kibwika, Pauline; Mayito, Jonathan; Ryan, Mairin; Merry, ConceptaTheWHO2020 Roadmap on neglected tropical diseases (NTDs) and the 2012 London Declaration on NTDs aim to ‘enable more than a billion people suffering from neglected tropical diseases to lead healthier and more productive lives’ and ‘chart a new course towards health and sustainability’. Two out of the five strategies for the prevention, control, elimination and eradication of NTDs set out in the WHO 2020 Roadmap involve sustaining and expanding existing drug donation programs to meet demand through to 2020. To this end, the governments of the US, UK and United Arab Emirates, theWorld Bank and the Bill and Melinda Gates Foundation along with 13 pharmaceutical companies, have announced the largest collaborative effort to date to combat NTDs.Item Efavirenz- but not nevirapine-based antiretroviral therapy decreases exposure to the levonorgestrel released from a sub-dermal contraceptive implant(Journal of the International AIDS Society, 2014) Kimberly, Scarsi; Lamorde, Mohammed; Darin, Kristin; Dilly Penchala, Sujan; Else, Laura; Nakalema, Shadia; Byakika-Kibwika, Pauline; Khoo, Saye; Cohn, Susan; Merry, Concepta; Back, DavidSub-dermal hormone implants, such as levonorgestrel (LNG), are a safe and desirable form of long-acting contraception, but their use among HIV-positive women on antiretroviral therapy (ART) may be compromised given the potential for a cytochrome P450 3A-mediated drug-drug interaction. Our study aimed to characterize the pharmacokinetics of LNG released from a sub-dermal implant over six months in HIV-positive Ugandan women on nevirapine (NVP)- or efavirenz (EFV)-based ART.Item The Effect of Gene Variants on Levonorgestrel Pharmacokinetics when Combined with Antiretroviral Therapy containing Efavirenz or Nevirapine(Clinical Pharmacology & Therapeutics, 2017) Neary, Megan; Lamorde, Mohammed; Olagunju, Adeniyi; Darin, Kristin M.; Merry, Concepta; Byakika-Kibwika, Pauline; Back, David J.; Siccardi, Marco; Owen, Andrew; Scarsi, Kimberly K.Reduced levonorgestrel concentrations from the levonorgestrel contraceptive implant was previously seen when given concomitantly with efavirenz. We sought to assess whether single nucleotide polymorphisms (SNPs) in genes involved in efavirenz and nevirapine metabolism were linked to these changes in levonorgestrel concentration. SNPs in CYP2B6, CYP2A6, NR1I2 and NR1I3 were analysed. Associations of participant demographics and genotype with levonorgestrel pharmacokinetics were evaluated in HIV-positive women using the levonorgestrel implant plus efavirenz- or nevirapine-based ART, in comparison to ART-naïve women using multivariate linear regression. Efavirenz group: CYP2B6 516G>T was associated with lower levonorgestrel log10 Cmax and log10 AUC. CYP2B6 15582C>T was associated with lower log10 AUC. Nevirapine group: CYP2B6 516G>T was associated with higher log10 Cmax and lower log10 Cmin. Pharmacogenetic variations influenced subdermal levonorgestrel pharmacokinetics in HIV-positive women, indicating that the magnitude of the interaction with non-nucleoside reverse transcriptase inhibitors (NNRTIs) is influenced by host genetics.Item Global patient safety and antiretroviral drug–drug interactions in the resource-limited setting(Journal of Antimicrobial Chemotherapy, 2013) Seden, Kay; Khoo, Saye H.; Back, David; Byakika-Kibwika, Pauline; Lamorde, Mohammed; Ryan, Mairin; Merry, ConceptaScale-up of HIV treatment services may have contributed to an increase in functional health facilities available in resource-limited settings and an increase in patient use of facilities and retention in care. As more patients are reached with medicines, monitoring patient safety is increasingly important. Limited data from resource limited settings suggest that medication error and