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TLD ARV side effects

Ab 50€ portofrei, 48h-Versand, 100 Tage Retoure, über 1 Mio. glückliche Kunden Schnell & einfach Preise vergleichen für Statins Side Effects von geprüften Onlineshops! Finde die besten Angebote für Statins Side Effects und spare Zeit & Geld • TLD is better tolerated with fewer side effects and lower overall incidence of adverse events (<5%) compared to EFV.2 • TLD is associated with fewer drug interactions. This means that compared to other regimens, it is easier to administer Because TLD is better tolerated and has fewer side effects Optimization of current antiretroviral drug regimens is a critical component to support country A few European cohorts have detected an increased occurrence of central nervous system side effects in people over 60 years of age, those using abacavir (ABC) and women [12-14]. TLD use and clinical outcomes from programmatic data in selected.

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  1. Adverse effects have been reported with all antiretroviral (ARV) drugs and were among the most common reasons for switching or discontinuing therapy, and for medication nonadherence in the earlier era of combination antiretroviral therapy (ART). 1 Fortunately, newer ARV regimens are associated with fewer serious and intolerable adverse effects.
  2. potential risks of TLD with their healthcare provider to make an informed choice. • To improve the lives of people living with HIV. • To provide rapid viral suppression. • High genetic barrier to resistance. • Fewer side effects. • Smaller tablet - easy to take. TLD doesn't replace condoms - use a condom consistently and correctl
  3. Some of the most common long term side effects of HIV treatment include: Lipodystrophy is a problem in the way your body produces, uses, and stores fat (also called fat redistribution). These changes can include losing fat in the face and extremities and gaining fat in the abdomen and back of the neck
  4. Considerations for the Introduction of TLD in National Programs - August 2018 3 101 03 ACRONYMS 3TC Lamivudine ABC Abacavir ADR Adverse Drug Reaction AE Adverse Event APR Antiretroviral Pregnancy Register ART Antiretroviral Therapy ARV Antiretroviral Drug AZT Zidovudine bPI Boosted Protease Inhibitor DNA Deoxyribonucleic Acid DSDM Differentiated Service Delivery Mode
  5. Antiretroviral drugs can cause side effects that can be severe enough to make some people stop taking them. But if a person with HIV skips doses of these drugs, the virus can start copying itself.
  6. What Are The Severe Side Effects Of HIV Drugs? Human Immunodeficiency Virus (HIV) attacks the immune system and decreases its natural ability to fight against other diseases and infections. Women Fitness Magazine has been selected as one of the Top 10 Women's Fitness Magazine and Top 100 Women Blogs on the web

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New high-quality antiretroviral therapy to be launched in South Africa, Kenya and over 90 low- and middle-income countries at reduced price fewer side effects, and greater potency against drug resistance than current regimens used in LMICs. To build momentum for TLD and familiarize healthcare workers with the drug in resource-limited. TLD is now considered the preferred first-line ARV regimen for adults and adolescents. Generally, it replaces TLE as it has been shown to cause fewer side effects and can suppress HIV viral load within 15 days Zimbabwe To Shift To New ARV That Has Fewer Side Effects. Zimbabwe is ready to transition to Teno-Lamuvudine Dolutegrevir (TLD), an Anti-retro Viral (ARV) drug with less side effects, moving away from the Teno-Lamivudine-Efavirenz (TLE) a three in one drug that is taken once a day, a top health official has said Initially d4T may be well tolerated but in the long term 20% of patients will have side effects. These may include serious complications such as peripheral neuropathy, pancreatitis, hepatitis, lipodystrophy and lactic acidosis due to mitochondrial DNA depletion

Buchen Sie jetzt Ihren Pauschalurlaub in Side einfach und sicher bei FTI! Überzeugen Sie sich von unseren zahlreichen Urlaubsangeboten Adverse Effects of Antiretroviral Medications This is a PDF version of the following document: Module 3: Antiretroviral Therapy In the only phase 3 trial completed with fostemsavir, serious side side effects were rare; the most commonly observed mild-moderate side effects were observed nausea, and diarrhea.[7