antiretroviral drug–drug interactions may pose a significant risk to patient safety. Commonly cited causes of medication error in the developed world include the speed and complexity of the medication use cycle combined with inadequate systems and processes. In resource-limited settings, specific factors may contribute, such as inadequate human resources and high disease burden. Management of drug–drug interactions may be complicated by limited access to alternative medicines or laboratory monitoring. Improving patient safety by addressing the issue of antiretroviral drug–drug interactions has the potential not just to improve healthcare for individuals, but also to strengthen health systems and improve vital communication among healthcare providers and with regulatory agencies.Item An Individual Participant Data Population Pharmacokinetic Meta-analysis of Drug-Drug Interactions between Lumefantrine and Commonly Used Antiretroviral Treatment(Antimicrobial agents and chemotherapy, 2020) Francis, Jose; Barnes, Karen I.; Workman, Lesley; Kredo, Tamara; Vestergaard, Lasse S.; Hoglund, Richard M.; Byakika-Kibwika, Pauline; Lamorde, Mohammed; Walimbwa, Stephen I.; Chijioke-Nwauche, Ifeyinwa; Sutherland, Colin J.; Merry, Concepta; Dentia, PaoloTreating malaria in HIV-coinfected individuals should consider potential drug-drug interactions. Artemether-lumefantrine is the most widely recommended treatment for uncomplicated malaria globally. Lumefantrine is metabolized by CYP3A4, an enzyme that commonly used antiretrovirals often induce or inhibit. A population pharmacokinetic meta-analysis was conducted using individual participant data from 10 studies with 6,100 lumefantrine concentrations from 793 nonpregnant adult participants (41% HIV-malaria-coinfected, 36% malaria-infected, 20% HIV-infected, and 3% healthy volunteers). Lumefantrine exposure increased 3.4-fold with coadministration of lopinavirritonavir- based antiretroviral therapy (ART), while it decreased by 47% with efavirenzbased ART and by 59% in the patients with rifampin-based antituberculosis treatment. Nevirapine- or dolutegravir-based ART and malaria or HIV infection were not associated with significant effects. Monte Carlo simulations showed that those on concomitant efavirenz or rifampin have 49% and 80% probability of day 7 concentrations 200 ng/ml, respectively, a threshold associated with an increased risk of treatment failure. The risk of achieving subtherapeutic concentrations increases with larger body weight. An extended 5-day and 6-day artemether-lumefantrine regimen is predicted to overcome these drug-drug interactions with efavirenz and rifampin, respectively.Item Intravenous artesunate plus Artemisnin based Combination Therapy (ACT) or intravenous quinine plus ACT for treatment of severe malaria in Ugandan children: a randomized controlled clinical trial(BMC infectious diseases, 2017) Byakika-Kibwika, Pauline; Achan, Jane; Lamorde, Mohammed; Karera-Gonahasa, Carine; Kiragga, Agnes N.; Mayanja-Kizza, Harriet; Kiwanuka, Noah; Nsobya, Sam; Talisuna, Ambrose O.; Merry, ConceptaSevere malaria is a medical emergency associated with high mortality. Adequate treatment requires initial parenteral therapy for fast parasite clearance followed by longer acting oral antimalarial drugs for cure and prevention of recrudescence. In a randomized controlled clinical trial, we evaluated the 42-day parasitological outcomes of severe malaria treatment with intravenous artesunate (AS) or intravenous quinine (QNN) followed by oral arteItem Lopinavir/ritonavir significantly influences pharmacokinetic exposure of artemether/lumefantrine in HIV-infected Ugandan adults(Journal of antimicrobial chemotherapy, 2012) Byakika-Kibwika, Pauline; Lamorde, Mohammed; Okaba-Kayom, Violet; Mayanja-Kizza, Harriet; Katabira, Elly; Hanpithakpong, Warunee; Pakker, Nadine; Dorlo, Thomas P. C.; Tarning, Joel; Lindegardh, Niklas; Vries, Peter J. de; Back, David; Khoo, Saye; Merry, ConceptaTreatment of HIV/malaria-coinfected patients with antiretroviral therapy (ART) and artemisininbased combination therapy has potential for drug interactions. We investigated the pharmacokinetics of artemether, dihydroartemisinin and lumefantrine after administration of a single dose of 80/480 mg of artemether/ lumefantrine to HIV-infected adults, taken with and without lopinavir/ritonavir. Methods: A two-arm parallel study of 13 HIV-infected ART-naive adults and 16 HIV-infected adults stable on 400/100 mg of lopinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors (ClinicalTrials.gov, NCT 00619944). Each participant received a single dose of 80/480 mg of artemether/lumefantrine under continuous cardiac function monitoring. Plasma concentrations of artemether, dihydroartemisinin and lumefantrine were measured.Item Lower artemether, dihydroartemisinin and lumefantrine concentrations during rifampicin-based tuberculosis treatment(Lippincott Williams & Wilkins, 2013) Lamorde, Mohammed; Byakika-Kibwika, Pauline; Mayito, Jonathan; Nabukeera, Lillian; Ryan, Mairin; Hanpithakpong, Warunee; Lefe`vree, Gilbert; Backf, David J.; Khoof, Saye H.; Merry, ConceptaMalaria and tuberculosis (TB) are co-endemic in many parts of the developing world. Although malaria transmission may occur throughout the duration of TB treatment, drug data between antimalarial drugs and anti- TB drugs are limited [1]. The WHO recommends artemisinin combination therapies (ACTs) for uncomplicated malaria caused by Plasmodium falciparum, whereas for TB treatment, the WHO recommends rifampicinbased therapy [2,3]. However, no data exist on drug interactions between ACTs and rifampicin-based TB treatment.Item Medicinal plants used by traditional medicine practitioners for the treatment of HIV/AIDS and related conditions in Uganda(Journal of ethnopharmacology, 2010) Lamorde, Mohammed; Tabuti, John R.S.; Obua, Celestino; Kukunda-Byobona, Collins; Lanyero, Hindam; Byakika-Kibwika, Pauline; Bbosa, Godfrey S.; Lubega, Aloysius; Ogwal-Okeng, Jasper; Ryan, Mairin; Waako, Paul J.; Merry, ConceptaIn Uganda, there are over one million people with HIV/AIDS. When advanced, this disease is characterized by life-threatening opportunistic infections. As the formal health sector struggles to confront this epidemic, new medicines from traditional sources are needed to complement control efforts. This study was conducted to document herbal medicines used in the treatment of HIV/AIDS and related opportunistic infections, and to document the existing knowledge, attitudes and practices related to HIV/AIDS recognition, control and treatment in Sembabule, Kamuli, Kabale and Gulu districts in Uganda.Item Nevirapine pharmacokinetics when initiated at 200 mg or 400 mg daily in HIV-1 and tuberculosis co-infected Ugandan adults on rifampicin(Journal of Antimicrobial Chemotherapy, 2011) Lamorde, Mohammed; Byakika-Kibwika, Pauline; Okaba-Kayom, Violet; Ryan, Mairin; Coakley, Peter; Boffito, Marta; Namakula, Rhoda; Kalemeera, Francis; Colebunders, Robert; Back, David; Khoo, Saye; Merry, ConceptaIn resource-poor countries, HIV and tuberculosis (TB) co-infection results in significant morbidity and mortality. Co-treatment is recommended by the WHO;1 however, drug interactions are common between anti-TB regimens containing rifampicin and antiretroviral drugs. In these settings, rifampicin is a key drug for TB treatment because alternative rifamycins are more expensive and usually not available in public TB control programmes. Similarly, for HIV treatment, only a limited number of antiretroviral drugs are routinely used. The problems arising from limited drug options are compounded by the wide use of fixed-dose combination (FDC) formulations for both diseases. When these formulations are used, drug substitutions are not possible and dose adjustments are usually difficult.Item Pharmacokinetic interactions between antiretroviral drugs and herbal medicines(British Journal of Hospital Medicine, 2012) Lamorde, Mohammed; Byakika-Kibwika, Pauline; Merry, ConceptaAntiretroviral therapy has improved the prognosis of patients with human immunodeficiency virus (HIV) infection (Palella et al, 1998). Currently, antiretroviral therapy is the only treatment that has demonstrated efficacy for HIV. However, herbal medicines are widely used by HIV patients to complement conventional therapy. In a cross-sectional study in the UK, 61% of patients on antiretroviral therapy had used herbal medicines or supplements (Ladenheim et al, 2008) while in a South African study, 30% of patients admitted herbal medicine use (Peltzer et al, 2008). In western countries, commonly used herbal medicines include garlic, echinacea, aloe, St John’s wort and ginseng. These remedies are widely available and accessible without prescription in many countries. Therefore, cotreatment with antiretroviral therapy may occur, even without the knowledge of HIV clinicians (Peltzer et al, 2008).Item Pharmacokinetics and pharmacodynamics of intravenous artesunate during severe malaria treatment in Ugandan adults(Malaria Journal, 2012) Byakika-Kibwika, Pauline; Lamorde, Mohammed; Mayito, Jonathan; Nabukeera, Lillian; Mayanja-Kizza, Harriet; Katabira, Elly; Hanpithakpong, Warunee; Obua, Celestino; Pakker, Nadine; Lindegardh, Niklas; Tarning, Joel; de Vries, Peter J.; Merry, ConceptaSevere malaria is a medical emergency with high mortality. Prompt achievement of therapeutic concentrations of highly effective anti-malarial drugs reduces the risk of death. The aim of this study was to assess the pharmacokinetics and pharmacodynamics of intravenous artesunate in Ugandan adults with severe malaria. Methods: Fourteen adults with severe falciparum malaria requiring parenteral therapy were treated with 2.4 mg/kg intravenous artesunate. Blood samples were collected after the initial dose and plasma concentrations of artesunate and dihydroartemisinin measured by solid-phase extraction and liquid chromatography-tandem mass spectrometry. The study was approved by the Makerere University Faculty of Medicine Research and Ethics Committee (Ref2010-015) and Uganda National Council of Science and Technology (HS605) and registered with ClinicalTrials.gov (NCT01122134).Item Steady-state pharmacokinetics of lopinavir plus ritonavir when administered under different meal conditions in HIV-infected Ugandan adults(Journal of acquired immune deficiency syndromes, 2012) Lamorde, Mohammed; Byakika-Kibwika, Pauline; Boffito, Marta; Nabukeera, Lillian; Mayito, Jonathan; Ogwal- Okeng, Jasper; Tjia, John; Back, David; Khoo, Saye; Ryan, Mairin; Merry, ConceptaWe investigated the effect of food on the steady-state pharmacokinetics of lopinavir and ritonavir in 12 Ugandan patients receiving lopinavir co-formulated with ritonavir (LPV/r) tablets using a cross-over design. Intensive pharmacokinetic sampling was performed seven days apart following LPV/r dosing under moderate fat, high fat and fasted meal conditions. Lopinavir and ritonavir concentrations were determined by liquid chromatography and tandem mass spectrometry. Compared to the fasted state, a high fat meal reduced lopinavir and ritonavir area under the curve (AUC) by 14% and 29%, respectively. With a moderate fat meal, AUC for both drugs was similar to the fasted state.Item Steady-State Pharmacokinetics of Rilpivirine under Different Meal Conditions in HIV-1-Infected Ugandan Adults(Journal of Antimicrobial Chemotherapy, 2015) Lamorde, Mohammed; Walimbwa, Stephen; Kibwika, Pauline Byakika; Katwere, Michael; Mukisa, Lillian; Sempa, Joseph