Adverse Effects of Antiretroviral Agents NI

Rash. Nausea. Diarrhoea. Dizziness. Frequent effects (events expected in at least 10% of treated PLWH), in bold. Severe effects (events that can put a person's life at risk and represent a medical emergency), in red. Neither frequent nor severe effects, in black. Still available, but generally not recommended due to toxicity ARVs and Possible Side Effects If you are HIV-positive, going onto antiretroviral treatment and adhering (taking it every day as prescribed) is the best way for you to ensure you stay healthy. It's never a good idea to wait until you get sick before taking ARVs Health Minister Zweli Mkhize has launched a fixed dose combination anti-retroviral called TLD in uMthwalume in the Ugu District on the KwaZulu-Natal south coast. The new regimen is believed to have fewer side effects and offers less resistance. Ugu is one of three districts in the province that looks set to attain their UNAIDS 90-90-90 target by December 2019 Information about the short-term side effects of antiretroviral therapy (ART) is becoming more available. However, information on the long-term side effects of ART is limited. Since many HIV drugs are so new, there has not been enough time to see their long-term effects. As people are living longer with HIV and taking ART for longer periods of time, we are starting to learn more about their.

ZIMBABWE is ready to transition to Teno-Lamuvudine Dolutegrevir (TLD), an Anti-retro Viral (ARV) drug with less side effects, moving away from the Teno-Lamivudine-Efavirenz (TLE) a three in one drug that is taken once a day, a top health official has said. By Michael Gwarisa. The development comes barely a year after government through the Ministry of Health and Child Care (MoHCC) deferred. Some side effects are common with all ARVs—albeit to varying degrees—while others may be confined to certain classes of drugs or individual drug agents. Although newer ARVs have far fewer side effects compared to older generation ARVs, side effects can still occur In April 2010, d4T was replaced by a drug known as Tenofovir, which has none of these side effects. Myth 5: ARVs drive you mad An ARV known as Efavirenz often causes people to have bizarre dreams. swelling or puffiness of the face. swollen, painful, or tender lymph glands in the neck, armpit, or groin. tightness in the chest. tingling of the hands or feet. unusual weight gain or loss. wheezing. Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to. It is a new fixed-dose combination of ARV drugs - tenofovir disoproxil fumarate, lamivudine and dolutegravir. It belongs to so-called intergrase inhibitors; drugs that help patients not to develop resistance to medicine that has been seen in older treatments. Anthony Mutema, a Pharmacist calls TLD a game changer in HIV treatment in Uganda

side effects of antiretroviral drugs pdf, hiv medication side effects chart, hiv side effects on skin, new hiv drugs less side effects, hiv drugs side effects long term, acriptega side effects, tld drug side effects, long term effects of hiv, Share this: Click to share on Pinterest (Opens in new window Does antiretroviral treatment have side-effects? As with all medication, starting to take ARVs can cause some side-effects, particularly in the first few days of treatment. This is another topic you could discuss with your doctor, as it might also affect your choice of drugs Table 20. Common and/or Severe Adverse Effects Associated with Antiretroviral Therapy; Adverse Effect Drug Class; NRTIs NNRTIs PIs INSTIs EIs; Bone Density Effects: TDF: Associated with greater loss of BMD than other NRTIs, especially when given with a PK booster. Osteomalacia may be associated with renal tubulopathy and urine phosphate wasting nausea. pale or blue lips, fingernails, or skin. red skin lesions, often with a purple center. red, irritated eyes. unpleasant breath odor. vomiting of blood. yellow eyes or skin. Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine

The side effects of HIV treatment (ARVs)

Side effects of HIV/AIDS medication, whether short-term or long-term, if any, should be dealt with by the treating doctor. Each drug of each class of antiretroviral therapy has different side effects and rarely they can be serious Organization (WHO) Treat All recommendation grows, global ARV drug spending is expected to double to $3.8 billion by 2020. i. Even as ARV drug expenditures mount, donor funding for ART is leveling off, and growth in funding from most low- and middle-income country (LMIC) governments is insufficient to fill the gap Side effects include joint pain, redness and rash at the site of injection, stomach pain, swelling, and muscle pain. The drug may also cause increases in blood sugar. The drug may also cause. Modern antiretroviral medications are very well tolerated and only rarely cause serious side effects. While some people taking antiretroviral medications (ARVs) can have side effects. Some people (such as those with liver or kidney disease) may body processes drugs more slowly than normal, and could have higher drug levels in their systems and.