B.; Else, Laura; Back, David J.; Khoo, Saye H.; Merry, ConceptaTo investigate the effect of food on the steady-state pharmacokinetics of rilpivirine when administered as a fixed-dose combination tablet containing tenofovir disoproxil fumarate, emtricitabine plus rilpivirine (TDF/FTC/RPV) in HIV-1-infected Ugandan patients.This was an open-label, three-period, longitudinal pharmacokinetic study with patients serving as their own controls. Fifteen consenting and virologically suppressed HIV-1-infected adults were switched from an efavirenz-based regimen to TDF/FTC/RPV for 56 days. Enrolled patients underwent 24 h blood sampling with TDF/FTC/RPV dosing in the fasted state (day 42), with a low-fat meal (11 g of fat/353 kcal, day 49) and with a moderate-fat meal (19 g of fat/589 kcal, day 56; reference). A viral load assessment was performed on day 56.Rilpivirine AUC0–24 was significantly decreased by 16% (geometric mean ratio, 90% CI: 0.84, 0.73–0.96) during administration in the fasted state when compared with AUC0–24 during administration with a moderate-fat meal. Similarly, rilpivirine C24 was significantly decreased by 21% (0.79, 0.65–0.97) in the fasted state compared with a moderate-fat meal. Pharmacokinetic parameters were unchanged during administration with a low-fat meal, except for C24, which was significantly increased by 15% (1.15, 1.01–1.31) when compared with the moderate-fat meal. Rilpivirine Cmax was similar under the three meal conditions. Virological suppression was unchanged at the end of the study.A food effect was observed for steady-state pharmacokinetic parameters of rilpivirine (AUC0–24 and C24) when TDF/FTC/RPV was administered in the fasted state compared with the moderate-fat meal. The TDF/FTC/RPV formulation can be administered with either a low-fat or moderate-fat meal.Item Steady-state pharmacokinetics of rilpivirine under different meal conditions in HIV-1-infected Ugandan adults(Journal of Antimicrobial Chemotherapy, 2015) Lamorde, Mohammed; Walimbwa, Stephen; Byakika-Kibwika, Pauline; Katwere, Michael; Mukisa, Lillian; Sempa, Joseph B.; Else, Laura; Back, David J.; Khoo, Saye H.; Merry, ConceptaOver 24 million people are living with HIV in sub-Saharan Africa, the region that also experiences the highest prevalence of food insecurity. ART is the cornerstone for management of HIV, but few treatment options are available in African countries. The WHO recommends that first-line antiretroviral regimens should include one of two NNRTIs, either efavirenz or nevirapine. Although these drugs are efficacious, some patients may experience treatment-limiting toxicities, drug resistance or drug interactions with these agents; hence the need for more treatment options.Item Suboptimal Nevirapine Steady-State Pharmacokinetics During Intrapartum Compared With Postpartum in HIV-1–Seropositive Ugandan Women(Journal of acquired immune deficiency syndromes, 2010) Lamorde, Mohammed; Byakika-Kibwika, Pauline; Okaba-Kayom, Violet; Flaherty, John P.; Boffito, Marta; Namakula, Rhoda; Ryan, Mairin; Nakabiito, Clemensia; Back, David J.; Khoo, Saye; Merry, Concepta; Scarsi, Kimberly K.Conflicting data exist regarding the effect of pregnancy on steady-state nevirapine pharmacokinetics (PK), although steady-state nevirapine concentrations during pregnancy have never been characterized in sub-Saharan Africa. Methods: This was a longitudinal intensive PK study in Ugandan pregnant women receiving nevirapine-based antiretroviral therapy. Participants underwent intensive 12-hour PK sampling during the second trimester (T2; n = 4), third trimester (T3; n = 15) and 6 weeks postpartum (PP; n = 15). HIV-1 RNAwas performed within 2weeks of each visit. Nevirapine C12 above 3000 ng/mLwas classified as optimal based on the suggested value for therapeutic drug monitoring.