Antiretroviral HIV Drugs: Side Effects and Adherenc

Researchers say the Tenofovir antiretroviral drug or TLD has less side effects and resistance. However, it does carry some risks including possible birth defects. South Africa has the largest HIV treatment programme in the world and aims to have more than 6 million people on ARVs by December 2020 Uganda's ARV drug manufacturer- Cipla Quality Chemicals started manufacturing the drug last year. Uganda, like the other 91 countries in low income countries that are just embracing TLD have access to the cheaper generic version produced by India-based drug makers - Mylan Laboratories (MYL.O) and Aurobindo Pharma (ARBN.NS) New ARV called TLD. South Africa has recently introduced a new state-of-the art ARV, known as TLD, which stands for Tenofovir, Lamivudine and Dolutegravir - three known ARV drugs. TLD is really good news, because it is easy on the body and gives very few side effects, and it helps us reach viral suppression quickly Dolutegravir seems to be a next-to-impossible to break antiretroviral drug (we still are not seeing resistance in first-line patients, after four years of use, mostly in the northern hemisphere but increasingly in the rest of the world), safer in terms of the mental side effects, and does not seem to affect blood parameters as much also interact with certain foods or other drugs and can also have side effects. To the extent possible, nurses and other service providers should use the same principles and approaches as for ARV-food interactions to help PLHIV understand and manage interactions between traditional medications and food and avoid any known negativ

antiretroviral drug necessitating transition of eligible children to TLD. Objective: The objective of this study is to compare the HIV viral suppression rate at baseline and after 6 months of transition to TLD and to determine adverse drug reaction associated with the use of TLD if any • The one ARV pill works the same as taking three ARV pills • You take one ARV pill once a day • You will take the one ARV pill at the same time every day • If you forget to take your one ARV pill you must take it even if it is later in the day • Take your one ARV pill after food • Do not miss or stop taking your treatmen South Africa offers three drugs in a single pill and one of the drugs - Efavirenz - will be replaced with the new drug‚ Dolutegravir‚ which has far fewer side effects. SA drops price of ARVs. This includes fewer central nervous system side effects such as depression and anxiety. The improved tolerability of dolutegravirshould make it easier for people to adhere to treatment in the long term. While not totally free from side effects, it is a big step forward. It is easy to take: People only require a small dosage of dolutegravir. The.

In 2017, when the U.S. FDA approved the currently preferred first-line ARV, tenofovir disoproxil fumarate, lamivudine, and dolutegravir — or TLD, it was a critical milestone promising HIV. South Africa has begun rolling out a state-of-the-art antiretroviral drug in a game-changing bid to drastically reduce the number of people living with HIV. The distribution of the new three.

Antiretroviral (ARV) agents are a class of drugs used to help control human immunodeficiency virus infection.Although they do not cure HIV, they may decrease the chances of developing acquired immunodeficiency syndrome and HIV-related illnesses such as serious infections or cancer.They reduce the number of HIV particles in the body (lowering viral load), thus causing the immune system to work. These side effects usually go away after a brief adjustment period, which can last anywhere from a few days to a month. If you notice any unusual or severe reactions after starting or changing an ARV, report the side effects to your healthcare provider immediately. Dealing with side effects can be a barrier to starting and continuing HIV.

The medication-associated factors include side effects, pill burden, type of regimen, drug interactions, ease of storage, and food requirements . Tolerability is also an important factor affecting treatment adherence. The efficacy of ART has improved, and the adverse effects of antiretroviral drugs have been reduced In addition to acceptability, side effects of DTG based regimens were assessed through two questions in the patient interviews. All patients were asked if they had experienced any of the 19 pre-listed side effects, and if so, to rank the severity of the side effect on a 5-point Likert scale with 5 being the most severe Increase prioritization of at least 3 active drugs. Options for patients with poor adherence. Select the patient's CD4 cell count (if known). Select the patient's HLA-B5701 status (if known). Select the patient's HIV tropism (if known). Select the patient's comorbidities or side effects from current ARV medications, or if the patient is pregnant Follow up experiments led scientists to discover the clash between ARV-110 and rosuvastatin (ROS), seeing as ROS concentrations were elevated in both patients. Subsequent studies revealed that ARV-110 inhibits breast cancer resistant pump (BCRP) transporter, of which ROS is a substrate. Upon correction, no more side effects were experienced.

tld drug side effects - Women Fitness Magazin

01 About OPTIMIZE. Antiretroviral treatment (ART) optimization ensures that people living with HIV receive the best-available ART in the most efficient and cost- effective manner possible. Optimized antiretroviral (ARV) drugs and formulations are those that are: Effective, safe, tolerable, and easy to use These side effects may disappear in two to six weeks. The same can hold true for other, more specific symptoms. In general, as the body adjusts to a medication, many symptoms can diminish or become more manageable. Many people who start antiretroviral therapy find the side effects to be much more manageable than they expected Avonza Tablet is used in the treatment of HIV infection. View Avonza Tablet (bottle of 30 tablets) uses, composition, side-effects, price, substitutes, drug interactions, precautions, warnings, expert advice and buy online at best price on 1mg.co Those struggling with ARV adherence should be reabsorbed into multi-disciplinary teams to meet their medical, psychological, and social needs. Universal HIV testing should be implemented and TLD should be offered to all eligible PLHIV given its limited side effects and greater accessibility Researchers are learning more about HIV with each day. This has allowed for new treatment options to arise with antiretroviral medications.Fortunately, many of these newer drugs have fewer side effects than the older (or original) options. 1 Talk to your doctor about medication side effects

Mylan launches first fixed-dose combination TLD for People

CARIN E. REUST, MD, MSPH, University of Missouri School of Medicine, Columbia, Missouri. Am Fam Physician. 2011 Jun 15;83(12):1443-1451. Patient information: See related handout on side effects of. Patients taking antiretroviral therapy should be screened for cardiac risk factors (e.g., dyslipidemia, diabetes mellitus) annually or after a change in therapy, or more frequently if clinically.

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ARV side effects can be broadly classified into categories namely:8 1) Mitochondrial toxicity: Lactic acidosis, hepatotoxicity, pancreatitis, peripheral neuropathy. 2) Metabolic: Lipodystrophy, hyperglycaemia, body habitus changes, insulin resistance, osteoporosis. 3) Bone marrow suppression: Pancytopenia. 4) Hypersensitivity reactions: Skin rashe switching to TLD, with counselling on side effects. If WOCP, provided they do not desire to fall pregnant. On DTG-based ART acquiring TB TLD + DTG 50 mg DTG has a significant interaction with rifampicin. As such, DTG must be dosed 50 mg 12-hourly (instead of daily) in TB/HIV co-infected patients being treated with rifampicin This three-in-one pill has predictable side effects that are usually minor. Because people only have to take one instead of three pills, they are also more likely to adhere to the treatment. The ARVs contained in the three-in-one pill also have few side effects - this also helps people to adhere to their treatment. The new ARV 'kid' on. A better ARV drug with less side effects is needed to reduce drug resistance and to increase adherence. The goal here should be a better quality of life for patients. While the decision should. HIV medicine can cause side effects in some people. However, not everyone experiences side effects. The most common side effects are. Nausea and vomiting, Diarrhea, Difficulty sleeping, Dry mouth, Headache, Rash, Dizziness, Fatigue, and; Pain. Talk to your health care provider if your treatment makes you sick

Sex with HIV positive person on ARVs is safe. The early treatment of people with HIV massively reduces their infectiousness and gives the world our first real opportunity to halt the HIV epidemic. This follows results of a trial released in May which found that sex with an HIV positive person on ARV treatment with an undetectable viral load is. A full list of side effects, including less common side effects, can be found in the patient information leaflet that comes with Dovato. Side effects can be described as: Common - a side effect that occurs in at least one in a hundred people (more than 1%) who take this drug. Uncommon - a side effect that occurs in fewer than one in a. The long term side effects of ARVs. Taking ARVs over many years can have long term side effects. They differ from person to person and some people may not have side effects. If you have any long term side effects, it is best to talk to your healthcare worker about medication to manage them.. Zenzele is an ARV adherence program that promotes adherence to ARV treatment an This includes the first antiretroviral drug regimen, called Cabenuva, that requires a once-monthly injection rather than having to take an oral dose every day. Antiretroviral therapy is quickly changing, with newer drug agents offering fewer side effects, greater durability, and a decreased risk of drug resistance The 2016 guidelines for antiretroviral postexposure prophylaxis for nonoccupational exposure to HIV recommend either raltegravir (RAL) 400 mg twice daily or dolutegravir (DTG) 50 mg daily in.

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The neurotoxic side effects of antiretroviral (ARV) agents are among several contributing factors to this continued prevalence. Effective penetration of the CNS by ARV agents is paramount to. Annex 6 - Severity grading of ARV side effects in adults.. 179 Annex 7 - Severity grading of ARV side effects in children.. 184 REFERENCES.. 192. 6 ACRONYMS AND ABBREVIATIONS ABC Abacavir HIV Human immunodeficiency virus AFB Acid Fast Bacilli HPV Human papiloma virus AIDS Acquired immunodeficiency.

dolutegravir (TLD) fulfils these criteria. Antiretroviral (ARV) drug resistance necessitates a change in regimen and is a major obstacle to achieving this target. Resistance results not only in poor The gastro-intestinal side effects of the protease inhibitors (PIs) make adherence difficult Side effects due to anti-HIV drugs are not new. Since the late 1980s, the earliest drugs used to treat HIV infection -- AZT (Retrovir) and other nucleoside analogs, generally at higher doses than.

Tenofovir Side Effects: Common, Severe, Long Term - Drugs

ARVs, antiretroviral, drugs, side, effects, combination, therapy, triple, cocktail, HIV, positive, AIDS, disease, management, Danny West, prevention, education Danny West is a trainer, coach, and leadership consultant, has been living with HIV for the past 24 years, and remains healthy today, having been successfully treated with antiretroviral. Study of peripheral leukocytes, which are a side effect of antiretroviral drugs, suggested that an integrated treatment approach may be of benefit . The use of Chinese herbs is associated with non-serious adverse effects in our included trials. However, potential risk of interaction between herbs and antiretroviral drugs need more explorations

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Antiretroviral drugs' regimens are, in fact, associated with several metabolic side effects, such as dyslipidemia, impaired glucose metabolism and abnormal body fat distribution, that increase the cardiovascular risk of HIV subjects. In addition, HIV infection itself, the chronic inflammatory status and the relevant presence in this population. New ARV drug a game-changer for HIV patients. The much-anticipated antiretroviral (ARV) dolutegravir will be introduced as the first-line treatment for the HIV infected in South Africa as early as. ARVs may affect the heart. New research suggests that certain antiretroviral treatment (ART) may increase a person' s risk for heart disease, yet scientists believe that its benefits still far outweigh the harm caused by any of its side effects. If these results, obtained from early animal testing, are also found in later studies involving. Danny West is a trainer, coach, and leadership consultant, has been living with HIV for the past 24 years, and remains healthy today, having been successfull..

Weight gain on HIV treatment: more common with newer drugs

combination is called TLD. based on a drug called efavirenz. Dolutegravir has fewer side effects than efavirenz - so it is even easier for people to take and for treatment to be effective. to change to another ARV. Some people find it better to take dolutegravir in the morning than the evening Researchers may have found the key to these side-effects, 1 and evidence that the drug may contribute to the subtle deficits in brain function usually attributed to HIV. As Sustiva or Stocrin, or in the once-a-day pill Atripla, efavirenz is a staple part of many people's antiretroviral therapy (ART): in London last year, 53% of all people on.

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ARV-110 is a protein degrader that targets the Androgen Receptor or AR. Prostate cancer is the second most common cancer in American men, and their leading cause of death. AR plays a critical role. The Ministry of Health is investigating individuals at the Kenya Medical Supplies Agency (Kemsa) believed to have released toxic antiretroviral drugs to Kenyans. The drugs, Zidovudine/Lamivudine. View ARV Side Effects, Adverse Drug Reactions.ppt from NURSING SURGICAL N at Egerton University. ARV Side Effects, Adverse Drug Reactions (ADRs) and Management Unit Specific Objectives At the end o Side effects only rarely led to discontinuation of treatment (first-line-group: 2%, n = 2/104; switch-group: 1%, n = 3/219). In this real-world setting, INSTI-based ART-regimens were highly efficacious with no significant differences between any of the 3 INSTIs. Overall, side effects were only rarely observed and generally mild in all subgroups SA makes ARV price breakthrough. Tenofovir, Lamivudine and Dolutegravir (TLD), in April 2018. which is well tolerated by patients and has fewer side effects. Patients are therefore more.

TLD regimen - best solution for people living with HIV SANA

Theme 1: ART side effects. Many women stated that they stopped their medications due to ARV side effects. The commonly reported side effects included hallucinations, nausea, vomiting, dizziness, body weakness, insomnia and rashes. Vomiting was the most commonly reported ART side effect ARV Side Effects. During the first 1 month of ARV administration, it is important to evaluate to monitor the body's response to treatment, both physical and psychological effects. Effects that are often felt at the beginning of the use of ARVs in the form of nausea, urticaria, giddiness / loss of balance, weakness, dizziness, and sleep disorders Recreational use of HIV antiretroviral drug linked to its psychoactivity a standard dose of efavirenz is known to carry a risk of side effects that include adverse neuropsychiatric. An HIV regimen is a combination of HIV medicines used to treat HIV infection. HIV treatment (also called antiretroviral therapy or ART) begins with choosing an HIV regimen.People on ART take the HIV medicines in their HIV regimens every day. ART helps people with HIV live longer, healthier lives and reduces the risk of HIV transmission.. The U.S. Food and Drug Administration (FDA) has approved. A series of fact sheets for patients on major side effects, including hepatotoxicity, hyperglycemia, hyperlipidemia, lactic acidosis, and skin rash. U.S. Department of Health and Human Services (DHHS) project providing information on antiretroviral treatment and drugs that treat or prevent AIDS-related illness

WHO New high-quality antiretroviral therapy to be

The most common obse rved side-effects after initiating ART; anemia (ZDV based) and peripheral neuropathy (d4T based) requires regular monitoring for early diagnosis. ZDV still remains the ARV agent of choice in the treatment of HIV disease in the resource limited settings MARCH 2017. South Africa Needs Assessment for Optimized Antiretroviral Drugs and Regimens. The analysis and recommendations presented in this assessment are based on the best-available information as of March 2017 and may require adaptation to align with future developments Using this trigger-based approach, we were able to combine information across multiple domains in which ARV side effects could occur, such as poor growth, neurologic problems, neurodevelopmental problems, hearing or language problems, and metabolic toxicities Children living with HIV in six African countries will soon get access to the antiretroviral (ARV) drug, dolutegravir (DTG), which is more effective, easier to take and has fewer side effects than many other ARVs. DTG will soon be recommended for children in Uganda, Benin, Kenya, Malawi, Nigeria and Zimbabwe, Kenyan AIDS activist Jacque Wambui.

These side effects can begin as soon as just a few days after beginning the Atripla treatment regimen. However, some other concerns can be associated with long term side effects of Atripla. According to WebMD, some of the more severe side effects of the HIV drug can include sudden weight loss, joint pain, muscle aches, extreme tiredness, vision. • Resulting side effects and further miscommunications led to an overall distrust by patients and apprehension about new ARVs Previous Challenges Highlighted a Need For: TLD Country Response: Visibility into global supply dynamics Coordinate with global mechanisms and efforts working with manufacturer Anti-HIV drugs can sometimes cause longer-term side effects. For example, some cause increases to cholesterol and other blood fats, or disturbances in the functioning of the liver or kidneys. Lipodystrophy (body fat changes, such as losing some fat from the face, legs, arms or buttocks, or gaining fat elsewhere) is a side effect of some of the. 3) Safety and tolerability. a) Clinical grade 3 or 4 adverse events (AEs) as classified by the Division of AIDS Grading Table, laboratory grade 3 or 4 AEs, serious AEs, and AEs requiring discontinuation of any antiretroviral drug in the TLD second-line regimen. b) 12-month mortality (all-cause) Therefore, to the extent possible, other interventions with potential value in managing HIV disease, ARV side effects and other sequelae and symptoms must be investigated where there is a reasonable basis for doing so. The Foundation for Integrative AIDS Research (FIAR) addresses those needs The fixed-dose combination of tenofovir (TDF), lamivudine (3TC), and dolutegravir (TLD) is now preferred first-line antiretroviral therapy (ART) for most adults with HIV in Sub-Saharan Africa. Yet, concerns remain about durability of TLD with high circulating resistance to 3TC and TDF and metabolic abnormalities observed in clinical trials. Limited programmatic data are available to describ